Under the Food Drug & Cosmetic Act, an article that is intended to diagnose, treat, cure, mitigate, or prevent any disease in man is regulated as a “drug”. Similarly, an article that is intended to affect the structure or any function of the body of man is regulated as a “drug”. However, dietary supplements enjoy a safe harbor for “structure/function” and “general health and wellbeing claims” under the Dietary Supplement Health & Education Act of 1994 (DSHEA). Dietary supplements containing New Dietary Ingredients (NDIs), which have not been described to FDA in a notification as reasonably likely to be safe (under the suggested uses on the labeling) are also likely to be regulated by FDA as unapproved new drugs. For more information regarding dietary supplement ingredients, please refer to our Dietary Supplement Ingredients & Safety page.

Ordinarily, however, most dietary supplements on the market in the U.S. cross the line into illegal disease claims. As a result, FDA has significantly increased its enforcement against such dietary supplements. (See our FDA News and Press page discussing recent enforcement actions brought against dietary supplements and their manufacturers and distributors).

Supplements that contain disease claims in their labels or labeling (advertising, marketing, Internet sites) are unapproved drugs and subject to FDA seizure or Customs seizure upon their importation. Distributors of such products can become defendants in federal injunction cases or worse; criminal prosecutions. Because most dietary supplements are distributed in interstate commerce via mail or common carrier (UPS, Federal Express, or similar intermediary couriers) and many are purchased over the Internet, the distributors who sell such products could be prosecuted for mail or wire fraud.

Dietary Supplement Labeling Claims

The Food Drug & Cosmetic Act, as amended by DSHEA now permits using “structure/function” and general health and well being claims about the effects of a dietary supplement. In addition, the law now permits claims of benefits that consuming a dietary ingredient may have with respect to classical nutrient deficiency diseases. FDA does not require these claims to be pre-approved prior to marking a dietary supplement containing such labeling claims. However, unless expressly authorized by FDA (as a health claim) dietary supplement labeling may not include implied or explicit claims that the supplement can diagnose, prevent, mitigate, treat, or cure a disease. Permissible claims (those related to “structure/function” effects of the supplement or “general health and well-being”, or “classical nutrient deficiency disease claims”) are subject to a notification requirement to FDA. Within 30 days of marketing a dietary supplement containing even permissible claims, the manufacturer or distributor of the supplement must submit a notification to FDA demonstrating the supplement meets the statutory criteria to make the claim. For instance, before making the claim on its product label, the manufacturer must have substantiation that the claim is truthful and not misleading.

A product’s “labeling” includes the actual “label” physically affixed to the container and any accompanying literature, such as product inserts, information sheets, books and publications associated with the article’s distribution. Because Internet sites may contribute to a product’s distribution scheme, the sites sponsored by the product’s manufacturer or distributor will often be considered a part of the product’s “labeling.”

It is critical to properly draft structure/function and general health and well being claims to avoid direct or implied disease claims, which are not within the DSHEA safe harbor.

FDAImports.com consultants and affiliated attorneys regularly assist companies in creating structure/function claims. We also draft structure/function and general health and well-being notifications to FDA and negotiate acceptable claims.

In addition, FDA regulations require certain labeling for dietary supplements including a proper statement of identity, a correct net quantity of contents statement, nutritional and ingredient labeling that conforms to a specific format and includes specific content, careful crafting and truthfulness in any claims made in the labeling, and some additional special rules respecting warning statements and the content of certain ingredients in a dietary supplement.

Failure to submit a notification to FDA for structure/function claims that are included on the label or labeling of a dietary supplement causes that dietary supplement to fall outside the DSHEA safe harbor. The result is FDA will regulated the dietary supplement as a drug -- an unapproved new drug. FDA has significantly increased its enforcement efforts respecting dietary supplements labeled with illegal disease claims or structure/function claims that have not been submitted to FDA within 30 days of their initial introduction into interstate commerce (See our FDA News and Press page discussing recent enforcement actions brought against dietary supplements and their manufacturers and distributors).