Nutrition News & Views

January 29, 2000
Are You Confused About Labels on Dietary Supplements? - January 2000/No. 2

On January 6, 2000, the Food and Drug Administration (FDA) published its final rule that defines the types of labels that can be used on dietary supplements. A dietary supplement is any product taken by mouth that contains a so-called "dietary ingredient" and its label clearly states that it is a dietary supplement. The "dietary ingredients" in dietary supplements may include vitamins, minerals, herbs, and amino acids as well as substances such as enzymes, organ tissues, metabolites, extracts or concentrates. Dietary supplements can be found in many forms such as pills, tablets, capsules, liquids or powders.

Under the Dietary Supplement Health and Education Act, dietary supplements may bear "structure/function" claims -- claims that the products affect the structure or function of the body ("Calcium builds strong bones," "fiber maintains bowel regularity"). These claims can made without prior FDA review. They may not, without prior FDA review, bear a claim that they can prevent, treat, cure, or diagnose disease (a disease claim). The final rule does not allow express disease claims ("prevent osteoporosis") and implied disease claims ("prevents bone fragility in post-menopausal women") without prior FDA review. The final rule clarifies that such express and implied disease claims can be made through the name of a product ("Carpaltum," "CircuCure"), through a statement about the formulation of a product (contains aspirin), or through the use of pictures or symbols (electrocardiogram tracings). The rule permits claims that do not relate to disease. These include 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 life stages ("for common symptoms of PMS," "for hot flashes").

Protecting consumer health and safety is one of the major purposes of this rule. The rule is designed to reduce confusion among patients, prevent consumers from being misled, diminish the number of inappropriate disease claims, and help consumers decide when to seek medical attention. FDA believes that this rule, which clarifies appropriate structure/function claims, will ultimately provide consumers with better information on dietary supplement labeling that will help them select appropriate products. The issuance of this rule is an important part of FDA's overall dietary supplement strategy, which is aimed at providing consumers with a high level of confidence in the safety, composition, and labeling of dietary supplements.

The rule is published in the January 6, 2000 Federal Register and will become effective 30 days after the date of publication. Any product that is marketed for the first time after the date of publication and any new claims made for an existing product for the first time after publication will be expected to comply with the rule beginning 30 days after publication. Small businesses that marketed a product as of the publication date will have an additional 17 months to bring existing claims into compliance and all other products that were on the market as of the publication date will have an additional 11 months to bring existing claims into compliance.

Submitted by Toymeka Quaites, MSU Dietetic Intern
Distributed by Barbara McLaurin, PhD., R.D., L.D., Human Nutritionist Specialist, MSU Extension Service, January 2000

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