On March 5, the U.S. Food and Drug Administration (FDA) announced the availability of a final guidance for industry titled “Dietary Supplements: New Dietary Ingredient Notification Procedures and Timeframes: Guidance for Industry.” According to the FDA, the guidance is intended to help manufacturers and distributors of new dietary ingredients (NDIs) and dietary supplements prepare and submit new dietary ingredient notifications (NDINs) to the FDA.

The FDA guidance provides information in a questions and answers format about the NDIN submission and review process. Topics include, among others:

• Who needs to submit an NDIN?
• How should the information be organized and presented?
• Where should an NDIN be submitted?
• What happens after an NDIN is submitted?

Under section 413(a)(2) of the Federal Food, Drug and Cosmetic Act (FD&C Act) (21 U.S.C. 350b(a)(2)), the manufacturer or distributor of a NDI that has not been present in the food supply as an article used for food, or of a dietary supplement that contains the NDI, must submit a premarket safety notification to FDA at least 75 days before introducing the product into interstate commerce.

In response, the National Products Association (NPA) said that the announcement was a major disappointment, noting that the guidance focuses on frequently asked questions about the NDI submission and review process, and stems from draft guidance dating back to July 2011.

“This process is critical for consumer safety, industry innovation and the regulatory regime, and by all counts this guidance misses the mark. It is a giant nothingburger that could very well weaken the great value of the NDI process because it leaves so many questions unanswered,” said Daniel Fabricant, PhD, president and CEO of NPA.

“The agency previously issued two sets of draft industry guidance that were intended to inform potential submitters regarding the content and formatting of the NDI notification. After the 2011 guidance was published, the agency received over 7,000 comments which were largely ignored in the 2016 draft guidance. The dearth of significance in the 2016 guidance precipitated an additional 700 comments to the docket.”

Fabricant continued, “Yet once again, the agency has chosen to kick the can down the road on the decisions that are most important to consumers and to the market. In the face of this inaction, NPA will continue to ask the FDA to develop a tangible plan for domestic enforcement of NDI guidelines. Too many companies are going to market without submitting an NDI notification for their ingredient because another firm has done the hard work, covered the costs, and submitted a notification, of which a large portion is public. This ‘piggybacking’ is unacceptable and does not allow the agency the opportunity to review their manufacturing processes or product specifications. This should raise bright red safety flags.”