Updates Draft Guidance On Premarket Safety Notifications
The U.S. Food and Drug Administration has issued a revised draft guidance to improve dietary supplement companies’ new dietary ingredient (NDI) premarket safety notifications to the agency.
According to the agency’s press release, these notifications help to identify safety concerns before products reach consumers.
The release noted that under the Dietary Supplement Health and Education Act (DSHEA), 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.
According to the FDA, it is estimated that there are more than 55,600 dietary supplements on the market, and that 5,560 new dietary supplement products come on the market each year.
However, the agency noted that it has received fewer than 1,000 NDI notifications since DSHEA was passed in 1994.
Based on feedback from an initial draft guidance, “Dietary Supplements: New Dietary Ingredient Notifications and Related Issues,” released in 2011, the agency has revised the draft guidance to ensure that there is clarity and understanding among stakeholders.
“This revised draft guidance is an important step forward in the agency’s work to protect public health from potentially dangerous new dietary ingredients,” said Steven Tave, acting director of the FDA’s Office of Dietary Supplement Programs.
He added that “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 The revised draft guidance is intended to improve the quality of industry’s new dietary ingredient reporting so the FDA can more effectively monitor the safety of dietary supplements.”
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.
Carol Maye, Readers Bureau, Fellow
Edited by Jesus Chan
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