FDA Updates Recommendations on Premarket Safety Notifications for New Dietary Ingredients

August 18, 2016

FDA Issues Revised Draft Guidance on Premarket Notification of New Dietary Ingredients

On Thursday, August 11th, FDA released a revised draft guidance, entitled “Dietary Supplements: New Dietary Ingredient Notifications and Related Issues.”  The revised document was issued “to improve dietary supplement companies’ new dietary ingredient (NDI) premarket safety notifications to the agency.”  These premarket notifications help the FDA identify safety concerns before products reach consumers, making them a critical component in the regulation of dietary supplements.


The Dietary Supplement Health and Education Act (DSHEA), which took effect in 1994, requires manufacturers and/or distributors to notify the FDA at least 75 days prior to marketing a dietary supplement containing a new dietary ingredient (NDI), or an ingredient that was not marketed in the US before October 15, 1994.  This requirement still stands today unless the NDI is used in the food supply without chemical alteration.

According to FDA’s recent news release, the Agency “estimates 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, since DSHEA was enacted in 1994, the FDA has received less than 1,000 NDI notifications.

Draft Guidance

In 2011, the FDA issued an initial draft guidance regarding DSHEA’s requirement to notify the Agency before marketing NDIs.  After reviewing and considering the feedback that the was received on that draft guidance, the FDA has decided to release a revised draft before publishing a final guidance.  The revised document:

  1. Clarifies several important points that were either misunderstood or not fully explained in the initial document
  2. Describes the public health significance of the recommendations
  3. Requests additional comments

“This revised draft guidance is an important step forward in the Agency’s work to protect public health from potentially dangerous new dietary ingredients,” notes Steven Tave, acting director of the FDA’s Office of Dietary Supplement Programs.  In addition, Mr. Tave also states 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  The revised draft guidance is intended to improve the quality of industry’s new dietary ingredient reporting so the FDA can more effectively monitor the safety of dietary supplements.”

FDA is asking all interested parties to submit public comments on the revised draft guidance before October 11, 2016.

Do you have a medical device or other FDA-regulated product that you want to ensure is both safe for use as well as compliant with all requirements and regulations?  We can help.  Contact us today to learn more about our services and how we can help you.


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