Supplement structure/function v. disease claims distinction made in FDA proposed rules.

SUPPLEMENT STRUCTURE/FUNCTION v. DISEASE CLAIMS DISTINCTION MADE by FDA in proposed rules scheduled for publication in the Federal Register the week of April 27. The agency proposal establishes the criteria both for structure/function claims allowed under the Dietary Supplement Health & Education Act and disease claims, which are prohibited for supplements. The law allows, without FDA authorization, "claims that are truthful and not misleading about the effect of a dietary supplement on the structure or function of the body for maintenance of good health and nutrition," FDA said April 24.

The proposal deems permissible structure/function claims, for example, that a product "Promotes regularity," "Helps maintain cardiovascular health" or "Supports the immune system." Examples of prohibited "disease claims" made for supplements include "Protects against cancer," "Treats hot flashes" and "Reduces nausea associated with chemotherapy."

"Disease claims...state or imply benefits for a disease," which is defined in the proposal as "any deviation from, impairment of, or interruption of the normal structure or function of any part, organ, or system of the body that is manifested by a characteristic set of signs or symptoms," FDA said. Supplements that "expressly or implicitly claim to diagnose, treat, prevent or cure a disease continue to be regarded as drugs and have to meet the safety and effectiveness standards for drugs" under the FD&C Act, the agency added.

The proposed rules additionally describe the means by which a supplement could make or imply a forbidden disease claim, such as through "product names, vignettes, graphics and citations," FDA noted. The agency has sent over 150 "courtesy letters" to supplement companies regarding their submitted structure/function claims, the majority on the basis that the statements are claiming to cure, treat or prevent a disease. The agency has issued warning letters for the same types of claims.

FDA also is publishing its response to the President's Commission on Dietary Supplement Labels final report along with the proposal, with a 120-day comment period on both.

The agency is answering the commission's call for a better definition of what constitutes a structure/function claim. Released Nov. 24, the commission report concludes that neither legislation nor regulations have established what makes an allowable structure/function claim ("The Tan Sheet" Dec. 1, 1997, pp. 1-4). Even the commission members disagreed among themselves on the issue. "While some members believe [structure/function claims] may imply disease prevention, at least one member believes" such claims "may neither expressly nor implicitly claim such usage," the report says.