FDA’s New Dietary Ingredient Final Guidance Is “Giant Nothingburger,” Says NPA

FDA’s New Dietary Ingredient Final Guidance Is “Giant Nothingburger,” Says NPA

Twelve Years in the Making and Still Waiting for Action on Most Significant Issues

Washington, D.C. – The National Products Association said that today’s announcement by the Food and Drug Administration (FDA) of final guidance for the dietary supplements industry, entitled “Dietary Supplements: New Dietary Ingredient (NDI) Notification Procedures and Timeframes: Guidance for Industry”, was a major disappointment. The guidance focuses on frequently asked questions about the NDI submission and review process, and stems from draft guidance dating back to July 2011.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, Ph.D. 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 After the 2011 guidance was published, the agency received over 7,000 comments which were largely ignored in the 2016 draft guidance.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.”

“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.”

Industry stakeholders are encouraged to comment on the docket related to this final guidance at any time. Public comments can be submitted electronically here. For more information, please see the FDA constituent update here.