How the Dietary Supplement Health and Education Act of 1994 Weakened the FDA


Stephen Barrett, M.D.
July 6, 2000

Most people think that dietary supplements and herbs are closely regulated to ensure that they are safe, effective, and truthfully advertised. Nothing could be further from the truth. Although some aspects of marketing are regulated, the United States Congress has concluded that “informed” consumers need little government protection. This conclusion was embodied in the Dietary Supplement Health and Education Act of 1994 — commonly referred to as “DSHEA” — which severely limits the FDA’s ability to regulate these products.

Background History

In the early 1990s, Congress began considering two bills to greatly strengthen the ability of federal agencies to combat health frauds. One would have increased the FDA’s enforcement powers as well as the penalties for violating the Food, Drug, and Cosmetic Act [1]. The other would have amended the Federal Trade Commission Act to make it illegal to advertise nutritional or therapeutic claims that would not be permissible on supplement labels [2]. During the same period, the FDA was considering tighter regulations for these labels.

Alarmed by these developments, the health-food industry and its allies urged Congress to “preserve the consumer’s freedom to choose dietary supplements.” To whip up their troops, industry leaders warned retailers that they would be put out of business. Consumers were told that unless they took action, the FDA would take away their right to buy vitamins. These claims, although bogus, generated an avalanche of communications to Congress [3].

The end result was passage of DSHEA, which defined “dietary supplements” as a separate regulatory category and liberalized what information could be distributed by their sellers. DSHEA also created an NIH Office of Dietary Supplements and directed the President to appoint a Commission on Dietary Supplement Labels to recommend ways to implement the act [4]. The Commission’s final recommendations were released on November 24, 1997 [5,6].

The Food, Drug, and Cosmetic Act defines “drug” as any article (except devices) “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” and “articles (other than food) intended to affect the structure or function of the body.” These words permit the FDA to stop the marketing of products with unsubstantiated “drug” claims on their labels.

To evade the law’s intent, the supplement industry is organized to ensure that the public learns of “medicinal” uses that are not stated on product labels. This is done mainly by promoting the ingredients of the products through books, magazines, newsletters, booklets, lectures, radio and television broadcasts, oral claims made by retailers, and the Internet.

DSHEA worsened this situation by increasing the amount of misinformation that can be directly transmitted to prospective customers. It also expanded the types of products that could be marketed as “supplements.” The most logical definition of “dietary supplement” would be something that supplies one or more essential nutrients missing from the diet. DSHEA went far beyond this to include vitamins; minerals; herbs or other botanicals; amino acids; other dietary substances to supplement the diet by increasing dietary intake; and any concentrate, metabolite, constituent, extract, or combination of any such ingredients. Although many such products (particularly herbs) are marketed for their alleged preventive or therapeutic effects, the 1994 law has made it difficult or impossible for the FDA to regulate them as drugs. Since its passage, even hormones, such as DHEA and melatonin, are being hawked as supplements.

Increased Safety Risks

DSHEA also prohibits the FDA from banning dubious supplement ingredients as “unapproved food additives.” Before DSHEA’s passage, the FDA considered this strategy more efficient than taking action against individual manufacturers. Now the only way to banish an ingredient is to prove it is unsafe. Ingredients that are useless but harmless are protected. Nor is there any practical way for the FDA to ensure that the ingredients listed on product labels are actually in the products.

Because manufacturers are not required to submit safety information before marketing “dietary supplements,” the FDA must rely on adverse event reports, product sampling, information in the scientific literature, and other sources of evidence of danger. Since the FDA is unable to monitor and regulate thousands of individual products, the public is virtually unprotected against supplements and herbs that are unsafe. In recent testimony, FDA Commissioner Jane E. Henney, M.D., even pointed out:

Products that contain substances similar to those found in prescription drugs are marketed for children as dietary supplements. Likewise, products with ingredients that simulate illicit street drugs are marketed as dietary supplements to adolescents via the Internet and shops specializing in drug paraphernalia.” [7]

In June 2000, the New England Journal of Medicine published a report by Nortier and others of an outbreak of urinary tract cancers in Belgium among users of a Chinese herbal product that contained aristolochic acid — a known carcinogen found in an herb called Aristolochia fangi [8]. In an accompanying editorial, Former FDA Commissioner David A. Kessler, MD. JD, noted that herbal products containing A. fangi had been banned in several European countries but were available in the United States. Commenting on DSHEA, he stated:

The 1994 Dietary Supplement Act does not require that dietary supplements (defined broadly to include many substances, such as herbs and amino acids, that have no nutritive value) be shown to be safe or effective before they are marketed. The FDA does not scrutinize a dietary supplement before it enters the marketplace. The agency is permitted to restrict a substance if it poses a “significant and unreasonable risk” under the conditions of use on the label or as commonly consumed.

The safety standard may sound as if the FDA has all the authority it needs to protect the public. The problem is that the burden of proof lies with the FDA. Even when the agency is able to act, how is it supposed to know which products contain aristolochic acid, and who sells them? What is the agency supposed to tell people who may have consumed these herbs? Congress has put the FDA in the position of being able to act only after the fact and after substantial harm has already occurred.

The association of A. fangchi with urothelial carcinoma is not the first instance in which dietary supplements have caused potentially serious harm, although this is the strongest association of an herb with a cancer in humans. Among the other well-documented examples of adverse reactions are the association of germander with acute hepatitis, of comfrey with hepatic veno-occlusive disease, of yohimbe with seizures and renal failure, and of ephedra with death from cardiovascular causes. The use of amino acids, herbs, and a host of other supplements is more likely to arouse concern about public health than is the use of traditional vitamin and mineral supplements at reasonable potencies. Even with the use of conventional medicines, the cause of adverse effects that are not immediate and dramatic is hard to pinpoint. This is especially true for substances that are given outside the conventional health care setting, since there is no adequate system of reporting adverse events that may be associated with these products.

It took a tragedy — poisoning caused by the use of an elixir of sulfanilamide — to prompt Congress to pass the Food, Drug, and Cosmetic Act of 1938, and it took reports of birth defects among the children of women who took thalidomide during pregnancy to secure passage of the Kefauver-Harris Amendments to that act in 1962. Congress has shown little interest in protecting consumers from the hazards of dietary supplements, let alone from the fraudulent claims that are made, since its members apparently believe that few of these products place people in real danger. Nor does the public understand how potentially dangerous these products can be. Examples like that described by Nortier et al. should persuade Congress to change the law to ensure the safety and efficacy of dietary supplements before more people are harmed [9].

“Nutritional Support” Statements

DSHEA allows dietary supplements to bear “statements of support” that: (a) claim a benefit related to classical nutrient deficiency disease; (b) describe how ingredients affect the structure or function of the human body; (c) characterize the documented mechanism by which the ingredients act to maintain structure or function; and (d) describe general well-being from consumption of the ingredients. The statement “calcium builds strong bones and teeth” is said to be a classic example of an allowable structure/function statement for a food. What constitutes an allowable statement for a supplement has not been established either by law or by regulation.

To be legal under DSHEA, a “nutritional support” statement must not be a “drug” claim. In other words, it should not suggest that the product or ingredient is intended for prevention or treatment of disease. However, the marketplace has been flooded by statements related to organs (such as “supports the eyes” or “supports the cardiovascular system”) that are really drug claims.

Actually, few statements about the biochemical or physiologic properties of nutrients have practical value for consumers. By definition, every essential nutrient is important to proper body function. Simple statements about nutrient function are more likely to be misleading than helpful. A statement such as “vitamin A is essential to good eye function” could suggest: (1) people need to take special steps to be sure they get enough, (2) extra vitamin A may enhance eyesight, and (3) common eye problems may be caused vitamin A deficiency or remedies by taking supplements. To be completely truthful, a “nutritional support” statement about vitamin A would have to counter all three misconceptions and indicate that people eating sensibly don’t need to worry about whether their vitamin A intake is adequate. In other words, truthful statements about nutrient supplements would have to indicate who doesn’t need them. No vitamin manufacturer has ever done this or ever will. Since herbs are not nutrients, the concept of “nutritional support” statements for herbs is absurd.

Under DSHEA, manufacturers who make statements of “nutritional support” must have substantiation that such statements are truthful and not misleading. The law also requires that the Secretary of Health and Human Services be notified no later than 30 days after the first marketing of a supplement for which the statement is being made. The law does not define substantiation.

Historically, the FDA has considered literature used directly in connection with the sale of a product to be “labeling” for the product. DSHEA exempts publications from “labeling” if they: (1) are not false or misleading, (2) do not promote a particular manufacturer or brand, (3) present a “balanced” view of pertinent scientific information, and (4) are physically separated from the items discussed. However, since most “dietary supplements” are either useless, irrationally formulated, and/or overpriced, the supplement industry is has little reason to provide literature that is not misleading. In addition, the FDA does not have the resources to police the huge numbers of “support” statements to ensure that they are appropriately “balanced.”

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