03.06.24
The National Products Association (NPA) called the Food and Drug Administration’s (FDA) final guidance on Procedures and Timeframes for New Dietary Ingredients (NDIs) “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The guidance focuses on frequently asked questions about the NDI submission and review process, and stems from draft guidance dating back to 2011, which was revised in 2016.
“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 filers regarding the content and formatting of the NDI notification.
By issuing its “Guidance for Industry: New Dietary Ingredient Notification Procedures and Timeframes - Dietary Supplements,” FDA displayed its intention to offer several final guidance documents on distinct sections of the NDIN process.
“This approach of separating the 2016 revised draft guidance into discrete sections for ease of use is responsive to comments received on the draft guidance,” the agency said in its announcement. “The FDA understands the importance of providing the agency’s thinking on the topic of NDINs and related issues and plans to prioritize finalizing other parts of the 2016 revised draft guidance as the agency completes its review and analysis of those sections.”
NPA noted that after the 2011 draft guidance was published, the agency received more than 7,000 comments. Fabricant said these comments “were largely ignored.”
“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,” he said.
NPA said it will continue to ask the agency 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,” said Fabricant. “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.”
NPA encouraged industry stakeholders to comment on the docket related to this final guidance. Public comments can be submitted electronically.
The guidance focuses on frequently asked questions about the NDI submission and review process, and stems from draft guidance dating back to 2011, which was revised in 2016.
“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 filers regarding the content and formatting of the NDI notification.
By issuing its “Guidance for Industry: New Dietary Ingredient Notification Procedures and Timeframes - Dietary Supplements,” FDA displayed its intention to offer several final guidance documents on distinct sections of the NDIN process.
“This approach of separating the 2016 revised draft guidance into discrete sections for ease of use is responsive to comments received on the draft guidance,” the agency said in its announcement. “The FDA understands the importance of providing the agency’s thinking on the topic of NDINs and related issues and plans to prioritize finalizing other parts of the 2016 revised draft guidance as the agency completes its review and analysis of those sections.”
NPA noted that after the 2011 draft guidance was published, the agency received more than 7,000 comments. Fabricant said these comments “were largely ignored.”
“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,” he said.
NPA said it will continue to ask the agency 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,” said Fabricant. “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.”
NPA encouraged industry stakeholders to comment on the docket related to this final guidance. Public comments can be submitted electronically.
