ODSP’s Welch: NDIN 'guidances are not enforceable'

Earlier this month, the Food and Drug Administration (FDA) released draft guidance​ for industry titled “New Dietary Ingredient Notification Master Files for Dietary Supplements,” which responded to requests from the dietary supplement industry for specific guidance on recommendations about Master Files for new dietary ingredient notifications (NDINs). While much of the industry saw the guidance as a step in the right direction, many are curious how it will be enforced.

"So the first point of clarification—guidances are not enforceable," Dr. Welch said. "They are recommendations from the agency as to how to comply with requirements."

She acknowledged the point of the question, noting that draft guidances are intended as proposals for important topics, such as how to assemble a master file and its subsequent use in a NDIN notification. She said that master files offer ingredient suppliers the opportunity to participate in ensuring the accuracy of a NDIN notification, adding that suppliers can directly submit identity, manufacturing and safety information to the agency, while manufacturers can rely on this master file to submit a NDIN down the road when using the ingredient in their products. 

When it comes to an anticipated timeline for release of any other parts of that guidance, Dr. Welch said, “Unfortunately, we don't have time frames for when we'll be able to publish, those are somewhat out of our control.” 

However, she suggested that everyone keep an eye on FDA's Food Program website, which is regularly updated with a list of guidance documents under consideration for the current year. 

Regarding the Foods Program, some industry stakeholders are concerned that the agency is grouping supplements with food additives, which DSHEA clearly states are not. So we asked Dr. Welch if she could clarify how ODSP will operate within that larger office. 

"The Foods Program reorganization proposal is…not just sort of shifting groups around or renaming offices," she said. "This is really sort of establishing an entirely new Foods Program that we think fits better for the various commodities that we're regulating."

Dr. Welch added that the integration offers opportunities for growth and tighter integration between dietary supplements and the food chemicals program, with the goal of leveraging scientific expertise and information systems for both foods and supplements to strengthen reviews of ingredient safety. 

"So the scientific expertise can still be appropriately applied to the supplement statutory authorities, the supplement safety standard," she said. "And that's really important to FDA to retain the appropriate authorities for the appropriate use of the ingredients."

To hear what the top priorities are for FDA/ODSP and what updates Welch would like to see in DSHEA, watch the full interview.