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FDA fortifies VMS oversight with revised draft guidance on NDIs


SILVER SPRING, Md. - In the latest move to fortify regulations governing the dietary supplement industry, the U.S. Food and Drug Administration on Thursday issued a revised draft guidance to improve dietary supplement companies' new dietary ingredient premarket safety notifications to the agency. These notifications help the agency identify safety concerns before products reach consumers.

In response to the news, the Council for Responsible Nutrition joined Informa Exhibitions with plans for an industry-wide webinar on the topic of New Dietary Ingredient Notifications.

“This is a topic that we’ve been actively involved in for several years now, and with the release of the new draft guidance, companies have questions and we’re poised to provide the right experts with answers,” noted Duffy MacKay, SVP scientific and regulatory affairs, CRN. “We’re taking the time to review the substance of the draft guidance in order to bring [the industry] the most qualified regulatory experts, and we expect the experts to include representatives from FDA.”  

MacKay added that the webinar will take place in September and the specifics (including date, speakers and pricing) will be announced soon.

"This revised draft guidance is an important step forward in the agency's work to protect public health from potentially dangerous new dietary ingredients," stated Steven Tave, acting director of the FDA's Office of Dietary Supplement Programs. "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 The revised draft guidance is intended to improve the quality of industry's new dietary ingredient reporting so the FDA can more effectively monitor the safety of dietary supplements."

Under the Dietary Supplement Health and Education Act, the manufacturer or distributor must notify the FDA at least 75 days before beginning to market a dietary supplement that contains a new dietary ingredient (one that was not marketed in the United States before Oct. 15, 1994), unless the NDI is used in the food supply without chemical alteration. Dietary supplements are considered adulterated if they contain an NDI not used in the food supply and the required notification has not been submitted to the FDA 75 days before marketing.

The FDA estimates that there are more than 55,600 dietary supplements on the market, and that more than 5,000 new dietary supplement products come on the market each year. However, the agency has received fewer than 1,000 NDI notifications in the more than 20 years since DSHEA was passed.

An initial draft guidance, "Dietary Supplements: New Dietary Ingredient Notifications and Related Issues," was released in 2011. After considering the feedback received on that draft, the FDA revised the draft guidance to clarify several important points that were misunderstood or not fully explained, to describe the public health significance of the recommendations and to request additional comment before publishing a final guidance.

Over the past three years, the FDA has taken numerous actions on dietary supplements, including action on several products containing new dietary ingredients that pose safety concerns and should have been the subject of an NDI notification but were not, such as Acacia rigidula.

In December 2015, the agency announced the creation of the Office of Dietary Supplement Programs, elevating the program from its previous status as a division under the former Office of Nutrition, Labeling and Dietary Supplements (now Office of Nutrition and Food Labeling). As part of that action, the agency reaffirmed its commitment to remove from the market products that contain potentially harmful pharmaceutical agents, are otherwise dangerous to consumers, or are falsely labeled as dietary supplements; enforce the dietary supplement good manufacturing practices regulation; and take action against claims that present a risk of harm to consumers (such as egregious claims of benefit in treating serious diseases) or economic fraud.


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