Gay Men's Health Crisis: Treatment Issues, Volume 7 no. 11/12 - Winter, 1993/94
Derek Hodel

A bill now before Congress, the Dietary Supplement Health and Education Act of 1993, has attracted considerable attention within the AIDS community and elsewhere. The Act was written in response to FDA rulemaking, and would significantly change the authority of FDA to regulate the dietary supplements marketplace. Sales of such supplements, to an estimated 60 million consumers, exceed $3 billion annually.[2]

The bill was introduced by Senator Orrin Hatch [R/UT] in the Senate and by Representative Bill Richardson [D/NM] in the House of Representatives, and has accumulated an impressive, bipartisan array of sponsors.[3] In the Senate, the bill is currently in committee, where significantly, Senator Edward Kennedy [D/MA], Chairman of the Labor and Human Resources Committee of the Senate, has expressed strong reservations. In the House, Representative Henry Waxman [D/CA], Chairman of the Health and Environment Subcommittee of the Committee on Energy and Commerce, has also voiced strong objections to the bill.

At balance are FDA's mandate to protect consumers from dangerous products and fraudulent health claims versus the consumer's "right to know" and freedom to choose.[4] The current debate represents only the most recent installment in a long-standing dispute between the industry and the agency[5], and was spurred by the Nutrition Labeling and Education Act of 1990 (NLEA). In the NLEA, Congress directed FDA to develop regulations governing health claims for foods, requiring that such claims be supported by "significant scientific agreement." The act resulted in substantial changes in labeling on grocery shelves, and reduced significantly the health claims that had become commonplace on everything from oat bran muffins to orange juice. The NLEA also required FDA for the first time to promulgate rules governing health claims for dietary supplements[6] - and here is where the trouble began.

Because the statute did not specify a scientific standard for health claims for dietary supplements, as it had for traditional foods, the matter was left to FDA discretion. The agency, arguing that to set a standard different for supplements than for foods would be illogical and would provide consumers with contradictory and confusing information, proposed rules that set the same, "significant scientific agreement" standard.

The supplements industry, faced with significant restrictions on what had become commonplace labeling claims[7], lobbied hard for Congressional relief. In response, the Dietary Supplement Act was appended to FDA user-fee legislation during the final sessions of the 102nd Congress. The Act, required FDA to propose rules governing health claims by June 15, 1993 and to finalize such rules by December 15, 1993.

In the intervening year, FDA released the final report of the Dietary Supplements Task Force, an internal agency task force that Commissioner David Kessler had charged with examining the regulatory issues surrounding dietary supplements, for public comment.[8] Previously, the agency had also commissioned the Federation of American Societies for Experimental Biology (FASEB) to review the scientific literature concerning the safety of amino acids - this report was released for public comment, as well.[9] Lastly, FDA did issue a final rule using the "significant scientific agreement" standard, already in force in the foods industry, as a means of regulating dietary supplements.

The Dietary Supplement Health and Education Act of 1993 anticipates the FDA rulemaking now under way, and carves out a separate regulatory class for dietary supplements that is more lenient than for traditional foods. In essence, the Act prohibits FDA from regulating dietary supplements under either the "drug" or "food additive" provisions of the Food, Drug and Cosmetic Act. Most notably, it also shifts the burden of proof of safety from the manufacturer to the FDA. In other words, it would be up to the agency to prove in court action that a particular supplement or ingredient was not safe, prior to enforcement action, rather than a manufacturer's obligation to prove that it was.

Strikingly, health claims would also be permitted, as long as they "accurately represent the current state of scientific evidence concerning the relationship between the supplement or dietary ingredient of the supplement and a disease or other health-related condition," a determination that would be left to the manufacturer (rather than to FDA) to make, a sharp curtailment of, and philosophical departure from, the "significant scientific agreement" standard. In effect, health claims that are currently not permitted on a carton of orange juice, could be permitted on bottles of Vitamin C.

The supplements industry, represented by the National Nutritional Foods Association (NNFA) and others, is waging an aggressive lobbying campaign in favor of the Hatch/Richardson Act and against the FDA rules. One very slick television spot features Mel Gibson, attired in bathrobe and holding a bottle of Vitamin C, being accosted in his home by an FDA "SWAT team."

Congressional aides have reported receiving "thousands" of letters from consumers, who are fearful that products on which they have come to depend may be removed from the marketplace. Much reporting on the issue, particularly in the lay AIDS press, has been vastly overwrought, with some reporters suggesting that FDA proposals would mandate that all such supplements would require a prescription from a doctor, or that herbs would simply be removed wholesale from the market, or that FDA is intent on shutting down the health foods industry.

For the AIDS community, the issue poses a particularly acute dilemma. Many people with HIV view supplements as an effective component of their treatment regimen. In testimony before Waxman's committee, Fred Bingham, Executive Director of DAAIR (Direct AIDS Alternative Information Resources) claimed that his T-cell count increased from 30 to over 900 and stabilized for two years "by using a combination of anti-oxidants, amino acids, and herbs, including an IV pharmaceutical preparation of licorice, called glycyrrhizin..."[10] Although Bingham spoke in favor of "full disclosure labels" and "non-misleading claims," the nexus of his testimony rested on alleged FDA institutional bias. Bingham claimed that FDA's concerns about the safety of amino acids, for example, was "pure politically motivated bias." In a credo typical of the tone of debate, Bingham said, "As a person living with AIDS, my very life depends on continued access to the supplements that the FDA apparently considers to be a threat to drug development."

The emotional tenor of the debate, combined with the usual cloud of smoke generated by Washington lobbyists, will make the issue a difficult one for the AIDS community to resolve. It is fair to say that there is a significant problem with fraudulent health claims, particularly in the dietary supplement marketplace, and that many of those claims are aimed directly at people with AIDS. Conversely, people living with HIV disease, faced with narrow enough (and mostly inadequate) treatment options from so-called mainstream providers, are understandably concerned with the prospect that their options might be further diminished.

Although the trajectory of the Dietary Supplement Health and Education Act of 1993 is uncertain, given the level of public interest and Congressional lobbying, it seems likely that it will assume a prominent position in the agenda of the AIDS community for some time.

1. As quoted in Frank, Richard L. and O'Flaherty, Michael J., "The Battle Gets Curiouser and Curiouser." Legal Times (September 20, 1993): 29-30.

2. Over 80% of "dietary supplements" are vitamins and minerals, which according to FDA, can fairly be called "nutritional supplements," since they are known to play a well understood role in human nutrition. Further, the agency says that such vitamins and minerals present no particular regulatory concern, when manufactured safely and when sold without unsupported health claims and in reasonable potencies. In terms of the current debate, "dietary supplement" is also being used to describe a variety of herbs, high-potency amino acids (such as those marketed to body-builders), and other products.

3. As of 18 October 1993, Senator Hatch reports 59 Senate cosponsors, enough to pass the bill. In the House, Richardson has accumulated 158 cosponsors, which include such odd ideological bedfellows as Reps. Pelosi, Holmes-Norton, Hall and Tauzin.

4. FDA's authority to regulate foods (which generally require no pre-marketing approval) and drugs (which do) is vested in the Food, Drug and Cosmetic Act of 1938. In 1958, Congress passed the Food Additive Amendments, which authorize FDA to require premarketing approval of additives not generally recognized as safe. After FDA proposed rules in the 1970's to regulate dietary supplements by specifying composition and potency, Congress passed the Proxmire Amendments, which prohibit FDA from limiting the maximum potency of vitamin and mineral supplements, except where the agency can demonstrate safety problems.

5. FDA reports directing only 1% of its enforcement resources toward dietary supplements. In the last three years, this amounted to 40 legal actions.

6. Traditionally, FDA had initiated enforcement actions against dietary supplements, either for misleading health claims or safety concerns, under the food additive or drug provisions of the Food, Drug and Cosmetic Act. Two recent court cases determined that FDA could not apply the food additive provisions of the Food, Drug and Cosmetic Act to a single nutrient. Since these provisions provide the basis for most enforcement actions in this arena, if these court cases stand, FDA jurisdiction in this arena would be sharply curtailed.

7. FDA published a report, Unsubstantiated Claims and Documented Health Hazards in the Dietary Supplement Marketplace, illustrating a vast, and troubling, array of clearly fraudulent health claims. (Hundreds of examples are included. For instance, the House of Hezekiah produces "Suma," which it claims "strengthens the immune system; reduces tumors and cancers;" a multitude of companies produce products claimed to be effective against AIDS, including Crystal Star Herbal Nutrition's "Biotec Extra Energy Enzymes.")

8. Dietary Supplements Task Force: Final Report. Washington, DC: Department of Health and Human Service, Public Health Service, Food and Drug Administration, May, 1992. The report, which does not represent current agency policy, recommends that FDA: 1) determine maximum safe intake levels for vitamins and minerals; 2) initiate rulemaking to categorize many amino acid products as drugs; 3) continue to apply the "food additive" standard to most dietary supplement products, unless drug claims are made; and 4) implement good manufacturing practice standards.

9. FASEB advised that there was insufficient data to determine safe levels of intake for amino acids, and recommended that the young, the elderly, women of childbearing age, smokers, and other potentially vulnerable subgroups use these products only under medical supervision. Concern surrounding amino acid toxicity had been generated by the voluntary recall of L-tryptophan, the ingestion of which published reports had associated with an epidemic of eosinophilia myalgia syndrome (EMS), a connective tissue disease which claimed 38 lives and injured 1500. After extensive investigations, FDA remains unable to conclusively determine the role of L-tryptophan in associated outbreaks of EMS. Although some studies suggest that contamination may have played a role, other studies demonstrate an association between the disease and L-tryptophan with no known contamination. The episode is instructive, in that current law permitted FDA to act swiftly - presumably, under S.784/H.R.1709, the burden of proving safety would be shifted to FDA, prior to enforcement action.

10. Bingham, Fred. Testimony before the House Subcommittee on Health and the Environment, Committee on Energy and Commerce. July 29, 1993.

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