U.S. moves to clarify rules for supplement makers

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U.S. health officials announced steps on Thursday aimed at clarifying the way regulators police the safety and advertising claims of vitamins, herbs and other products in the $15-billion-a-year dietary supplements industry.

Food and Drug Administration officials said they hope being straightforward and consistent about what is required will lead to better compliance by the industry with federal rules.

"We think that if we are clear and transparent in telling people what our expectations are, we will facilitate compliance,” said Michael Landa, deputy director for regulatory affairs in the FDA’s Center for Food Safety and Applied Nutrition.

Supplements do not have to pass the strict safety and effectiveness testing required for pharmaceuticals before they can be sold. Makers have restrictions, however, on what type of health benefits they can claim on labels and in promotions.

The FDA issued draft guidelines explaining what types of evidence the agency expects a company to compile to back up its assertions. Inspectors will start checking retail shelves to look for products that bear unsubstantiated claims, an FDA statement said.

“This is a logical package of initiatives that builds on things they have issued before,” said Annette Dickinson, president of the Council for Responsible Nutrition, an industry group.

The FDA will hold a public meeting on some of the new efforts on Nov. 15. Details on the measures can be found on the FDA Web site at http://www.fda.gov/bbs/topics/news/2004/NEW01130.html

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