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“The Dietary SuppIement Debate of 1993: An FDA Perspective”

presented by

MichaeI R. Taylor
Deputy Commissioner for PoIicy
U.S. Food arid Drug atid Administration

. .

at the

AnnuaI Meeting
Federation of American Sokieties for Ex-perimentaI Biology
New Orleans, buisiana
March 31,1993 ”
One of the longest running public policy debates in
Washington -- certainly'within the province of the Food and,,Drug
Administration -- is about to I.take.c~,~ter.,stage again, this time
in the halls of Congress as the result of,a vigorous grass roots
lobbying campaign. It is the debate about how dietary .
supplements sholld be m,ay~,e.~ed.,and,,,usedil in 1.the
"_A." 3'.
;_I_xbest _ I.interest of.‘
consumers. And it is ,about the,,,,ro.e government should play in
regulating dietary supplements. '

The terms of the debatehaveevolved“,,. _L1 $5 the _,,_, I,

early years, immediately following the 1938 passage of the
Federal Food, Drug, and Cosmetic Act, FDA's concern was to

identify appropriate daily intakes of vita,mins-and minerals to

being !
assure that minimum nutritional I_j _.needs
;;. ,.,_ 1: ' met.
were r.rv-

By the early 70's, FDA's interest -- and the public debate -

- had shifted to high potency vitamin supplements .and whether
their potencies 'should b,e limited
^,._ ..(. __ :i r:~i~b'>~‘d.‘rational"
to "nutritionally ~<l':,
levels if-they were to be marketed asp ll.foodsl' rather than
"drugs." Congress settled that $ebat.e.-in,I9~76 with the Proxmire
i 02', _,,,"*
Amendment, which permits FDA to limit potency only for safety

The current versio,n of .t,he dietary supplement debate is very

different from previous ones,. It's driven,by the emerging new
scientific understanding
.il ,"^ of the links between dietand health and~_
by the strong interest many Americans have,~in improving theia808
. :

health through diet. And, it is fueled byethe 1990 Nutrition

Labeling and Education Act (NLEA),
in which Congress for the,.
, ,
first tim e authorized FDA to allow'dise.ase-rela,tec! health claims
for nutrients on food and dietary supplem ent labels without going

through the drug approval process.

% At one level, the debate is about how FDA should implement

its new authority to review and approve health claims for
nutrients. But the debate has been m ade m uch broader by som e in
the dietary supplem ent industry who question the need for any FDA
role in the prem arket review of disease-related health claims,
including claims for a wide range of products beyond vitam ins and
m inerals -- such as amino acid and herbal products -- m any of
. have no recognized nutritional.role in the form in which
they are sold,. FDA's tools for assuring the safety of these
products are also under challenge.

My goal, today is to define the terms of the forthcom ing

legislative debate, from FDA's perspective. It is critical that
the values at stake in the debate be underktood by the scientific
com m unity, public health groups, consum ers, and the industries
FDA regulates, because Congress is going to be asked to alter --
in the m ost fundam ental way -- FDA's role in the regulation of
disease-related health claims.

2 I.809
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But the outcom e of this debate is important for reasons weI& ,

beyond the particulars of FDA's regulatory role. The emerging
knowledge about the potential role of diet, including specific
nutrients, in prom oting health and reducing the risk of certain
diseases has enorm ous implications for public health. .

There is m uch to be gained for the health of our citizens

ir if, as a society, we successfully develop and capitalize on this
f .
knowledge by m eans that are grounded in science and take account
of both the'benefits and potential risks of any significant
dietary intervention.

There is also m uch to be lost if we,drift from our

scientific m oorings and allow the m arketplace to be filled with
unsupported claims on products of unproven safety. The public's
health could be at risk, proven therapies and interventions m ay
be passed up, and scarce health-care dollars will be,wasted.

The critical first step in defining the terms of the dietary

supplem ent debate is to understand how broadly the term ndietary
Supplem ent1 is being used. The term is unfortunately being used
without discrim ination to refer to a very diverse spectrum of
* products that pose widely varying concerns and that m ay not all
be subject appropriately to the sam e regulatory approach.

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The term of course includes products 'consisting solely of
vitamins and e,ssential minerals, substances that have redognized
and well-understood roles in.nutrition. These products can
fairly be called nutritional supplements. In economic terms,
they account for the great majority, as muoh as,80% or more, of
the sales in the multi-billion dollajc dietary supplement market.
When sold without disease claims and-at reasonable potencies --
i as most of them are -- they are of no particular regulatory -
concern to FDA. And they are not what the forthcoming debate is

As used in NLEA and the dietary supplement debate, however,

the term "dietary supplement" is held to encompass not only
vitamins and minerals but also herbs, and and a host of other
products, such as,high potency amino acid supplements; This
broad use of.the term has confused the debate about supplement
regulation because it lumps together with vitamins and essential
minerals many products that have no recognized role in nutrition,
that frequently bear express or implied disease claims, and that
, '
have been marketed for specific therapeutic purposes. From a
scientific standpoint, the claimed benefits of many of these
products are better evaluated in pharmacological rather than
nutritional terms.

These products are also more likely to raise public health

concerns than vitamin and mineral supplements. There are, for

example, many unanswered questions about the safety of amino acid

supplements. FASEB reported last far& that~the-re
: is ,$nsu,fficient
scientific evidence to establish safe upper levels of intake for
any of the amino acid supplements on the market today, and it
recommended that such products be used by the young, the-elderly,
women of childbearing age, smokers, and other potentially
vulnerable subgroups only under responsible medical advic~e and
i .
* ,e.% supervision.

The need to address the safety of the amino acid products is

underscored by the fact that many of them are marketed to body
builders and other athJe,tes in )?ays that encourage high
consumption. From FDA's perspective, high potency amino _.acid
supplements are very different from the
typical multivitamin supplement.

So too are many of the herbal and other botanical (or plant-
derived) products that are being sold as "dietary supplements."
While some of these consist cf famiJ.i, herbs,
..^i,."‘.",-._<_ many ar6
made from piants that'have no traditional food . "aj
use. _,..? The
scientific literature doc~,me~nts th,e,~to~$~city of some .herbs,
especially those from pyrrolizidine alkaloid:containing plants.
Even such widely used herbs as germander, comfrey, and chaparral
have been linked with severe.liver toxicity,
I- I ,..‘ : despite the fact
that their tradition.aJ use"had not been
..,,.. . thought to raise safety
concerns. FDA recently requested that chaparral be removed from
the market following at least five reported cases Of acute toxic
hepatitis. The,se products illustrate that coming from a natural
source is no guarantee of safety.

Herbal products are also more likely than nutritional

products to be marketed or used for their perceived therapeutic
or disease prevention purposes. Make no mistake. Herbs and
5 other botanicals have made real contributions to our therapeutic
armamentarium. Digitalis (derived from foxglove) is an old
example. The recently approved cancer drug taxol is a new one.
But it is a misnomer to describe as dietary supplements herbal
products marketed under such names as "Immunotonic," "Immune
Plus," "Arth-X Bone, Joint and Ligament Nutritional Health
Formula," "Blockaid 200 Cholesterol Contro1,'f or "Acnetonic."

Finally, lumping vitamins and minerals together with amino

acids and herbals under the label "dietary supplementtf has
contributed to some rather egregious rhetorical confusion and
excess among the press and some critics of FDA's regulatory
policies. Some so-called."dietary supplement" products that have
no recognized nutritional role are sold for therapeutic uses. It
is a simple fact that these products are legally drugs and
properly regulated as such, but some have-used that fact as a
springboard for the charge that FDA plans to regulate ordinary
l *
vitamin and mineral supplements as drugs. Vitamin C by
prescription only! Or that FDA wants to take 'away' the consumer's

- --

freedom to chqose high potency vitamin and mineral supplements

because FDA does. not consider such products nutritionally
rational, even though such action is expressly prohibited by the
Proxmire Amendment. .,

These charges are nonsense, and they've been rebutted, but

they do raise the question of.what FDA's regulatory goals really
'-are. What are the legal responsibilities and public health -
values embedded in the current statutory framework and entrusted
to FDA to advance? And what questions must Congress ask in
considering whether to change the current framework? I will take
the balance of my time to address these points.

FDA's goals in regulating the entire spectrum of products

referred to as dietary'supplements are a~s'straightforward as they
are simple. They are to assure that the products are safe and
properly labeled and that any disease claims
are scientifically supported. Letme talk a little about what
these goals mean, how we pursue them, and the nature of the
debate we are about to have about them., 1

First, safety. No one questions the goal of safety. It is

FDA's top priority and the first thing consumers have a right to
expect in any FDA-regulated product promoted
. directly
/ , to

I consumers
and sold pver
commonly assume that
the counter.
In fact,
a health-related
we find that
product is

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readily available in the marketplace it must have been evaluated

and approved for safety by FDA.

The legal provisions governing safety are complicated, and

the details depend on whether the supplement ~slegally'a food or'
a drug, but they embody two basic principies. One is that the
manufacturer is legally obligated to produce a safe product. The
5 other is that a premarket safety review by FDA is either required
(as in the case of drugs), or, in the case of most true food
supplements, authorized when appropriate to answer safety

Although only a minority of currently mark'eted dietary

supplement products have undergone a formal FDA safety review,
the current .. statutory framework permits FDA to adless identified
safety problems swiftly by placing the burden an the manufacturer
to resolve the problem in order to continue or resume marketing.
FDA used this tool effectively to deal with the L-try@tophan case
a few years.ago.

In two recent cases, courts have ruled that this authority

is not available for single "nutrientl' supplement products. If
these decisions become the established law, FDA will have lost
one of its most effective tools for assuring the safety of this
category of products.

:, ”

- - .

Some believe Congress should take away FDA's authority to

conduct premarket safety reviews for
the e.ntire spectrum of
/ "
dietary supplement products, from vitamins and ninerals to
pharmacologically active amino acid and herbal products, and rely
instead on the manufacturer's own substantiationof safety, under
a less rigorous safety standard, and .with the burden on FDA to
prove that safety has & been Substantiated.

This would be a radical philosophical departure from the

current system. It would remove,FDA fromany role in premarket
safety review for this wide array of products, and give FDA the
burden of proof on safety when problems arise.

Congress will have to examine whether this approach would

provide the level assurance the public needs and
expects. Congress will also have to consider whether it'makes
sense to require a premarket safety review for plant-derived
drugs made by pharmaceutical companies but to abandon it for all
plant-derived products marketed as herbal supplements.

rJ FDA's second goal under current law is that dietary

supplements be properly labeled. This is the most

I straightforward
FDA, and I will
mention it briefly.
Congre-ss has assigned
Suffice it to say, the

II label
of a dietary
how much it
how it
what the
be used,

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. . I.

-.d - - -

.-and precautions necessary to assure safe use. All other
inform ation on the label should be truthful and not,m isleading.
There is com paratively little debate'about these basic

The big debate is over FDAt.s third regulatory goal, which is

to assure that disease-related health claims are scientifically
supported in accordance with applicable legal standards.
Congress has established a legal iram ework that contem plates as a
general rule FDA prem arket review and approval of a disease-
related health claims. If the substance involved qualifies as a
food (because it is used for its taste, arom a, or nutritional
value), this review is conducted under the"GLb health claim
provisions. If the product does‘not qualify as a food, the
review would be conducted under the drug approval provisions of .,.
the law.

While the legal standards for approval of disease-related

claims are different for; foods and drugs, -they 'both kmbody'the
core principles of
FDA prem arket review and ,, a requirem ent that
-- I z- ._ :" '"
the validity of the claim be established by high quality
scientific evidence.

Why did Congress adopt such-a-rigorous regulatory regim e for .'

health claims? *I think there are several good reasons. First, l +
Congress witnessed throughout the 1980's the proliferation of

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health-relqted clai,ms.on.foods, many of whioh se&d to ref,iect

more the latest dietary fad than sound science. In passing NLa,
Congress was saying that such claims have the potential to do
much good, but only if they are true; Because health claims are
such potent marketing tools, companies were under great pressure
to push up to, or beyond, the limits of science and truth.
Congress decided that FDA review would provide a necessary check
.on.the pressures of the marketplace'.

Premarket review under a rigorous scientific standard also

addresses important public health and safety concerns. A claim
linking a nutrient with a disease-related benefit is typically
intended to increase intake of that nutrient. It-can also induce
overconsumption of the nutrient, with the attendant risk of
adverse effects. FDA-review assures that the risks as well as
the benefits of the nutrient are addressed and that the approved
claim includes whatever cautions are needed to deter

FDA review also diminishes the possibility that people will

be induced by unsupported disease claims to forego effective
medical or dietary interventions. Passing up the proven for the
unproven could jeopardize health. And money spent in the pursuit
of health on products that don't work is money wasted.

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_ ._

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In the com ing legislative debate, Congress"wil1 be asked by

som e elem ents of the dietary supplem ent iridustry to abandon.the
principle of FDA review of health claims. The COqtentiOn will be
that the FDA standard‘for review i&too strict and that the
process unduly delays consum er a.ccess to inform ation about the
potential disease-related benefits of dietary supplem ents. It
will be argued that these products are generally safe and that
consum ers should be free to choose. them , without any FDA
intervention, based on claims the'm anufacturers believe fairly
depict the relationship between the supplem ent and a disease or
health-related condition, eve6 if there is not significant
agreem ent among scientists that, the linkhas bee-n established.
The burden would be on FDA to prove that the claim had not been

This proposition will force Congress to consider very

thoughtfully som e hard questions. If coupled'with a prop&& to
take FDA out of the business of prem arket safety review, the
necessary risk-benefit assessm ent for-.,. disease-related claims
would be left, in the first instance, entirely to'the
m anufacturer. In light of m arket pressures to m ake @aims, is
this adequate to protect public health? Azsumg,ng conventional
foods rem ain under the same standard and FDA review procedure for
health claims that Congress established for them in 1990, why
should dietary supplem ent health claims be subject to a lesser
standard with no FDA review? Is there a scientific or public

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.,,., . (,

,^ I

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health rationale for treating'the Vitamin C in a tablet _ I

differently from the'v itamin C in orange juice or broccoli? For
pharmacologically active amino acid a.nd herbal prbdudzs,'which in
many cases are func tionally indis tinguishable from
pharmaceuticals, is review of c la$qs by the manufacturer.
.sufficient to protect consumers from unsafe or ineffec tive

FDA welcomes the debate that these questions will generate

in the coming year. FDA believes that the current s tatutory
framework for disease-,rel,ated health c laims embodies ,~~rn~~
important public health princ iples that deserve and can withs tand
v igorous public debate -- princ iples such as grounding disease-
related c laims in a body of sound and widely accepted s c ientific '
evidence, subjec ting to the tes t of a third harty'-.
s c ientific review, and addressing both ris k s and benefits before
making any such c laim.

Public debate of these princ iples will help policymakers and

consumers understand them and help assure that Congress
approaches its legis lative tas k with a full appreciation of the
public health values at s take. W e also hope thdt, in the course
of the coming debate, several basic tenets of FDA's think
. ing will
become better understood.

I ..,


F D A u n d e r s ta n d s a n d respects th e viey o f m a n y .A m e r i c a n s th a t 39

th e y should b e free to
c h o o s e n u tritional'supplem e n ts e y see
* : ‘i -,^ .
fit to m e e t their individual n e e d s without g o v e r n m e n t i m p e d i m e n t.
A n d F D A a g r e e s with this view, provided th e p r o d u c ts a r e safe and
a n y claim s o f n u tritional b e n e fit a r e true. M o s t vitam in and
m ineral s u p p l e m e n ts a r e safe , a n d F D A w a n ts to work with th e
n u tritional supplement industry to d o c u m e n t scientifically th e
safe u p p e r lim its o n daily intake.of vitam ins a n d e s s e n tial
m inerals.

The "freedom o f choice" a r g u m e n t is m o r e difficult when

p r o d u c ts a r e m a r k e te d for serious th e r a p e u tic or disease-related
purposes. Just h o w real -- h o w free -- is th e choice if th e
claim is n o t scientifically valid or if th e risks of
o v e r c o n s u m p tio n a r e n o t also disclosed? W e think all c o n s u m e r s
-. .
e x p e c t a n d deserve th a t lllecognized standards for scientific
support a n d full disclosure h a v e b e e n m e t so th a t their exercise
o f choice c a n b e well inform e d a n d th u s truly free.

A n d let m ,e stress again a point I m a d e a t th e o u tset. FDA .

sees in th e e m e r g i n g science o n diet a n d h e a l th enormous
p o te n tial to improve th e h e a l th of Americans. F D A is e n g a g e d in
a c o m m o n c a u s e with th o s e w h o seek tq 'dever‘b p '& & .e ~ ioit'fhis
science for th e public good. A n d .this‘include$ approving
scientifically s o u n d disease-related h e a l th claim s o n labels of
l *

fo o d s a n d n u tritional s u p p l e m e n ts.

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Let's not forget that we are just at the beginning of this a*

'__ new era of diet and health. We'ye'all got a lot to learn, but we
know this m uch: the ultim ate prom ise" and payoff of this 'new'&ra
will be only as good as the science that under"l$_es it and the
quality and thoughtfulness of ours efforts to exploit that

We hope that you in the scientgfic com m unity will join i'n
the forthcom ing public debate and dollaborate with those of us in
governm ent and industry who are working to solidify and build
upon the link between diet and health.

* * * *

A closer look at the legal indirectly, in its hrcoming a tom-
pond or othenoise agecting the
fast proved in court that the additive was i@?
in iact poisonous and/or deIeteIious.’In
principles used to deter- characteristics of any food (ii- spite df the fact that such cases u.:re
mine tix adverseaffects cludi.?g any .rubstance intqzdq.?
fbr use inproduc@g, ma?tu/actur-
brought in federal courtz where civil
mattersgenera.& have moved along more
crf”foodadditiveson the ing, packing, processing, preitii- quickly &an i.n state co@, it u’a not
---, treatin$ packaging,~‘rrati- unusual for such caSesto drag on for two
Jtor;ing or holding food; and in- years or longer while the public remained
By Jay !-I. Geller
;luding any source of radiation unprotectedfrom the use of ‘he substance
intecdedfor any such use), [fsrch In other fo&s against which FD.4’s
4 Of late, hardly a day goes by when .wbstance is not gerlera& recog- limited resources would not permit regu-
wme aspect of the debateover the safety Kited among qoerfs r;ualr$L*dby latory a&on. The ideai situation en+-
sf food additives such as saccharin, scie/:@ic training nnd experience sioned by Congress was that Gth t E
sodium nitmte and nitrite, FCBs, PBBs, to evaluate its safety, as having newly required preclearance procedure,
MA, acrylonitrile and amygdalin d= beer: dequately shown through the prcbkm of testing food additive issues
not appez in either tie printed or e&c- xient$c prose&uWs (or in the ia court would disappear. ‘Unfoanately,
rronic media Some of these substances case of a substance used i? food this has simply not happened.While it is
>xepraised and vitally necessq, others pn’or !o Januqy 1,1.958, thigh true that the law deemswtain substances
are condemnat and consideredcouplete- zither sci&icprocedures or ex- b be food additives, it is often necessary
!y unnecessary. Fo: the most part, haw- 2erience bated oz common vs$ in that FDA institute. an enforcement pro-
wef, the i5gd cocceptsoffoodadditives ,Godj to be sa,f>u.qder the co&i- ceeding a-gainst such a subskzce a7d
;md f& additive safety are misunder- rior-s of its intended use prove that it comes within the statutcr):
s&d by the public. This is a len,&y definition, complicated, defnition.” Thus, regardless of whetl. :r
Most recently, the greatestfocus has and dif5sult for most judges, jtie.; and one approaches the food additive issue
been on sacchark. Saccharin has di- other laymen to understand.Zn_+&e short- from the poisonous and deleteriqllssand-
rected a new kind of public attention on hand vernacular of there who deaJ,.viith poinf or the safety preclearance stand-
hd additives. We now seehundreds of the fc& additive on a regular basis, a point, FDA often ends up in COLXhaving
newly created experts ou such issues as food additive is a substance add,@Jo !o prove its case. Nevertheless, most
the safety of f&d additives,the meaning footi that is not gcnera!ly recognized by sponsorsand promoters of food aM.iti~es
of data derived from toxicologicaI k-sting expert5 a5 safe. foliow the procedures that are o~~j.inecfin
with food additives,the Delaney Clause’, the statute for obtaining’approva! for use
rind artificial sweethers.The purpose of J-egislation of their food additives.
this article is to discussthe legal aspects The food additive formally came into
of food additives and what the Delaney xisteace in 195K2 In .thg year, in Types of Food Additives
Clause is, as well as to illustrate how zspoase to the urging of many industry Food additives fall into fo++r.bzsiz
these principles operate,using saccharin rssCrti9as a&the DepartmentofHeal& categories.First, there are the intention-
as a relevant exampIe. Education and Welfqe, Congress adOp al additives,5 those that are added inten-
.edthe Focd Additive.&neadme.nts, the tionally to food for a specific reason,
,a.sic feature of which was the require- preve,ntingcaking and lumping
nent of safety preclearance for all Sub- preserving by preventing growth of mi-
any people speaka good deal abut mces added to fc+ The,Jegislative croorganisrrq retarding deterioration.
additives such as saccharin but dory of the Food Additive Amend- imparting coIor, increasing shelf’life.
do not know what a food,additive nents reveals that Congress was con- establishing uniform dispersion or emul-
actually is. Defined at Section 321(s) of xrned with the rapid technological ad- sicn, ftig the product, producing L
Title 21 of the United States Code, a :ances that were being made k the desired tzxture, controhing insects, pre-
food additive is )rocessedfood industry and that.under venting sticking to focd contact surfaces,,
a any substance the intended use of he law then in ei’?ect,FDA was unableto sweetening,supplementing nuuienis, ir
which results or may rea-onably :reveat the use of poisonous and delete parting body, increasing palatibiliv, a~
be erDected to result directly or ious submnces in food until the agency affdng the appearance of the focd.’
,&-@y.-ft bJ-4&g w;i’&“>&&~ed-&
Second, there are the i&dental .,-.11144” addi-
,. _, _ i i_ _) -; i

rives, those that may reasonably be ex- statute se.8 up a scheme whereby any in food First, one can look at 21 CFR
pected to become a component of any interested person may submit a food, 172-l 8 J which lists allLfood : additives
I^._“‘*;-*,, .,ifor.,
focdor to a@$ the^ characteristics
I>,_ s*-s.w a,./ additive vet$ion to the FDA .see*k$g
ofany which approved food add$ve pehnons
fcx:d, but arehot added to fc&&~$i~$-~: promulgation of a reylllation alIo~,gthe exist. Secoud, one can look at the 21
el!y for the gurpose of affecting the use of the substan:e in food in accord- CFR 184186 listing
v., ._. 1b-8 of all substances
characteri&. of the food’ These apdi- axe with safety and firnotionalrty data which may be added to foods without:an I
tives are p&&f&&z sa h pack- contained ic the petition.‘? Ifthe FDA is approvedfood additive petition because
aging materials for fc0d products and satisfied that the additive can.“b,ez$ely they do not meet the statutory definition
thoseused on and_around _, __(. .,/_manufachuing used for its intended purpose, i! will
a,.>.^. , j, ,+a‘“S”?“<
of food additive. Third., one c&r Iook at I
equipment f&contact surfaces, such promulgate m 1 “‘on permitting the’ 21 CFR. 189
prohibitzd fromwfiich lists eubs+es
u-k ‘i.$wg&“G-.g&, ,
ss pl%ics, resins, adhesives and iudus- additive to be u~ed.~~Almost without ”‘- ‘“:‘s,
trial chemic&.8 Gese substances be- esctptioa the rezu!a~onprc~uisafe~~~ Fourth, pcrsuazt to the provisrons of 21
cOmeincidental additives ~.~ed(‘~~~~~~ the FDA &I, $ace a tolerance on the. CFR 17,@3,8,one can request a fonnaI
-;___*. ,.~__ :; :.
t$: capab-‘sty of migra~ng from the amountofthead~ti-vetSatm~y~addesd advisory opinion from the FDA pu=
paskaging or food contact surface into to a f-i prod3~;~~ ~&forrt&on,~~~~ sum:to21 CFR lQ,85 as+awhetheror I
t&efood product. For example, FDA has comes available after approval af tne DOEthe substance is ,.a “.“, f4 j,w,__“,
determined that,the (,,_,*;‘ chernic.4 food adchtive petition and promuIgat!ou
“.*.*, acryIoni-
m Fin&y, a person can incorporate the
bile may not be used i.r~plast~ beverage of a foo.3 additive regulation that. que-s- substanceinto a f& market the produCr,
containers because it migrates into the
I. .II(. ,, j #““l.... tioq the continued safe use ofa1=the ,)fciorf
,,xx ,%‘
=“, It: us.c* $3$?&~~.~&&&&~
beverage, and it has -not &en. shopip additive, the FDA m2y move to have the be& are to 21 i&s OLhCiuise Gt+
through adequate scientific procedures regulation rapealeJ.16 .2.L 85-929.72 StaL 17L(s-~.rM).
to be safe for its intended use.g Repealing a food additive regulation 1558 U.S. code, tong & Adm. New, pp.
*ere are,..-s
x6 Lhe’~;c;ri.g&-@: &j&.
may involve a lengthy administrative 5300 et se-q; see also J 342(aXI).
aSae $ 342(axZXC) ad 5 334;serokoUnitei
ti.:es, those which are not fc@ additives _ ,,.,~ prxeedingl’ If an objection is raised,Fp_ Stars Y. xrticlq qfFc&~@ @ug . .‘. CeLkrol80
k the sratitorysense becauseConFess the proposed repeal of acl$ive hkIicst.d, 372 F. S~pp. 915 (ND. Ga, 1974)
has determined thai,thhy should not fall re,gdatiou, a public adminiskatiye hear: aFd 5 18 F2d 743 (5th Cir, 1975);‘%rih Paper-
within +hestatutory deftition. Acciden ing is requiredI resulting k ZE order baardZorp. v.‘FC’einteger,498 F.2d lX(lstCir.,
td additives are substances which mav issued by the FDA Commissioner.. either 1974); Bdl v. Gzddad, Mb F.2d 177 (6th Cir,,
” ‘-..I... * ..*_.,,
_- ,. %., 9 1966):Uit~Statrv.~clesofF~Coasistin~
accidentally get into a food - for exam; repealing, retainins or smending the food of Pocrcry Lab&d Cathy Xcsc,‘3idi’.‘Eu~~~71
ple, paints or cieaning s01uti0n~ used in additive regulationl?fhe order --- must.”be2._ (E.D. hi&, 1974); Ucited Stars ,v. Artjcle of
food Becausethese supported by detied finds .&conc!u- FoodCocjistingofDNms,hioreorLeyofOrotic
substances if properly used would not sions.20 Where the dk.l.ity of such an Acid 414 F. Sqp. 793 (ED. MO., 1976). .
5 19SB U.S. Ccdc Coag &A&n News, p. 5303.
reasonably be expected to become,corn-. order is di&rt&judici~*revieti is r~vail- kste 21 CFX 170.3(d).
;.r.;ktsof the f@ they are not food able-mthe @ited Stam CoyrtcfAppeds ‘1958U.S.Code,Cc~g&AdwNews,p.5304.
*. for the Cistrict of ‘CohtmJbf~~ or ,m the Kk 21 CFX 374-378.
Finally, there are the food a&iitives United States Court of Appeals for the gszr 41 F.R 48523 (Scpt u, 1977).
10195X U.S. Code, Caag & Ad& NW, p.
that do not come, within the, etatutory circuit in Which .thC ‘CompIairlingpar 5304.
deFtitioa because t&y are generally resides.2t If the FDA Commissioner *[Sze21 CFX 182, 184,186.
recognized by experts as safe.” T&e determines $&continued useof& f&d .
additive presents &-~;<<ga-g-. ‘24 345.
substancesinclude most condiments,vi- ,”w*,x.-, li *_/o. 135 348(b).
.. .
tanins and.&era+, essential~oils;and the public health he may order use ofje “5 333(c), (4. (d.
lJ $ 343(cX4).
natural flavor extracts. . food additiveto cease immediately
.s. . iend-
b.“*--ai^.“*ie.*: _* __.~I 165 343(h); 21 CF-X 170.3, 170.20, 170.22,
ing the outcome of f2formal $rnmMra- 171.1.
?%e Fooh Additiye Approval Process bve prwee&g and my subseq~&$&~ I’Src 21 CFX 17I.“Ijo.
Lf a substance does fall within the &,I review,*2 . . we2 fi 349ml).
19s~~ j 349(ljizj. -_- .
s*atutory defLnition of q.fc& additive_ Ij i,..j! ‘it c *There _^
seve:d methods of deter- 2OIC
. .

I . whether
m.tagg a d&n substance
rnut be preckared by the United States 21&e 3 349 (8x1)-
Fc4 and Drug Administration (FDA) requires an approved-.f%d*&lditive peti- z:sec 2 I CT-X 25. - _ -.
- i * I. .. .-
-- -.

znd wait to see if FDA institutes regula- r”ives,IO indr;ce cancer in man or (3) Test .doses must be close to the
tory action against the food pursuant ti animals.24 pharmaceuticaIly active range, but sev-
21 U.S.C. 342(a)(2)(C) od the groli nd Similar “Delaney Clauses” exist uit: eral magnitudes above the actual use
that it contains an unsafe focd addi& Je. respect to color additives2s and anima level;
drugs that are used in food-producln, (4) The greatest feasibIe number of
THE DELANEY CLAUSE animals.26The Delaney Clause is short animals must be in the test Population;
There are many potentid ioliicOI0;pi- simpIe and straightfonvard. The tintio (5) The route of administration of the
cal safety problems with food additive3, versy over the provision comes not whel1 substance in the test animal must be
including chemical poisoning, aIl‘k;E$‘C one is dealing with a substance that analogous to that by which humans will
reactions and f&lure to control the grouth causescancer at expectedlevels df con be exposed to the substance;
of harmful bacteria and other lllicr ‘o- sumption,but, rather,when t.hzsubstance : (6) Whenever possible, the test shou&
organisms. However, no safety con& inducescancer at levels far in excesso f commence during pregnancy and cpn-
evokes the specter of danger in the pu;: ’what would rezonably be expectedto bi tinue throughout the life of the animal,
SC’Sm ind more than that of cancer. A nd (consumedon a daily, weekly, or even CI1 often into the secondand third generations.
so it is with focd additives that Congress ;a Wetimebasis. T%efiGt ofthe &or& However, even with theseguidelines,it is
enacted the Delmey Clause.23This pr‘o- ’versy in this area is how to interpret tic accepted in the scientific community that
vision has attair,ed wide recog&i! 3n Idata that yie!ds results that do not easily: absolute evidence of noncarcinogenidity
am?_ngthe consuming public because it 1ranslate into an imznediatethreat to the is impossible and that nbn+rcinogenicity
appears routitly in neivspa2er-sand is (consumingpublic’s hea.ith.Tnis contra in animals is not a guaranteeof noncar-
.videly discussedon radiiidandielevisio n. 7;rersial aspect of the Ddaney Clause cinogenicity in hum&.
However, vet-y few people reaIJy knc)W (convenientlyleads to an analysis of the It is not surprising that many con-
axactly what the Delaney Clause is. !saccharinproblem. sumers question the .use of extremely
At the time that the F& Add,itiyve Iarge doses of a substancein a test anima1
4 :\#nendmen!s were enacted, Congres CRITERIA FOR EVA’LWATING and the application offindings from such
man JamesDe!ari&y ofNew Yoik SOUR ;rr TCIE SAFETY OF a test to human toxicity potential. lhe
co assurethat substancescausing carrcer FOOD ADDITIVES*’ rationale for higher dosesin test animals
.orthat had the potential to <r, Most Americancons~ers know We, Ithan what would normally be consumed
wculd not be aIlowed as focd additiv: f anythir,g,a’bcuthow f& additives are /by humans include the followings
*fius, since 1958, the Federal Fe> i’ :zvaluated fiJr safety in hi~n-.ans.It is; I[I) The lim its on the sheer number of
Drug and Cosmetic Act has provide:d iaccepted in tcxicoiogicd research, ianimals that one can test (one simply
that the FD.4 may not promulgate a thr@U&OUt the world that animal $E,Etiilg t:annot test enough animals to approxi-
rsgul ation i s a valid method for predicting short mate the likely number of human usersj;
So wing :he use’of any substance t erm acute and lcng term ckflonic effects 112) The need for meaningful resuits hl a
ln &od i.r it is found to ‘indtice C)f ir.gesdon of chemical substances. :eladvrly short period of time; and
cancer w.hen ingested by man or i rherefore, the primary tests done to1 ;13) The ability to extrapolate from the
animul, or ifit irfound. ‘afertests Cleterm inethe safetyoffood additives are 1Lest figures what the risk at a lower
which areappropn’atefortheeva~- CjU laboratory animals.The fmt testing is ( josage is.
uation of the safety offood addi- onducti to determ ini‘acutetoxic effazts. The relevance to humans of data de-
; n theseshort term ttsts, varying amounts Iived from animal tests, such as those
1 : If a subs!anceare fed to test timdls to &cussed above, has been stated by the
letem tine what size dose, if any, will ;‘DA in terms ofthe following principles:
F jrcduce an immediatetoxicological re- (:1) Certain substances can be shown in
ponse. The secondtesting that is con- 7&idly controlled experiments to cause
: lucted is the chronic long term feeding :ancer in animals;
tudy c.arriedout with varying levels of ; 2) Those substances causing cancer in
:: he substancefed to a fixed (3ne species often will cause cancer in
Plercentage of their total diet over a (Ithers, thereby making any substance
li:fetime, often extendinginto the second that causescvlcer in an animal species a
and third generations.These tests riie suspectcarcinogen for humans;
ntendedto demonstrateif there are any f 3) Chemical carcinogens generally
;:>ng term toxicity problems with the Clemonstrate a dose-responserelation-
S ’ubstance,includingwhether or not it is a zhip - that is, the greater the dose, the
C arcinogenor causesgenetic mut.atic?ns. geater the tendency to produce tumors
Scientists have devised six m inim u m i and many scientists believe that once a
- tt :sting requirements for dete&ing ssubstancehas been shownto causecancfr
Jay H. Geller is a partner in the Lo 1s Hrhether a substanceis a carcinogen: a11any level it is unsafe becausethere 1s
Atzgeles la wjiti of Gel& & Boiemar r; (:I) More than one species should be IIO threshold levei below which the sub
He is a former associate chief counst u sed to demonstratethat a substance is S;t;ui%ezt.n be considered safe for con-
$0~ erlforcement for the U.S. Food an h n ot a carcinogen; ;u@ption);
Drug Administration. HiFpiaciice’em !- Cj2) The feeding must be over the prac- 4) The tests are conducted at dose
phastes the regal cqoeck o/foods, drug! r, h’cat lifetimeof the testanimal tq establish Eevels that wiI1 produce an effect so that
cosmetics and medical &vices. a negative fmdi.nK t he scientist can calculate the risk at a
aer dose;
) A conservative method of.extrapo-
ting is used, resuIting in enbrs‘of over-
:ope. Its use resulted in no apparent ill
effects in consumers, but no in-depth
:pidemioIo&%stidies were Conducted.
of i&ho fired
sting rather than understating, the risk;
Some animal studies
with sacch& but ‘ho’were conducted
~~‘gf.c~ the fi.rst
weieobserved.’ .. _,.. “-.i- 1,
j) The results of animal tests and tpeir
rtrapolation to lower doses provides a
~*_Ic.,A* ,b_
je(d estimate of the ,risk of cancer in
Current Use30
Today, the use of saccharin in the claims shot,_,.-,A>
,, ,_
With this somewhat cqnceptually dif- United States is widespread. In 1976,
;cult legal and scientificXframework $I estimates,of ‘s&h& con$rnption by
$nd, let us examine saccharin as %c& Americans range4 f&m aioqof 6 million
,tudy in f& additive sa.f&$‘” I**’’ 1- ~ :o a high of 7.6 million pounds. Of $s
staggeringamount,70 percent was used
SACCHP$JN in foods and beverdges:74 percent of this
The FDA h& dete&$d that saccha- amount in low calorie soft drinks; I2
,-$ tposesa s&r&ant risk pfjc‘&&r for perceu: as a table sweetener for coffee,
~,ui-iw~s.~* This is the conclusion reached tea and breakfast cereals; arrd’the ie-
by FDA Co&m.lssionerDon~d I%i&dy miniag in such foods &p&&red driqk
in his July 1977 proposal to remove andjuice dyes, salad dressings, sauces,
saccharinfrom the list of approved food canned fruits, cookies, gum, can& and
additives.and~prohibit its use in drugs, ice cream. Saccharin also has a tide-
cosmeticsand a$rnal -feeds. Before ex- spread use in pharmaceuticals to’mask
a& the evidence ‘&merly%ig’~the the often unp!easanttaste ofpharrnaceu-
comm.issioneIs .‘j_.i“.dpropbssl, a look tically active ch?
i-recent . 7 -a;,>* Sacchqrin
L,.<.&‘.‘- ... is
at the history of saccharin is in order. especially used in periratnc mecbcatrons.
The substance is also usedin lipsticks,
Early Historyzg denture cleaners, *‘I “S(I’, ., toothpastes,
,” )‘%.,_, rnC&-
Sacch* is a1,,- nonnutritive artificial
.>,;,.;:..,~.f‘“yy:‘.,. i, ( washes, aftershave louons, skinmoistur-
sweetener izers, hair tonics,rrtd animal feeds. THUS,
sug~-z-. or thatitsis discOv~~~~-~
356 tumessweeter than
’i-~~~~‘ its ye- .d “r.~,“~w,:.“-l’. “,; -L ,”
the problems assocratedulth the current
early useswere asan-a$septic,preserv. effort
ket to :emove
extend’ saccti%?in
~~,~j;ijfi‘ Ei~~~~t from the mrir-
&iters ruAd
athe and as an artificial s%ef?nei for
diabetics, Since i~‘d.%ove?y~ there has diabetics will do to find alternate normu-
ken c0ace.mover the safety of sadqin tritive sweeteners;-removing saccharin
Some early ‘tk”iG.’wit)i’ tie substance from the market has broad’,implications.
showed no harm ., when consumed by for the pharmaceutical )‘,*and
..I”*i.icosmetic in-
diakti- at a level of five grams per day dustries as well,as.,he, food and bevera$
,.I ^“i:i.n,_c ,- i “,~i
for five mon~;‘w~Iebther.early tests industries.
showed that many of those taking the V!hether you’re representing the
substance compiained of stomach ,cl$- Early Safety Evaluatlops p!aintiff or the defendant, WHl’s
turbances.Tests conducted with sacch,$ of Saccharin3’ claims analysis/preparation se&c+
rin to demonstrate its effectiveness‘m a In 1955,’the National Academy of
“tiev if pi”;:;;.& ‘&;-aers epi&ed Sciences (NAS), a prestigious group of could be the winning edge.
Successful settlemenJso?vz2 ~!!C~+~.
unsucces@l.‘-.~As j as’l~07:‘~cSaniH scientists -representingsome of the best
I _..,.;__ worth of construction rn 44 stat&&
of food in the United States desiredto use scientific min& in the United States, Send for yoir ” copy of ‘our’
saccharin in fk bzcaus~~~ids~~~~e~~ after a review &%ii CvaiiZ&scientific
-;yd&, -& ,1g 12, literature, co~clud;d~ih~~‘~,~~~~~~~ complete services brochure Today!
inp properties. .A
PresidentThe&ore Rooseveit convened day of saccharinconsumejby the average ----T------l----.
Amegc& iduit ~;j~f;iS~~(+b~hazardous wagner.hohns;~~Xis.ine
.I." -6,._
a board of scien&c a&so& lo ‘ad&e
the Department of&&&&e (&ich’i! to health. However, due to ihe d&tic
that time had jurisdiction over foods an? (Conrinu>d”b~ $ge 38)
chugs)to evaluate the sa& of sa&arin .I ,. e.,,~.’ ‘ .I ‘”‘:. I
sumed board
in anconcluded that saccharincon-
--~t”c~~~ywGw~&>~~ii 23 !j 348(c)(3)(A).
143 Id.

or less was safe but that consumption 01 25 5 376(bXSXB).

263 36iSB (d)(l)(H).
more than one gram pei’day’could ca~$ m-his SeCtiOn is adspccdfrom w FDA ?f;,CC.OII
digestive disturbances in, many i.n&vrd- sacchuin.~See 42 F.R 19996 (April 15, 1977)
UdS. conecud $2 FX~3!!9 jhiaj
/) 1977).
,_ 17. I ,_
During the period from !920 to 1950 =Ia! Addteu
saccharin was used in the UniGd St&: JoId. City state - ZiOG
but was much mo;e widely us& & “I% 3’Idl-
-4 _-

. Food Additives When cyclamate, then the mos;popular. charin and other chemicals. Because of
(Continued from page 37) artificial sweetener was removed.,from increasing concern over the safe use of
,, -.;. the market in 1969 due to suspicion that saccharinin unhrnited amounts,the FDA
increase in the use of artificial sweeten- it caused cancer in man and animals, in 1972 removed saccharin from the list
ers during the 1960‘s,the FD’A asked the FDA anticipated a widespread i,ncrease of substances generally recognized as
NAS to evaluate all artificial sweeteners in the use of saccharin an?l calred upon safe and provided for interim marketing
for safety. In 1968, the NAS reported the NAS to undertake a new review of of the substance provided that labels on
that an intake by an adult of one gram or the safety of saccharin. products containing saccharin bore a
!ess per day of saccharinwas acceptabIe In 1970, the NAS reached the same statement to the effect that their use
+om a safety standpoint, but’ recom- conclusion that it had reached: eartier, should be lim ited to persons who must
mended that a carcinogenesis (tumor but recommendedthat chronic toxicity restrict their intake of sugar.3z FDA
producing) study be u.ndcrt&&i”with tests be conductedwith saccharin. It-also concluded at that time that saccharin
saccharin to determ ineifsaccharin could recommendedthe conducting ofepidem- posed no significant risk to the public
cause cancer‘since no such study had iological studiesamong populations with health
theretofore been conducted.It was at this steady saccharin usage; comparative
time that concern with industrial carcin- metabolism studies of saccharin in ,man Carcinogenicity Testing
ogens was becoming prevalent among and animals;and studies to determ ine the With Saccharin33
m&y leading environmental scientists. toxicological interactions between sac- Two studies conducted-m 1970, cne
,“, .. “,_I ..wl..

a.,, , .I ., ., ..I’
e.,* ., , :7,y 1”” .,; ,, / ^A..” .ll \ _ ..T7‘
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by the FDA and the o~thee~by the Wis- that cancerof,mistype would most likely The moratorium expire in the spring
consinAlumni Research,Foundation in not manifest i,ge,jf,mg!yery late in Iife, il
I.%_,,,,_.,, of 1979, but current expectations are
>fdison, Wisconsin, demons”trate”d that at all,. “and thereby justify shortening that the moratorium will be extended
Saccharinproduced tumors $!a@~a$y one’s life in later years while having until de~.~~tive,tqxicq!pgyhas beencom-
aimals when the &rnaJs, pe_refed_re- saccharin available ,^ ,,in younger years tc pleted.
jpeCtiYely 7.5 percent &dj:ij percent-of prevent obesity which, in and of itself, is The congressionalmoratorium can be
&cir total diet. However, scientists eval- asignificant healthproblem inthe United traced in part to the tremendousoutcry
u&ngthksk: iesis %ie$nab!e tq,ece,,$e” States? These jssues-a’ are
?a.e.i di.fficuIt
.“ss+ a..“~; issues
“; from the American I citizenry j .1\_“,e,“. that has
increase in tumors to saccharm ,or a and bring into play complex rssues of arisen over the FDA’s proposedban on
substanceknown*- -.a**
as OTS ,_which
/*,.-_ >. + _, personal freedom versus tl~~*+y of the
..,,li,\’ sacche+in. Congress was also subjected
found with’ saccharm,..~n,,!.97~?, FDA government to provide for the co,b%on to intense pressure from trade associa-
receivedthe resultsiof a Cana&,anstudy wetfare and protect the pubIic her&h. tions representingmanufactureniof prod-
v;hich showe.d that?sacs&@ fed at a However, thesephilosophical considera- ucts contair&g saccharin, from the sac-
level of 5 percent of the total diet to”‘&% tions notwithstanding, _,_#u FDA, in the face
1.l.Ix-.“,_ll charin manufacturers themselves
‘c ,”,L,and
^ ~.,,-..“~u..:,,,--~~,
causedan increase ~,~n$l&%tb”~dder of the data curre,n{y available to it, feels from physicians who behevet&t S&al,
tumorsin first and second ., generationtest that it hasheen left with no choice under
i-w*** r-inoffers the promise for a more,no@
annirnals.Xt was determined that OTS did the existing law but to remove sa&%& life for the mi!Iions of diabetics- c. .-. I- ^, in, the
i ._
not play ,a role in the ir+<ask in ‘the’ from the market. United States.
incidence of tumors. Based up%*“tiik. The matter does not end-with FDA What effect this congressiond mora-
rest&s of the Canadian‘snrdy,’ FDA having the final word, ho&ver?%,% torium against the FDA’s @king action
daily Over that one diet
a lifet-& soda cbnsuined vember 23,1977, Congressenacted the
~;;‘;-j;;;av;~ii~~d”dult‘ to removesaccharin Ij,. ,_ from the
.. .“I_r-.:^I market
_ will
“Saccharin Study and Labeling Act.“35 haveover the FDA’s long term ability to
Xm&an could result in up to 1200 administerthe-*,- food_,% safety
iirn.“dw^ law is unclear.
additional cases of biadder ,car,cer per The purpose of this act is Certainly it would seem).that Congress
yearamong the Arr,eri&n$o;iulace. The to require studies concerning car- should uphold the very law it enactedto
cinogenic and or+ .roxic . .. _,_ sub insurethatsubstances
*, ). 1)‘r* ofdoubtful
~~,*)‘e..*ar.rar safety,
stances in food. the regulation”“bf” such as saccharin, would b-eremove-d
%J cases?or~a&~O,~OOin&idua!s. If such food, the impurities in and from the market pending additional test-
the consumption of sac,charinis,,figured ruxiciry of saccharin, and hea!rh ing, rather than the market
in, the rate is raised to _1.54
I<. . ) percent, or benefits, $any, resulting from the and posing a potential risk to the con-
154 cases for each 10,000 individuals. use of nonnutn’rive sw.eereners; to sumer whiIe,
ur,dertaken to the additional
resgj+g- ‘&~v-&“e~ettesting is
FDA believes
conclusivety -fay$that the Canadian
.&aT Acch$; tessu;
;$-i prohibit for 18 months the Secre-
tary of Health, Education and questions.
carcinogenand that its use in food canno tYe[farefrom taking certain acn’on
, The exception that Congresshas pro
longer be justified. There is no epidem- restricting the continued usf of posed for saccharin points up a signifi-
iological or user .evidence.that ‘demon- sacchani! as a food, drug and cant shonco+g in the FDA’s_abiiity
.. . to
strates that saccharin is a carcinogen in cosmetic; Corequire certain labels administer and enforce the food additive
iafety law. Once congii;egw&* ZG& ~._
humans. However, the statute $oes not and notices for foods containing
concempIate epidemiologicat studies; sacchprin; and for other pur- Jut an exception for saccharin,
., .. _ what will
rather, it contemplates ani@ studies of poses.34 Jrevent it from making exception after
the type discussed above:34 .S&%ic Continued useof saccharin(n food and :xception in cases of other ac@ives of
studies have been conducted‘accordmg dri* is now wmittedj ;+& ir“f$gy Kidespreaduse when t+i: safety has
to accepted scien& ‘&o&d& c&t labels carry the-following wa&.ng~~~ xen brought into question. ‘ff; in fact,
demonsuate‘ that saccharin has the po
tential for caus’f;F ‘~~~;“~~“.“‘~~~~~e. Use of this product may be haz- Congressis unhappy with the current
ardous to your health. This prod- hod additive law, and there are many
Thus, if one chooses to believe that $e uct contains saccharin xho will arguethat theDelaney Clauseis
been dererTni&d lo y&j$,which has
~$g$y+ .i.-,
Czradian and other test results
.I, I ‘,.*“-*s;_..*‘ arevalia
;i, “II!, l-l- AI. ““.,,“.._ i,, :m restrictive and &f!exible,
;,,._xit should
consumption of sacchann does &eed in laboratory animals. unend or abolish the foodPadditivesafety
aw. Proceeding in’ ; I;;~e;;.r;;Led;.;-di~
posea risk of additional casesof bladder 1”-.,;r
cancer in humans. In addition, the new law gives the FDA ive-by-add&e basis, can only under-
authority to require sin-&r Iab$ on nine the regu1atot-yschemeit has estab
‘ ..”
oN. -.6ij;,~.-cDrTwEs.. THOUGHTS vending machines that dispense soft ished sit
ci.ri&s.3* Retail stores$I& sac’charin
metier people &;;id <a;‘; &i ii’<&” and saccharin+onta$ng pr&iu?Xs,‘With Jzse, 21 CFR
.I L ,.,
_x_, s, (,
’ -*‘,i*. >- ‘“‘.,1,‘,. ’ % <

dom of choice to accept the riskposed~by the exceptionof restaur~ams, are required 33.5~ fn. 27, supra.
saccharin is a matter that this
‘“a.;.d.I/stI11”1 article will
J.,_ to post signs warning customen‘ of the J’Sec 21 CFR 170.3(h).
not address. The Issue, however, IS a cial cancer threat from ingestion of
swe;;;n-;.jg’“*‘yy- -% 18-mon*the &K J3P.L 95-203. 91 SW. 1451 (1977).
viable one, in that there are~competing morato’~~*~~~~~~~‘fP~tfi~~~“~~ ‘6ILi
37fd. J 4(a). Faihre of a food label to bear the
concerns,especiallywherediabehc~ . da% ._x;_,“-. has b;dy-;;;poS;J “~4”k&yp&y$~ runhg statement raulu in,lhe feed b&g mis-
that the conveniencethat saccharin adds rar.ded un+i $ 343(0X1).
to their lives outtieighs“‘their’ risk OF provisionsofthe food additive safety law ‘*Id. g 4(c).
I^ _^- 7- -~L-l;t:nn mioht one not argue and the DelaneyClausenotwithstanding ‘qlci, 5 4(b).
Food and Drug Administrakion
RockvilleMD 20857 3

Dear M r. Biliraki?t _ ,,, ," ,_ ,, _

This is in ,_further
-;.:,(S. response
i ,p _",
. to your letterof.,July 14, 1995, on
behalf of M r. David Helphrey of Palm Harbor, Florida,
Je .: .-& 2”. ,..* l

requesting an update (slncep& N.ovember

"d"..ll."-,;l,_~17, 1994, letter
,li , ,,.i_ to -
you) on the status ,of the"Food a~qd ,&ug Adnitiistration's (FDA)
-jnvesti-gation regarding IISGij“&'g‘"'ff$~~&~'i$ '?@a11:yhjc@ is
distributed by Nutrition Products, Fresno, California. We, _ ,- ,
apologize for the delay in this response.

warning to consumers $s~app~op~*?at&'diid ‘u*sePul, and such a_

label statement may reduce the.incidence~,.of adverse
j "".i, %. t‘,'.'*.i";i._ effectsi.4)
rr*~% %,
appropr~~Ze~~~"~~~~~ed lab-e,& 'statemq~ts have
reduce abuse of .products conta~~;l~~~~~,~~~~~~~~~~:~aiiesf‘ 5) an a potential to
extensive edu.cational",L _&.1 campaign
: is not warranted(the.~resources -es/ ./a*_
required would be too great for‘the,expected benefit), but an
informational effort targeted
. I. -,I,./",.
.*ba*a** toward physicians and other
appropriate professional 'groups could ,hav~e,.some ‘"___3,-id_ Y,Impact;
I and'6)
committee and educatiqr?-
cannot predict effortsij,~&-cg~'will iti ~inform cony%?
're'~~~~~-~-;~~~~~",5;~~~. ??,&J$~ ,, -In
information. The working group went on to devise .a dqft .&&& .
statement that a'iE"'a$eed
." __f., . was'too long but which incorporated
the various elements 0.f potential adverse
1 _,b," effects
o ,,I
*j 3&>:%" about
,a&!*which .-/ ~.."~,~~.~,
.~~~~~*.~~‘ _j
they felt consumers needed to be info~e&,
Committee approved $-&- .~~~~~~~~~~i~~~~~":~~he,.~.,s~,~~~~,~~~rY
special working
--o- rir i,,w-i***
.lnl'^*,I, *" ‘, , j __ .(
group at its of June 8-9, 1995.

-4 - _

Page 2 - The Honorable M ichael .(, Hilirakis "._‘.,^",,_

,,"_eI. ._ _,)_^,I^.,,_ - . "I, ." . i

On August 7, 1995, a m eeting was held between California State

offici"als and industry to discuss a label statem ent for foods
containing subs&%&s with stim ulant laxative .effecfs. In that
m eeting, the State of California.rea~,~e;i-‘a.~con.sensus,with
industry representatives on the specific wording of a label'
statem ent as follows: _ *
NOTICE: This product contains (nam e of ingredient
and com m on naqe,"if~ different}.
-;e, I/ /IsI Read and follow
directions carefully. Do not use if ou have or
loose stools

% If you are pre*gnant, nursing, faking m edication, or

have a m edical condition-, consult your physician
before using this product.
During the August 7, 1995, m eeting, and in subsequent telephone
conversations, California requesfez that“PDA‘*tioNefit on the
statem ent. Our com m ents were as follows,; ~

1. A label statem e,nt..oq foods, including dietary

supplem ents, that contain. substan~~e,s.,,with, ,
stim ulant laxative x a"effects .., ,:I,-.I ",that
.1 S‘i.., m ay cause
adverse gastrointestinal effezts,,$ay be of value
because consuqersshould be inform
1>. (‘".h,.r_ ed l".laboutthe,
".dsl_/.m ,,.^ ,. __
potential effec$s,,,of t,h,e,se, products. "'An
appropriately worded statem en,t~m ay reduce the
incidence of adverse effects,and
," c _ . ,,abuse
,L "ah 1ri nof-i, the-s,e ,_:" .., ,
2. We noted that som e plant m aterialscontaining
substances with stim ulqt ~laxative
p.,s.*-anl_ effects
**. L,_.**-* " are...>% ,__,
approved for use in foods as flavors I ,..,,, ,",(.at,th'eU'*'
m inim um level n.ecess,ary to achieve the flavoring
effect and arelistedin Section
" ,,.,'v-‘./">l.""sy*>
-~*..I* 172.510
."a""-" I*.w"iu-‘dl+.e*, of *__.,_/
<... ,Ulj.,",,. .
title 21 of,the 'Code of Federal Resulatlons (2i‘-' _
GFR 172.510). When used" in azor'd 'w.ith "
8 172.510, these substances woul,d,.be..expected to'
be used at levels below those ,,that
/ *'I.c,i-x.*"ix-r
"ese can
"a*,-*y,.--rJ %cause
l, -.,.a $,& I ._‘ -s*<., .,
laxation. Thus , -' use
"' -*' of these substances in
accord with 5 .172.510 and at,levels,that,wqr?ld
not cause adverse< effects should ..,.I,">.: not*,,reguire
special labeling.
3. California's statem ent incorporated m any, but
not all, of the Advisory Com m itteefs
the specific The
ingredient statem
,^ consumI ers,,.qf~
that:“~~~"~~.'~~~iuc~ +
, ,1,,,..__.".
contains, to follow direcf~pnS,,cgyefully, about
instances i,n whfch, the,, product should not

Page 3 - The Honorable gicha"e~l Bilirakis

. i.i^ _xI./__/_I
/_^+"*?\,, UP ,~,\l‘. *, .~_ ,) ,,

be used, and of situations .I. ..where a

physician should be con_sulte';i""~~~owever,
‘iI ,.,,2.. 7, -I."‘,ic.dp
the statement:may not adequately warn of
specific undesired effects.anddtheir
consequences directly related to
consumption o.f the product ~on.a, s&ngl& dose
basis (that it canact as a1,-"..1", laxative)
*_ or
adverse health effects related .-,.,.‘,; to ,.
consumption on a chronic basis~~'(ch6oni.c"
diarrhea and impaired colon function t-hat
may lead to s.erious.s,eguelae). In
addition, the statement does~,not, include
the concept that laxatiye-gnducea"di~~-~ ,**v.x
, ., ", ;_ ,
does not significantly reduce absorptz.on of
. food calories, which the Adyispry Committee
recommend.@ be included
(. al,,..
because these‘l' products 4""":~. “v';,in**",,the
I';are statement
dF~g;i,'"sb.i"d":~ag~ ., "I (. j__)
weight loss products including dieter's
4. The Agency also pointed out thateven a
be misbranded under" 's-~~yw~~~q."~). oft the still_
beak the,Slabel statement, it may
,"‘h"i ,. .l~*,ji~
Federal Food, Drug, and Cosmetic (FDC)‘*'Act if
other information on the labelpi_,.*,,
*~l,l,",/j causes
I)SL the-ii ‘<,Ilabel
.(iir,- ; .I",&&:..:"i;‘".*, ,_ _
to be or9 misleading.
We believe then eff.orts -,.I. ,.*on,*.j the
liMbl,part of California,,are.,usef,ul,
despite the fact that all the <face*ts,o,f the Advisory
Committee's recommendations
I 2.~.-1 were not,,inc~~~po~~~~~~~~' Wit will
follow carefully the aspro;f;;rQ~~'~~~~~~ea~~~~~~~~.~.
well as the response in their labeling
of -~~~-g'~'~~~~~~~ww;
initiative efforts,
and will~contir&e ,--,.,, Wto.,I ./,consider
* j_+-/
..i. d&ion
,;ii@St: on,.L,,
ini"","$2' the
_. part
"6‘.I~* ofj . .."._FDA
. ,_,n ^
is necessary.
We agree with the recommendation
a,?9,..__, _/*& of__
"/*,a:<./ ~J ,"_the,&Adv,iFory Committee that
an infoma,tq@ ef~~~r-~:~,.t~a,~geted tow~'?~'?v?alth ‘care providers
and other appropriate professionalgroups could have some
consumer impact .and~ are,'therefore, considering mechanisms by
which this informstional
" *\a.,*.,
>5, effort
*a,,,,.a-,* could
*,Oil)I^:",,"a be effectively
j: ,i /
We recognize, as the Advis.ory Committee, cpncluded, that
labeling and educationa" effqrts ..a.-.-_
.':_,. provide consumers with
some protection. Becaus,% ~~$-~~,~~~~~~i!l.",~..~~~~,~bnsos ,.tfi,o,SW&
information cannpt be predicted, we have requested that,
California State o:ffi.,cials keep
, j IX,,,__,lW".
jc us informed about.consumer
. .

.._ .,’

- _. -

Page 4 - The Hon.qrabl+? ,pl+h&L i .Bilirakis

,; .2,,i,. ,, .~‘,i*',i"-l<._I, (,I ). j. "_, ,, ,,

response to their label, statement..

I%.. """"*p'.,
/*._^.I This
+,,II.." information
:"*"*>#ei. will
s,_.," j, y^)""
"__, ? ^ ( ,) \
assist us in assessing
) " _.,_
. our optlons. .
We hope this infqrmat.ion is,‘‘_,".a",
/_I(".I helpful.
/M/*B/lnd 1
iane E. 'Thoqpson
Associate Commissionqg,
for Legislative Affqirs

& .” L ’ *’Citizens For H & a !t
-a - -

C f TfZE M S


C O D E X : A S l ? E C IA & R E. P O I$ T . .- .
R e p o rt o n th e 2 0 th C o d e x C o m m itte e M e e tin g o n N u tritio n a n d
F o o d s fo r S p e cia lD ietary Uses
o f th e F o o d a n d A g ricu ltu r e o r g a n iza tio n (FA O )
o f th e U n ite
”“,..,d/”*,_N)’.a. tio1;n s q @
\ W o rld H e a lth O r g a m z a tlo n( W H O )

B o n n , G e r m a n y , O cto b e r 7 - 1 1 , 1 9 9 6

.j _ A_ u th o r e d B y:
A l e x a n d e r ^ G . ‘S chkuss, c(.,, P h D ,
U .S .A . N G O:__,C ,_o dLe_x^* D/(‘,.,
Ie l e g a te
P residerit,‘C itize n sFsr & a lth
O cto b e r 1 1 , 1 9 9 6 --’
__ .; .- ,_ _ I., -,.
._,A _, _:,,..,,-_. I )
- ‘_
..~.-f,‘~ . . I. I.“. .^j’ . _,,,; ,,“,ki ,_,. /

Citizens For Heal ecial Report

for these deviations. However, even though a deviation to the standard has been
declared, the country is expected- to indicate when it will give full acceptance, implying
that deviations are only tem porary steps taken by countries to give.them tim e to
implement the standard as written.

For exam ple, if the United States refused to abide by a hypothetical ‘Co&x s,tandard that set
a m axim um level for vitam in/m ineral supplem ents, then it would have to indicate to
the Codex Com m ission in what Gays its present or proposed requirem ents would differ
from the general standard, and. if possible, the reasons for these, while also
indicating whether it expects’to be able to give full acceptance to the general standard,
and, if so, when.

For this reason, dom estic laws and regulations can significantly influence’intem ational
s’ m le al that
analm sts
ight that
the odbe; imposed upon .sta~~~~~~~~~...a~~~~
tlom m ission”~s it.‘This is ne ‘reason su-y
wh lem
the ents
theorza of
e g: V e rv vv V
force a countrv to adovt that standard in defiance of its oti” national statutesbv trade
treatv covenants is auestionable.

As was observed at the i996 Bonn m eeting, the USA’delegation represented by the
.Director of the Office of Special‘NuWionals at the U.S FDAi’D& Elizabeth Yetley, RD,
Ph.D., m ade it ‘@erfectly clear to the Codex Com m ittee that it$jected’ certain proposed
standards and would not agree to them because they would violate our country’s laws.
This was $articularly true in the case of certain dietary supplem ent proposed standards,
which would conflict with statutes of,i‘the
“.< *o/ Supplem ent Health and Education Act
of 1994 (DSHIX)).^ Dr.“Yetleydid’& very good job m aking this issue knoti on several
occasions to the Com m ittee during the m eeting.

It is also important to point out that the Codex Alim entarius Com m ission,and its
subsidiary .<bodies,
,“, >”^ ~.,e such as &*,
Com m ittee on*d*,sl
,.“:,,,_ and-9-;Poods
i Lj f..“,,fir% , Special
r,,~,~~.~~“~~“~.*?~,~~ l%etary
Uses (CNFsou), i$92;$-+ltted (;;-;i;~;+&) to re&~&@&&tand+s and related .
texts to ensure that they are consistent with and reflect current. scien.tific‘knowledge and
other relevant inform ation (i.e. consum er opposition). When required, a standard or
related text shall be revised or rem oved using the’sam e procedure as followed for the
elaboration of a new standard. Each m ember of the Com m ission is resoonsible for
identifving, and vresentine: to-the aDvror&te com m ittee, anv’new scientific and other
relevant inform ation that m av warrant revision of anv existing Codex standards or
related texts.

This is important to know. If, for’kxam $e;‘the U.S. IVational-Academy of Sciences issues
significantly higher safe lim its‘ of intake-of certain vitam ins ,and, @era+ than is
allowed by the existing Codex standarh, that scientific knowledge would be taken before
the Com m ission and CNFSDU to‘encourage a r&.&i& in “the standard. However, it
would be expected that opposition would be based on the prem ise that such new
inform ation had not been considered adequately by the m ember country(s) opposing the
revision, thereby potentially delaying by years a revision or elim ination of that standard.

@ usages,and trial results mz&room cultivation; one of Look for capsirle-making in- creams may corztain DHEA,
would be another section to the&z is The
.”.i,“tT. Shiitake
- )^Gl..
i:ia Growers
;a,-1 formation
, -- in future issues of’ ther Nature did no
the maga;;il:;;:e,
“~qthe ));;
consider including in your Handbook by I? Przybillotoicz
publication. azzdJ. Donoghue (Kendall/ time, the article about caps
Tina L. Arellano Model behavior?
Hzznt Publishirzg, 1990). manufacturing on page
Wieatridge, Colorado may interest yozz. Dear Herbs for Health,
Herbal tiakhg In Mark Blumenthal’s ar-
We hope you enjoy the article We can’t be quite as re
about herbal care forpets on Dear Herbs for Health, sponsiveto your homebpa ticle “Herbs and the Law” _
page 28. Look for more arti- I am very interested in query. While horn&pa (September/October 1996),
cles in theft&r-e. We, too,find herbalism and herbal heal- draws.upon herbal renzedt he makes several good
the herbal information comizzg ing. Can you recommend a it is a topic outside ozlr‘rea points. Forexample, “Gov-
reputable sourcefor ,training? HomeopathicEducationhiSe ernments of other advanced
out of Europe to be very inter-
esting and are always looking Don Christie vices, 2124 Kittredge Stree nations have already dealt
St. Louis, Missouri Berkeley, CA 94704, may be with the challenge of evalu-
for ways to include it in the I”
better qualified to respond to ating herbs for the thera-
magazine. Many training progranzs are
this question. peutic benefits,” and “Ger-
available, but we cannot en- many’s Commission E, a
My on mushrooms Regardingg&zseng,trzregin-
dorse a particular program. federally appointed panel of
Dear H&bs for Health, As a startingpoint, you might sengs are ginsengs belonging
to the Araliaceae fa’mily ai‘d experts that have reviewed
I have been interested in refer to oar article on North
the genus Panax. That in- more than 309 herbs and
growing shiitake mushrooms American correspondence
cludes both red and zuhite herbal combinations and
(“Mushrooms as Medicine’: courseson page 58‘of theJan-
Chinese ginseng (Panax gin- have approvedmore than 200
January/February 1997) for uary/February 1997 z&sue. It’s
seng), Korean ginseng (Pan- of them as,safe and effective
some time. I tried to grow also helpful to ask herbalists
ax ginseng), and American medicines, might serve as a
them in logs without much and people in the medicinal
‘ginseng (Panax quinquefoli- model for the United States.”
success.I see where they can herb business about repzitable
urn). It doesnot include Siber- Unfortunately, experience.
be grown in sawdust.I would programs.
ian ginsezzg(Eleutherococcus
has shown that companiesin-
like more information about
senticosus), also known as volved in the”dietary supple-
this. Also, I would like to pur- This and that
ment businessdo not want I.s__ Ito._.
chase Kenneth Jones’sbook Dear Herbs for Health,
adopt these models. For ex-
as well as some of the other What a great little sister Yams and hormones ample, after discoveringsev-
books listed. Can you provide .Herbs for Health is-as ex- eral deaths linked to a popu-
information? Dear Herbs for Health,
pected with a big sister like lar herbal diet tea containing
Donna Miller What is the percentageof
Greenville, Ohio The Herb Companion. over-the-counterlevelsof lax-
DHEA in wild Mexican _ rv * _( _” atives and diuretics, industry
Where can I get education
You can find Kenneth Jones’
on making my own capsules? Phillip Hopkins representatives met and op
book Shiitake: The Healing. What are the Lubbock, Texas posed efforts to label these
Mushrooms (Healing Arts the sizes and, how can I~be diet teas aud other herbal l,ax-
Press, 1995) at selectedbook- sure that I’m taking the right According to James A. Duke, atives with the warnings
stores, or you can order it for amount of capsuIes with-my Ph.0.; yams don’t contain the and/or cautionsthat the.Ger-.
$8.95 plus $3 shipping and own herbs? adrenal hormone,DHEA +PIIx.” (de- man CommissionE requires.
handling by calling (800) I would also be interested hydroepiandosterone). Yams The same kind of opposi-
2468648. Another usefiil text in an article onj homeopathic do contain diosgenin, which tion exists with regard to the
^ ,. ,. .I
is Medicinal Mushrooms: An courses to answer questions through severalchemicalsteps labeling of herbal supple-
Exploration of Tradition, such as the kind of degree tan be converted to proges- ments containing the herb
Healing, and Culture (Botan- you obtain, how you can use terone, testosterone,or DHER ma huang* commonlyknown
ica Press, 1995) by Christo- the knowledge, and what the Our bodies, however, do not as ephedra.
pher Hobbs, which is offered average cost iS per course. have the enzymatic pathways Once,again, mainstream
through Interweave Pressfor Lastly, are Siberian, Ko- capable of producing such a manufacturerswould likelJ,the
_..a,^; ,_,
$16.95 plus $4; 75 shipping rean, and American ginsengs transformation. In short, Dn public to believe that prod-
and handling. To order call true ginsengs? Duke says, it is not possibleto ucts contz+ng ma huang
(800) 645-3675.Hobbs’sbook Sonya Anthony get DHEA from yams 07 a wi* “street-drug-like,,..‘...a,,, names”,
contains a fist of referenceson Decatur, Illinois yam tinctzrre. Some wild yam such as Herbal Ecstasy, are
. h, r. ,i.. ;*< ,; 4 . ~ 9 .:’

titi aberration. H o w e v e r , lest r&Its’

h a v e s h o w q th a t, m a n y m a i n & e a r n
e p h e d r a - c o n ta i n i np gr o d u c tswith “nice
n a m e s ”c o n ta i n a $ m u c h if n o“_t signifi-
c a n tly h i g h e r levels o f e p h e d r a th a n
p r o d u c tsw h i c h th e i n n @ ry claimsa r e
p r o d u c e db y r e n e g a d ec o m p a n i e s .
In short, u n til th e p e o p l einvolvedin
th e b u s i n e s sq f m a k i n g th e s ep r o d u c ts
a r e willing to m e e t a n d a c c e p testab-
Iished,g o o d m a n u facturinga n d label-
i n g practices,th e c o n troversywill n e v e r
H o p e fully,M r. B l u m e n th a will l sup
port legitimate aqcjrezW q n & leC ffo F ts
to i m p l e m e n tpolicieslike th o s e estab-
lishedb y G e r m a n y ’sC o m m i s s i o nE in-
steado f th e s c q e @ tics u s q l _ @thy e in-
d u s tryto g e t th e c o n s u q e j tp - .+ t& + ffie ,
U .S . F o s d a n d D r u g A d m inistration
w h e n e v e itr h a s a tte m p te dto i m p l e m e n t
policieslike & p :,e “established
l-..“l, in-8.
.I *y‘_r u .-,:.e , er i ,
a d v a n c e dn a tio n s ”.
ChristopherE . G rell
S a nFrancisco,California

Toxic citrus.peel?

D e a r H e r b s for Health,
In th e N s v e m b e r / D q z e m p eissuer of
H e & fir H e & z , th e r ew a sa letter a b p u t
o r a n g ep e e l oil. T h e r e s p o n s esaid it
. ‘Y.’
c o u l d b e h a r m ful orfatal. I m a.,..k e can-
.. .“k,,
N o w y o uc a n c o m p l e m e n tyour six issueso f H e & fo r H e a l th d i e d o r a n g e p e e l a s well a ? c a n d ‘.i e_d”
with, in alternatem o n ths, six issueso ,fT h e,.”H.>e..r. b. C o @ p u n i o n . g r a p e fruit a n d l e m o n p e e l .T h e s e a r e
This stalwart m a g a z i n eprovides.a~varietyo f w a y s to e n j o y th e b o i l e d 2 to 3 m ig.vtesJhen n _ _c,o o k.._ e d in
.,,,. _
rich scentsa n d flavor: o f h ,exbs..Lively , I recipes,s o o th i n g te a s a n d
%. %*i?” s u g a ru n til c a n d i e d Is
, & -ish aI r m fu l ?
b a ths, fragrant p o tpourrisa n d b o u q u e ts,tip s for g r o w i n g h e r b s in J Boschen
W indsor,M a s s a c h u s e tts
simple p o ts or elabbratek n o t g a r d e & - - e v e + issuebrims 9yer,,with
th e kind o f n e w s F h a t $ I! elri,c& your h e r b a l k n p w l e d g e a n d E a tin g r e a s o n a b l eu m p u n t~o f c a n d i e d
e n j o y m e n t. citrus p e e lp o s e sn o h e a l thk h h r e b te c a u s e
S u b s c r i b eto T h e H e r b C p m p a n i o nto d a y a n d s a v e a s m u c h a s y o u w o u l d n o t~ ingeste n o u g he s s e n tialoil
$ 1 7 .4 0o ff n e w s s ta nprices!
d Call toll-free8 0 ( 2 - $ 4 5 -, 3-.,6 7 5D,e p t.A -FB. to b e toxic.

p ..s . W it‘h a n y subscriptionto T h e H e r b Q m p a n i o n y o u a r e a u to - W ew e l c o m~eO U Y ~ “dintiiih a n d q u e s tio n s .

m a ticallye n title d to significantdiscountsp n h e rIb a“P lbb*‘/w,.~
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s letten to H e r b sfor Health Let-
.~ S~ _a ”g e
te n ,In te n v e a vPress,
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L o u e l a n dC, O8 0 5 3 7 - 5 6 5 5 ;fa x ( 9 7 0 ) 6 7 7 -
a n d representsyour freeo p p o r tunity for s & i ~ g s ~ ? ‘k ~ r ea r e rio:dues, 8 3 17 7w e - m a i~l H ~ H @ iu$xccntuiI.ctnn~us~e.
n o obligations.Y o u o r d e r qnly w h e n y o u w a n t to a n d th a t’s’it. corn.P l e a s ei n c l u d ey o u rn a m ea n da d d m s s .

1 H e r b sfar Health M a y h n e 1 9 9 7
. -3
Herbs and the law
l@ark Blumenthal

Viewpoints to consider

ore and more con- the practitioner must have headache”.However,millions

sumers are turning personally examined the pa- of consumers use herbs pre-
to herbal medicines tient; the treatment, when cisely for therapeutic rea-
to tr@t minor ailments and used as directed, must not sons: to help t&t minor, self-
to help increase overall well- help consumers is the tricky present a danger to the pa-
limiting ailments.
ness and resistance to dis- part. tient; and the patient must be Governments of other ad-
ease. In October 1994, a The Dietary Supplement informed in writing that the
Health axd E@catiqn Act of treatment has not been ap- vanced nations have already
Gallup survey estimated that
17 percent of all Americans 1994 @SHEA) was designed proved by the f&era1 gov- dealt with the challenge of
use herb supplements,which to protect consumers’access ernment. evaluating herbs for their
are now available in main- not only to dietary supple- Theeact would
_k,e _.“(obviously
. ‘?..,_\,
., therapeutic benefits. Ger-
stream retail outlets, not just ments, including herbs, but deal with more than only many’s Commission E, a fed-
in health-food stores and also to information‘on how to herbal issuesand treatments. erally appointed panel of ex-
mail-order catalogs. In 1994, use them. The issues sur- jGits tliat”has reviewed more
the latest year for which fig- rounding DSHEA’s passage herba medicine would come than 300” herbs
I and herbal
ures are available, herb sales cut across conventional party under “. the-purview of this act .combination,s
. ; .,-I:-- and approved
rose 35 percent in pharma- lines, reaching both ends of and, if so, why. In ^myview, more than 200 of them as
cies and supermarkets. the political spectrum. herbs should be part’of con- safe and. effective nonpre-
This interest in herbal More recently, a bill titled ventional medical practice; scription medicines, might
medicine is unprecedented, Access to Medical Treatment ample scientific and’histori-
serve as a mode1 for the
not only here but all over the Act (S.1035 ,and HX’2019) cal evidence ,supportsX-$s.
United States.We need a sys-
developed world. A big issue was introduced last year by But. the problem is one of
regul;L&6n*&@.&.& goes tem that allows consumers
surrounding all of this herb Sen. Tom‘D&hlk ‘(D-SD)
growth is education of the and Rep. Peter DeFazio (R- so far. Rallows herb product and health professionals to
general public as well as of Ok). It would be a boon to labels to~mclude~usage “di- use and recommend herbal
health professionals and law- the democratization ofhealth rections and side effects and products that are properly la-
makers. Most experts agree care as well as to consumer ‘warnings, yet it permits only beled with therapeutic infor-
that the best way to ensure access to less expensive and limited claims about how a matio,n ~that haa,,been re-
that people will use herb often gentler modes of treat- product affects the body- viewed ‘,and _ approved by
products safely is to put ment. The act’would let peo- “Cranberry helps maintain a herbal experts. Gnly’then
straightforward directions on ple receive any type of med- ‘heakliy‘urinary tract”, for ex- can the herbal renaissance
labels, including expected ical treatment they want from ample-so long as these become, a complete reality.
benefits, proper dosage, pos- a‘.licensedhealth-care practi- statements are .truthfLil,iion-
sible side effects, and pre- tioner, including treatments misleading, and” backed j_.A<‘_.,_”by
cautions. However, getting not approved by the U.S: sec- scientific evidence. DSHEA Mark Blqqwnthal is founder and
the industry and the govern- retary of health and human does not permit products to executive director of the Amm’can
ment to agree on appropriate services. The act includes make “therapeutic” ;,. / /)” claims
;. ‘ @tan%<, ,. _,. .b^
_ “,I and edits
and responsible regulation to several provision& includ’mgz && ..&-. ;;figIps cure a ,Sie+alC$a? 3nagazineY

8 Herbs for Health September/October 1995

(Continued from pnge 6)
improves, sales through
VSM Study Internet -- “the modern
predicts. equivalent of mail order” --
M inerals tallied $725 m il- should grow.
lion in sales last year, com-
pared to $590 m illion in ]9?“2. Positive Factors
This represented a CAGR ,of The passage of DSHEA,
5.2%. M inerals generated 11% the introduction of new types
of VSM sales in 1996: of supplements and wider
Sales of m inera!? -are pro- distribution were all cited by
jected to be $840 m illion by Packaged Facts as positive
the year 2001. factors affecting market
growth for VSM products. In
Bieakdown By Store addition, the report says that
Health and natural foqd key demographic and
stores remain the stronghold lifestyle shifts in the U.S. --
for VSh$ products, accounting notably aging baby boomers
for - 38.1% of sales, the and
_ growing
_ interest in pre-
Packaged Facts report states. TheSe stores, wi!j,, remain the. __,_, ventative
^ .I*,a, medicine and
”“),““(_*.L.IIX,..“tLl~ISd.,, self healthcare
-iv,,_,..,,.s*..”‘“A:‘\.*~ --
** ,,( I< ‘driving
Y*.,.:i-. are ,. % I, this
top seIlers of VSM products for some time, according to market.
Packaged Facts, due to the fact that the in?ustry is new- Other factors supporting continued market growth
product driven. “The market et-$ry cost for new products include positive scientific research, and changing attitudes
is much lower. through this sector, and health and natural of the conventional ‘ ; ,I”,i. :,.,medical
_”.”./.*I2icommunity, *;1*+q( the report stated.
food retailers and consumers are,b@ter.~~.~
informed and
I ,,. “” _“.%,s,* have
‘, ^,,,O.
Yi _FoKeign.i\;Ia;Get;~ ...( ., . . -3s. .“” / (., > ~,/_ \ .i . l..ri , ~
a higher level of interest is VSM products,” the report
states. According to the report, 1996 sales for the European
Among mass marketers, drug stores account for 20.2% VSM market surpassed $6.7 billion: -Germany and France
of VSM sales, while mass merchandisers agd food stores. _have _the
____ largest market shares at 26% and 21%, respective-
have a 14.8% and 10.8% share of sales, respectively. ly, the report states. The-United Kingdom follows with a
The report states that while VSM sales. through all 13% share, trailed by Italy (9%) and Spain (8%).
channels are growing, the share of sales in,bpth chain.,ar$. Gf?r&, ginkgo biloba and magnesium are said to be
independent drug stores and in supermarkets is declining best Germany, while calcium, ginkgo and mag-
in wake of gains by mass merchandisers nesiul~~+aretop sellers in France. In the U.K., top selling
(discounters/warehouse clubs and deep-discount drug products include co@.liver oil, evening primrose oil, garlic
stores) and food/drug combo stores. Both di,rect-sei!ing and multivftamitis, the report states.
and mail order are also showing a decline in market share Tl-g 300:page Packaged Facts report is priced at $2,250.
(but not total sales), the report adds. The report also pre- For further information, call (800) 265-?%36. 1

(Continued from page 6) .. ;.nI?$,‘

,, ..> l(^ $-I? ;-e{;ted an incident in
exhibitors -- which inc$uded a fair : retailers. .<.
^( ,,.,
number of new companies -- was gen- which a supposed retailer --who actu-
Expo West Report erally seen as a positive sign for the ally worked at a bicycle shop that did-
voiced various frustrations. For, one health “food industry, representative of n’t sell su.pplements-- tied him up dis-
retailer whose store focused pn ngltri- overall industry growth and the cussing products while some actual
tional supplements, the show seemed strength of the marketplace. health food retailers passed right by
to have “too much food”. and _not As for the exl$l@rs, the majority his booth.
enough space devoted to supplement of companies on the trade show floor “I fully intend to return to the
exhibitors.. . said they were pleased by booth traf- show, but it doesn’t seem fair that +e
Others noted that the sheer s,ize of fit and the gum&r _;,,. orders placed manufacturers pay for the shows
of /I&“>“_j,_u,
this year’s show made it impossible by retailers at the .+o~~~,,.Still, ~some (through their exhibit fees), but are
for one person to cover the whole had a bone to pick about the “quality” then undermined, because the ‘green
show, despite expanded exhibit hours. of retailers wh6’ were’ allo\ved to,, badges’ are diluted by non-retailers,”
The joke of the show was that a per- attend the ihow. For example, Jery commented Cochern.
son could spend no more than one Cochern, President of Pure EssenFe
m inute at each booth in order to visit, Labs, a private labelni’afiufactuyer, felt k Changing Climate?
all of the exhibitors. that- many of the attendees granted According to Mark Kaylor,
Of course, the high amount of green retailer badges were not “real” herbalist for Nature’s Answer, the rea-
-4 - -
(415) 541-9866
F A X (415) 541-9869

Novem ber 20, 1996

.David Kessler, M .D.

Com m issioner
U.S. Food & Drug Administration
%5600 Fishers Lane .
Rockvilfe, M aryland 20857-1706 '
Dr. Elizabeth Vetley
FDA - Office, of Special Nutritionals
200 C Street Southwest, _
Washington, D,%. 20204
Re: Proposed G M P 's Under DSHEA..- What Is,'The FDA,%.D"oing?
Dear Dr. Kessler and D,r* ,Vet,ley:
I read recently that the FDA is abou,t to,adopt G M P 's
developed by several m ajor industry trade groups including AHPA,
CRN, NNFA and UNPA (See exhibit A). -Given the fact that these.
trade associates and ~the individuals ll".i*",I,I,,( *,who
./ As,&*
_I_*i, are
/<>"c,,_m eeting
,,,_ (+/, to develop
the G M P 's also work for ccm panies that,,m ak.e"t,heir living selling
these products, what m akes the F.DA.thi?k, ~t&$. .,&,.. $Z!.P,~~aJi?g&ns
proposed will be valid "Go,od M a.~.~-~.a,c~t,~rlng Practices? For '
exam ple, GNC continues t"o sell Herb~al~.,Diet .^..I*,.*"II"Teas *; that,- contain
,,\d.ri"J _ /<C,iiZ.~i.~ OTC
levels of senna and.d~uretic.s,.,whi,~h.,~~h~ ,Food
); s $6 %/,AjAdvisory
, Com m ission '-
to the FDA, not to m ention the Herb .Rese,arch 1 .\ .*_,_",< Cpunc,i-l,, concluded
was dangerous and a bad idea for people to use.. Not withstand,ing
these findings, in addition to,selling these products, in the
litigation I'am involved,+, and in ,whi,ch a defendant,
they take
used the .position
in these diet tea,s that the .wich
com pl,y, se&a 'and~o'cher*'herbs
Gbod M~~~~~~df~~~~~~~:'"~~~~~~~~~~~'! ' -'_

Similarly, several states have ba.nned ephedra.containing

products that GNC continues to sell .(See Exhibit B). I imagine
that the Industry will contend that,.these b,.b
.a.lix. products- also com ply
with Good M anufacturing Practices given their pr-esent conduct.
Daniel MeSweeney
The Numbers look
.., ,” Good.I
People who are looking to invest in a particular
business or indlistry will typically ask, “What do
the numbers look like?“. They want to know “the
bottom line,” meaning what kind of return they can
reasonably expect from their investment.
Now, I’m certainly no expert market analyst,
having only recently learned the difference between
a “bull” and a “bear” market, But, based on join?’
facts that recently came across my desk, I’d say that
the outlook for those looking to invest in the dietary
supplement industry -- or for those retailers and suppliers who are already a
part of this marketplace -- is quite positive.
Yes, the “numbers” look good with respect to dietary supplements. What .N
numbgrs? I’m referring to those numbers appearing in the annual “U.S.
Market for Vitamins, Supplements and Minerals” report published by the
New York-based research firm, Packaged Facts.
Our news story on this important report begins on page 6 of ,*.,
^_.*a this month’s
issue. Some of the highlights I personally found most“interestmg mclude:
54% of the U.S. adult population used sotie type of d’ietary supplement:

product last year, up from 43% in 1993. This is a significant increase in Sup-
plement consumers in just a three-year period. It wasn’t reaIly very long ago
that dietary supplements were considered by many people to be “&G-teceS-
sary” or even “useless.” Now, the majority of adult Aniericatis use d’tir itidus-
try’s products!
Total US. sales of vitamins, minerals and dietary supplements have

increased by 75% for the five-year period ending in 1996, with overall sales
now surpassing the $6.5 billion dollar level. And in the next five years, this
amount will nearly double to $12.3 billion, Packaged Facts plojeds. ”
More than 800 new dietary supplemefit products were launched in just

the first 10 months of 1996, compared to 379 new products in all of 1992. This
is a sign of a very robust industry.
Despite increased retail competition and the rush among many dietary

supplement suppliers to introduce their products to the mass market, health

and natural food stores are still doing quite well. These stores command a
38% share of dietary supplement industry sales, ranking number one in sup-
plement sales for all retail ‘outlets. Their clo&tcompetittirs (drug stores) ’
came in a distant second at 20% of dietary supplement sales, followed by
mass merchandisers and food store’s. The main reasons cited for the,,strength
of the health food stores wkre that these outlets. _..
do the best jdb of introducing
new products and educating consumers about dietary supplements.
Key demographics and lifestyle shifts bode well for the dietary SUppie-

ment industry: aging baby boomers looking to “stay young,” increased inter-
est in preventive medicine and self health care, and less trust of the medical
establishment. In addition, positive scientific research findings and changing
attitudes toward dietary supplements among the conventional medical com-
munity are also positive signs.
These and other facts as presented in the Packaged Facts study all add up
to a very bright outlook for our industry.
As I said, I wouldn’t know Dean Witter even if I bumped into him while
crossing Wall Street, but I’m prepared to issue a “buy” recommendation for
dietary suppIement companies and products. The numbers look very good!

4 l
APRIL 1997
Reflects, Sfrong
Retail sales of vitamins, supple- By the year 20011r&l sales in the
ments and minerals (VSM) surged VSM market are expected to exceed lndu~fr y Growfh
past $6.3 billion in 1996, according to a $12.3 billion, for a CAGR from 1992 to The blue skip< and warni w<afh&
new report by -the New York-based ZOO1of iX2%,“th&
- ,,,._.‘+b~ iepo;t say;. of Southkm‘ C&fo&a are hard to
research firm Packaged Facts. The .’The steady mtroducfio;i ‘of tiov- resist;” especially d&i@ early March
company’s report, “The U.S. Market ative products is a primary marketing when much df the country is still
for Vitamins, Supplements and trend in the VSM industry, Packaged experiencing winter. Add in a busi-
Minerals,” was releasdd last month. Facts Notes. Iri’ C990, oniy357tj;-M n&? *fexc’tisk” for visiting the area,
product were intro- and it is hardly surprising to find that
duced, but ivell moie than 24,000 health food industry
over 800 products members made the trek to Anaheim
were launched in for last month’s Nitural Products
the first 10 months Expo West trade show.
of 1996, the report According to show organizer
states. New Hope Communications,
In 1996, 54% Boulder, CO, approximately 24,600
of the U.S. adult retailers, distributors, and other mem-
population used bers of the natural products industry
vitamin, supple- from around the country converged
ment or mineral on Anaheim for the annual Expo West
products, up from show. This represented an increase of
43% in 1993, accord- approximately 2,000 from last year’s
ing to Packaged attendance, New Hope said. This
Facts. Most U.S. year’s show featured some 1,200
adults who take exhibitors, which was 100 more than
VSM products are last year, organizers added.
classified as “medi- Most observers said the foot traf-
urn users,” n leaning fic on the trade show floor kept up a
According to Packaged Facts, they take a VSM product on& a ‘da;, s’t”ady pace throughout the thqee
sales of dietary supplements the report notes. days of exhibits. Many exhibitors
increased by 75% from 1992 to 1996 commented on the fact that the usual
for a compound annual growth rate Breakdown By Prod&t Type “ghost towti” effect that- te& to
(CAGR) of 15%. Packaged Facts 16 1996, sales of vitamins tirere of&r abdtit‘& h&r befbre the end of
attributes this growth in large part to placed at $3.5 billion, compared to each exhiijit day hid not seem to hap-
the passage of the Dietary $2.57 billion in’ ‘i492 (8% CAGR). p&n at this s&W.-’ fie>;’ noted that
Supplement Health and Education Vitamins”accdiint*~d “for 54%‘bf \ot‘$l ‘hen’ on tlie‘last day of the show, a
Act (DSHEA). VSM sales, Packaged Facts reported. sfeady stream of people kept going
The fastest growing segment was Vitamin sales are expected to Z&tg.
supplements -- defined as herbal reach’ S4.S billion ~by the year 2001, ’ ” Bill Johnson from Henkel
products, phytonutrients, essential P&&agea Facts states. -C&poration quipped: “If this is the
fatty acids, hormones and other prod- Supplements generated $2:3 bil- ‘go away day,’ then no one’s going
ucts -- whose sales more than quadru- lion in sales duri@ fg96, a ‘CAGR df gtiay yet.”
pled from $570 million in 1992 to $2.3 almost 42% from 1992 when sales
billion in 1996, for a 41.7% CAGR. were placed a‘t $57O‘million. These Success, But Some Frustration
Herbal supplements and “VSM” com- products accounted’ for “35% ‘bf <‘all The general’ feeling among
bos -- new combinations of vitamins, VSM sales in 1996, the i;e@t stated. ^ exhibitois and attendees al&e was
herbs and minerals -1 are contributing Supplement sales Will ‘reach. $7 that the show was- a success.
to this category’s growth, the report billion by the year 2001,. the report However, factions of the attendees
(Continued on page 8) (Continued on page 8)
I A ;, ,l I ., .( ,___ _ 2 :.. I ,‘..

* David Kessler, M .D. & p# Elizabeth Vetl$y

Food and'D?ug Administr~kibfi I^
-4 Re: Proposed G M P 's. Under DSREA
'November 20, 1996 - _
Page 2

In short, isn't allowing the Dietary‘Supplem ent Industry to

develop GMPls that will be adopted by the FDA like letting the
fox guard the hen house? Worse, by abdicating this
responsibility to trade associations.,which~have bee,n less than
supportive of the FDA's, attem pts to regulate this industry, isn't
the FDA placing the,public in a potentially dangerous situation
that the FDA hasa responsibility to prevent?
As a trial lawyer 'with over a d.ecade of...e,xperience in the
asbestos litigation, there are num erous-parallels between the
trade associates invp~~,~,~,"in~~~eldping G M P 's and the trade
asSociations that ~were inv,olved wi.h,"safe ds~~~~~~s"-~hr'~s~ol_dr,"
& "'.o tim es :~g~y/;.<&gi.,.i;ls&d;E.6~, rn-,>ii. >,%"9 ,
values. I cab a&q+ "you;
associations propose guidelines that were pro-public safety.
&Given the trem endou-s ;im ourit of m oney involved in the dietary-
supplem ent industry, coupled with the.~f.act that the indiv,id.uals~ _
representing these trade organizati0n.s are-em ployed by the very
com panies the"FDA is attem pting to r‘egulate, it is inconceivable
that these groups will be able to&put "aside their bias and
develop G M P 's that will provide the public with the protection
they need and that the FDA has an obligation to provide.
Why can't the F,DA engage people who- are involved in
conventional food industry to assist in developing G M P 's
especially since the G M P 's presently in effect for dietary
supplem ents are based on this,.,indu,~stry's standards. For exam ple,
what is the Good M anufacturing Practice in the conventional food
industry regarding the use of senna as a fo,odadditi+ve?, ,,Joes~.
anyone in the FDA even 'know? ,,,Given.GN,C's I/ contention~that
"_\,._.lL**/,,. . >./ I,theses
^ " D__.,,, e _ i. /'
Diet Teas com ply, I suspect that the G M P for..senna use will be a.
For exam ple, according to the California FDB report, the
conventional food industry reported using less than three. hundred
pounds of senna a year. According to sworn testim ony of a
Zuellig Botanical representative, who by the wgy, employs Dr.
Fran Ertl, who is representing
.,,.. , _,__
J.I.-.", AHPA in --develop"ing
l,ll..‘// new'-GM P % , 1
Zuellig supplied'an 'average of?"lbd;*d0~O,pounds of henna to Laci Le
Beau for use in its Super Dieter's Tea and., fqrJ+e .in 'GN;C,'s
Twenty-Four Hour Diet Tea, re-branded by Laci Le Beau. As you
m ay know, Dr. Ron Thom pson, of GNC is,representing both the CRN
and NNFA. is developing G M P 's. These com panies ali m aintain that
the use of senna m eets the,appropriate GMP.
In addition, to .ha.v,i,ng experts from then, conventional, food
industry involved, why not have experts from the A m erica-n
Botanical Associatiqn inv,o,lve,d? D,,r, varr,o, -Tyler, one of the
wife's of ,the ABC has describedthe
aeat,; as a, h;a,k*; jyT'-g ‘&- tj-'e" gg& j-r$&c~ 'Diet Tea involved
that Gficitiini;*~
;:. , ,*.A
rA,v&& my
: -4
other com panies claim ,.c&m plies wifg= ~~-gyy@ ,~fJ$lKGf,,g+u_ring
Practices for the use of. _senna; " _,.V.,‘/_>."Has- dnyone
L,.:.,~~,++ ‘. asked
,. * him .to~_be -.
,. 1,


David' Keksler, .M'.I);“. -& Elizabeth Vetley . *

Food and Drug Administfation ")
Re: Proposed G M P 'B Under.DSHEA
-4 November 20, 1996 _ - -
Page 3

. .
involved? (See Exhibit C)
In short, to proceed in the m awgg in which the ,,,,,FFL is ,..-
heading, is but another step in the wrong directionby the FDA to' -'
see to it that this industry and the products"it m anufacturqs
are safe for public consum ption.
Indeed, in light of recent news arti,cW, ,,in~,,&c,h, the FDA
took the position that, it's hands are, tied .,from ,.,+d,qi"ng anything to
rem ove dangerous dieta.ey supplem ents from the m arket ,until~,there
is enough evidence to prove'a product is dangerous;'doesn't"
allowing this industry to propose G M P 's increase this burden?
I hope that the FD&,,wi~ll. see the folly
i9.. and da;;e;otn
allowing G M P 's to be form ulatedin this
^_,,, fashion. , .._^* +1,,#,/^ c 1 hope
i that the' FDA will at'least t~ell,~tLhe~,~public the truth, i.e.-that
the FDA has no control of this ind,us,try and that the FDA,has
decided to let.this,"i~~d~t~y regulate itself. This way, the
public will at least know." that things like GMP"s were developed
by biased people representing
^. the industry that employes them
instead of people who have-the publics safety at heart.
As .an aside, would you please provide m e with,that,
I canprovide a publid‘com m ent 'before,~.these ‘new,G&P'Zs‘t,ake
effect. In fact, please include this le_tLer,. &-J the~ "I ,,,cc%!en&
1 ___,
opposing the G M P process in case I do .wt receive j . . . / nqtice a_,~,h,aq.b, __
happened in the past 'tiith'other FDA" hearings.
Thank you. A

CEG:yb _
cc: See Attached List ~ _ _ ,," _"

4. 21 C.F.R. Part 7, Subpart C, “Recalls” to production of the ingredient by a particular 14. New section 402(f)(i)(C); 21 U.S.C. $
5. 21 U.S.C. 5 381 cpmpany, and that there is no rqson Jo believe 342(D(lXC). If the Secretarv declares a dietarv

6. New 5 402(f)(l)(D) of the FDC Act, which that all L-trvotoohan (which is, after all, an es- supplement or d’ietary iti@edient “to pose an im-
cross-references$ 402(a)(l) of the FDC Act, 21 sential amitiya&) is cotiprehensively unsafe. I minent hazard,”the agency must promptly there-
U.S.C. $342(a)(l) am a lawyer and not a toxicologist, and f do not after conduct a? ~c$ir$st&ve proceeding to re-
7. 21 U.S.C. rj 342(a)(3) have the scienti%Ykxperienceto take a position view the merits of this conclusion.I)ucing the pro-
8. I want to be clear that I do not representAlliance on the merits of the factual this situ- ceeding, however, the product could not be sold
U.S.A. and that I have no dir&t knowledge df the ation. Mj; fioik’in this paragraph, however, is to the public. The law does not provide any simi-
merits of this particular maker, including-whkhtr simply t&t set&X 402(a)(3) has provided FDA lar “in+itie~t f+a$” a@ority to the Secretary
Alliance U.S.A. may have had a sufficient basis an ample and sufficient basis for stopping alto- with resDectto conventional food oroducts.
to defend its product from FDA’s allegations. My gether the introduction into U&d, $?tes, corq- 1.5. ,21 U&k. 5 34?(a)(?), (4)
point in this paragraph is simply that sections tierce of a dietary ingredient to which the agency
402(a)(l) and 402(f)(l)(A) of the FDC Act pro- currenily objects. (The samesection of the,law-
vide FDA a basis for ia!?ing prompt tid &zF,es- i.e., &&‘402($(3) of the FDC Act - could
sive regulatory action when it believes that a di- also bj: used bv.mA to siiodort’a ‘civil seizure
, I.

etary sripplement product is dangerous or other- action-or to recoq-qend the initiation of an i?- ,.-Stephen H. McNamara is a partner
wise unsafe for human con:umption. junction action or a &$&I p;oYecGGnkiti;“& with ihe law firm of Hyman, Phelps $2
9. FDA Impprt Alert No. 54-04, “Automatic Deten- spect to a pioduct that is in interstate commq~~ McNamam, RC., a Washington, D.C., firm
tidn of L-Tryptophan” (issuedMarch 22,199Oand 21 U.S.C. $1331-334.)
still in effect) Il. New section 413(c) of the FDCAct; 21 U.S.C.V which generally confines its practice to as-
10. I understand that there is a viewthat is strongly 350b(c) sisting corporations and other law firms in
held by many within the dietary supplement in- 12. New section 413(a) of the FDC Act; 21 U.S.C. $ mptters that,_,.conce? [[heregulation offoods,
dustry that this import alert is an unreasonabkand 350b(a)
overly prohibitory measure,in that the problems 13. New section 402(f)(l)(B) of the FDC Act: 21 drugs, medical devices; cosmetics and re-
that were experienced-with L-tryptophan related U.S.C. 0 342(f)(l)(B) lated products. _


The U.S. Food and prug Administration Section.9 of the,@ary SuppIementHealth Thompson of General Nutrition Products
(FDA) has acknowledgedand will soonpub- and EducationAct<*. of_.1994^_,)I (DSHEA) autho- participatedasa representativeof both CI$N
lish a proposalfor good manufacturingprac- rizes FDA to establish ^.“.”” ‘,.new
”.e, GMPs designed
(, and NNFA. M i#a$i$$uffin ahd,Dr.Fran
tices (GMPs) developedby a coalition of or- for d,i$ry supplementproducts but based Ertl, and Jeff Hinrichs representedAHPA,
ganizationsin the dietary supplementindus- on current food ,.. j,GMPs,
--.* and Loren
.,/.dI‘.S,WII,, Israelsen,
A.~.< 4. 3_I ExecutiveDirector, rep-
try. In a m id-July meeting Dr. Elizabeth Shortlyafterpassaii of DS$IEAmem- resented UNpA.
Yetley, Director of FDA Off& df $<%I ‘b&s bf die four major industry tradegroups G&s Z hroceduresthat manufac-
Nutritionals, announced that FDA would that manufacture and market
~I -_“*.._.~_“..ra”~dai,@~.dAs+. dietary
.,.,ii?&,“*,a&. /_, supple- tures must fcWw to en$Je quality control
publish the proposedGMPs for public com- mentsbeganto meetto developCfi?ps: nci’ arid ‘qu&ty ass&a&& GMps in@& mea-
ment as an Advanced Notjce c& Proposed are the American Herbal _j,-6”.Products ,._ _<,-- ‘~,suies
‘S./.i _^_;a>Associa- _,,,
i,*.*. designed
i to assure sanitation of the
Rulemaking (ANPR) in the Federal iiegis- tion (AHPA), Council for ResponsibleNu- manufacturing.fa&lity and all production
ter within the next few months. trition (CRN), the NationalNutritionalFoods equipment, testing or other procedures to
-.’ ^/’‘.
Until now, manufacturers,of dietary Association (NNl?A), and the Urah Natural ensure accurate 44;identity
e/li I. I,.-L1a*~,-**,?and quantification
supplements(which include yitarni_ns,m in- P:y~.~~~h&~l$y:,(UNl+V. The
..” ,. ,“I effort was of all ingredients, requirements to assure
erals, herbsand similar pro&s) have been chared by Pul BolaiX Pharmav+ Corpo- prop& labeling,andothermeasuresdesigned
subject to the same GMPs as required for ratiqn, a member company of the Council to assyre@$t 6&K5is x .__. ti&. provided with
*I __/.
processorsof conventionalfoods, l@nufac- for ,ResponsibleNutrition, and was staffed safe,properly labeleddietary supplements.
turersof pharmaceuticals,on the other hand,’ by Dr. Annette,Dic&i~~on,CRN’s Director According to NNFA Executive Direc-
mustconform to much morestringentGMPs. of Scientific and Regulatory
. “W.’L*_j.‘eF~. Affairs. Dr. Ron tor M i&ael Q. Ford, “FDA’s acceptanceof

our industry’s draft is a giant step and a sign years the American Spice Trade Associa- ing are’fairly standard for alldietary ingre-
c - ‘*e maturing of the industry’s relations tion has worked out with FDA the DAIS d&s.’ ‘When it comes to‘iden&i&ion how-
\ the agency. A major goal of the fram- for major spices imported
I,“,~,. into the‘U.S. ever,there are mz$y herbs fbr which chemi-
ers of DSHEA was to see industry-backed FDAhas questionedwhetherDALs Setfor cil’*i&8y& does not exist. HistoricaIly,
spices are adi;i-.ife for-bdta.c;fs ii;‘& “
standardsas the starting point for GMPs with I_ -,ii .~. manufacturers‘and practitioners have relied
the force of law. By using our draft as an etary supplements. I upon’properly qualified staff to perform or-
ANPR, FDA shows its respectfor our indus- * ‘FDA’staff qu&ti&ied whether certifica-’ ganoleptic’[recognitionby’sight, smell, taste,
try that wants GMPs to be issuedpromptly.” tion in lieu of testing of raw materials is etc.] arialysis. We, iveie’ iible to in&e’ tI;‘fs
At the mid-July meetingbetweenFDA adequate for”filih, microbial content”“and “point”to’the other cdriimittee members and
and members of the four organizations that identity’of raw ma&-i%1 “?‘hat”is~can .a to include language in the-&& prop&alto
compiled the draft GMPs, Dr. Yetley and Dr. niandfadturei~o‘rprocessorrely on.a cer- recog?%e mechani~ian’ me validity’ of such identification
Robert Moore of her staff indicated that they tificate of analysis supplied by a’seller di: zxcO~unlcatlo,~~~~~~~~~v~~~~~~~~‘ !
_.\.(“,l.,.4,, p‘‘e.. ~~t~
had circulated the5ndustry’s GMP proposal importer as sufficient ‘basisto‘“dete%ine mA; $?his and Gih;i y,Agi ;;;?] .%c;~o~~~ ). . ‘I_;,
amongFDA staff inside and outsidethe Cen- the
dieny cleanliness
inst‘ead’bfand/or identity new
petfbtiKi of anand
mgre- “. .._-.I __
in * r_”
requ*re ,..“.A
fu*era~~~~:‘ f;ii*,~~~a~~~‘,~~~~~~~~ ,, :
ter for Food Safety.and Applied Nutrition. ,tiii.~~~:‘,;i~~~~~~h~~.‘~n ihe. F
The ANPR when published will note some some casespotentially’dre-
of the specific concerns raised by FDA and dundant tests on all ingredients? !
Federal Register there will usuaSlybe a 90
will invite comment on wheth_erthe public l mA’is ‘co;i&ne&b’~~t &i;iew and ban- I
to period forl$&ic‘con$nent after
sharesthe same concerns. l dling of complaint filesandraisedthe ques- which FDA will publish proposedtentative
tion whether there is a need for medical GMPs. ‘and’ultimately a final -regulation. 1:
SOME OF THE CONCERNSiAlSED evaluation of complaints. Many manufacturers already wilI have
BY FDA ARE: l TheStandardOperatingPr&ceduies‘ .I..- ” (SOPs)~
xi geared‘cae;;‘-~an;l~~~~~~~~~~‘proEedured to
l The need for more specificity in various of the proposed GiMPs“will not requtre accon%iddate‘thenew standardsby that time,
areas. records to exist to assure SOPS are fol- The new level ofGMPs will 1Xely have little ,
. Testing to assureidenty, especiaIlyfor bo- lowed. Are written records needed? effect on-many
uc;tS*‘(<‘g&ifready manufacturers
_./ ~_“‘
j.__^. of herbal
fo,loG;i~~,.&~GMps. prod;
tanicals. FDA recognizedlimits on l Controls&e neeessaj to”assurethat corn-
industry’s ability to identify some ingre- puter-assisted’opemtions are working -.’ r:
r;a;non@-&~-~ggf-* FDA .., ._ to
~. p&l;sh x;
Its but neverthelesswants a more de- properly. FDA may require validation of
.,.led approach. such operations.
_, . NNlXIndustry GMPs: Newport Beach,CA: .“I.1_,,
* Defect Action Levels (DALs)--FDA is NatidnalN$-itional FqOdsA&n., July 24.
-~.~iv~iiso~*;4.-i*“gg~~p,,,,a1;~on~l commu- 9
concerned about DALs for botanicals. “It was clear
represeriiaiiSes‘ to Dr. Eitl and~~i~~l
~~,~~~A~~~~t‘ myself
‘iwe~as nic~~io~,~S~pie~~r”~~”II ,: .‘iS ‘l.“^,,,-:--,.,.,,,. / r
DALs deal with maximum levetj of for- ,, .I ”gfiG;Kn, Mi: rgg6 ~person~com- I
eign material that are’allowed in’botani: diknts present some
establish6ent unique challengesinscih
of meaninifGlhGMPj., the ‘miinicaGor;;Septenii;ii:gf~‘
cals, which in their crude state by nature
are raw agriculture products. For many issuesas facility sanitation and record keep-


._,l_, ._,\._ '-
by Mark Blumenthal and Ann2tte Dickinson, Ph.D.

The long sagaof the controversialherb sultants to the Food’Advistiry Committee, per daily”mtake. .;.. ‘Ilie Working Group also
mahuang, also called ephedia (E”hed~a haa bet ;revibuslyjri (a.j&-; 1gg5-mdhad madeother recommendat& including the -
. ., ,~.?
rinica), continues. On August 27-28 the concluded’with“*w,,,. the iecotiendation
>.“” that
”I,:,,.Y ~s**.y3 .<need’ foi”adequate’ w&$ingson ephedra-con-
,. nq.2’ -‘g*l;ioducts, sizlti .*fb.wha( thi h‘e^ib
Food and Drug Administration (FDA)’C&y * 8&l%‘tei-$%rous reportsof adversereacaons y‘ indGiti71ha‘d *p;ev~~o*usl;;.recom~~~~~~- . -.
VC its Food Advisory Committee Meet- to commercial dietary supplementscontain-
i;;g.‘the ‘Ker$.*z&;an,o, *e_* herb
<_-/I shoild..not
:ng on Ephedra-Containing Dietary Stipple: ‘” <,L,._‘” (Blumenthal, 19%):
j il ,“A”,
nents. A Special Ephedra Working Group, be-banued,but,%%ad, the levelsof the ephe- _.” “‘Despite a highly publicized death of a
:he members of which are considered con- dti alkaloids‘shouldbe limited per&e and 20-year-oldcollege’smdentin March from a


- :,. d
Regardin: what FDA Will eventuaily -REFEREf$Xs AND ScirrR<$s”“=’
.:propose,Ford says,“I think tliey’ll come out Anonymous. 199h. E$iwkine Akloid ‘SupplementSafe
DoseCannot Be Identified. rite 7&S&r. Chc$yCChse.
somewhere between Canada’ssystem and XiD: F-D-C Repot-b Sepr. 2. Davidson, bfichacl H. 1996. Sutement Before the F‘&
Dr. Croom’s recommendations-no addi- Anonymous. 19965.YSetious Adrerse ReactionsReponed visory Corn&tee and EphedrineSpecid \Vo~ortine
for EphedrineSuppkrxnts ic, I-5 big Range. The Ton Food and Drug Administnrion. hfceting on Fo& P
tives, lots of warnings, low dose,no claims. Sheet.Chevy Chase.MD: F-D-C Reports,sept. 2. ucts Cont@inp E$%~;‘.&loid;. August 27.
If this happens, this could kill this product AnOll)7llOUS. 1996c*Ephdine AIkdoGJSafetyAssunnceDif- Dickinson. A. 1996. Food Advisory Committee hicetin;
RcultiesHighlight DSHEX~*&itntio+ ~l,e %gSl&. ” EphedmContaining Dietary Supplements:Summaq
1 cate,oory.There hasbeena lot of irresponsi- Chevy C+c. AID: F-D-SRe&k, Sept. i. .’ _ Commentary.Washington.DC.: Council for Respons
. l$ity in the industry by both suppliers’and Anonymous. 199&l fydiFo$~Herbal hledicinis Category NWiti00.

Might Be&t Ephedn Regulation.77re& .$&. Chevy Food and Drug Administraalion.1996. PressRelease:SL
:-,,retaiIers. There have beentoo many suppli- ment on +cet ,Drugs Containing bdcanical Ephec
Chase,hlD:F-D:C Reports. Sept. 2..
‘ers that have not usedthe quality control that Anonymous. 1996~. Cpntinued~Ma$eitng of Eph&ine April 10.
they should and have not used the warning “Slreet Drugs+’is %resjck+,.“~~k 7% Slreer.Chevy Ford, Xl. Q. 1996. Pcnontl communication. Sept. 3.
Chtse, ,LfD: F-D-C Rcjzaxs,Sept. 2.
language th’at they should. Many retailers rinonymous. 1996L FDA Eph+ Hearing Used as a Forum
have ‘not taken the time to acquaint them- to QuestionS‘upp’lemen~and’dl~~otRepsdofDSHfA.
Mark &rnrer~thal is Founder and E
selves7with the safety problems associatid SpecialFG”prr. Bbulder. C’6: Cikens fokH%th,“d”;“& ecurive Director ofABC and Editor of Her
30. ,_ _,./ M, I ,,.b alGrain. Ar&ette Dickinson is Director
with theseproductsandinform their custom- Anonymous. 1996$‘Eph?d% ‘&fdpssed $1 FDA Advisory
er: !boot the potential adverseeffects. The Conmiitce hfeering. X.vE4 Todo< N&$arr E&h. CA: Scientific andRegulatory Affairs at the Core
Notional Nutritional FoodsAssn.. Sepr cilfor Responsible Nrrtritio~~in~Washit,gto.
FDA may be the one who may be taking this Blumenthal.M. 19961FDXH&fdX.+&Advisory Commit-
product category away, but industry needs tee Hearing on hq ~u%~:&perts Recommend~ppro- D. C.
pria~c Labeling and Warnings- ;4’ork&~~ th> Herb.
to take a hard lookgt its own quartersin this HubalGram 36: 21-23.73.
a&a.” (Ford, 1996jo


,,. I ,,,. i,,,, ,.
Bow& to pressurefrom the NeEjraskaPhar- sales of all dietq supplements containing ,Pro,ift
macists Association, the NebraskaLe,oisla- ephkdraor ma”‘huang(Ephe& &tica), re- ProRipp$
ture passeda law July 17, 1996,categorit- gardless of the product claims, aIthouph Quick Shot Ene;GeIs
ing any materia1, compound, mixture, 0; FDA-approvedOTC drug products properly Ripped FueI
preparationcontaining any quantity of ephe- labeled and mtiketed maj rem&n on store Super Chromaplex
drine. its-salts, optical isomers,and salts of $$es. ^’ .” ^) ThemoGenics Plus -adrenalsupport
optical isomers as a ScheduleIV contri;lle;i ‘__”1 i ““,Q+L< .+i--.,+ I ,I : eri:.- ,~j,._“,-c.*<,-,\^
- df1&.‘i :A~ ““*b-P”
>i”M.3~.“--,I UltF? Diet Pep
substance. Schedule IV coritrolleh”jub- Tne NebraskaPharmacistsAssociation Up Your Gai
stancesmay-only be dispensedwith a writ- has circulatect ‘ihe fdihtiin$ iist “bf
ten prescription. ephedra-con@.ining products “ma&e&d f& This list does not cover all product:
Exempted from Scfiedule IV status vitaiity, energy,improvementof leanmuscle affectedby the law which GsoId in the hert
under the new law are ephedrine-containin, mass,etc.,”which~wc+dbejubject ib Sched- and heaIth food markets’.The law went intc
drug products which may be lawfully sold tile’?~‘~$~~~~~&hany retailers, inc&ling effect Ju!y-l9; 1996. ;-
over-the-counter(OTC) without‘8 prescrip- health fqpd,~~~res,%Ke&GkZ ” The NebrasFa_State Patrol has beer
tion under the FederalFood, Diu& &K!os- 24 Hour Diet
‘. ._“. .(..... _lw,--l--.I DietGels informed of the char&in the law and ma)
metic Act; are Iabeledand marke&d’i&dr$ Buzz’s Bombers enter heaIth food stores to determine com-
pIiance with an FDA-issued 01% final I &i’&wer pliance. Possession and sale 01
mono,g-aph or tentative finaIWy?5!pgraph
OTC bronc~~~~~~~‘;~~;i;i~~j;aremanufac- (i.e., Diet Mti ephedrine-containingpioducis- not exempt
,_ Diet Fuel from ScheduleIVstatus may r&uli in felony
turecjand distributed ~o~~“Ie~iti~na~~m;hici- Ener-Max prosecgon.
nal use”in a mannerwhich reducesor glimi- EnergyRise -*-
nates the IikdliIiood’of ibu&i &&$‘~ot Ephedrine-Plus’ [Anon. 1996. Nebraska Enacts Ephedrine
marketed,advertisedor I~beled~fo?‘&e indi- EJxceiEnk@ ” _“.- Law to Go &to Effect Ju!y 19, 1996.
cations of stimlIation, m&ii3 &%i&~; ~’ -’ Extra StrengthGuarana WA, Newport Beach, C&for%a.
weight Ioss, muscle enhancement,appetite Mega Ripped Stoker, S. 1996. Personalcoi3munication.
control, or energy. - Metabolift I July 22.1. 0 .
. As enacted,this law will prohibit the Nepegen ,
The Board of Trustees of the American Bdtanical’Council in ,; ,.‘“, ‘The
,_r ._ ‘-~.~, Board-of
, u*^*,“i.i^-‘ l~._‘*_lP
I,.* fmstees’also
j((..,_announced the
.“.~,“;‘~~~,..“:‘ ... election
: .x- * ofvarro E.
June announced the formation of ABC’s new AdvisoryBoard. Thrs Tyler, Ph.D., as a trustee.~‘ .,..._I ~j&r~~s the Lilly Drstmguished Professor
group constitutes some of the leading researchers and educators in of Pharrnacognosy at Purdue University and author of several lead-
North America in areas related to herbs and medicina1 plants. The ing herbal‘books.
“- ._ atih’phb”’ , #& “.ti.i;it;k”rs’
ABC Advisory Board members will assist in. ~uggestmg. -, _. _I. ./
’ . boardare.*isteh
bslow. .-_AddIt*ona”q;G6.;
1 . ., I I i M$W”‘gma&&.$~M&f”i~~ future*
ning research and educational projects and pubf&tions as well as
provide p:er review for HerbalCram.

Dennis Y C Awang, Ph.D., F.C.I.C., MediPIant *.Steven

.i ,.I.>,= Botanist; photographer, author,
Natural .Products Consulting Services, Ottawa, Fayettevrlle,Arkansas
Ontario, Canada
Christopher Hobbs L.Ac., AHG, Herbalist, $Iark J;‘Plotkin,Ph.D, ExecutiveDirectbr,“Eth-
Michael J. Balick, Director of the Institute of botanist, licensedacupuncturist,SantaCruz: Caii- nobotany’ar;aConsertion Team,Author;ArlinS-
Econ&nic Botany, the NkW York Botanical Gar- fomia ton, Virginia
den, Bronx, New York ”
-* -. David Hoffmann, B. SC.;M.N.I.i%I.H., Med2al Eloy~BZlrigue~, Ph: D.,‘.james Perkins Profes-
Joseph M. Betz, Ph.D., ResearchChemist, Cen- “herbalis~~S,‘Santa
California sor of El?viron,~entalStudies,School ofA&icul-
ter for Food Safety and Applied Nutrition, D&i- mre & life Sqiences,Come11University, Ithaca,
sion of Natural Products, Food and Dmg Admin- MauiiCe hi. IwU, PI&X’, Biomsources Develop-
/. I .--‘“w*,x--.aqv i^ New Yoik ’
istration, Washington, D.C. mentand C%nsetiatioiiPioSram,Semor Research
_.**a.“( at G,,the Division
, ,~^_^ of ExpetimentalThera- James E. Simon, Ph.D., Professor of HOI&~- ”
, ” ., .” _,_,_)
Donald J. Brown, N.D., Director, Natural Prod- peuttcs,Walter ReedArmy Institute of Research, mre and Reseea%h
& P,a;;t”Prb”h;“~ls:‘ Director, Center
~~~~$uk for New Crops
.u..;v;.~ii, West
ucts Research Co,nstiltants,Faculty, Bastyr Uni- Washington,D.C.
versity, Seattle, Wasliiringion Lafayette, Indiana
.,x. _^_” King, Ph.D., SeniorVicePresident I/ I of.“,~,~~l~._
Manuel F. Balandrin, R.Ph., Ph.D., Research nobotanyand’Conse&ion, ShamanPharmaceu- Be@ Simpson, PhrD:;‘6. L. Lu&.ii Professor
Scientist, NPS Pharmaceuticals:SaltLake city, ii??%, South San Francisco, California of Botany, Department of”^nivkrsityof
Utah Texasat Austin, Austin . .’Texas
Fredi Kronenberg,
.“.,..e_,.e, il>“a..sY%h*_.Ph.D., Director, ~kosentha‘ l
Thomas J. Carlson, MS,, M.D., Senior Direc- Center forAltemattve/Complementary
t (A, * Medicine, S. H. Sohmer, I%.D:, F%sidentand’Directot(Bo-
tor, Ethnobiomedical Field Research, S’h%an “~%$?of Phystctans& Surgeons of Columbia Texas tani~al’1Research‘” Institute‘of 1T’&&%TFog’Worth,
Pharmaceuticals, South San Francisco, Califor- ‘University, New YoKNew York ”
nia _._ __
Tom Mabry, Ph.?., Professorof Plant Bioctiem- Barbara N. Timnierm~n, Ph. b., Professor-of
Jean Carper, Author and syndicatedcolumnist, istj, Department of Botany: University of Texas Pharmacology -& To%olo,oy, College of‘Phar-
Washinpton, DC. at Austin, Austin, Texas macy, University of Arizona, Tucson,Arizona
g‘lcI: rir&~rd;.Ari;$.yDI; A;$--6i Emkniui’~F. 1.
Jerry Cott, Ph.D., Chief’
.,z- id*-“...x
Treatment Research Program. Nattonal Institute ~~~~~~;B‘iiian~Deijarrrnent, University of Biit-
of Mental Health, Rockville, X!aryland ish Columbia, Vancouver, British Columbia,
Canada j,
Paul Alan Cox, Ph.D., Professorof Botany and Dennis ‘J.‘ M6Een”na; Ph.D;, Consultin,b
Dean of General Education and Hbnors;Bri,oham Ethnbphannacologist,Minneapolis,.Minnesota Arthur 0. Tucker; Ph.D., ResearchProfessorof
Young University, hove, Utah A&iculture arid Naturaf Resources, Delaware
Daniel E. ?vloer$tan, Ph.D., TKi
Pi;;~~~~-~~~~~iopo*~gy, William E. Stirton
.u;i’;i;;;itj;’ cf State aIUniversity, Dove<Delaware
Lyle E. Craker,Ph.D., Professor,Department of
Plant and Soil Sciences,University of Massachu- Michi&n, Dearborn, Michigan Nancy Turner, Ph.D., Pr&ssor and Ethnobota-
setts,Amherst, Massachusetts nist, Environmental StudiesProfqrn, University
Samuel I%! Page, Ph.D., Director, Division of of Victoria, ” ‘Yi~~~~a;“~~~~b’~o!umbia,Canada
Edward M. Croom, Jr., Ph.D., Coordinator,Phy- Natural Products, Center for Food Safety and
tomedicine Project, National Cenier’for the De- Applied Nutrition, Food and Drug Administration, Andrew T. Well, M.D., Author, Director of the
velopment of Natural Products, University of Washington,D.C. - Eo$%I & %&rative’ Medicine and Associate
Mississippi, Oxford, Missi$pi Director
bfeifici..gofgfthe Division of Social Perspectives
th;~;yfgmg$-~;gJ~Je, in
Gail B. Mahady, Ph.D., ResearchAssistant Pro-
Wade Davis, Ph.D., Author, ethnobotanist,Wash- fes@<~D$a.rt%entof Medical Chemistry & Phar- of Arizona, Tu&on, Arizona
ington, D.C. macognosy,College of.Pharmacy, University of
Illinois, Chicago, Illinois ad hoc advisor:
Steven Dentali, Ph.D., Natural ProductsConsult- DavidM. E$enberg, M.D., Director,‘Center for
ant, Portland, Oregon Julih.,E Morto,n, D.!+. F.L.S., Dire~~or,~Mprton Alternative Me&&e Reseamh,B’ethIsmel Hos-
C$ol$~nea,Uuversrty of Miami; Coral Gables, pii~arv~d’~~~~~S~h~~l~Bosto~, M/Iassachu-
Hardy Eshbaugh, Ph.D., Professorof Botany & setts
Assistant Curator, WillardSheii;;an’T’t$~~%er- .x , I, ,% . ,, _,. “i., _ ,_._.
barium, ?&amiUniversity, Oxford; 6hio . ‘.
1 I/20/96 Mailing List for Letter Re: Proposed GMP’s Under DSHEA - What is the FDA Doing?
” /_,.

The Honorable Michael Ms. Leslj,e Brinkley Ms. Kathy Ericson Ms. Kathy Ericson
Bilirakis *Km-TV Channel 7 West Publishing Company c-1:2O’CGs;‘27’
U.S. House of Representatives 900 Front Street C-1-20 Cube 27 West Publishing Company
4111 Land O’Lakes Blvd. Ste. San Francisco, CA. 9411 I- 620 Oppetman Drive 620 Oppetian Drive
306 1450 Eagan, Minnesota 55 123
. Eagan, Minnesota 55 123
Land O’Lakes, Florida 34639 2

Senator Diane Feinstein John, Gleason Victpr Herbert, M.D., J.D., Professor’Ryan J. Huxtable
U.S. Senate Center for Science and Public F.A.C.P. Department of Pharmacology
Washington DC. 20510-0504 Interest Director, Nutrition Center Health Services Center
1775 Connecticut Northwest, Mount Sinai School of University of Arizona
Suite 300 Medicine and Medical Center & Tucson. AZ 85724
Washington, D.C. 20009 Bronx Vet&as Aff$ _ Medical
130 West Kingsbridge.Rd.
Bronx, New York 10468

Ms. Jane Lee Ms. Patricia Long Mr. Rojs McGowan Ms. Elizabeth Moore
Columbia Graduate Student Health Magazine KTVU Channel 2 Staff Writer
362 Riverside Dr. Apt. 9Cl 301 Howard St., 18th Floor P.O. Box 22222 Ldng Island Newsday
New York, New York 10025 San Francisco, California Oakland, CA 94623 598 Byoadhollo-wRd.,
94105 Melville, New York 11747

Dr. Robert J. Moore bjs. Nancy Moore Ms. Judy Rybak Health Letter Associates Editor
Division of Programs & Bureau of National Affairs for Prime Time Live University of Californiaat
Enforcement Policy Toxic Law Reporter 147 Co$&us’Avenue Berlielki
Office of Special Nutritionals 1231 25th Street N.W. New York, NY 10023 P.0: BOX 412
Food & Drug Administration District of Columbia‘20037 Prince Street Stations
Washington, DC 20204 New York, NY 10012-0007

Senator Wellstone David Z,immeqnan Dr. Dean Edell, M.D. ’

_,..., Dr. Bruce Ijensel
Scott Adams Probe KF-v CQnnel 7 News, K+C Channel,.”(_.( 4
Mark Anderson 139 West 13th Street, #6 900 Front Street 3000 West Alameda Avenue
2550 University Rm. 100 New York, New York 1001l- San Francisco, CA. 94111 Burbank. CA 91523
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