Dietary Supplements: What Can They Claim?
Blank, Dennis, Drug Topics
Because current law is unclear, the Nonprescription Drug Manufacturers Association is asking the Commission on Dietary Supplement Labels, an advisory agency set up by the Clinton Administration two years ago, for some guidance. It wants the commission to clarify the difference between structure/function claims, which define what a product does, and therapeutic claims, which go beyond structure/function to assign curative properties to a product. It is felt by some groups that therapeutic claims enter into regulatory territory and should therefore be backed up by stringent clinical trials to determine their safety and efficacy.
"Manufacturers are trying to understand the regulatory difference between these two types of claims," said Patrice B. Wright, director of pharmacology and toxicology for NDMA. "Currently, no guidance exists." The organization cited the lack of clarity in the Dietary Supplement Health & Education Act (DSHEA), which allows third-party literature to be distributed and manufacturers to include label claims with nutritional support.
The Commission on Dietary Supplement Labels, which was created by DSHEA, is wrapping up a two-year study and will make its recommendation in June. "The major hurdle facing manufacturers of dietary supplements complying with DSHEA is a definition of the difference between a statement of nutritional support and a therapeutic claim," Wright told the recent commission meeting in Washington, D.C. "While manufacturers are required to notify [the Food & Drug Administration] of their claims, and guidance should come through FDA's action on questionable claims, the agency does not currently have the resources to manage this new requirement."
Wright was supported by the Council for Responsible Nutrition (CRN), which wants the commission "to draw a highly visible, bright line" between therapeutic claims for herbal products and the health claims for dietary supplements allowed under the law. "CRN opposes the creation of a new statutory or regulatory category for herbal products that would require an amendment to DSHEA," said John Cordaro, president of CRN.
At the same time, the commission is facing pressure from herbal manufacturers to create a new category of botanicals. The American Herbalists Guild (AHG) told the commission that there is a legal basis for providing nonmisleading information about the therapeutic use of botanicals on the labeling of herbal products. …