“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 Washington Administration in the lobbying supplements i consumers. regulating halls --







certainly'within -is about

the province to I. take.c~,~ter.,stage as the result of,a about

of the Food and,,Drug again, vigorous how dietary this grass . of.‘ in time roots

of Congress It

campaign. sholld And it dietary

is the


3'. be m,ay~,e.~ed.,and,,,used in 1. ;_I_xbest _ I.interest the il "_A." is ,about the,,,,ro.e ' government should play


_L1 $5 the _,,_, I, The terms of the debatehaveevolved~~Xe~,~~ime~ “,,.
early Federal identify assure years, Food, immediately Drug, following the Act, 1938 passage FDA's concern of the and Cosmetic daily intakes was to minerals to !

appropriate that

of vita,mins-and

minimum nutritional

being needs were r.rv-1: ' met. I_j _. ,.,_ ;;.

By the - had shifted their levels "drugs." Amendment, reasons.



FDA's potency

interest vitamin


and the public



to high 'should were to


.and whether

potencies if-they

d.‘ _( ~<l':, ..ss:i r:~i~b'>~‘ rational" >. ,e> b,e limited..(. __ "nutritionally ^,._ to be marketed that

asp ll.foodsl'

rather with only

than the for Proxmire "* ,,, i 02', _ safety

Congress which

settled permits

$ebat.e.-in,I9~76 limit potency


The current different scientific by the


of .t,he dietary ones,. It's links

supplement the

debate emerging

is very new and~_

from previous


understanding ,"^ of the .il strong interest

between dietand have,~in improving

health theia808

many Americans

. -4


health Labeling first for



And, Act





1990 Nutrition the,. claims

and Education tim e authorized on food drug

in which Congress for , , FDA to allow'dise.ase-rela,tec! health and dietary process. supplem ent labels without


nutrients the




At one level, its new authority



is about and approve

how FDA should health claims

implement for by som e in any FDA

to review debate

nutrients. the role dietary in the

But the

has been m ade m uch broader who question of disease-related range of products

supplem ent prem arket for

industry review a wide

the need for health beyond -form of

claims, vitam ins m any of in which these and

including m inerals

claims --

such as amino


and herbal

products in the the

.which have no recognized nutritional.role . they are sold,. FDA's tools for assuring products are also under challenge.


My goal, today legislative the values debate, at stake public

is to from




of the It

forthcom ing is critical by the that

FDA's perspective. debate be underktood consum ers, is going FDA's role

in the health


com m unity, FDA regulates, in the

groups, Congress way -claims.

and the

industries alter of --


to be asked to in the regulation

m ost fundam ental health







But the beyond the

outcom e

of this


is important role.





particulars about the

of FDA's regulatory potential health implications role of diet,

The emerging specific of certain .

knowledge nutrients, diseases

including the risk

in prom oting has enorm ous

and reducing for public



is m uch to be gained we successfully


the health

of our

citizens on this account


as a society,

knowledge of both dietary

by m eans that the'benefits intervention.

develop and capitalize f . are grounded in science and take risks of any significant

and potential

There scientific unsupported health could

is also m oorings claims

m uch to be lost and allow on products proven the




our with

m arketplace

to be filled safety.

of unproven therapies dollars

The public's m ay

be at risk, and scarce

and interventions will be,wasted.

be passed



The critical supplem ent Supplem ent1 without * products be subject debate



in defining

the terms the



dietary ndietary

is to understand used. The term to

how broadly


is being

is unfortunately a very diverse and that

being spectrum m ay not

used of all

discrim ination that

to refer varying to the

pose widely



sam e regulatory

c c



The term vitamins

of course

includes minerals,

products substances

'consisting that have



and e,ssential

redognized can terms, of

well-understood be called account sales for

roles nutritional the great

in.nutrition. supplements. majority, dollajc claims and-at

These products In economic

fairly they the

as muoh as,80% or more, dietary supplement

in the multi-billion without disease -they

market. -is

When sold


potencies regulatory debate

i as most of them are concern about. to FDA.

are of no particular are not what the

And they


As used

in NLEA and the dietary
supplement" but also is held herbs,



only other This




to encompass not and and a host supplements; about of

vitamins products, broad

and minerals such as,high term it


amino acid the

use of.the

has confused lumps that together


and essential

regulation minerals that




many products

have no recognized or implied


in nutrition, and that
From a these than


bear express ,
for specific the evaluated




have been marketed scientific products nutritional standpoint, are better terms.

therapeutic benefits

purposes. of many of rather


in pharmacological

These products concerns than vitamin



more likely

to raise

public There are,


and mineral 4





many unanswered

questions last

about far& safe






supplements. scientific any of the

FASEB reported evidence amino that acid

that~the-re : upper levels market

is ,$nsu,fficient

to establish supplements

intake and it the-elderly,


on the

today, young, potentially


such products age, only

be used by the and other

women of childbearing
* ,e.% i

smokers, under





advic~e and


The need to underscored builders

address fact

the that






products to body


by the and other

many of them are marketed in )?ays that high encourage potency high


consumption. supplements typical

From FDA's perspective, are very

amino _.acid ,


different from the I. supplement.

So too are derived) While products

many of the herbal that are being cf

and other sold




as "dietary


some of these


famiJ.i,ar.food-use ."‘ ._<_,,>.l,"~.~.~,.l ar6 many ..^i, .",- herbs, food . "aj . _,. The use .? of some .herbs, plants. and chaparral the fact safety from

made from piants scientific especially


no traditional

literature those from

doc~,me~nts th,e,~to~$~city pyrrolizidine

alkaloid:containing comfrey, despite

Even such widely have been linked that their

used herbs with

as germander, toxicity, : I- I ,..‘ not

severe.liver use"had

tradition.aJ FDA recently

been . thought ..,,.. that chaparral

to raise


requested 5

be removed


the market hepatitis. source is





reported that

cases coming




The,se products no guarantee

illustrate , of safety.


a natural

Herbal products


are also

more likely their


nutritional therapeutic


be marketed prevention

or used for purposes.



no mistake.

5 other


have made real Digitalis (derived approved to describe

contributions from cancer

Herbs and .. to our therapeutic is is an old a new one. herbal "Immune Health

armamentarium. example. But it products Plus," Formula," is

foxglove) drug taxol

The recently a misnomer marketed "Arth-X

as dietary



such names as "Immunotonic," and Ligament Nutritional




200 Cholesterol


or "Acnetonic."

Finally, acids

lumping under

vitamins the

and minerals label "dietary

together supplementtf

with has


and herbals


to some rather press


rhetorical of FDA's

confusion regulatory


excess policies.

among the

and some critics

Some so-called."dietary nutritional fact that these role are

supplement" sold are for

products therapeutic drugs that fact

that uses. and as a

have It

no recognized is


products but that


properly springboard vitamin

regulated for the

as such, charge

some have-used FDA plans as drugs. to

to regulate Vitamin take

ordinary C by consumer's
l *

and mineral only!

supplements Or that


FDA wants 6

'away' the




freedom because rational, Proxmire

to chqose


potency consider


and mineral


FDA does. not even though Amendment.

such products is expressly

nutritionally prohibited ., by the

such action

These charges they '-are. values to do raise the



question legal

and they've been rebutted, . of.what FDA's regulatory goals and public framework must Congress framework? points. health

but really -

What are the

responsibilities current statutory

embedded in the

and entrusted ask in I will take

FDA to advance? whether

And what questions to change the current these

considering the balance

of my time

to address

FDA's goals referred are

in regulating


entire are


of products as they safe and

to as dietary'supplements They are to labeled and that assure that

a~s'straightforward products are



properly are these debate

any disease Letme them,

or.health-related talk a little nature about of

claims what the

scientifically goals


mean, how we pursue to have about

and the

we are about

them., 1



No one questions and the first thing



of safety.


is to

FDA's top priority expect


have a right

in any FDA-regulated and sold pver the

product counter. if 7


consumers consumers

promoted directly to / , . In fact, we find that a health-related product is

commonly assume that



available for


the marketplace by FDA.


must have



and approved


The legal the details but


governing the

safety supplement principies. to produce review



and food the The required or'

depend they is

on whether

~slegally'a One is that a safe product. either true safety

a drug,

embody two basic legally obligated safety or, in


5 other is that a premarket (as in the case of drugs), supplements, questions. authorized

by FDA is case of most



when appropriate

to answer

Although supplement the


a minority


currently a formal

mark'eted FDA safety adless an the or resume the

dietary review, identified manufacturer marketing. case


have undergone framework by placing in order to to

current .. statutory .. safety problems swiftly to resolve the problem tool

permits the

FDA to burden

continue deal with

FDA used this a few years.ago.



In two recent is not available decisions its most for

cases, single


have ruled



authority If


supplement law, assuring

products. have lost

these one of category

become the established effective tools for

FDA will the


of this

of products.



” .

- -

Some believe conduct dietary premarket supplement

Congress safety

should reviews

take for

away FDA's authority


products, active

the e.ntire spectrum of / " from vitamins and ninerals to and herbal products, safety, burden and rely under

pharmacologically instead a less prove

amino acid

on the rigorous that

manufacturer's safety has & standard,

own substantiationof and .with the

on FDA to


been Substantiated.

This current safety burden

would system.

be a radical It for would this

philosophical remove,FDA fromany

departure role



in premarket FDA the

review of proof

wide array

of products, arise.

and give

on safety

when problems

Congress provide expects. sense drugs to the

will level

have to examine whether of.safety will also assurance have to safety the

this public



Congress require

consider review but for

needs and " whether it'makes plant-derived it for all

a premarket

made by pharmaceutical products


to abandon supplements.



as herbal


FDA's supplements




current This

law is




properly of only





straightforward FDA, and I will

the.*,respbnsibilities mention supplement how much it it briefly. should contains, 9

Congre-ss has assigned Suffice accurately how it it state should to say, the


label product

of a dietary contains,

what the be used,



. . -.d








necessary the label







inform ation There

should little

be truthful debate'about

and not,m isleading. these basic

is com paratively


The big to > assure that




FDAt.s third health applicable

regulatory claims legal that are




disease-related with


supported Congress general related food value), provisions. review the law.

in accordance has established rule health FDA prem arket claims. it is used is

standards. contem plates of a diseaseas a as a

a legal review If for the its

iram ework

and approval involved arom a, the"GLb qualify drug

substance taste, under

qualifies or nutritional 1 health claim the

(because this

review If the



does‘ not under the

as a food,

would ..

be conducted



of .,.

While claims core the



standards for; foods



of disease-related -they 'both kmbody'the that ._ :" '"

are different principles of

and drugs,


FDA prem arket review -of the claim be established

and ,, a requirem ent I zby high quality



Why did health Congress claims?

Congress * think I

adopt there

such-a-rigorous are the 10 several 1980's

regulatory good reasons. the proliferation

regim e First, of


l +





health-relqted more the Congress much good, such to potent latest

clai,ms.on.foods, dietary that if fad than

many of whioh


to ref,iect

was saying but only marketing

sound science. In passing NLa, 2 such claims have the potential to do are true; Because health were under of science provide great and truth. a necessary check claims are

they tools,

companies the limits


push up to, decided pressures

or beyond, that of

Congress .on.the

FDA review the



Premarket addresses linking intended


under public

a rigorous health




important a nutrient to increase of

and safety

concerns. is It-can

A claim typically also risk of as induce


a disease-related of that with assures nutrient.


intake the

overconsumption adverse the claim effects.


the attendant that the risks and that

FDA-review nutrient

as well

benefits includes

of the

are addressed

the approved



are needed to deter


FDA review be induced medical unproven of health


diminishes disease




people effective for


by unsupported

claims Passing

to forego

or dietary could

interventions. health. that don't

up the proven



And money spent

in the pursuit

on products

work is money wasted.





_ -4




com ing of the

legislative dietary

debate, supplem ent claims. i&too

Congress"wil1 iridustry The strict

be asked by to abandon.the , be

som e elem ents principle that the

of FDA review FDA standard‘ for unduly delays

of health review consum er


will the the It

and that

process potential will

a.ccess to

inform ation


disease-related that these

benefits products

of dietary are generally without

supplem ents. safe

be argued should

and that

consum ers intervention, depict the

be free

to choose. them ,

any FDA believe fairly or

based relationship

on claims between

the'm anufacturers the supplem ent is not

and a disease significant

health-related agreem ent The burden substantiated.

condition, among scientists would

eve6 if that,

there the

linkhas that the

bee-n established. claim had not been

be on FDA to prove

This thoughtfully take

proposition som e hard of the



Congress If

to consider

a prop&& to


coupled'with safety

FDA out


of prem arket


the claims

necessary would

risk-benefit in the In light

assessm ent first

for-.,. disease-related entirely to'the

be left,


m anufacturer. this foods health should standard adequate rem ain claims dietary with

of m arket public

pressures health?

to m ake @aims, Azsumg,ng conventional procedure


to protect under that the

standard established

and FDA review for



them in 1990,


supplem ent



be subject a scientific

to a lesser or public

no FDA review?

Is there 12


.,,., ,^ -_ I





health differently





C in a tablet or broccoli? prbdudzs,'which from manufacturer. or ineffec tive

_ For in


from the'v itamin active


C in orange juice .. amino acid a.nd herbal indis tinguishable of c la$qs by the

many cases are func tionally pharmaceuticals, .sufficient products?



to protect


from unsafe

FDA welcomes in the coming for public public c laims year.




these that

questions the current



FDA believes

s tatutory

framework important v igorous related evidence, s c ientific making

disease-,rel,ated health debate


c laims that

embodies ,~~rn~~ and can withs tand grounding accepted of a third and benefits diseases c ientific harty'-. before '

princ iples -princ iples of


such as

in a body

sound and widely to the both tes t ris k s

subjec ting review,

such.claims and addressing

any such c laim.

Public consumers approaches public of the

debate understand its


these them

princ iples and help tas k with

will assure a full

help that

policymakers Congress of the


legis lative values at

appreciation in



s take.

W e also basic

hope thdt,

course will

coming debate, understood.



of FDA's think ing .

become better



AI ..,


F D A u n d e r s ta n d s th e y fit should b e free to m e e t their

a n d respects to

th e viey

o f m a n y .A m e r i c a n s

th a t


c h o o s e n u tritional'supplem e n ts as.th e y see * : ‘i -,^ . 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. this view, provided th e p r o d u c ts a r e safe and th e th e and

A n d F D A a g r e e s with a n y claim s m ineral n u tritional safe

o f n u tritional

b e n e fit

a r e true.

M o s t vitam in

s u p p l e m e n ts

a r e safe , industry

a n d F D A w a n ts to work with to d o c u m e n t scientifically vitam ins a n d e s s e n tial


u p p e r lim its

o n daily


m inerals.

The "freedom p r o d u c ts purposes. claim

o f choice" for

a r g u m e n t is m o r e difficult th e r a p e u tic --


a r e m a r k e te d Just

serious --

or disease-related
if th e

h o w real

h o w free valid

is th e choice th e risks of

is n o t scientifically also

or if

o v e r c o n s u m p tio n a r e n o t -. e x p e c t a n d deserve th a t support o f choice a n d full

disclosed? W e think all c o n s u m e r s . lllecognized standards for scientific h a v e b e e n m e t so th a t a n d th u s truly free. their exercise


c a n b e well

inform e d

A n d let

m ,e stress

again science th e

a point o n diet

I m a d e a t th e a n d h e a l th

o u tset.


sees in th e e m e r g i n g p o te n tial to improve

enormous F D A is e n g a g e d in

h e a l th

of Americans.

a c o m m o n c a u s e with science for

th o s e

w h o seek tq 'dever‘b p '& & .e ~ ioit'fhis A n d .this‘include$ h e a l th approving claim s o n labels of
l *

th e public


scientifically fo o d s

s o u n d disease-related s u p p l e m e n ts. 14

a n d n u tritional


. -4 --






we are


at the beginning got a lot and payoff to learn,

of this but 'new'&ra we


'__ new era of diet know this will quality science. m uch:

and health. the ultim ate as the

We'ye'all prom ise" science

of this it

be only

as good


under"l$_es to exploit

and the that

and thoughtfulness

of ours efforts

% the

We hope that forthcom ing

you public

in the debate


com m unity with

will those



and dollaborate

of us in

governm ent upon the

and industry link between

who are working diet and health.

to solidify

and build








indirectly, in its hrcoming a tomor othenoise agecting the characteristics of any food (iicludi.?g any .rubstance intqzdq.? fbr use inproduc@g, ma?tu/acturing, packing, processing, preitiii.ng, treatin$ packaging,~‘ rratiJtor;ing or holding food; and in;luding any source of radiation By --- Jay !-I. Geller intecdedfor any such use), [fsrch Of late, hardly a day goes by when .wbstance is not gerlera& recogwme aspect of the debateover the safety Kited among qoerfs r;ualr$L*dby sf food additives such as saccharin, scie/:@ic training nnd experience sodium nitmte and nitrite, FCBs, PBBs, to evaluate its safety, as having MA, acrylonitrile and amygdalin d= beer: dequately shown through not appez in either tie printed or e&cxient$c prose&uWs (or in the rronic media Some of these substances case of a substance used i? food >xepraised and vitally necessq, others pn’ !o Januqy 1,1.958, thigh or are condemnat and considered coupletezither sci&icprocedures or ex!y unnecessary. Fo: the most part, haw2erience bated oz common vs$ in wef, the i5gd cocceptsoffoodadditives ,Godj to be sa,f>u.qder the co&i;md f& additive safety are misunderrior-s of its intended use s&d by the public. This is a len,&y definition, complicated, Most recently, the greatestfocus has and dif5sult for most judges, jtie.; and been on sacchark. Saccharin has di- other laymen to understand.Zn_+&e shortrected a new kind of public attention on hand vernacular of there who deaJ,.viith hd additives. We now seehundreds of the fc& additive on a regular basis, a newly created experts ou such issues as food additive is a substance add,@Jo the safety of f&d additives,the meaning footi that is not gcnera!ly recognized by of data derived from toxicologicaI k-sting expert5 a5 safe. with food additives,the Delaney Clause’ , rind artificial sweethers.The purpose of J-egislation 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 Clause is, as well as to illustrate how zspoase to the urging of many industry these principles operate,using saccharin rssCrti9as a&the DepartmentofHeal& Education and Welfqe, Congress adOp as a relevant exampIe. .edthe Focd Additive.&neadme.nts, the ,a.sic feature of which was the requirenent of safety preclearance for all Submces added to fc+ The,Jegislative any people speaka good deal abut additives such as saccharin but dory of the Food Additive Amenddo not know what a food,additive nents reveals that Congress was conactually is. Defined at Section 321(s) of xrned with the rapid technological adTitle 21 of the United States Code, a :ances that were being made k the )rocessedfood industry and that.under food additive is he law then in ei’ FDA was unableto ?ect, any substance the intended use of :reveat the use of poisonous and delete which results or may rea-onably ious submnces in food until the agency be erDected to result directly or

A closer look at the legal principles used to determine tix adverseaffects crf”foodadditiveson the consumer. ---

fast proved in court that the additive was i@? in iact poisonous and/or deIeteIious.’In spite df the fact that such cases u.:re brought in federal courtz where civil mattersgenera.& have moved along more quickly &an i.n state co@, it u’ not a unusual for such caSesto drag on for two years or longer while the public remained unprotectedfrom the use of ‘ substance he In other fo&s against which FD.4’ s limited resources would not permit regulatory a&on. The ideai situation en+sioned by Congress was that Gth t E newly required preclearance procedure, the prcbkm of testing food additive issues ia court would disappear. ‘ Unfoanately, this has simply not happened.While it is true that the law deemswtain substances b be food additives, it is often necessary that FDA institute. an enforcement proceeding a-gainst such a subskzce a7d prove that it comes within the statutcr): defnition.” Thus, regardless of whetl. :r one approaches the food additive issue from the poisonous and deleteriqllssandpoinf or the safety preclearance standpoint, FDA often ends up in COLX having !o prove its case. Nevertheless, most sponsorsand promoters of food aM.iti~es foliow the procedures that are o~~j.inecf in the statute for obtaining’ approva! for use of their food additives. Types of Food Additives Food additives fall into fo++r.bzsiz categories.First, there are the intentional additives,5 those that are added intentionally to food for a specific reason, includi.ng preve,ntingcaking and lumping preserving by preventing growth of microorganisrrq retarding deterioration. imparting coIor, increasing shelf’life. establishing uniform dispersion or emulsicn, ftig the product, producing L desired tzxture, controhing insects, preventing sticking to focd contact surfaces,, sweetening,supplementing nuuienis, ir parting body, increasing palatibiliv, a~ affdng the appearance of the focd.’



w;i’ &“>&&~ed-& _ i i_ _) -; i

statute se.8 up a scheme whereby any interested person may submit a food, additive vet$ion to the FDA .see*k$g promulgation of a reylllation alIo~,gthe use of the substan:e in food in accordaxe with safety and firnotionalrty data contained ic the petition.‘ Ifthe FDA is ? satisfied that the additive can.“b,e z$ely used for its intended purpose, i! will promulgate m 1 “‘ permitting the’ on additive to be u~ed.~~Almost without esctptioa the rezu!a~onprc~uisafe~~~ the FDA &I, $ace a tolerance on the. amountofthead~ti-vetSatm~y~addesd to a f-i prod3~;~~ ~&forrt&on,~~~~ comes available after approval af tne food adchtive petition and promuIgat!ou of a foo.3 additive regulation that. que-stioq the continued safe use of1=,,xxfciorf a the,) ,%‘“, ,,1 = additive, the FDA m2y move to have the regulation rapealeJ.16 Repealing a food additive regulation may involve a lengthy administrative ti.:es, those which are not fc@ additives prxeedingl’ If an objection is raised,Fp_ _ ,,.,~ k the sratitorysense becauseConFess the proposed repeal of the.food acl$ive has determined thai,thhy should not fall re,gdatiou, a public adminiskatiye hear: ing is requiredI resulting k ZE order within +hestatutory deftition. Acciden td additives are‘ ... * ..*_.,, which mav issued by the FDA Commissioner either substances .. ,. %.9 , ” -..I x~*;-**~9&*;M.,~*~.~ _accidentally get into a food - for exam; repealing, retainins or smending the food be ple, paints or cieaning s01uti0n~ used in additive regulationl?fhe order must.” 2._ --food processingpIants.re Becausethese supported by detied finds .&conc!usubstances if properly used would not sions.20 Where the dk.l.ity of such an is r~vailreasonably be expected to become,corn-. order is di&rt&judici~*revieti ;.r.;ktsof the f@ they are not food able-mthe @ited Stam CoyrtcfAppeds for the Cistrict of ‘ CohtmJbf~~ ,m the or *. Finally, there are the food a&iitives United States Court of Appeals for the CompIairlingpar that do not come, within the, etatutory circuit in Which .thC ‘ deFtitioa because t&y are generally resides.2t If the FDA Commissioner determines $&continued useof& f&d recognized by experts as safe.” T&e additive presents &-~;<<ga-g-. substancesinclude most condiments,vi,” ,x.-,*_/o. w* li tanins and.&era+, essential~oils;and the public health he may order use ofje food additiveto ceaseimmediately iend-I natural flavor extracts. . -1*..+_- “*--ai^.“*ie.*:__.~ .s.b. . _* ing the outcome of f2formal $rnmMraand my subseq~&$&~ ?%e Fooh Additiye Approval Process bve prwee&g Lf a substance does fall within the &,I review,*2 . . There are seve:d methods of deters*atutory defLnition of q.fc& additive! ‘ c * . _^ ,-.I *>,_ _ Ij i,..j it I m.tagg whether a d&n substance rnut be preckared by the United States requires an approved-. f%d*&lditive petiFc4 and Drug Administration (FDA) * - i

Second, there are the i&dental addi.,-.11144”_, ,. rives, those that may reasonably be expected to become a component of any focdor to a@$ the characteristics ofany ^ I>,_-s.w s* a,./ fcx:d, but arehot added to fc&&~$i~$-~: el!y for the gurpose of affecting the characteri&. of the food’ These apditives are p&&f&&z sa h packaging materials for fc0d products and thoseused on and_around manufachuing ,+a‘“S”?“< _, __(. .,/_ a,.>.^. , j, i equipment f&contact surfaces, such ss pl%ics, resins, adhesives and iudustrial chemic&.8 Gese substances becOmeincidental additives ~.~ed(‘ ~~~ ~~~ -;___*. ,.~__ :. :; t$: capab-‘ of migra~ng from the sty paskaging or food contact surface into t&efood product. For example, FDA has determined that,the (,,_,*;‘ acryIonichernic.4 m “.*.*, bile may not be used i.r~ plast~ beverage containers because#““l.... I. .II(. ,, j it migrates into the beverage, and it has -not &en. shopip through adequate scientific procedures to be safe for its intended use.g x6 *ere are,..-s ~;c;ri.g&-@: Lhe’ &j&.

in food First, one can look at 21 CFR 172-l 8 J which lists allLfood *;-*,, ““*“,ifor I^._“‘additives ., : ,““‘ ., which approved food add$ve pehnons exist. Secoud, one can look at the 21 CFR 184186 ._. 1b-8 of all substances v. listing , which may be added to foods without:an approvedfood additive petition because they do not meet the statutory definition of food additive. Third., one c&r Iook at 21 CFR. from u-k i.$wg&“G-.g&, prohibitzd 189 wfiich ‘lists eubs+es , ”‘ ‘ s, - “:‘ Fourth, pcrsuazt to the provisrons of 21 CFR 17,@3,8,one can request a fonnaI advisory opinion from the FDA pu= sum:to21 CFR lQ,85 as+awhetheror DOEthe substance is ,. “.“, j,w, ,.“-i.*>(~, a f4 __“, additive. Fin&y, a person can incorporate the substance a f& market the produCr, into It: us.c* $3$?&~~.~&&&&~
be& are to 21 u.sc: i&s OLhCiuise Gt+ .2.L 85-929.72 StaL 17L(s-~.rM). 3se 1558 U.S. code, tong & Adm. New, pp. 5300 et se-q; see also J 342(aXI). aSae $ 342(axZXC) ad 5 334;serokoUnitei Stars Y. xrticlq qfFc&~@ @ug . .‘ CeLkrol80 . hkIicst.d, 372 F. S~pp. 915 (ND. Ga, 1974) aFd 5 18 F2d 743 (5th Cir, 1975);‘ %rih PaperbaardZorp. v.‘ einteger,498 F.2d lX(lstCir., FC’ 1974); Bdl v. Gzddad, Mb F.2d 177 (6th Cir,, 1966):Uit~Statrv.~clesofF~Coasistin~ of Pocrcry Lab&d Cathy Xcsc,‘ .‘ 3idi’ Eu~~~71 (E.D. hi&, 1974); Ucited Stars ,v. Artjcle of FoodCocjistingofDNms,hioreorLeyofOrotic Acid 414 F. Sqp. 793 (ED. MO., 1976). . 5 19SB U.S. Ccdc Coag &A&n News, p. 5303. kste 21 CFX 170.3(d). ‘ 1958U.S.Code,Cc~g&AdwNews,p.5304. Kk 21 CFX 374-378. gszr 41 F.R 48523 (Scpt u, 1977). 10195X U.S. Code, Caag & Ad& NW, p. 5304. *[Sze21 CFX 182, 184,186. . ‘ 345. 24 135 348(b). .. . “5 333(c), (4. (d. lJ $ 343(cX4). 165 343(h); 21 CF-X 170.3, 170.20, 170.22, 171.1. I’ Src 21 CFX 17I.“Ijo. we2 fi 349ml). 19s~~ j 349(ljizj. . . -_-





21&e 3 349 (8x1)z:sec 2 I CT-X 25. I.

- _ -.

.. .-







znd wait to see if FDA institutes regula(3) Test .doses must be close to the r”ives, indr;ce cancer in man or IO tory action against the food pursuant ti pharmaceuticaIly active range, but sevanimals.24 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.26 Delaney Clause is short animals must be in the test Population; The There are many potentid ioliicOI0;pi- simpIe and straightfonvard. The tintio (5) The route of administration of the cal safety problems with food additive 3, versy over the provision comes not whel1 substance in the test animal must be including chemical poisoning, aIl‘ $‘C one is dealing with a substance that analogous to that by which humans will k;E reactions and f&lure to control the grouth causescancer at expectedlevels df con be exposed to the substance; of harmful bacteria and other lllicr ‘ sumption,but, rather,when t.hzsubstance (6) Whenever possible, the test shou& o: organisms. However, no safety con& inducescancer at levels far in excesso f commence during pregnancy and cpnevokes the specter of danger in the pu;: ’ would rezonably be expectedto bi tinue throughout the life of the animal, what SC’ m ind more than that of cancer. A nd (consumed a daily, weekly, or even CI1 often into the secondand third generations. S on 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?_ng consuming public because it 1 the ranslate into an imznediatethreat to the is impossible and that nbn+rcinogenicity appears routitly in neivspa2er-sand is (consuming in animals is not a guaranteeof noncarpublic’ hea.ith.Tnis contra s .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 conaxactly what the Delaney Clause is. sumers question the .use of extremely !saccharinproblem. At the time that the F& Add,itiy Iarge doses of a substancein a test anima1 ve :\#nendmen!s were enacted, Congres and the application offindings from such CRITERIA FOR EVA’ LWATING man JamesDe!ari&y ofNew Yoik SOUR ;rr a test to human toxicity potential. lhe TCIE SAFETY OF co assurethat substancescausing carrcer rationale for higher dosesin test animals FOOD ADDITIVES*’ Ithan what would normally be consumed .orthat had the potential to cause%s.nc? <r, Most Americancons~ers know We, wculd not be aIlowed as focd additiv: f anythir,g,a’ how f& additives are /by humans include the followings bcut *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 approxirsgul ation i s a valid method for predicting short mate the likely number of human usersj; 12) So wing :he use’of any substance t erm acute and lcng term ckflonic effects 1 The need for meaningful resuits hl a :eladvrly short period of time; and ln &od i.r it is found to ‘ indtice C)f ir.gesdon of chemical substances. i rherefore, the primary tests done to1 ;13) The ability to extrapolate from the cancer w.hen ingested by man or 1 figures what the risk at a lower Lest animul, or ifit irfound. ‘ afertests Cleterm inethe safetyoffood additives are (josage is. which areappropn’ atefortheeva~CjU laboratory animals.The fmt testing is The relevance to humans of data deuation of the safety offood addionducti to determ ini‘ acute toxic effazts. ; n theseshort term ttsts, varying amounts Iived from animal tests, such as those If a subs!anceare fed to test timdls to &cussed above, has been stated by the DA in terms ofthe following principles: letem tine what size dose, if any, will ;‘ jrcduce an immediatetoxicological re- (:1) Certain substances can be shown in &idly controlled experiments to cause ponse. The secondtesting that is con- 7 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 animals.as 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-responserelationubstance,includingwhether or not it is a zhip - that is, the greater the dose, the S’ 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 has ssubstance been shownto causecancfr - tt :sting requirements for dete&ing 11 a any level it is unsafe becausethere 1s Jay H. Geller is a partner in the Lo 1s Hrhether a substanceis a carcinogen: Atzgeles la wjiti of Gel& & Boiemar r; (:I) More than one species should be IIO threshold levei below which the sub zt.n be considered safe for conHe is a former associate chief counst u sed to demonstratethat a substance is S;t;ui%e ;u@ption); $0~ erlforcement for the U.S. Food an h n ot a carcinogen; 4) The tests are conducted at dose Drug Administration. HiFpiaciice’ !- Cj The feeding must be over the pracem 2) evels that wiI1 produce an effect so that phastes the regal cqoeck o/foods, drug! r, h’ lifetimeof the testanimal tq establish E cat t he scientist can calculate the risk at a cosmetics and medical &vices. a negative fmdi.nK

1 : F : ::


Current Use30 Today, the use of saccharin in the With this somewhat cqnceptually dif- United States is widespread. In 1976, s&h& con$rnption by ;cult legal and scientificXframework $I estimates,of ‘ Americans range4f&m aioqof 6 million $nd, let us examine saccharin as %c& I**’’ 1- ~ :o a high of 7.6 million pounds. Of $s ,tudy in f& additive sa.f&$‘” staggering amount,70 percent was used in foods and beverdges:74 percent of this SACCHP$JN The FDA h& dete&$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, the ~,ui-iw~s.~* is the conclusion This reached tea and breakfast cereals; arrd’ ieminiag in such foods &p&&red driqk by FDA Co&m.lssionerDon~d I%i&dy 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 tidemask cosmeticsand a$rnal -feeds. Before ex- spread use in pharmaceuticals to’ a&i.ag the evidence ‘ &merly%ig’the the often unp!easanttaste ofpharrnaceu~ comm.issioneIs recent . 7 -a;,>*L,.<.& ... ‘.‘ i- .‘ “.dpropbssl, a look tically active ch?mica.ls. Sacchqrin is j_.i especially used in periratnc mecbcatrons. at the history of saccharin is in order. The substance is also usedin lipsticks, denture cleaners, toothpastes, rnC&Early Historyzg *‘ “S , ., ,” )‘ _, I (I’ %., Sacch* is a1,,- .>,;,. nonnutritive“yy:‘ i, ( washes,aftershavelouons, skinmoisturartificial ;:..,~.f .,. ‘ sweetener its 356 tumessweeterthan izers, hair tonics,rrtd animal feeds. THUS, ye- .d “r.~,“~w,:.“-l’ “,; -L ,” . sug~-z-. that is discOv~~~~-~i-~~~~‘ or ’ its the problems assocratedulth the current effort to :emove saccti%?in &iters mrirfrom early useswere asan-a$septic,preserv. ket extend’ ~~,~j;ijfi‘ Ei~~~~t the ruAd athe and as an artificial s%ef?nei for diabetics, Since i~‘ d.%ove?y~ there has diabetics will do to find alternate normutritive sweeteners;-removing saccharin ken c0ace.mover the safety of sadqin Some early ‘ tk”iG.’ wit)i’ tie substance from the market has broad’ ,implications. showed no harm when consumed by for the pharmaceutical,*..I”*i.i IX,.,.r,l.r.r”**. ., )‘and cosmetic indiakti- at a level of five grams per day dustries as well,as.,hefood ^“i:i.n,_c ,- i “,~i , ,.I and bevera$ for five mon~;‘ w~Iebther.early tests industries. showed that many of those taking the substance compiained of stomach ,cl$- Early Safety Evaluatlops turbances.Tests conducted with sacch,$ of Saccharin3’ In 1955,’the National Academy of rin to demonstrate its effectiveness‘ a m “tiev if pi”;:;;.& ‘ &;-aers epi&ed Sciences (NAS), a prestigious group of unsucces@l. As,.;__ as’ ~cSaniH scientists -representingsome of the best ‘ I _.. early’ l~07:‘ -.~ j of food in the United States desiredto use scientific min& in the United States, saccharin in fk bzcaus~~~ids~~~~e~~ after a review &%ii CvaiiZ&scientific ~,~~~~~~~ -;yd&, -& ,1g 12, literature, co~clud;d~ih~~‘ inp properties. .A PresidentThe&ore Rooseveit convened day of saccharinconsumejby the average Amegc& iduit ~;j~f;iS~~(+b~ hazardous a board of scien&c a&so& lo ‘ ad&e to health. However, due to ihe d&tic the Department of&&&&e (&ich’ i! that time had jurisdiction over foods an? (Conrinu>d”b~ $ge 38) chugs)to evaluate the sa& of sa&arin .I ,. e.,,~.’ ‘ .I ‘ ‘ I ” :. The board concluded that saccharincon23 !j 348(c)(3)(A). sumedin an --~t”c~~~ywGw~&>~~ii 143 Id.

aer dose; ) A conservative method of.extrapoting is used, resuIting in enbrs‘ overof sting rather than understating, the risk; -.d j) The results of animal tests and tpeir rtrapolation to lower doses provides a je(d estimate of the ,risk of cancer in

:ope. Its use resulted in no apparent ill effects in consumers, but no in-depth :pidemioIo&%stidies were Conducted. Some animal studies were conducted with sacch& but ‘ ~~‘ ho’ gf.c~ weieobserved.’ .. _,.. “-.i- 1,


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25 5 376(bXSXB). or less was safe but that consumption 01 263 36iSB (d)(l)(H). more than one gram pei’ could ca~$ day’ m-his SeCtiOn is adspccdfrom w FDA digestive disturbances in, many i.n&vrd- sacchuin.~See 42 F.R 19996 (April
conecud $2 FX~3!!9 jhiaj


15, 1977)

During the period from !920 to 1950 saccharin was used in the UniGd St&: but was much mo;e widely us& & “I%

29ld. JoId. 3’ Idl-

,_ 17. 1977). /)

Addteu City state -





. Food Additives

When cyclamate, then the mos;popular. artificial sweetener was removed.,from the market in 1969 due to suspicion that ,, -.;. increase in the use of artificial sweeten- it caused cancer in man and animals, ers during the 1960‘ the FD’ asked the FDA anticipated a widespread i,ncrease s, A NAS to evaluate all artificial sweeteners in the use of saccharin an?l calred upon for safety. In 1968, the NAS reported the NAS to undertake a new review of that an intake by an adult of one gram or the safety of saccharin. !ess per day of saccharinwas acceptabIe In 1970, the NAS reached the same +om a safety standpoint, but’ recom- conclusion that it had reached: eartier, mended that a carcinogenesis (tumor but recommendedthat chronic toxicity producing) study be u.ndcrt&&i”with tests be conductedwith saccharin. It-also saccharin to determ ineifsaccharin could recommended conducting ofepidemthe cause cancer‘ since no such study had iological studiesamong populations with theretofore been conducted.It was at this steady saccharin usage; comparative time that concern with industrial carcin- metabolism studies of saccharin in ,man ogens was becoming prevalent among and animals;and studies to determ ine the m&y leading environmental scientists. toxicological interactions between sac(Continued from page 37)

charin and other chemicals. Because of increasing concern over the safe use of saccharinin unhrnited amounts,the FDA in 1972 removed saccharin from the list of substances generally recognized as safe and provided for interim marketing of the substance provided that labels on products containing saccharin bore a statement to the effect that their use should be lim ited to persons who must restrict their intake of sugar.3z FDA concluded at that time that saccharin posed no significant risk to the public health Carcinogenicity Testing With Saccharin33 Two studies conducted-m 1970, cne ,“, .. “,_ ..wl.. I


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that cancerof,mistype would most likely by the FDA and the o~thee~by Wisthe consinAlumni Research,Foundation in not manifest i,ge,jf,mg!yery late in Iife, il I.%_,,,,_.,, >fdison, Wisconsin, demons”trate”d that at all,. “and thereby justify shortening one’ life in later years while having s Saccharin produced tumors $!a@~a$y aimals when the &rnaJs, pe_refed_re- saccharin available,,in younger years tc ,^ prevent obesity which, in and of itself, is jpeCtiYely 7.5 percent &dj:ij percent-of asignificant healthproblem inthe United &cir total diet. However, scientists evalStates? These jssues.e.i di.fficuIt issues u&ngthksk: iesis %ie$nab!e tq,ece,,$e” -a’ are .“ss+.“~; ;,@, ?a **A-, a. &**..#> “; increase in tumors to saccharm ,or a and bring into play complex rssues of substance known -.a**/*,.-_..,,li,\% >. + _, personal freedom versus tl~~*+y of the which .is-often:’ *- as OTS ,_ government to provide for the co,b%on found with’ saccharm,..~n,,!.97~?FDA , receivedthe resultsiof a Cana&,anstudy wetfare and protect the pubIic her&h. v;hich showe.d that?sacs&@ fed at a However, thesephilosophical consideralevel of 5 percent of the total diet to”‘ &% tions notwithstanding,FDA, in the face 1.l.Ix-.“,_ll _,_#u of the data curre,n{y available to it, feels causedan increase ~,~n$l&%tb”~dder tumorsin first and secondgenerationtest that it hasheen left with no choice under i-w*** ., annirnals. was determined that OTS did the existing law but to remove sa&%& Xt not play ,a role in the ir+<ask in ‘ the’ from the market. The matter does not end-with FDA incidence of tumors. Based up%*“tiik. having the final word, ho&ver?%,% rest&s of the Canadian‘ snrdy,’ FDA estimated a lifet-& ~;;‘ soda cbnsuined daily Over that one diet ;-j;;;av;~ii~~d”dult‘ vember 23,1977, Congressenacted the “Saccharin Study and Labeling Act.“35 Xm&an could result in up to 1200 additional cases of biadder ,car,cer per The purpose of this act is yearamong the Arr,eri&n$o;iulace. The to require studies concerning carcinogenic and or+ .roxic sub . .. _,_ %J cases?or~a&~O,~OOin&idua!s. If the consumption of sac,charinis,,figured in, the rate is raised to _ I<. . ) percent, or 1.54 154 cases for each 10,000 individuals. FDA believes that .&aTAcch$; ;$-i conclusivety -fay$ the Canadian tessu;
stances in food. the regulation”“bf” such food, the impurities in and ruxiciry of saccharin, and hea!rh benefits, $any, resulting from the use of nonnutn’ rive sw.eereners; to prohibit for 18 months the Secretary of Health, Education and tYe[farefrom taking certain acn’ on restricting the continued usf of sacchani! as a food, drug and cosmetic; Corequire certain labels and notices for foods containing sacchprin; and for other purposes.34

The moratorium is.tp expire in the spring of 1979, but current expectations are that the moratorium will be extended until de~.~~tive,tqxicq!pgy beencomhas pleted. The congressionalmoratorium can be traced in part to the tremendousoutcry from the American I citizenry that has j .1 \_“,e,“. arisen over the FDA’ proposedban on s sacche+in. Congress was also subjected to intense pressure from trade associations representingmanufactureniof products contair&g saccharin, from the saccharin manufacturers themselves and ^ ~.,,-..“~u..:,,,--~~, ‘ ,”,L, c from physicians who behevet&t S&al, r-inoffers the promise for a more,no@ life for the mi!Iions of diabetics in, the - c. .-. I- ^, i ._ United States. What effect this congressiond moratorium against the FDA’ @king action s to removesaccharin fromr-.:^I market will Ij,. ,_ .. .“I_the _ haveover the FDA’ long term ability to s administerthe food safety law is unclear. -*,- _,% iirn.“dw^ Certainly it would seem). Congress that should uphold the very law it enactedto insurethatsubstances ofdoubtful safety, *, ). 1)‘ ~~,*)‘ :;,ri?,j r* e..*ar.rar such as saccharin, would b-eremove-d from the market pending additional testing, rather than rem.ai@ng the market on and posing a potential risk to the consumer whiIe, resgj+g-‘ ur,dertakento the additional testing is &~v-&“e~et questions. The exception that Congresshas pro posed for saccharin points up a significant shonco+g in the FDA’ s_abiiity to .. . administerand enforce the food additive ~._ iafety law. Once congii;egw&* ZG& Jut an exception for saccharin, what will ., .. _ Jrevent it from making exception after :xception in cases of other ac@ives of Kidespreaduse when t+i: safety has xen brought into question. ‘ in fact, ff; Congressis unhappy with the current hod additive law, and there are many xho will arguethat theDelaney Clauseis :m restrictive and &f!exible, it should “S.,. ;,,._x unendor abolish the foodPadditivesafety aw. Proceeding in’ ; I;;~e;;.r;;Led;.;-di~ ive-by-add&e basis, can only undernine the regu1atot-y schemeit has estab ‘ ..” ished sit
Jzse, 21 CFR .I L ,., _x_, !80.!! s, (, ’ -*‘ ,i*. >‘“‘.,1,‘,. ’ % <

carcinogenand that its use in food canno , longer be justified. There is no epidemiological or user .evidence.that ‘ demonstrates that saccharin is a carcinogen in humans. However, the statute $oes not concempIate epidemiologicat studies; rather, it contemplates ani@ studies of the type discussed above:34 .S&%ic Continued useof saccharin(n food and studies have been conducted‘ accordmg dri* is now wmittedj ;+& ir“f$gy to accepted scien& ‘ &o&d& c&t labels carry the-following wa&.ng~~~ demonsuate‘ f;F ‘ that saccharin has the po Use of this product may be haztential for caus’ ~~~;“~~“.“‘ ~~~~~e.
ardous to your health. This prod-

Thus, if one chooses to believe that $e uct dererTni&d lo y&j$, beencontains saccharin which has .i.-, ~$g$y+ Czradian and other test;_..*‘1~,r*,,<r”& “II results arevalia !, l-l- AI. ““.,,“.._ i,, .I, I ‘ *s _,j ,.*“;i, in laboratory animals. consumption of sacchann does &eed posea risk of additional casesof bladder;r 1”-., In addition, the new law gives the FDA cancer in humans. authority to require sin-&r Iab$ on SOME FURTHER THOUGHTS vending machines that dispense soft oN. -.6ij;,~.-cDrTwEs.. ci.ri&s.3* Retail stores$I& sac’ charin metier people &;;id <a;‘ &i ii’ ; <&” and saccharin+onta$ng pr&iu?Xs,‘ With dom of choice to accept the riskposed~by the exceptionof restaur~ams, required are of saccharin is a matter.d. .‘ article“3,”,_ to post signs warning customen‘ the will ‘ .; that this “a I/stI11”1 “-,y*.-i;“.~~~i~~~,~, J. cancer threat from yy- -% the &K not address. The Issue, however, IS a cial swe;;;n-;.jg’ ingestion of 18-mon* “*‘ viable one, in that there are~competing morato’ ~~*~~~~~~~‘ fP~tfi~~~“~~ concerns,especiallywherediabehc~ . da% ._x;_,“-. has b;dy-;;;poS;J “~4”k&yp&y$~ that the conveniencethat saccharin adds to their lives outtieighs“‘ their’ risk OF provisionsofthe food additive safety law I^ _^- 7- -~L-l;t:nn mioht one not argue and the DelaneyClausenotwithstanding

33.5~ fn. 27, supra. J’ Sec 21 CFR 170.3(h). J3P.L 95-203. 91 SW. 1451 (1977). ‘ 6ILi 37fd. J 4(a). Faihre of a food label to bear the runhg statement raulu in,lhe feed b&g misrar.ded un+i $ 343(0X1). ‘ *Id. g 4(c). ‘ qlci, 5 4(b).

Food and Drug Administrakion RockvilleMD 20857


," ,_ ,, _ This is in ,_"I.,. ,(S.,p _",'*.lrrr< further i response to your letterof.,July 14, 1995, on -;.: I . behalf of M r. David Helphrey of Palm Harbor, Florida, requesting an update (slncep& N.ovember, ,,.i_ 1994, letter to "d"..ll."-,;l,_~ ,li 17, 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.
Je .: .-& 2”. ,..* l

Dear M r. Biliraki?t

_ ,,,



warning to consumers $s~app~op~*?at&'diid ‘ u*sePul, and such a_ label statement may reduce the.incidence~,.of adverse";i._effectsi.4) , j "". %t‘ .i ,.,".I rr*~% % i, . ,'.'* e-,* '~>r";,",~, appropr~~Ze~~~"~~~~~ed lab-e,& 'statemq~ts have a potential f‘ 5) toan reduce abuse of .products conta~~;l~~~~~,~~~~~~~~~~:~aiies extensive edu.cationalL _&.1 : campaign is not warranted(the.~resources ./a*_ >, -es _<.,_..", / ", -".*.--dp, required would be too great for‘ the,expected benefit), but an informational effort -,I,./",. targeted toward physicians and other . I. .*ba*a** appropriate professional 'groups could ,hav~e,.‘___ YImpact; and'6) some , I " 3, -id_ labeling will ??,&J$~ ,, -In committee and educatiqr?- efforts cannot predict ij,~&-cg~' iti ~inform cony%? 're'~~~~~-~-;~~~~~",5;~~~. information. The working group went on to devise .a dqft .&&& . statement that a'iE"'a$eed was'too long but which incorporated ." __f., . the various elements 0.f potential adverse_,o ,,Iie, *j 3&>:%" ,a&!*which .-/ ~.."~,~~.~, about L _.w*., b,"effects ms:i,.:+-1 .~~~~~*.~~‘ _j \. 1 __, t-z-, they felt consumers $-&- .~~~~~~~~~~i~~~~~":~~he I~~~~~~...ro~,.~.,s~,~~~~,~~~rY needed to be info~e&, Committee approved special working --o- rir i,,w-i***'^* *" ‘ , j __ .( .lnl ,I, , group at its mee-tj.ng of June 8-9, 1995.

F -4 _


2 - The Honorable

M ichael .(, Hilirakis "._‘ .,^",,_ ._ ,,"_eI.



. "I,





was held between California State On August 7, 1995, a m eeting offici"als and industry to discuss a label statem ent for foods In that containing subs&%&s with stim ulant laxative .effecfs. 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: _ * This product contains NOTICE: and com m on naqe,"if~ different}.I/ /IsI ,h -xx_., \,.-m -;e, Do not directions carefully. loose stools % (nam e of ingredient Read and follow ou have or use if or

If you are pre*gnant, nursing, faking m edication, have a m edical condition-, consult your physician before using this product.

and in subsequent During the August 7, 1995, m eeting, California requesfez that“PDA‘ *tioNefit conversations, ~ Our com m ents were as follows,; statem ent. 1.

telephone on the

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






Page 3 - The Honorable

gicha"e~l Bilirakis /_ \,, UP ,~ ‘. . i.i^ _x ^+"*? I./__/_I ,\l







be used, and of situations .I. ..where a physician should be con_sulte';i""~~~owever, ‘iI ,.,,2.. 7, -I.",i 1&?-1~a."_ ‘c.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 a laxative)_ 1,-"..1", * ,I."W_,*i_(~jl- or \I.>, 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.I.-we.?"'"i ,,%.., ,*", "9,, , .*a ", ;_ , does not significantly reduce absorptz.on of which the Adyispry Committee food calories, recommend.@ be products "":~.are ",,the statement in (. al,,.. 4" ;, because these‘ included I'; “v'** dF~g;i,'"sb.i"d":~ag~ ., "I (. l' weight loss products including dieter's teas. The Agency also pointed out thateven thou.gh a product beak under" 's-~~yw~~~q."~). oft may still the,Slabel statement, it the _ be misbranded ,"h" ,. .l~*,ji~ ‘i *'Act if Federal Food, Drug, and Cosmetic (FDC)‘ other information on the ~.~3S," *._ ...a label thei < &&:..: ".*, .,.~‘.(,l pi_,.*,,)SL;c%..;L>*-*i,Ilabel "i;‘ ,_ _ *~l,l,",/j causes .(iir,-‘ ; .I", I -i to be fa.l.se or9 misleading.



We believe then eff.orts -,.I. ,.* j the part of California,,are.,usef,ul, on liMbl, ,*. despite the fact that all the <face*ts,o,f the Advisory Committee's recommendations were not,,inc~~~po~~~~~~~~' Wit will I 2.~. -1 the as well as the response in -~~~-g'~'~~~~~~~ww; pro;f;;rQ~~'~~~~~~ea~~~~~~~~.~. their labeling follow carefully of initiative efforts, and will~contir&e ,--,.,, W., ./,consider IIx**a ..i. toI S" * j_+-/ ._1 ~~*~*i,'i&",,). "$2' ,.L,,_<,, part . ,_of . .."FDA d&ion on _. the V.-Lb" 'i- whether _*</, ini"", 'q&a,.,) ,a_,*. .I~* ,nj ._^ .a>, ,;ii@St: "6‘
is necessary.

We agree with the recommendationa:<. ~J,"_the,&Adv,iFory Committee that ,.aI..c,__*"I__, _/*& / of a,?9,.. "/*, __ an infoma,tq@ ef~~~r-~:~,.t~a,~geted tow~'?~'?v?alth ‘ care providers and other appropriate professionalgroups could have some considering mechanisms by consumer impact .and~ are,'therefore, which this informstional *\a.,*.,,,, *, )I^ -~, effort :",,"a could liv^i*..) ,~-,-r;~"~~~~~~i ,i be<.v* effectively ix j: " >5, .a-,* *a, Oil -~,'f'i'~,-?.?.w+J / wi( "c. accomplished. as the Advis.ory Committee, cpncluded, that We recognize, labeling and educationa" effqrts ..a. may 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 ,,,__,lW". us informed about.consumer keep , j IX -,_ jc

.. . . .._ .,’


_. ,pl+h&L

Page 4 - The Hon.qrabl+?

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

j. "_, ,, ,,



to their label, statement../*. +,,IIThis ..-.A+ >",'*i.i is.,:"...," j, y^)"" ? ^ information d -_A.. I%.. """"*p'.,_^.I .." --c,.*..*r:.@s :"*" ,a._ i."+k..\<.:i. *>#ei.will "__, s,_ us in assessing our optlons. ) " _.,_ . .


,) \

We hope this


is,‘_,".a", /_I(".I‘ helpful. _,., Sincerely, . 1 /M B/lnd /* iane E. 'Thoqpson Associate Commissionqg, for Legislative Affqirs



& .”


’ *’Citizens For H & a !t

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.,/”_)’. tio ;n s q @ d ”“,. *,N.a 1 \ 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, P h D , ,. .._.,, I. c( U .S .A . N G O_ ,,_o d e x* DIe l e g a te (‘,., : _C L _ ^ / P residerit,‘C itize n sFsr & a lth O cto b e r 1 1 , 1 9 9 6 --’



_:,,..,,-_. . . I. I.“. .^j’ . _,,,;

__ .; -



_ ,_,.

I., -,. / I ) ‘ _

..~.-f,‘ ~

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 dilferenc.es, while also indicating whether it expects’ be able to give full acceptance to the general standard, to and, if so, when. For this reason, dom estic laws and regulations can significantly influence’ intem ational standards al that m sts that the odbe imposed upon .sta~~~~~~~~~...a~~~~ su-y lem ents za of ight otherwise it.‘ This is ne ‘ reason wh the theor s’ m le anal ; tlom m ission”~s . 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’ laws. s This was $articularly true in the case of certain dietary supplem ent proposed standards, which would conflict with statutes of,i‘,c__Dietary Supplem ent Health and Education Act the “.<ypr”, , ,~II ‘ *o/ L. ,,a‘ 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, such as &*, ,,:r”yp m ittee on Nutrition and-9Poods“,,fir , Special l%etary the Com L1.-. r,,~,~~.~~“~~“~.*?~,~~ and related ,.“: re&~&@&&tand+s % -; i Lj f.. ,“, Uses (CNFsou),^ ~.,e i$92;$-+ltted (;;-;i;~;+&) *d*,slto ,,,_ 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. 4


@ usages,and trial results would be another section to consider including in your publication.
Tina L. Arellano Wieatridge, Colorado We hope you enjoy the article about herbal care forpets on page 28. Look for more articles in theft&r-e. We, too,find the herbal information comizzg out of Europe to be very interesting and are always looking for ways to include it in the magazine.
My on mushrooms

mz&room cultivation; one of the&zis The i:ia tiI,B.**.*-,i.Aii .”.i,“tT.)^Gl.. r+w Growers - Shiitake ;a,-1 Handbook by I? Przybillotoicz azzdJ. Donoghue (Kendall/ Hzznt Publishirzg, 1990).
Herbal tiakhg

Look for capsirle-making in- creams may corztain DHEA, ther Nature did no formation in future issues of’ , -the maga;;il:;;:e, “~qthe ));; time, the article about caps manufacturing on page may interest yozz. We can’ be quite as re t sponsiveto your homebpa query. While horn&pa draws.upon herbal renzedt it is a topic outside ozlr‘ rea HomeopathicEducationhiSe vices, 2124 Kittredge Stree Berkeley, CA 94704, may be better qualified to respond to this question. Regardingg&zseng, gintrzre sengs are ginsengs belonging to the Araliaceae fa’ mily ai‘ d the genus Panax. That includes both red and zuhite Chinese ginseng (Panax ginseng), Korean ginseng (Panax ginseng), and American ‘ ginseng (Panax quinquefoliurn). It doesnot include Siberian ginsezzg (Eleutherococcus senticosus), also known as eleuthero.
Model behavior?

Dear Herbs for Health, I am very interested in herbalism and herbal healing. Can you recommend a reputable sourcefor ,training?
Don Christie St. Louis, Missouri I” Many training progranzs are

Dear H&bs for Health, I have been interested in growing shiitake mushrooms (“Mushrooms as Medicine’ : January/February 1997) for some time. I tried to grow them in logs without much success.I see where they can be grown in sawdust.I would like more information about This and that this. Also, I would like to purchase Kenneth Jones’ book Dear Herbs for Health, s as well as some of the other What a great little sister books listed. Can you provide .Herbs for Health is-as exinformation? pected with a big sister like
Donna Miller Greenville, Ohio

available, but we cannot endorse a particular program. As a startingpoint, you might refer to oar article on North American correspondence courseson page 58‘ theJanof uary/February 1997 z&sue. s It’ also helpful to ask herbalists and people in the medicinal herb business about repzitable programs.

The Herb Companion.

You can find Kenneth Jones’ book Shiitake: The Healing. Mushrooms (Healing Arts Press, 1995) at selectedbookstores, or you can order it for $8.95 plus $3 shipping and handling by calling (800) 2468648. Another usefiil text

Where can I get education on making my own capsules? What are the differences.in the sizes and, how can I~be sure that I’ taking the right m amount of capsuIes with-my own herbs? I would also be interested in an article on homeopathic j ^ ,. ,. .I is Medicinal Mushrooms: An courses to answer questions .^,.^ Exploration of Tradition, such as the kind of degree Healing, and Culture (Botan- you obtain, how you can use ica Press, 1995) by Christo- the knowledge, and what the pher Hobbs, which is offered average cost iS per course. through Interweave Pressfor Lastly, are Siberian, Ko$16.95 plus $4; 75 shipping rean, and American ginsengs and handling. To order call true ginsengs? (800) 645-3675.Hobbs’book s Sonya Anthony contains a fist of references on Decatur, Illinois

Dear Herbs for Health, In Mark Blumenthal’ ars ticle “Herbs and the Law” _ (September/October 1996), he makes several good points. Forexample, “Governments of other advanced nations have already dealt with the challenge of evaluating herbs for the therapeutic benefits,” and “Germany’ Commission E, a s federally appointed panel of experts that have reviewed more than 309 herbs and herbal combinations and have approvedmore than 200 of them as,safe and effective medicines, might serve as a model for the United States.” Unfortunately, experience. has shown that companies involved in the” dietary supplement businessdo not want Ito I.s__ ._. adopt these models. For example, after discoveringsevYams and hormones eral deaths linked to a popuDear Herbs for Health, lar herbal diet tea containing What is the percentageof over-the-counter levelsof laxDHEA in wild Mexican _” _ rv * _( atives and diuretics, industry yams? representatives met and op Phillip Hopkins posed efforts to label these Lubbock, Texas diet teas aud other herbal l,axAccording to James A. Duke, atives with the warnings Ph.0.; yams don’ contain the and/or cautionsthat the.Ger-. t adrenal hormone,DHEA (de- man CommissionE requires. +PIIx.” hydroepiandosterone). Yams The same kind of opposido contain diosgenin, which tion exists with regard to the through severalchemicalsteps labeling of herbal suppletan be converted to proges- ments containing the herb terone, testosterone, DHER or ma huang* commonlyknown Our bodies, however, do not as ephedra. have the enzymatic pathways Once,again, mainstream capable of producing such a manufacturerswould.a,^; the _. like ,_, lJ, transformation. In short, Dn public to believe that prodDuke says, it is not possibleto ucts contz+ng ma huang names”, get DHEA from yams 07 a wi* “street-drug-like ,,. ...a, .‘ ,, yam tinctzrre. Some wild yam such as Herbal Ecstasy, are

. h,




,; 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 n go d u c ts pr with “nice n a m e s ” o n ta i n a $ m u c h if n o t signific “_ ,... 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 ts h i c h th e i n n @ ry claimsa r e w produced y renegade ompanies. b c In short, u n til th e p e o p l e involvedin 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 testabIished,g o o d m a n u facturinga n d labeli n g practices, e c o n troversy n e v e r th will end. H o p e fully,M r. B l u m e n th a will s u p l port legitimate aqcjrezW q n & le ffo F ts C to i m p l e m e n tpolicieslike th o s e establishedb y G e r m a n y ’s o m m i s s i o n inC E steado f th e s c q e @ tics u s q l _ @th e iny 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 it h a s a tte m p te d i m p l e m e n t r to policieslike & p :,e “established -8.i-,e r i l-..“l,*y‘ u .-,:.eth .I _r in oA , a d v a n c e d a tio n s ”. n
Christopher. G rell E S a nFrancisco, California
Toxic citrus.peel? D e a r H e r b s for Health,




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

with, in alternatem o n ths, six issues ,fT h e H e..r. b. C o @ p u n i o n . o ,.”.> This stalwart m a g a z i n e provides.a~variety f w a y s to e n j o y th e o rich scentsa n d flavor: o f h ,exbs..Lively recipes,s o o th i n g te a s a n d % %i?” . *,I 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 simple p o ts or elabbrate n o t g a r d e & - - e v e + issuebrims 9yer,,with k 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 n j o y m e n t. 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 $ 1 7 .4 0o ff n e w s s ta nprices! d Call toll-free8 0 ( 2 - $ 4 5 - 3 6 7 5 ,e p t.A -FB. , -., D p ..s . W it a n y subscription T h e H e r b Q m p a n i o n y o u a r e a u to ‘h to m a ticallye n title d to significantdiscounts n h e rIb a“Po o k sfrom S _ ” e p lbb*‘/w,.~ .~ ~ a g \..“*.-Ferrlr B o o k s .T h e S a g elisting a c c o m p a n i e s every c o p y o f th e m a g a z i n e a n d represents your freeo p p o r tunity for s & i ~ g s ~ ? ‘k ~ r ea r e rio:dues, 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.

In th e N s v e m b e r / D q z e m p e r issueo f 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 c o u l d b e h a r m ful orfatal. .“k,,a k e can.. I m .,.. d i e d o r a n g e p e e l a s well a ? c a n d ‘.e_ ” i d 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 b o i l e d 2 to 3 m ig.vtesJhenc,o o k.._d in _ e .,,,. n_ _ s u g a ru n til c a n d i e d Is & -ish a r m fu l ? , I
J Boschen W indsor, a s s a c h u s e tts M

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 citrus p e e lp o s e sn o h e a l thk h h r e b t c a u s e e y o u w o u l d n o t~ ingest n o u g h s s e n tial e e oil to b e toxic. W ew e l c o m~eO U Y ~ “dintiiih a n d q u e s tio n s . A d d r e syourletten to H e r b s Health Lets for te n ,In te n v e a vPress, 0 1E a s t o u r thS treet, e 2 F 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 , 8 3 1 7 e - m a i~ H ~ H @ iu$xccntuiI.ctnn~us~e. 7w l corn. l e a s en c l u d e o u rn a m ea n da d d m s s . P i y


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 consumers are turning to herbal medicines to tr@t minor ailments and to help increase overall wellness and resistance to disease. In October 1994, a Gallup survey estimated that 17 percent of all Americans use herb supplements,which are now available in mainstream retail outlets, not just in health-food stores and mail-order catalogs. In 1994, the latest year for which figures are available, herb sales rose 35 percent in pharmacies and supermarkets. This interest in herbal medicine is unprecedented, not only here but all over the developed world. A big issue surrounding all of this herb growth is education of the general public as well as of health professionals and lawmakers. Most experts agree that the best way to ensure that people will use herb products safely is to put straightforward directions on labels, including expected benefits, proper dosage, possible side effects, and precautions. However, getting the industry and the government to agree on appropriate and responsible regulation to
8 Herbs for Health

the practitioner must have personally examined the patient; the treatment, when used as directed, must not help consumers is the tricky present a danger to the papart. tient; and the patient must be The Dietary Supplement informed in writing that the Health axd E@catiqn Act of treatment has not been ap1994 @SHEA) was designed proved by the f&era1 govto protect consumers’access ernment. not only to dietary suppleTheeact would obviously _k _.“(. ‘ ., ,e ?..,_\, ments, including herbs, but deal with more than only also to information‘ how to herbal issuesand treatments. on .Hio”.eve;;ph’ iEji.&Eettier use them. The issues surrounding DSHEA’ passage herba medicine would come s cut across conventional party under the-purview of this act “. lines, reaching both ends of and, if so, why. In ^myview, the political spectrum. herbs should be part’ conof More recently, a bill titled ventional medical practice; Access to Medical Treatment ample scientific and’ historiAct (S.1035 ,and HX’ 2019) cal evidence ,supportsX-$s. was introduced last year by But. the problem is one of regul;L&6n* &@.&.& goes Sen. Tom‘ D&hlk ‘ (D-SD) and Rep. Peter DeFazio (R- so far. Rallows herb product Ok). It would be a boon to labels to~mclude~usage “dithe democratization ofhealth rections and side effects and care as well as to consumer ‘ warnings, yet it permits only access to less expensive and limited claims about how a often gentler modes of treat- product affects the bodyment. The act’ would let peo- “Cranberry helps maintain a ple receive any type of med- ‘ heakliy‘ urinary tract”, for exical treatment they want from ample-so long as these a‘ .licensedhealth-care practi- statements are .truthfLil,iiontioner, including treatments misleading, and backed by ” j_ ‘ _” .A<_., not approved by the U.S: sec- scientific evidence. DSHEA retary of health and human does not permit products to services. The act includes make “therapeutic” /)”;. ‘ ;,. / claims several provision& includ’ mgz && ..&-. ;;figIps cure a

headache”.However,millions of consumers use herbs precisely for therapeutic reasons: to help t&t minor, selflimiting ailments. Governments of other advanced nations have already dealt with the challenge of evaluating herbs for their therapeutic benefits. Germany’ Commission E, a feds erally appointed panel of exjGits tliat”has reviewed more than 300 herbs and herbal ” I .combination,s and approved . ; .,-I:-more than 200 of them as safe and. effective nonprescription medicines, might serve as a mode1 for the United States.We need a system that allows consumers and health professionals to use and recommend herbal products that are properly labeled with therapeutic informatio,n ~that haa,,been reviewed ‘ _ approved by ,and herbal experts. Gnly’ then can the herbal renaissance become, a complete reality. 3%
Mark Blqqwnthal is founder and executive director of the Amm’ can @tan%<, ,. _,. .b^_ “,I and edits Council ,Sie+alC$a? 3nagazineY

September/October 1995


from pnge 6)

VSM Study
predicts. M inerals tallied $725 m illion in sales last year, compared to $590 m illion in ]9?“2. This represented a CAGR ,of 5.2%. M inerals generated 11% of VSM sales in 1996: Sales of m inera!? -are projected to be $840 m illion by the year 2001.

improves, sales through Internet -- “the modern equivalent of mail order” -should grow.
Positive Factors

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

Expo West Report
voiced various frustrations. For, one retailer whose store focused pn ngltritional supplements, the show seemed to have “too much food”. and _not enough space devoted to supplement exhibitors.. Others noted that the sheer s,ize of this year’ show made it impossible s for one person to cover the whole show, despite expanded exhibit hours. The joke of the show was that a person could spend no more than one m inute at each booth in order to visit, all of the exhibitors. Of course, the high amount of

exhibitors -- which inc$uded a fair : retailers. $-I? ;-e{;ted an incident in ,, ..> l(^ number of new companies -- was gen- which a supposed retailer --who actuerally seen as a positive sign for the ally worked at a bicycle shop that didhealth “food industry, representative of n’ sell su.pplements-- tied him up dist overall industry growth and the cussing products while some actual health food retailers passed right by strength of the marketplace. As for the exl$l@rs, the majority his booth. “I fully intend to return to the of companies on the trade show floor t . said they were pleased by booth traf- show, but it doesn’ seem fair that +e fit and the gum&r _;,,./I&“>“_j,_u, of orders placed manufacturers pay for the shows by retailers at the .+o~~~,,.Still, ~some (through their exhibit fees), but are then undermined, because the ‘ green had a bone to pick about the “quality” of retailers wh6’ were’ allo\ved to,, badges’ are diluted by non-retailers,” attend the ihow. For example, Jery commented Cochern. Cochern, President of Pure EssenFe Labs, a private labelni’ afiufactuyer, felt k Changing Climate? According to Mark Kaylor, that- many of the attendees granted s green retailer badges were not “real” herbalist for Nature’ Answer, the rea-

;.nI?$,‘ ,I***_) .<. .” ^( ,,., %_~,




- SAN FFtANCISCO. CALIFORNIA (415) 541-9866 F A X (415) 541-9869


Novem ber



.David Kessler, M .D. Com m issioner U.S. Food & Drug Administration %5600 Fishers Lane 20857-1706 Rockvilfe, M aryland Dr. Elizabeth Vetley of Special FDA - Office, 200 C Street Southwest, Washington, D,%. 20204 Re: Dear Dr. Proposed Kessler Nutritionals _



G M P 's Under

DSHEA..- What Is,'The


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 ,I,,(As,&*_I_*i, /<>" m<*.a (+/, to develop who are .* ,,,_ ll".i ./ *,‘,*," ,e":" c,,_ eeting *",I ,~*~,**, 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&$. .,&,.. $Z!.P,~ ~aJi?g&ns For ' proposed will be valid "Go,od M a.~.~-~.a,c~t,~rlng Practices? exam ple, GNC continues t"o sell Herb~al~.,Diet ,.*" "Teas*; that,- contain ";,l*‘-,$. ,*;i_ /< C,iiZ.~i.~OTC ,._;a," .^..I* II ,,\d.ri"J 'levels of senna and.d~uretic.s,.,whi,~h.,~~h~ Advisory Com m ission ,Food% 1/., ); s $6/,Aj to the FDA, not to m ention the Herb .Rese,arch",< Cpunc,i-l,, concluded 1 .\ .*_,_ was dangerous and a bad idea for people to use.. Not withstand,ing in addition to,selling these products, in the these findings, and in ,whi,ch GNC.is a defendant, litigation I'am involved,+, they in the diet se&a 'and~o'cher*'herbs used take these .positiontea,s that pl,y, .wich Gbod M~~~~~~df~~~~~~~:'"~~~~~~~~~~~'!-'_ com the .leve.ls._of ' several states have ba.nned ephedra.containing Similarly, I imagine products that GNC continues to sell .(See Exhibit B). that the Industry will contend that,.these b,.b productsalso com ply .a. lix. with Good M anufacturing Practices given their pr-esent conduct.


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’ certainly no expert market analyst, m 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’ say that d 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 numbgrs? I’ referring to those numbers appearing in the annual “U.S. m 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 ^_.*athis month’ 6 s _we. of ,*., 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 Supplement consumers in just a three-year period. It wasn’ reaIly very long ago t that dietary supplements were considered by many people to be “&G-teceStir sary” or even “useless.” Now, the majority of adult Aniericatis use d’ itidustry’ products! s 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 supplement 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’ The main reasons cited for the,,strength s. of the health food stores wkre that these outlets _.. the best jdb of introducing . do new products and educating consumers about dietary supplements. Key demographics and lifestyle shifts bode well for the dietary SUppiement industry: aging baby boomers looking to “stay young,” increased interest 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 community 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’ know Dean Witter even if I bumped into him while t crossing Wall Street, but I’ prepared to issue a “buy” recommendation for m dietary suppIement companies and products. The numbers look very good!
l l l l l

Daniel MeSweeney




APRIL 1997





Retail sales of vitamins, supplements and minerals (VSM) surged past $6.3 billion in 1996, according to a new report by -the New York-based research firm Packaged Facts. The company’ report, “The U.S. Market s for Vitamins, Supplements and Minerals,” was releasdd last month.

According to Packaged Facts, sales of dietary supplements increased by 75% from 1992 to 1996 for a compound annual growth rate Breakdown By Prod&t Type (CAGR) of 15%. Packaged Facts 16 1996, sales of vitamins tirere attributes this growth in large part to placed at $3.5 billion, compared to the passage of the $2.57 billion in’ ‘ i492 (8% CAGR). Dietary Vitamins”accdiint*~d “for 54%‘bf \ot‘ $l Supplement Health and Education Act (DSHEA). VSM sales, Packaged Facts reported. The fastest growing segment was Vitamin sales are expected to supplements -- defined as herbal reach’ S4.S billion ~by the year 2001, P&&agea Facts states. products, phytonutrients, essential Supplements generated $2:3 bilfatty acids, hormones and other prodlion in sales duri@ fg96, a ‘ CAGR df ucts -- whose sales more than quadrupled 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‘ $57O‘ t million. These bf all Herbal supplements and “VSM” com- products accounted’ for “35% ‘ <‘ bos -- new combinations of vitamins, VSM sales in 1996, the i;e@t stated. ^ herbs and minerals -1 are contributing Supplement sales Will ‘ reach. $7 to this category’ growth, the report billion by the year 2001,. the report s states.
(Continued on page 8) 6

By the year 20011r&l sales in the VSM market are expected to exceed $12.3 billion, for a CAGR from 1992 to ZOO1of iX2%,“th& ~ iepo;t say;. - ,,,._.‘ +b .’The steady mtroducfio;i ‘ tiovof ative products is a primary marketing trend in the VSM industry, Packaged tj;-M Facts Notes. Iri’ C990, oniy357 product were introduced, but ivell over 800 products were launched in the first 10 months of 1996, the report states. In 1996, 54% of the U.S. adult population used vitamin, supplement or mineral products, up from 43% in 1993, according to Packaged Facts. Most U.S. adults who take VSM products are classified as “mediurn users,” n leaning they take a VSM product on& a ‘ da;, the report notes.

Reflects, Sfrong lndu~fr y Growfh
The blue skip< and warni w<afh& of Southkm‘ C&fo&a are hard to resist;” especially d&i@ early March when much df the country is still experiencing winter. Add in a busin&? *fexc’ tisk” for visiting the area, and it is hardly surprising to find that moie than 24,000 health food industry members made the trek to Anaheim for last month’ Nitural Products s Expo West trade show. According to show organizer New Hope Communications, Boulder, CO, approximately 24,600 retailers, distributors, and other members of the natural products industry from around the country converged on Anaheim for the annual Expo West show. This represented an increase of approximately 2,000 from last year’ s attendance, New Hope said. This year’ show featured some 1,200 s exhibitors, which was 100 more than last year, organizers added. Most observers said the foot traffic on the trade show floor kept up a s’ t”ady pace throughout the thqee days of exhibits. Many exhibitors commented on the fact that the usual “ghost towti” effect that- te& to of&r abdtit‘ h&r befbre the end of & each exhiijit day hid not seem to happ&n at this s&W.-’ fie>;’ noted that ‘ hen’ on tlie‘ last day of the show, a sfeady stream of people kept going Z&tg. ’ ” Bill Johnson from Henkel -C&poration quipped: “If this is the ‘ away day,’ then no one’ going go s gtiay yet.”
Success, But Some Frustration

among The general’ feeling exhibitois and attendees al&e was that the show was- a success. However, factions of the attendees
(Continued on page 8)

APRIL 1997













2 :..


,‘ ..


* David Kessler, M .D. & p# Elizabeth Food and'D?ug Administr~kibfi I^ Re: Proposed G M P 's. Under DSREA 'November 20, 1996 Page 2

Vetl$y _

isn't allowing the Dietary‘ Supplem ent Industry to In short, 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 there are num erous-parallels between the asbestos litigation, trade associates invp~~,~,~,"in~~~eldping G M P 's and the trade asSociations that ~were inv,olved "'.o wi.h,"safe & tim es :~g~y/;ds~~~~~~s"-~hr'~s~ol_dr," .<&gi.,.i;ls&d;E.6~, rn-, i. >,%"9 >i I cab a&q+ "you; values. associations propose guidelines that were pro-public safety. &Given the trem endou-s ;im ourit of m oney involved in the dietarycoupled with the.~f.act that the indiv,id.uals~ supplem ent industry, 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 For exam ple, supplem ents are based on this,.,indu,~stry's standards. what is the Good M anufacturing Practice in the conventional food industry regarding the use of senna as a fo,odadditi+ve?, ,,Joes~. theses anyone in the FDA even 'know? ,,,Given.GN,C's I/ contention~that ^ " D I, ,_. ‘ e _ i. /' "_\,._.lL **/,,. . >. / __.,,, ..i, *a< I suspect that the G M P for..senna use will be a. Diet Teas com ply, joke. according to the California FDB report, the For exam ple, reported using less than three. hundred conventional food industry According to sworn testim ony of a pounds of senna a year. representative, who by the wgy, employs Dr. Zuellig Botanical AHPA in -- l,ll..‘ develop"ing new'-GM P % , 1 Fran Ertl, who is representing.", .,,., _,__ . J.I.// 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 As you by Laci Le Beau. Twenty-Four Hour Diet Tea, re-branded both the CRN m ay know, Dr. Ron Thom pson, of GNC is,representing These com panies ali m aintain that and NNFA. is developing G M P 's. the use of senna m eets the,appropriate GMP. In addition, to .ha.v,i,ng experts from then, conventional, food why not have experts from the A m erica-n industry involved, Botanical Associatiqn inv,o,lve,d? D,,r, varr,o, -Tyler, one of the directors aeat,; ,the a,ABC has jyT'-g ‘ tj-'e" gg& j-r$&c~ involved rA,v&& dnd of as describedthe 'Diet Tea in j^:_ , ,*.A itii;*~-4 ;:. wife's h;a,k*; &that Gfic ,\: my other com panies claim ,.c&m plies wifg= ~~-gyy@ ,~fJ$lKGf,,g+u_ring L ~~,++ ‘ ,.:., . Practices for the use of. _senna; /_>."Has- dnyone asked * him .to~_be " _,.V.,‘ ,. -.



a ,i_ 1


David' Keksler, .M'.I);“. -& Elizabeth Food and Drug Administfation Re: Proposed G M P 'B Under.DSHEA November 20, 1996 _ Page 3


. - -

* " a-)


(See Exhibit


. . -'

In short, to proceed in the m awgg in which the ,,,,, FFL is ,..is but another step in the wrong directionby the FDA to' heading, see to it that this industry and the products"it m anufacturqs are safe for public consum ption. in light of recent news arti,cW l.es, ,,in~,,&c,h, the FDA Indeed, to took the position that, it's hands are, tied .,from ,.,+d,qi"ng anything 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,,..a-. i9.. folly and da;;e;otn .\.. <,+, allowing G M P 's to be form ulatedin this *A,..fashion. , .._^ +1,,# c 1 hope ,/^ ^_,,, *.,* *,._s,*^*,_, <e~./,,#_ * 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 This way, the decided to let.this,"i~~d~t~y regulate itself. 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. would you please provide m e with notice-.so,that, As .an aside, provide a publid‘ m ent com 'before,~.these ‘ new,G&P'Zs‘ t,ake In fact, effect. ~ cc%!en& 1 please include this le_tLer,. &-J the"I ,,,_/__^,I ___, a_,~ ,h,aq.b, __ opposing the G M P process in case I do .wt receive . / nqtice j .. happened in the past 'tiith'other FDA" hearings.
I can




CEG:yb cc:

_ List ~ _ _ ,," _"

See Attached


4. 21 C.F.R. Part 7, Subpart C, “Recalls” 5. 21 U.S.C. 5 381 6. New 5 402(f)(l)(D) of the FDC Act, which cross-references$ 402(a)(l) of the FDC Act, 21 U.S.C. $342(a)(l) 7. 21 U.S.C. rj 342(a)(3) 8. I want to be clear that I do not representAlliance U.S.A. and that I have no dir&t knowledge df the merits of this particular maker, including-whkhtr Alliance U.S.A. may have had a sufficient basis to defend its product from FDA’ allegations. My s point in this paragraph is simply that sections 402(a)(l) and 402(f)(l)(A) of the FDC Act provide FDA a basis for ia!?ing prompt tid &zF,essive regulatory action when it believes that a dietary sripplement product is dangerous or otherwise unsafe for human con:umption. 9. FDA Impprt Alert No. 54-04, “Automatic Detentidn of L-Tryptophan” (issuedMarch 22,199Oand still in effect) 10. I understand that there is a viewthat is strongly held by many within the dietary supplement industry that this import alert is an unreasonabkand overly prohibitory measure,in that the problems that were experienced-with L-tryptophan related

to production of the ingredient by a particular cpmpany, and that there is no rqson Jo believe that all L-trvotoohan (which is, after all, an essential amitiya&) is cotiprehensively unsafe. I am a lawyer and not a toxicologist, and f do not have the scienti%Ykxperienceto take a position on the merits of the factual #egations.in this situation. Mj; fioik’ this paragraph, however, is in simply t&t set&X 402(a)(3) has provided FDA an ample and sufficient basis for stopping altogether the introduction into U&d, $?tes, corqtierce of a dietary ingredient to which the agency currenily objects. (The samesection of the,lawi.e., &&‘ 402($(3) of the FDC Act - could also bj: used bv.mA to siiodort’ ‘ a civil seizure action-or to recoq-qend the initiation of an i?junction action or a &$&I p;oYecGGnkiti;“& spect to a pioduct that is in interstate commq~~ 21 U.S.C. $1331-334.) Il. New section 413(c) of the FDCAct; 21 U.S.C.V 350b(c) 12. New section 413(a) of the FDC Act; 21 U.S.C. $ 350b(a) 13. New section 402(f)(l)(B) of the FDC Act: 21 U.S.C. 0 342(f)(l)(B)
, I.

New section 402(f)(i)(C); 21 U.S.C. $ 342(D(lXC). If the Secretarv declares a dietarv supplement or d’ ietary iti@edient “to pose an imminent hazard,”the agency must promptly thereafter conduct a? ~c$ir$st&ve proceeding to review the merits of this conclusion.I)ucing the proceeding, however, the product could not be sold to the public. The law does not provide any similar “in+itie~t f+a$” a@ority to the Secretary with resDectto conventional food oroducts. 1.5. ,21 U&k. 5 34?(a)(?), (4)
._... I


,.-Stephen H. McNamara is a partner with ihe law firm of Hyman, Phelps $2 McNamam, RC., a Washington, D.C., firm which generally confines its practice to assisting corporations and other law firms in mptters that ,.conce? [[heregulation offoods, ,_ drugs, medical devices; cosmetics and related products. _


Health Thompson of General Nutrition Products The U.S. Food and prug Administration Section.9 of the,@ary SuppIement of of 1994 (FDA) has acknowledged will soonpub- and EducationAct<*._. ^_,)(DSHEA) autho- participatedasa representative both CI$N and I ahd,Dr.Fran lish a proposalfor good manufacturingprac- rizes FDA to establishnew GMPs designed and NNFA. M i#a$i$$uffin ^.“.” ‘ ”.e, .,.‘ ” ,. “c,;2~,n...>-, (, tices (GMPs) developedby a coalition of or- for d,i$ry supplementproducts but based Ertl, and Jeff Hinrichs representedAHPA, andI‘ I,, Israelsen, ganizationsin the dietary supplementindus- on current foodj,GMPs, ,.. --.* .,/.dLoren A.~.< 3_I ExecutiveDirector, rep.S,WI 4. Shortlyafterpassaii of DS$IEAmem- resented UNpA. try. In a m id-July meeting Dr. Elizabeth G&s Z hroceduresthat manufac‘ bf die four major industry tradegroups b&s Yetley, Director of FDA Off& df $<%I and .,., “*,a&. Nutritionals, announced that FDA would that manufacture market dietary supple- tures must fcWw to en$Je quality control ~I -_“*.._ _“..ra”~dai,@~.dAs+. .~ ii?&, /_, qu&ty ass&a&& GMps in@& meapublish the proposedGMPs for public com- mentsbeganto meetto developCfi?ps: nci’ arid ‘ Associa- ~,i,*.*. ‘i ment as an Advanced Notjce c& Proposed are the American Herbal.Products,._ _<,-- ‘ suies designed to assure sanitation of the _j,-6”‘ /.i _^_ S. ;a> _,,, L/j~,ji _(, Nu- manufacturing.fa&lity and all production Rulemaking (ANPR) in the Federal iiegis- tion (AHPA), Council for Responsible trition (CRN), the NationalNutritionalFoods equipment, testing or other procedures to ter within the next few months. -.’ ^/’‘ . Until now, manufacturers, dietary Association (NNl?A), and the Urah Natural ensure accurateidentity and quantification of e/ I. I,.-L1 li 44; a*~,-**,? supplements(which include yitarni_ns, in- P:y~.~~~h&~l$y:,(UNl+V. ,. ,“I effort was of all ingredients, requirements to assure m The ..” designed erals, herbsand similar pro&s) have been chared by Pul BolaiX Pharmav+ Corpo- prop& labeling,andothermeasures to assyre@$t 6&K5is __/. . provided with ti& subject to the same GMPs as required for ratiqn, a member company of the Council x .__. -<lr *I Nutrition, and was staffed safe,properly labeleddietary supplements. processors conventionalfoods, l@nufac- for ,Responsible of According to NNFA Executive Direcs turersof pharmaceuticals, the other hand,’ by Dr. Annette,Dic&i~~on,CRN’ Director on s of mustconform to much morestringentGMPs. of Scientific and RegulatoryAffairs. Dr. Ron tor M i&ael Q. Ford, “FDA’ acceptance . “W.’ L*_j.‘ eF~.



our industry’ draft is a giant step and a sign s c - ‘ maturing of the industry’ relations *e s \ the agency. A major goal of the framers of DSHEA was to see industry-backed standards the starting point for GMPs with as the force of law. By using our draft as an ANPR, FDA shows its respectfor our industry that wants GMPs to be issuedpromptly.” At the mid-July meetingbetweenFDA and members of the four organizations that compiled the draft GMPs, Dr. Yetley and Dr. Robert Moore of her staff indicated that they had circulated the5ndustry’ GMP proposal s amongFDA staff inside and outsidethe Center for Food Safety.and Applied Nutrition. The ANPR when published will note some of the specific concerns raised by FDA and will invite comment on wheth_er public the sharesthe same concerns.


The need for more specificity in various areas. . Testing to assureidenty, especiaIlyfor botanicals. FDA recognizedlimits on industry’ ability to identify some ingres Its but neverthelesswants a more de.,.led approach. * Defect Action Levels (DALs)--FDA is concerned about DALs for botanicals. DALs deal with maximum levetj of foreign material that are’ allowed in’ botani: cals, which in their crude state by nature are raw agriculture products. For many

years the American Spice Trade Associa- ing are’ fairly standard for alldietary ingreWhen it comes to‘ iden&i&ion howtion has worked out with FDA the DAIS d&s.’ ‘ for major spices imported into the‘ U.S. ever,there are mz$y herbs fbr which chemiI,“,~,. .__, .._r FDAhas questionedwhetherDALs Setfor cil’ *i&8y& does not exist. HistoricaIly, spices are adi;i-.ife for-bdta.c;fs ii;‘ “ & manufacturers‘ practitioners have relied and I_ -,ii .~. I etary supplements. upon’ properly qualified staff to perform or* ‘ FDA’staff qu&ti&ied whether certifica-’ ganoleptic’ [recognitionby’ sight, smell, taste, tion in lieu of testing of raw materials is etc.] arialysis. We, iveie’ iible to in&e’ tI;‘ fs adequate for”filih, microbial content”“and “point”to’ other cdriimittee members and the identity’of raw ma&-i%1 “?‘ hat”is~can .a to include language in the-&& prop&alto niandfadturei~o‘processorrely on.a cer- recog?%eme validity’ such identification r mechani~ian’ :we‘ of s‘ lijo~~o~~~li.~~~~n~i~~e~ ! tificate of analysis supplied by a’ seller di: zx_.\. l.,. , p‘e.. (“, 4, ‘ cO~unlcatlo,~~~~~~~~~v~~~~~~~~‘ ~~t~ importer as sufficient ‘ basisto‘ “dete%ine mA; $?his and Gih;i y,Agi ;;;?] .%c; I_ ~o~~~ ). . ‘ ;, “. _-. ,.. the cleanlinessand/or identity new and in * r_”.. I __ “.A of an mgre- requ*refu*era~~~~:‘ f;ii*,~~~a~~~‘ ,~~~~~~~~ ,, : dieny inst‘ bf petfbtiKi ead’ F ...men ,tiii.~~~:‘ ,;i~~~~~~h~~.‘ ihe. ~n some casespotentially duplicated.an’red ! dundant tests on all ingredients? Federal Register there will usuaSlybe a 90 to 123.day period forl$&ic‘ con$nent after dling of complaint filesandraisedthe ques- which FDA will publish proposedtentative 1: tion whether there is a need for medical GMPs. ‘ ultimately a final -regulation. and’ evaluation of complaints. Many manufacturers already wilI have TheStandardOperatingPr&ceduies‘ xi geared‘ cae;;‘ -~an;l~~~~~~~~~~‘ proEedured to .I..- ” (SOPs)~ of the proposed GiMPs“will not requtre accon%iddate‘ new standards that time, the by , records to exist to assure SOPS are fol- The new level ofGMPs will 1Xely have little lowed. Are written records needed? effecton-manymanufacturersof herbalprod; j.__^. uc;tS*‘ g& _./ ~_“‘ (<‘ ifready fo,loG;i~~,.&~GMps. Controls&e neeessaj to”assure cornthat r: puter-assisted’ opemtions are working -.’ .., ._ ~. x; r;a;non@-&~-~ggf-* FDA to p&l;sh properly. FDA may require validation of such operations. NNlXIndustry GMPs: Newport Beach,CA: .1_,, _, . .“I NatidnalN$-itional FqOdsA&n., July 24. 9 -~.~iv~iiso~* ;4.-i*“gg~~p,,,,a1;~on~l commu“It was clear r iS l.“^,, ,.,., represeriiaiiSes‘ to Dr. Eitl and myself as nic~~io~,~S~pie~~r”~~”II ,: .‘ ‘ ,-:-- ,,. / ~~,~~~A~~~~t‘ ‘ ~~i~~l iwe~ I ,, .I ”gfiG;Kn, Mi: rgg6 ~person~comdiknts present of meaninifGlhGMPj., scih establish6ent someunique challengesin the ‘ miinicaGor;;Septenii;ii:gf~‘
l mA’ is ‘ co;i&ne&b’ ~~t &i;iew and banI l l

issuesas facility sanitation and record keep-

by Mark Blumenthal and Ann2tte Dickinson, Ph.D. The long sagaof the controversialherb sultants to the Food’ Ilie Advistiry Committee, per daily”mtake. ‘ 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’ “*w,,,. **“x_,*l+s,~ .Y ~s**.y3 .<need’ foi”adequate’ w&$ings ephedra-conon with the iecotiendation that y‘ g*l;ioducts, sizlti .*fb.wha( thi h‘ n ,s,,. >.“” ”I,:,, ,. nq.2’ -‘ e^ib Food and Drug Administration (FDA)’C&y * 8&l%‘ tei-$%rous reportsof adverse reacaons indGiti71ha‘ *p;ev~~o*usl;;.recom~~~~~~ . -. d VC its Food Advisory Committee Meet- to commercial dietary supplementscontaini;;g.‘ ‘ the Ker$.*z&;an,o, *e * herb shoild..not _ <_/I :ng on Ephedra-Containing Dietary Stipple: ‘ ” j il ,“A”, _‘ (Blumenthal, 19%): < ” ,L,. nents. A Special Ephedra Working Group, be-banued, Despite a highly publicized death of a but,%%ad, the levelsof the ephe- _.” “‘ :he members of which are considered con- dti alkaloids‘ smdentin March from a shouldbe limited per&e and 20-year-oldcollege’




Regardin: what FDA Will eventuaily -REFEREf$Xs AND ScirrR<$s”“=’ .:propose,Ford says,“I think tliey’ come out Anonymous. 199h. E$iwkine Akloid ‘SupplementSafe ll DoseCannot Be Identified. rite 7&S&r. Chc$yCChse. somewhere between Canada’ system and s XiD: F-D-C Repot-b Sepr. 2. Dr. Croom’ recommendations-no addi- Anonymous. 19965.YSetious Adrerse ReactionsReponed s for EphedrineSuppkrxnts ic, I-5 big Range. The Ton tives, lots of warnings, low dose,no claims. Sheet.Chevy Chase.MD: F-D-C Reports,sept. 2. If this happens, this could kill this product AnOll)7llOUS. 1996c*Ephdine AIkdoGJSafetyAssunnceDifRcultiesHighlight DSHEX~*&itntio+ ~l,e %gSl&. 1 cate,oory.There hasbeena lot of irresponsiChevy C+c. AID: F-D-SRe&k, Sept. i. .’ _ . l$ity in the industry by both suppliers’ and Anonymous. 199&l fydiFo$~Herbal hledicinis Category Might Be&t Ephedn Regulation.77re& .$&. Chevy :-,,retaiIers. There have beentoo many suppliChase,hlD:F-D:C Reports. Sept. 2.. ‘ that have not usedthe quality control that Anonymous. 1996~. Cpntinued~Ma$eitng of Eph&ine ers “Slreet Drugs+’ %resjck+,.“~~k is 7% Slreer. Chevy they should and have not used the warning Chtse, ,LfD: F-D-C language th’ they should. Many retailers rinonymous. 1996L FDARcjzaxs,Sept. 2. Used as a Forum at Eph+ Hearing to QuestionS‘ lemen~and’ upp’ dl~~otRepsd ofDSHfA. have ‘ taken the time to acquaint themnot SpecialFG”prr. Bbulder. C’ Cikens fokH%th,“d”;“& 6: selves7 with the safety problems associatid 30. ,_ _,./ M, I ,,.b with theseproductsandinform their custom- Anonymous. 1996$‘Eph?d% ‘&fdpssed $1 FDA Advisory Conmiitce hfeering. X.vE4 Todo< N&$arr E&h. CA: er: !boot the potential adverseeffects. The Notional Nutritional FoodsAssn.. Sepr FDA may be the one who may be taking this Blumenthal.M. 19961FDXH&fdX.+&Advisory Committee Hearing on hq ~u%~:&perts Recommend ~pproproduct category away, but industry needs pria~c Labeling and Warnings- ;4’ k&~~ or th> Herb. to take a hard lookgt its own quartersin this HubalGram 36: 21-23.73. a&a.” (Ford, 1996jo ZL


Davidson, bfichacl H. 1996. Sutement Before the F‘ & visory Corn&tee and EphedrineSpecid \Vo~ortine Gr Food and Drug Administnrion. hfceting on Fo& P ucts Cont@inp E$%~;‘ .&loid;. August 27. Dickinson. A. 1996. Food Advisory Committee hicetin; ” EphedmContaining Dietary Supplements: Summaq Commentary.Washington.DC.: Council for Respons

Food and Drug Administraalion.1996. PressRelease:SL ment on +cet ,Drugs Containing bdcanical Ephec April 10. Ford, Xl. Q. 1996. Pcnontl communication. Sept. 3.

Mark &rnrer~thal is Founder and E ecurive Director ofABC and Editor of Her alGrain. Ar&ette Dickinson is Director Scientific andRegulatory Affairs at the Core cilfor Responsible Nrrtritio~~in~Washit,gto. D. C.

,,. . I ,,,. i,,,, ,.

Bow& to pressurefrom the NeEjraska Phar- sales of all dietq supplements containing ,Pro,ift macists Association, the NebraskaLe,oisla- ephkdraor ma”‘ huang (Ephe& &tica), reProRipp$ 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 ‘ i ““, .+i--.,+1&.‘I ,I : eri:. ,~j “,-c.*<,-,\^ 1 ““*b-P” 3~. -,I UltF? Diet Pep >i”M. “__” Q+L< - df i :A~ - ,._ substance. Schedule IV coritrolleh”jubTne Nebraska Pharmacists Association 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’ ~$~~~~~& ?~‘ hany retailers, inc&ling effect Ju!y-l9; 1996. ;over-the-counter(OTC) without‘ prescrip- health fqpd,~~~res,% 8 Ke&GkZ ” The NebrasFa_ State Patrol has beer tion under the FederalFood, Diu& &K!os24 Hour Diet DietGels informed of the char&in the law and ma) ‘. ._“. .(.... _lw,--l--. . I metic Act; are Iabeledand marke&d’ i&dr$ Buzz’ Bombers s enter heaIth food stores to determine compIiance with an FDA-issued 01% final I &i’ &wer pliance. Possession and sale 01 mono,g-aph tentativefinaIWy?5!pgraph or (i.e., Diet Mti ephedrine-containingpioducis- not exempt OTC bronc~~~~~~~‘ ;~~;i;i~~j; manufacare ,_ Diet Fuel from ScheduleIVstatus may r&uli in felony turecjand distributed ~o~~“Ie~iti~na~~m;hiciEner-Max prosecgon. -*nal use”in a mannerwhich reduces glimior EnergyRise -nates the IikdliIiood’ ibu&i &&$‘ of ~ot Ephedrine-Plus ’ [Anon. 1996. Nebraska Enacts Ephedrine marketed,advertisedor I~beled~fo?‘ indi&e EJxcei Enk@ ” _“.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. I Metabolift . July 22.1. 0 , . As enacted,this law will prohibit the Nepegen


The Board of Trustees of the American Bdtanical’ ,_r ._ ‘in ,; ,.‘, ‘ , u*^*,“i.i^-‘ ‘ Council -~.~, also ,_ announced the. election ofvarro E. ~~~,..“:‘. * : .x. “ The Board-of *_lP I,.* fmstees’ j((...“.~,“;‘ l~._ June announced the formation of ABC’ new AdvisoryBoard. Thrs Tyler, Ph.D., as a trustee.~‘ s ~j&r~~s the Lilly Drstmguished Professor .,..._I group constitutes some of the leading researchers and educators in of Pharrnacognosy at Purdue University and author of several leadNorth America in areas related to herbs and medicina1 plants. The ing herbal‘ books. ’ . ABC Advisory Board members will assist in. ~uggestmg. -, _. _I. ./ ..~ bslow. .-_ 1 . ., I I i AddIt*ona”q;G6.; M$W”gma&&.$~M&f”i~~ ‘ future* ning research and educational projects and pubf&tions as well as provide p:er review for HerbalCram. 9 Dennis Y C Awang, Ph.D., F.C.I.C., MediPIant Natural .Products Consulting Services, Ottawa, Ontario, Canada Michael J. Balick, Director of the Institute of Econ&nic Botany, the NkW York Botanical Gar” den, Bronx, New York -* -. Joseph M. Betz, Ph.D., ResearchChemist, Center for Food Safety and Applied Nutrition, D&ision of Natural Products, Food and Dmg Administration, Washington, D.C. Steven .i ,.I.> *. j.”./,_ Foster, Botanist; photographer, author, e,, ,= Fayettevrlle,Arkansas Christopher Hobbs L.Ac., AHG, Herbalist, botanist, licensedacupuncturist,SantaCruz: Caiifomia David Hoffmann, B. SC.;M.N.I.i%I.H., Med2al “herbalis~~S,‘ ‘ Santa California Rosadsa, $Iark J;‘ Plotkin,Ph.D, ExecutiveDirectbr,“Ethnobotany’ ar;aConsertion Team,Author;ArlinSton, Virginia

..f.thk“ne& board *isteh “- ._ atih’ ’ , #& “.ti.i;it;k”rs’ XgydSvisbrj; are. phb”

Eloy~BZlrigue~, Ph: D.,‘ .james Perkins Professor of El?viron,~entalStudies,School ofA&iculmre & life Sqiences,Come11 University, Ithaca, MauiiCe hi. IwU, PI&X’ Biomsources Develop- New Yoik , /. I .--‘w*,x--.aqv ’ “ i^ mentand C%nsetiatioiiPioSram,Semor Research Associate at the Division _,_,_) _.**a.“( G,,,~^_^” ., .” 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 ~~~~$uk for New Crops Director, Center & P,a;;t”Prb”h;“~ls:‘ .u..;v;.~ii, West ucts Research Co,nstiltants,Faculty, Bastyr Uni- Washington,D.C. versity, Seattle, Wasliiringion Lafayette, Indiana Steven King, Ph.D., SeniorVicePresidentof Eth.,x. _^_” I/ I .“,~,~~l~._ Manuel F. Balandrin, R.Ph., Ph.D., Research nobotanyand’ Conse&ion, ShamanPharmaceu- Be@ Simpson, PhrD:;‘ L. Lu&.ii Professor 6. Scientist, NPS Pharmaceuticals:SaltLake city, ii??%, South San Francisco, California of Botany, Department of”Botany~.ir^nivkrsity of Utah Texasat Austin, Austin.’Texas . Fredi Kronenberg, Ph.D., Director, ~kosentha‘ l .“.,. ,.e, il>“a..sY%h*_. .e_ Thomas J. Carlson, MS,, M.D., Senior Direc- Center forAltemattve/Complementary Medicine, S. H. Sohmer, I%.D:, F%sidentand’ Directot(Bot (A, cm- * _r. ~._S tor, Ethnobiomedical Field Research, S’ h%an “~%$?of Phystctans& Surgeons of Columbia Texas 1 tani~al’ Research‘ of T’ Fog’ ” Institute‘ 1 &&%T 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‘ PharWashinpton, DC. at Austin, Austin, Texas macy, University of Arizona, Tucson,Arizona 1. g‘ rir&~rd;.Ari;$.yDI; A;$--6i Emkniui’ lcI: ~F. Jerry Cott, Ph.D., Chief’ .,z- id*-“...x Phar?nacolo&cal .%_d\.of‘ Treatment Research Program. Nattonal Institute ~~~~~~;B‘ iiian~Deijarrrnent, University of Biitof Mental Health, Rockville, X!aryland ish Columbia, Vancouver, British Columbia, Canada j, Paul Alan Cox, Ph.D., Professorof Botany and Dennis ‘ M6Een”na; Ph.D;, Consultin,b J.‘ 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$tan, Ph.D., William ;i;;;itj;’ cf aI Pi;;~~~~-~~~~~iopo*~gy, TKi .u;i’ E. Stirton StateUniversity, Dove<Delaware Lyle E. Craker,Ph.D., Professor,Department of Plant and Soil Sciences,University of Massachu- Michi&n, Dearborn, Michigan Nancy Turner, Ph.D., Pr&ssor and Ethnobotasetts,Amherst, Massachusetts nist, Environmental StudiesProfqrn, University Samuel I%! Page, Ph.D., Director, Division of of Victoria, ‘ ~o!umbia, Canada ” Yi~~~~a;“~~~~b’ Edward M. Croom, Jr., Ph.D., Coordinator,Phy- Natural Products, Center for Food Safety and tomedicine Project, National Cenier’ the De- Applied Nutrition, Food and Drug Administration, Andrew T. Well, M.D., Author, Director of the for velopment of Natural Products, University of Washington,D.C. Eo$%I & %&rative’ Medicine and Associate Mississippi, Oxford, Missi$pi Director of the Division of Social Perspectivesin bfeifici..g gf th;~;yfgmg$-~;gJ~Je, University Gail B. Mahady, Ph.D., ResearchAssistant ProWade Davis, Ph.D., Author, ethnobotanist, Wash- fes@<~D$a.rt%ent Medical Chemistry & Phar- of Arizona, Tu&on, Arizona of ington, D.C. macognosy,College of.Pharmacy, University of ad hoc advisor: Illinois, Chicago, Illinois Steven Dentali, Ph.D., Natural ProductsConsultDavidM. E$enberg, M.D., Director,‘ Center for ant, Portland, Oregon eth Julih.,E Morto,n, D.!+. F.L.S., Dire~~or,~Mprton Alternative Me&&e Reseamh,B’ Ismel Hos~~~~~S~h~~l~Bosto~, M/IassachuC$ol$~nea,Uuversrty of Miami; Coral Gables, pii~arv~d’ Hardy Eshbaugh, Ph.D., Professorof Botany & setts Assistant Curator, WillardSheii;;an’ t$~~%erT’ _,. “i., _ ,_._. ,, , I, ,% . .x ‘ . barium, ?&amiUniversity, Oxford; 6hio .


1 I/20/96 Mailing List for Letter Re: Proposed GMP’ Under DSHEA - What is the FDA Doing? s
” /_,.

The Honorable Michael Bilirakis U.S. House of Representatives 4111 Land O’ Lakes Blvd. Ste. 306 Land O’ Lakes, Florida 34639 Senator Diane Feinstein U.S. Senate Washington DC. 20510-0504

Ms. Leslj,e Brinkley *Km-TV Channel 7 900 Front Street San Francisco, CA. 9411 I1450

Ms. Kathy Ericson West Publishing Company C-1-20 Cube 27 620 Oppetman Drive Eagan, Minnesota 55 123 . 2

Ms. Kathy Ericson c-1:2O’ CGs;‘ 27’ West Publishing Company 620 Oppetian Drive Eagan, Minnesota 55 123

John, Gleason Center for Science and Public Interest 1775 Connecticut Northwest, Suite 300 Washington, D.C. 20009

Victpr Herbert, M.D., J.D., F.A.C.P. Director, Nutrition Center Mount Sinai School of Medicine and Medical Center & Bronx Vet&as Aff$ _ Medical ._ Cent& 130 West Kingsbridge.Rd. Bronx, New York 10468 Mr. Rojs McGowan KTVU Channel 2 P.O. Box 22222 Oakland, CA 94623

Professor’ Ryan J. Huxtable Department of Pharmacology Health Services Center University of Arizona Tucson. AZ 85724

Ms. Jane Lee Columbia Graduate Student 362 Riverside Dr. Apt. 9Cl New York, New York 10025

Ms. Patricia Long Health Magazine 301 Howard St., 18th Floor San Francisco, California 94105 bjs. Nancy Moore Bureau of National Affairs for Toxic Law Reporter 1231 25th Street N.W. District of Columbia‘ 20037

Ms. Elizabeth Moore Staff Writer Ldng Island Newsday 598 Byoadhollo-wRd., Melville, New York 11747 Health Letter Associates Editor University of Californiaat Berlielki P.0: BOX 412 Prince Street Stations New York, NY 10012-0007 Dr. Bruce Ijensel K+C Channel 4 ,.” .( (_ 3000 West Alameda Avenue Burbank. CA 91523

Dr. Robert J. Moore Division of Programs & Enforcement Policy Office of Special Nutritionals Food & Drug Administration Washington, DC 20204 Senator Wellstone Scott Adams Mark Anderson 2550 University Rm. 100 N. St. Paul, Minn. 55114 Mr. David Hinchman Dateline NBC 4001 Nebraska Avenue Washington, DC. 20016 Ms. Michele Murray WM-TV 3213 W Kenpedy Blvd. Tampa, FL 33609 Nancy Sneiderman, M.D. c/o KPIX Channbl 5 855 Battery Street San Francisco, CA 941 I 1

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