HOPS

REGULATION OF DIETARY SUPPLEMENTS












Plants, Pills And People

Herbal Chemist

 By Paul A. Kimpel

 Proponents of herbal remedies need to understand that there is a huge difference between going in the backyard to cut a piece off an Aloe plant for a sunburn, and buying concentrated Ginkgo Biloba capsules because a Ph.D. declares in a "natural remedy" magazine that Ginkgo improves memory. The main difference is the Ph.D. often gets paid to write favorable articles about dietary supplements. The force behind the $12-billion-a-year dietary supplement industry is money, not your health.


The FDA and the FTC

 Dietary Supplements are regulated by the Food and Drug Administration and the Federal Trade Commission. The FDA's responsibility is to ensure that consumers receive dietary supplement products that have accurate labels and safe ingredients.  However, because much of the agency's regulatory power over dietary supplements was taken away when Congress passed the Dietary Supplement Health and Education Act (DSHEA) in 1994, consumers must use special caution when shopping for products.  SEE: WARNINGS

 The Federal Trade Commission regulates the advertising of Dietary Supplements by manufacturers and distributors.

The following is a partial list of dietary supplement advertising cases settled by the FTC:

* American Urological Corp. - 1999 - Settled charges that the company lied about the effectiveness of products to treat impotence. Sold herbal Viagra products over the Internet and through mail order under the names of Vaegra, Testosterone-21 and Prosta-Gen, among others. An $18.5 million judgment was entered against the defendants as part of the settlement. The company will turn over $2 million in frozen assets, which will be used to provide redress to consumers who bought the products.

* TrendMark International Inc. - 1998 - Consent order to not make unsubstantiated claims for the Lipo-Thin weight-loss product made of "chitin," a fiber made from ground-up exoskeletons of shellfish.

* Nu-Skin International - 1997 - Permanent injunction and $1.5 million civil penalty for violation of order not to advertise fat loss, muscle maintenance and other claims for the following dietary supplements: Metabotrim, OverDrive, GlycoBar, Appeal Lite and BreakBar, containing chromium picolinate and L-carnitine.

* Global World Media Corp. - 1997 - Consent order for the supplement "Herbal Ecstacy," advertised to produce a "natural high." Agreement not to make claims in media with large youth audiences without disclosing side effects and health risks. The herbal supplement produces an effect similar to pharaceutical versions of Ecstacy.

* Body Wise International - 1995 - Consent order for failure to disclose that healthcare professionals who gave testimonials for weight loss and cholesterol reduction products had a financial interest in the companies.

* Live-Lee Productions - 1995 - Consent order for unsubstantiated health claims made by TV personality Ruta Lee on Home Shopping Network for three vitamin sprays and a stop-smoking spray.

* Sharper Image Corp. - 1994 - Consent order to not make unsubstantiated claims for Essential Factors with Oxy-Energizer, a nutritional supplement for fatigue and extra energy.

NOTE: The FTC said consent agreements are for settlement purposes only and do not constitute an admission of a law violation. When the FTC issues a consent order on a final basis, it carries the force of law with respect to future actions.

Under the FTC Act, its Deception Policy Statement reads: "Advertisers must have substantiation for all objective claims before the claims are distributed."

However, the agency also advises that consumers operate under the auspice of "buyer beware."


Playing Games with Label Claims

  Elaine Turner, assistant professor of human nutrition at the University of Florida, said another area of dietary supplement regulation that needs clarification is label claims.   There are several types of claims allowed for dietary supplements. In addition to structure-function claims, there are health claims, which show the relationship between diet and disease. Structure-function claims on the other hand, cannot claim to treat or cure disease. Unlike structure-function claims, health claims must be approved by the FDA. Since implementation of the Nutrition Labeling and Education Act in 1990, which allowed for health claims on labels, the FDA has approved 11 health claims for foods but only three for dietary supplements.

  Those are the links between: 

Sufficient calcium intake and decreased risk for osteoporosis.

Folic acid and decreased risk of neural tube defects.

Psyllium seed husk and reduced risk of coronary artery disease.

 The Food and Drug Modernization Act of 1997 includes a provision to expedite approval of health claims, but because the claims require "significant scientific agreement among recognized authorities," few claims have been approved.  Because the FDA has not defined what constitutes significant scientific agreement,  there is much confusion among manufacturers trying to make health claims for their products.  However, health claims are allowed on the basis of an authoritative statement published by a "scientific body of the U.S. government that has official responsibility for public health protection, or responsibility for research directly relating to human nutrition."

This would include for example, the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), or the National Academy of Sciences (NAC).  However, the FDA has not decided which federal organizations can make these statements or who within those bodies can make them. Obviously, there is still much confusion in the regulatory marketplace  of dietary supplements.

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