September 28, 2016

FDA Issues Revised Draft Guidance to Improve Supplement Safety Notifications

The FDA issued a revised draft guidance on August 11, 2016 to improve dietary supplement companies’ new dietary ingredient (NDI) premarket safety notifications to the government. These notifications help the FDA identify safety concerns before consumers buy these products.

Pills

The Dietary Supplement Health and Education Act (DSHEA) requires a manufacturer or distributor to notify the FDA at least 75 days before marketing a supplement that contains a new dietary ingredient, unless the NDI is used in the food supply without chemical alteration. A new dietary ingredient is one that was not marketed in the U.S. before October 15, 1994. Supplements are considered adulterated if they contain an NDI not used in the food supply and if notification has not been submitted to the FDA 75 days before the product goes on the market.

There are 55,600 dietary supplements on the market, according to government estimates. About 5,560 new supplements come onto the market each year. But the agency has received less than 1,000 NDI notifications since DSHEA was passed in 1994.

An initial draft guidance called “Dietary Supplements: New Dietary Ingredient Notifications and Related Issues” was released in 2011. Feedback on that draft led the FDA to revise it to clarify points, to describe the public health significance of the recommendations, and to request additional comment.

Steven Tave, acting director of the FDA’s Office of Dietary Supplement Programs said in a statement, “this revised draft guidance is an important step forward in the agency’s work to protect public health from potentially dangerous new dietary ingredients. Notification of new dietary ingredients is the only pre-market opportunity the agency has to identify unsafe supplements before they are available to consumers. The revised draft guidance is intended to improve the quality of industry’s new dietary ingredient reporting so the FDA can more effectively monitor the safety of dietary supplements.”

The agency is committed to remove products from the market that contain potentially harmful pharmaceutical ingredients, that are falsely labeled as dietary supplements, and are otherwise dangerous to consumers. The FDA created the Office of Dietary Supplement Programs in December 2015 to enforce good manufacturing practices regulation and to take action against claims that present a risk to consumers or economic fraud.

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