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FDA Seeking to Clarify Supplement Safety Rules


The U.S. Food and Drug Administration has issued draft guidance clarifying agency expectations on new dietary supplement ingredients as required by the new Food Safety Modernization Act (FSMA).

The FSMA was signed into law by President Obama on January 4th, 2011. It’s aim is to ensure the U.S. food supply is safe by shifting the focus of federal regulators from responding to contamination to preventing it.

Seventeen years ago, President Clinton signed into law the Dietary Supplement Health and Education Act (DSHEA) in October 1994 which classified dietary supplements as a subcategory of food. This allowed supplement manufacturers to market products without submitting safety or efficacy to the FDA.

Over the years, the FDA has had to respond to tainted or otherwise hazardous supplement products, after the fact as the law required, by offering evidence that the product is unsafe, contains a controlled substance, or is absent ingredients listed on the product label after the product has appeared in retail outlets. Only after supplying this evidence, has the FDA been able to remove unsafe or tainted supplement products from the market.

Examples of FDA’s response to unsafe supplement products can be found in the warnings not to use Fruta Planta weight-loss products, antimicrobial dietary supplements, Venon HYPERDRIVE 3.0, and Man Up Now.

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The FDA’s aim with the draft guidance is to clarify the agency’s expectations on new dietary ingredients for industry and to ensure that consumers are not exposed to unnecessary public health risks from new ingredients with unknown safety profiles.

Dietary supplement manufacturers are required to notify the FDA in advance when they intend to add a new dietary ingredient to their products, except in certain situations when the ingredient has been part of the food supply and has not been chemically altered for use in supplements. The notifications must identify the new dietary ingredient and be accompanied by evidence on its safety.

The FSMA required the FDA to issue these draft guidelines on or before July 3, 2011, or within 180 days of the signing of FSMA into law.

FDA has created a special website to inform the public about the various aspects of FSMA implementation.

Food and Drug Administration: Draft Guidance for Industry; Dietary Supplements; Availability: New Dietary Ingredient Notifications and Related Issues

Commentary: Dietary Supplements—Regulatory Issues and Implications for Public Health; Bryan E. Denham; JAMA. 2011;Published online July 5, 2011. doi:10.1001/jama.2011.982

The New FDA Food Safety Modernization Act (FSMA)