Correspondence

Regulation of Dietary Supplements

N Engl J Med 2000; 343:1270October 26, 2000

Article

To the Editor:

In his editorial on cancer and herbs, Kessler (June 8 issue)1 criticizes the Dietary Supplement Health and Education Act of 1994. This act provides the public with considerably more protection than the editorial reveals and was enacted because the Food and Drug Administration (FDA) had been improperly trying to ban safe dietary-supplement products.

The Senate Committee on Labor and Human Resources, in its report on the need for the act, stated bluntly, “In fact, FDA has been distorting the law in its actions to try to prevent the marketing of safe dietary supplement substances,”2 and four courts were scathingly emphatic that the FDA had been abusing the law.

Although the Dietary Supplement Health and Education Act took away from the FDA the authority to regulate dietary ingredients in dietary supplements as “food additives,” an authority that the agency had been “distorting,” the law also provided substantial new powers to protect the public. For example, it stipulated that a dietary supplement shall be deemed adulterated (illegal) if it “presents a significant or unreasonable risk of illness or injury.”3 This provision does not require proof that a product will harm someone; a “significant or unreasonable risk” of harm is sufficient for the FDA to take regulatory action. The law authorizes substantial sanctions for violation of this provision, including seizure of the product, injunction, and criminal prosecution.

The Dietary Supplement Health and Education Act also requires premarketing notification of the FDA about new dietary ingredients. If notification fails to show that the use of an ingredient “will reasonably be expected to be safe,” the FDA informs the manufacturer that it should not introduce the product. Moreover, the act authorizes the secretary of Health and Human Services to stop shipment of any dietary supplement immediately by declaring that it poses “an imminent hazard to public health or safety.”

Stephen H. McNamara, J.D.
Hyman, Phelps & McNamara, Washington, DC 20005-5929

3 References

1. 1

   Kessler DA. Cancer and herbs. N Engl J Med 2000;342:1742-1743
   Full Text | Web of Science | Medline

2. 2

   Committee on Labor and Human Resources, S. Rep. No. 410, 103d Cong., 2d Sess., at 16 (1994).
   

3. 3

   21 U.S.C. Sec. 342 (f)(1)(A).
   

Author/Editor Response

Dr. Kessler replies:

To the Editor: McNamara represented a coalition of dietary-supplement manufacturers in Utah who asked Senator Orrin Hatch to introduce and sponsor the Dietary Supplement Health and Education Act. His letter is incorrect on two points. First, he argues that the FDA has tried to ban safe dietary-supplement products. Rather, the FDA has tried to ensure the safety of dietary supplements and the validity of their claims. The Dietary Supplement Health and Education Act has limited the ability of the agency to carry out these tasks. Second, McNamara argues that the provision regarding “significant or unreasonable risk of illness or injury” is sufficient to assure the American public that dietary supplements are safe. McNamara knows that the act shifted the burden to the FDA to prove that dietary supplements pose a significant or unreasonable risk rather than have the manufacturers bear the responsibility to establish the safety of the products they sell. The provision for premarketing notification about new ingredients applies to a very small percentage of the dietary supplements that are marketed in the United States.

The problem, for both existing and new dietary supplements, is that there are few or no adequate data for the FDA to evaluate, unless a group of investigators decides independently to conduct studies. Without a systematic review of safety and an adequate data base on safety, the American public remains at risk.

David A. Kessler, M.D.
Yale University School of Medicine, New Haven, CT 06510