Many submitted public comments implored FDA to hold new dietary ingredient scofflaws accountable and to implement a confidential master file system.
The recent FDA meeting on innovation in dietary supplements highlighted potential tools to incentivize compliance with new dietary ingredient notification (NDIN) requirements and support development of novel ingredients and products, such as allowing master files and tweaking the interpretation of what qualifies as a “dietary ingredient.” But the industry has strongly advised the agency that any such tools would be pointless if enforcement remains lax and inconsistent.
“New tools and mechanisms will not result in significant change to the regulatory landscape without more rigorous enforcement,” warned the Council for Responsible Nutrition (CRN), in its submitted comments.
The agency’s May 16 public meeting on dietary supplement innovation was announced in an April 11 Federal Register notice that requested public comments through July 15.
“We understand that the public meeting and added comment period are part of the agency’s strategy to promulgate a final NDI guidance,” said the Natural Products Association (NPA), in its comments to FDA.
Thus, submitted comments from dietary supplement trade associations and prominent companies advised FDA to use its existing authority to enforce NDIN regulations and to include a master file as an option for such notifications to help protect intellectual property (IP) and foster innovation. Other key suggestions included suggested tweaks to FDA’s drug exclusion clause—a hot topic in this CBD-crazed market—and broadening of its application of the statutory definition of “dietary ingredient,” including for synthetic copies of botanical ingredients.
Act of Congress not needed
By far, the most common theme from industry comments was for FDA to establish a sound NDI enforcement plan to address low compliance trends.
“While much discussion has centered on asking Congress for new authorities, which is inconsistent with the present administration’s goals, where there is a commitment to remove two regulations with every one that is added, nothing that has been presented from the agency’s behalf has clearly demonstrated the metrics of compliance and where the actual gaps are regarding compliance,” posited Daniel Fabricant, Ph.D., president and CEO of the Natural Products Association (NPA), in submitted comments.
“There is a clear lack of meaningful and effective enforcement over NDIs,” wrote Najli Guthrie, president and CEO of KGK Science Inc., in the company’s submitted comments. “The industry perceives that there are no consequences for failure to comply with the NDI provision.”
Fabricant noted the always resource-challenged agency hasn’t publicly identified the tools that foster effective, but efficient, enforcement and oversight of NDI compliance.
A cyber warning letter program was recommended in KGK’s comments.
“There is no reason why FDA could not cast a wide net to noncompliant firms, by issuing untitled warning letters as part of an NDI blitz, based upon failure to demonstrate reasonable expectation of safety for dietary ingredients the agency believes to be ‘new’ or never sold in commerce prior to October 15, 1994,” Guthrie wrote. “KGK Science believes a similar untitled letter/cyber warning letter program could be adapted to identify ingredients the agency has determined to be new dietary ingredients.”
Both KGK and NPA suggested FDA consider the use of import bulletins and alerts to address non-compliance from foreign products.
These measures “would signal a very serious message to the industry on adherence to federal statutory requirements,” Guthrie wrote.
In NPA’s comments, Fabricant asked ”if there is no enforcement against foreign NDI products that at a minimum have not presented their specifications to the FDA, why would a domestic firm ever see the NDI gate as a real priority to the agency?”
He noted some FDA personnel have said such imports are”technical adulteration” but not a priority, yet the agency issued such alerts for both androstenedione and kratom over technical adulteration and NDI non-compliance.
Master files for IP protection
A resounding complaint from industry submitters was over FDA’s lack of IP protection for innovative dietary supplement companies.
“Lack of IP protection has led some firms to use alternative safety review mechanisms not specifically designed for NDIs, such as the GRAS self-determination approach,” CRN wrote. “This approach addresses safety of new ingredients but does not require disclosure of intellectual property or proprietary data.”
FDA teased the use of a confidential master file in its 2016 draft guidance on NDIs but sought more input on the idea during its public innovation meeting.
In comments submitted for the innovation request, industry largely backed the concept of a master file for NDINs to foster innovation that would otherwise be unprotected.
“As described previously by CRN and others, the [master file] can house ingredient-specific confidential information and/or safety data, and can be used or cited (with permission) by subsequent notifiers,” CRN commented, noting the tool would streamline the collection and protection of data investments made by ingredient manufacturers. “Each [master file] should receive a unique file number and description, the contents of which should be protected as trade secrets.”
“Health Canada’s Natural and Nonprescription Health Products Directorate (NNHPD) uses a [master file] system as well to protect proprietary information,” said KGK Science Inc., in its submitted comments. “FDA should also require the listing of NDI notification numbers on the label similar to how Canada does with Natural Product Numbers (NPNs).”
In its submitted comments, the American Herbal Products Association (AHPA) stressed the importance of assurances from FDA that it would consider the data in such master files as protected trade secrets to be undisclosed except for as directed by the original NDIN submitter (via licensing, for instance).
However, AHPA recommended FDA issue a targeted guidance to establish a master file system for NDINs. It suggested two other key areas ripe for such targeted guidance include areas of common non-compliance, such as ingredient identification and broad conditions of use.
AHPA’s comments, composed by its president Michael McGuffin and its general counsel Will Woodlee, noted other industry trade associations have promoted the idea of targeted guidance for non-controversial issues, rather than areas of legal interpretation.