FDA Sets Boundaries For Dietary Supplement Labeling Claims

Continuing its quest to establish boundaries for dietary supplements, the Food and Drug Administration (FDA) has published a proposed rule limiting the types of effectiveness claims that can be made for such products. (See April 29, 1998 Federal Register.) Comments on the proposal are due by August 27, 1998.

The proposal seeks to draw a line between permissible claims relating the effect a dietary supplement may have on the structure or function of the body and impermissible claims relating to disease treatment or prevention that would cause the product to be regulated as a drug.

What You Can Do

The Dietary Supplement Health and Education Act (DSHEA) authorizes dietary supplement manufacturers to make statements of nutritional support for their products. Manufacturers can make the type of statements that:

1. Claim a benefit related to a classical nutrient deficiency disease and disclose the prevalence of such disease in the United States.

2. Describe the role of a nutrient or dietary ingredient intended to effect the structure or function in humans.

3. Characterize the documented mechanism by which a nutrient or dietary ingredient acts to maintain such structure or function.

4. Describe the general well-being from consumption of a nutrient or dietary ingredient.

As with any label claim, manufacturers must ensure that they are not false or misleading in any particular. In addition, each claim must be accompanied by the following disclaimer: "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease."

Finally, companies wishing to make these statements must notify FDA no later than 30 days after marketing a product that includes such a statement on its label. FDA may then object to a claim if it believes the claim explicitly or implicitly goes beyond the four categories of permitted statements.

Until now, the policy guidelines that FDA has been using to judge the legitimacy of structure/ function and other permissible claims have been largely unwritten and, to some, give the appearance of being somewhat ad hoc. Now, with this proposal, FDA is codifying its policy, and giving the dietary supplement industry fair notice of what claims can be made.

Overall, the proposed rules permit the use of structure/function claims on the label and labeling of dietary supplements as long as the claim does not relate to a specific disease. Defined in the proposed regulation, "disease" is "any deviation from, impairment of or interruption of the normal structure or function of any part, organ, or system (or combination thereof) of the body that is manifested by one or more signs or symptoms including laboratory or clinical measurements that are characteristic of a disease."

Therefore, a "disease claim" is "any statement about a product that claims to diagnose, mitigate, treat, cure or prevent disease (other than a classical nutrient deficiency disease)."

What You Can't Do

The proposed rule then sets forth specific criteria that the Agency will use to determine the permissibility of a claim.

Claims that refer to the natural or normal state of the body (such as, "helps maintain a healthy heart" or "provides optimal nutrition to women during menopause") are permitted as long as the claim does not suggest that a dietary supplement has an effect on a specific disease or class of diseases (such as, "helps prevent cardiovascular disease").

In addition, claims may not refer to the signs or symptoms of a disease, including a laboratory or clinical endpoint that is characteristic of a disease (such as, "reduces joint pain and stiffness" for arthritis, "lowers cholesterol" for coronary heart disease or "reduces the occurrence of hot flashes during menopause"). A more general statement (such as "maintain healthy cholesterol levels") would be allowed because it does not refer to an endpoint that is characteristic of a specific disease.

The proposal also prohibits:

* representing a dietary supplement as an effective alternative to traditional drug therapies (such as, "more effective in controlling pain than aspirin");

* saying that it belongs to a particular class of drugs (such as, "St. John's Wort -- the natural anti-depressant");

* stating that it was formerly regulated as a drug by FDA (such as, "1-carnitine now available without a prescription");

* representing a dietary supplement as a companion to traditional drug therapies (such as, "reduces the nausea and vomiting associated with chemotherapy"); or

* using a product name that suggests a disease condition or class of drug (such as, "Herbal Prozac" or "Arthritis Complex").

The product also may not cite to a publication which references a disease (such as, "Vitamin E and its Usefulness in the Prevention of Coronary Heart Disease").

Statements that refer to the body's natural disease fighting capabilities are permitted as long as they do not refer to a disease condition (such as, "helps maintain a healthy immune system" or "helps promote your body's natural defenses"), or include words (such as antiviral, antibacterial, antiseptic, antibiotic, laxative, analgesic) that would suggest that the product is one of a class which has an effect on disease or disease symptoms.

The label and labeling of products may include graphics, but may not through the use of pictures, vignettes, symbols or other means suggest that a supplement is useful in the cure, treatment or prevention of a disease. For example, a picture of a hand with the joints highlighted in red could be interpreted as representing arthritis, and, therefore, considered an implied "disease" claim.

A Guide for Food Companies?

This proposal might represent a helpful guide to food processors on the types of structure/function claims that can be made for food products. While not directly relevant to conventional foods, it seems that any claims made for food products based on their nutritive value are legitimate, provided that companies avoid the types of specific disease references mentioned above.

Compliance Countdown

Once final, compliance with the regulations will be required within 30 days, except for small businesses, which will be given 18 months to comply for products with claims that are already on the market at the time the regulation becomes final if (1) notification for the claim has been provided to FDA in accordance with the regulations and (2) FDA has not objected to the claim.

The meaning of this compliance period extension is unclear. Either FDA is granting small businesses an 18 month grace period (in which companies may use impermissible claims that the Agency hasn't objected to before issuance of the final rule) ... or the extension is meaningless, because, if FDA catches an impermissible claim being made, it will require its removal regardless of the 18 month phase-in.

It's highly unlikely that FDA will let a company continue to make illegitimate product claims just because the company has provided a notification that the Agency hasn't objected to yet. The Agency may allow companies a bit more leeway in terms of how the situation is handled, but we doubt FDA intends to give companies amnesty for patently violative product claims for 18 months following issuance of the final regulations.

Todd Harrison, an associate at Keller and Heckman, helped prepare this article.

George Misko, Partner, Keller & Heckman Inquiries or comments may be sent to Mr. Misko at 1001 G St., N.W., Suite 500W, Washington, DC 20001; phone (202) 434-4100 or fax (202) 434-4646. E-mail: misko@khlaw.com

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