WASHINGTON -- In the absence of stricter regulatory measures at its disposal, the Food and Drug Administration here has issued a proposal designed to rein in vitamin and supplement manufacturers making wild claims on product labels.
The proposal attempts to clarify which "structure/function" claims are acceptable for manufacturers to make and which disease-specific claims are off limits.
"The law allows, without FDA's 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," the agency said in a prepared statement.
Examples of claims that are OK, according to the FDA, include "promotes regularity," "helps maintain cardiovascular health" and "supports the immune system."
"Under the proposal," the statement continued, "dietary 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 Food Drug and Cosmetic Act."
Examples of prohibited claims are "protects against cancer," "treats hot flashes" and "reduces nausea associated with chemotherapy."
"Consumers want access to dietary supplements, but also need reliable information about the products they are consuming," said William Schultz, the FDA's deputy commissioner for policy. "By clarifying for manufacturers what types of claims can and cannot be made on a dietary-supplement label, this new proposal helps consumers make more informed and wiser choices."
The action will not affect the availability of nutritional supplements, the FDA said.
Announced late last month and published in the Federal Register, the FDA's proposal came in response to recommendations made by the Commission on Dietary Supplement Labels, an independent panel of experts appointed by President Clinton as part of the Dietary Supplement Health and Education Act of 1994.
The FDA is accepting comments and recommendations for a 120-day period and has sent more than 150 letters to manufacturers to urge compliance with the claim definitions.