Article: Influencing FDA; industry must be more

proactive in FDA's decision-making processes.(The

Research Process)
Article from: Nutraceuticals World /Article date:April 1, 2010 / Author:Kalman, Douglas/Copyright

It should come as no surprise that this FDA (under the Obama administration) is taking a tougher, harder look at
legislation and regulations for foods and dietary supplements. FDA and other regulatory agencies are interested
in the claims made by manufacturers, retailers and all companies in the "sales chain."

How FDA Views Claims

Some of the basic tenets of the Dietary Supplement Health & Education Act (DSHEA) have been reviewed
since its introduction in 1994, especially over the last several years. Health claims have been questioned
particularly, so let's take a look at how FDA views them today.

Federal law allows for certain claims to be made in the labeling of food and supplements. These include claims
approved by FDA that show a strong link, based on scientific evidence, between a food substance and a disease
or health condition. These approved claims can state only that a food substance "reduces the risk" of certain
health problems, not that it can "treat" or "cure" a disease. Two examples of approved health claims are: "The
vitamin folic acid may reduce the risk of neural tube defect-affected pregnancies" and "Calcium may reduce the
risk of the bone disease osteoporosis."

Dietary supplements may also carry claims in their labeling that describe the effect of a substance in
maintaining the body's normal structure or function, as long as the claims don't imply the product treats or cures
a disease. It is important to remember that FDA does not review or authorize these claims. An example of such
a claim is: "Product B promotes healthy joints and bones." When a dietary supplement uses a claim like this it
must be accompanied with the disclaimer: "This statement has not been evaluated by the Food and Drug
Administration. This product is not intended to diagnose, treat, cure or prevent disease."

[ILLUSTRATION OMITTED]

FDA clearly spells out examples of allowed label claims. But this can be confusing, because there is some
overlap between the regulations of claims--as the Federal Trade Commission (FTC) regulates the marketing of
products in the U.S.

It is important to note that FDA's budget is set by Congress. However, FTC's budget allows it to go after
infringers and to keep any monies awarded by the courts or in their actions against companies that have violated
U.S. laws. In other words, FTC has added incentive to fine individuals or companies. FDA does not have that
monetary carrot to perform their work. So sometimes the best way to affect change is from within, especially in
the case of FDA. But is promoting change within the agency even possible?

Getting a Seat at the Regulatory Table

Currently, FDA is seeking new members/new volunteers for its scientific review and guidance committee
(officially named "Science Board to the FDA"). To me, when reviewing this buried call and opening by FDA,
this spells opportunity for the dietary supplement industry to have representation on the Advisory Board. If you
read through the list of members, it is interesting to note that the nutrition-centric committee members are
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mostly from the food industry (i.e., Coca Cola, Mars Inc., etc.), while medicine is represented by a mix of
academia and industry. Interestingly, no one represents the scientific side of dietary supplements. Ts this an
issue? It depends. Does it concern you if no one represents your thoughts or desires, yet makes rules and laws
that will affect your company and products, and ultimately consumers' freedom of choice?

Using leading trade groups--UNPA, CRN, NPA, AHPA--that have a presence in the science world helps
influence the thinking and rule-making process. But it is the industry's responsibility to nominate well-
established professionals from academia and companies to represent what's in their best interest on the FDA
Science Advisory Board (SAB).

Doreen Kezer, MSN, the senior science policy analyst at FDA, is the point person for obtaining information on
this SAB as well as to apply to be on the board. Industry often complains when decisions are made for it that are
either uninformed, biased or do not represent its best interests. But there simply is no room for complaints if the
industry is not involved at the highest levels.

What Next?

The vast majority of dietary supplement companies abide by FDA and FTC regulations; it is only a rogue few
that run afoul of the law. But it is these "bad apples" that get more attention, and the negative is what drives the
media and, of course, the headlines. The only way to bring a branded ingredient or product to market is to
incorporate firsthand, product-specific research in the development process.

Once a formulator has decided upon the final mix of ingredients) for a product, utilizing universities, private
research institutions or contract research organizations (CROs), tax credits and other means allows for low-cost
validation of a proof of theoretical concept for the product's intended use or a confirmatory study of what the
product can actually do.

Contrary to popular belief, obtaining firsthand data on your finished product is economically feasible. Further, it
increases the potential for patents and added intellectual property (IP) for the product, brand and company. And
once a product and a brand have added IP, valuations go up.

"It is the industry's responsibility to nominate well-established professionals from academia and companies to
represent what's in their best interest on the FDA Science Advisory Board."

By Douglas Kalman, PhD, MS, RD, CCRC, FACN

Douglas Kalman, PhD, MS, RD, FACN, is director of clinical nutrition at Miami Research Associates (MRA),
Miami, FL, in the Nutrition and Endocrinology Division. MRA is a clinical service organization involved for
over 10 years in phase II through post market trials for the pharmaceutical and nutraceutical industries. Mr.
Kalman is also an active member of the American College of Sports Medicine, American College of Nutrition,
the American Dietetic Association, the National Strength and Conditioning Association and the Association of
Clinical Research Professionals, lie is also the executive vice president and treasurer of the international Society
of Sports Nutrition (ISSN). lie can be reached at 305-666-2368; Fax: 305-669-8966;

Kalman, Douglas. "Influencing FDA; industry must be more proactive in FDA's decision-making processes.
(The Research Process)." Nutraceuticals World. Rodman Publications, Inc. 2010. HighBeam Research. 6 Oct.
2010 <http://www.highbeam.com>.