FDA plans consumer survey on dietary supplements

המידע באדיבות www.medicontext.co.il
Last Updated: 2001-08-06 14:00:15 EDT (Reuters Health)

WASHINGTON (Reuters Health) -The US Food and Drug Administration (FDA) is planning to survey 2,000 US consumers to help evaluate the legislation that governs labeling claims for dietary supplements and foods, the agency said on Monday.

The FDA said the survey is needed to help determine whether regulatory changes or educational programs are needed to ensure that consumers receive appropriate information.

The data will aid in measuring the effectiveness of the Nutrition Labeling and Education Act of 1990 (NLEA) and the Dietary Supplement Health and Education Act of 1994 (DSHEA).

NLEA is the legislation that allows food labels to make health claims that are cleared by the FDA. DSHEA requires FDA approval for disease or health claims on dietary supplement labels, but allows the labels to carry a wide range of claims about the products' effects on the structure and function of the body without clearance from the agency.

A number of FDA officials have expressed dismay about DSHEA, which some view as having created an environment in which manufacturers are free to make claims that have little or no scientific basis.

The FDA's poll will collect information about Americans' use of dietary supplements as well as their knowledge about the benefits and risks posed by the products. The FDA said the survey would help quantify consumers' sources of information, dietary practices, adverse experiences and use of supplements in combination with or as a substitute for prescription drugs.

"This information can be used to understand and describe the consumer environment that is the intended target of labeling and education initiatives," the FDA explained.

Participants will be selected at random and interviewed by phone in a process that could take a total of over 1,000 hours. As a result, an agency source told Reuters Health, it could be 6 months before the survey produces results.

The agency will publish its proposal in Wednesday's Federal Register and will accept comments for 60 days afterwards.

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