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

Stephen Barrett, M.D.

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: (a) people need to take special steps to be sure they get enough, (b) extra vitamin A may enhance eyesight, and (c) 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: (a) are not false or misleading, (b) do not promote a particular manufacturer or brand, (c) present a "balanced" view of pertinent scientific information, and (d) 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."

Section 303 of the Food and Drug Administration Modernization Act of 1997 authorizes health claims based on current authoritative statements by U.S. Government agencies or the National Academy of Sciences about the relationship between a nutrient and health-related condition [10]. Under this provision, if the FDA considers a claim of this type to be misleading, it must issue a regulation or go to court to stop its use. The fact that these procedures are cumbersome further weakens the FDA's ability to protect consumers. In 1999, an FDA advisory group recommended how to determine whether "substantial scientific agreement" exists for health claims [11].

New Rules in 2002

On April 29, 1998, as required by DSHEA, the FDA proposed rules for statements about the effect of dietary supplement products on body structure and function. These rules included:

On January 6, 2000, after receiving more than 100,000 protest messages from the supplement industry and its allies, the FDA published a revised final rule on health claims for dietary supplements [13,14]. DSHEA permits claims that products affect the structure or function of the body, provided the manufacturer has substantiating documents on file. Without prior FDA review, products may not bear a claim that they can prevent, treat, cure, mitigate or diagnose disease. The final rule still prohibits express disease claims (such as "prevents osteoporosis"), and implied disease claims ("prevents bone fragility in postmenopausal women"), including claims made through a product's name ("CircuCure") or through pictures or symbols. The rule permits health-maintenance claims ("maintains a healthy circulatory system"); other non-disease claims ("for muscle enhancement," "helps you relax,"); and claims for common, minor symptoms associated with pregnancy, menopause, or other life stages (e.g., "for common symptoms of PMS," "for hot flashes"). However, osteoporosis and other serious conditions associated with aging, menopause or adolescence will still be treated as diseases.

FTC Jurisdiction Threatened

The Federal Trade Commission (FTC) has jurisdiction over the advertising of "dietary supplements." In December 1998, it issued "Dietary Supplements: An Advertising Guide for Industry," a detailed document to clarify the need for substantiation [15]. Although the FTC is far too small to control the dietary supplement industry, the threat of FTC action still causes some marketers to be cautious. Bills like the so-called "Dietary Supplement Fairness in Labeling and Advertising Act"—introduced in 1999 as H.R. 3305 by Representative Dan Burton (R-IN) and as S. 1749, by Senator Michael Crapo (R-ID)—would force the FTC to allow the same information in advertising of dietary supplements that the FDA allows in labeling of the same products. Fortunately, no such bill has been passed.

A Token Improvement

The Dietary Supplement and Nonprescription Drug Consumer Protection Act (S. 3546), enacted in December 2006, will require manufacturers of dietary supplements and nonprescription drugs to notify the FDA about serious adverse events related to their products. Beginning in December 2007, manufacturers must report deaths; life-threatening experiences; inpatient hospitalizations; persistent or significant disability or incapacity; birth defects; or the need for medical intervention to prevent any such problems. Manufacturers will also have to place a telephone number or address on product labels so consumers can contact them. The bill was passed in response to concerns about how difficult it was for the FDA to ban ephedra sales even though thousands of people had adverse effects. Congress reasoned that if notification could be increased, the FDA could do a better job of identifying and dealing with dangerous products. However, public protection is only slightly increased because other parts of DSHEA make it very cumbersome for the FDA to ban dietary supplements and herbs.

What Consumer Really Want

Several surveys have determined that consumers really want protection against false claims and unsafe products [16,17]. A Roper survey of 1,480 persons age 50 or older conducted in 2001, for example, found that about 75% of the respondants wanted the government to review safety data and approve dietary supplements prior to sale and to verify all health-related claims before they can be included in advertisements and on product labels [16]. This is just the opposite of what DSHEA permits.

The Bottom Line

The FDA has never had enough resources to cope with the enormous amount of deception in the supplement and health-food marketplace. DSHEA has made the problem worse. If I were FDA Commissioner, I would drop any pretense of being able to protect the public. Instead, I would announce that unless Congress provides an adequate law, the FDA cannot protect the public from the deceptive marketing of what DSHEA calls "dietary supplements." The FTC is still able to take effective protective action, but some federal legislators are trying to cripple it also.

For Additional Information

References

  1. Food, Drug, Cosmetic, and Device Enforcement Amendments of 1991 (H.R. 2597, 102nd Congress).
  2. Nutrition Coordinating Act of 1991 (H.R. 1662, 102nd Congress).
  3. Barrett S., Herbert V. The Vitamin Pushers: How the Health Food Industry Is Selling America a Bill of Goods. Amherst, NY: Prometheus Books, 1994.
  4. Dietary Supplement Health and Education Act of 1994. [FDA Summary]
  5. The Report of the Commission on Dietary Supplement Labels, November 1997.
  6. Barrett S. Major Recommendations from the Dietary Supplement Commission. Nutrition Forum 14:28, 1997.
  7. Henney JE. Statement by Jane E. Henney, M.D., Commissioner, Food and Drug Administration, Department of Health and Human Services Before the Committee on Government Reform U.S. House of Representatives March 25, 1999.
  8. Nortier JL and others. Urothelial carcinoma associated with the use of a Chinese herb (Aristolochia fangchi). New England Journal of Medicine 342:1686-1692 , 2000
  9. Kessler D. Cancer and herbs. New England Journal of Medicine 342:1742-1743, 2000.
  10. Food and Drug Administration Modernization Act of 1997. [Full Text]
  11. Food Advisory Committee Working Group. Interpretation of significant scientific agreement in the review of health claims. Final report, June 1999.
  12. Regulations on statements made for dietary supplements concerning the effect of the product on the structure or function of the body. Proposed rule. Federal Register 63:23624-23632, 1998. [PDF format]
  13. FDA finalizes claims for claims on dietary supplements. FDA Talk Paper T00-1. Jan 5, 2000.
  14. Regulations on statements made for dietary supplements concerning the effect of the product on the structure or function of the body; final rule. Federal Register 65:999-1050, 2000.
  15. Bureau of Consumer Protection. Dietary Supplements: An Advertising Guide for Industry. Washington, DC: Federal Trade Commission, 1998. [Summary], [Complete Text]
  16. Eskin SB. Dietary supplements and older consumers. Washington, DC: AARP Public Policy Institute, Dec 2001.
  17. Survey of Consumer Use of Dietary Supplements. Emmaus, PA: Rodale Press, 1999.

This article was revised on February 2, 2007.