“Unsubstantiated move”: Industry slams FDA guidance aimed to boost supplement safety

21 Jul 2022 --- The Council for Responsible Nutrition (CRN) deems the latest US Food and Drug Administration (FDA) draft on new dietary ingredient (NDI) filings as a paradox. Calling on the agency to “fix it”, the industry association unveiled six solutions that could tackle company concerns.

“While well-intentioned, FDA needs to address the uncertainties and enforcement gaps CRN has outlined before it can expect full compliance with NDI notifications. The industry has repeatedly implored FDA to address major concerns related to its revised NDI draft guidance issued in August 2016. CRN submitted these comments to ask the FDA, once again, to stop putting the NDI cart before the horse,” says Steve Mister, president and CEO of the CRN.

The CRN emphasizes gratitude for the opportunity from the FDA as they invite insight sharing from marketers and the industry. However, “the FDA has not progressed in developing useful tools that would help companies determine their notification obligations and incentivize participation in the NDI notification process,” says the report of response from the CRN.

The FDA highlights awareness that manufacturers and distributors market products without the required premarket NDI notification.

“To increase the amount of safety information we have about NDI-containing dietary supplements in the marketplace and to promote risk-based regulation, we are informing manufacturers, distributors, and other interested persons of our intent to exercise enforcement discretion, for a limited time and in limited circumstances, to encourage firms to correct past failures to submit an NDI notification,” says the agency.

Dive into criticismInconsistencies in draft and previous acts need clarifications, the CRN argues.
Even though the CRN and the FDA claim to work against the same goal of providing safe products to the market, their approaches and beliefs of how to get there differentiate. The FDA highlights that the guideline helps ensure access to safe dietary ingredients and supplements and that the NDI notification helps address and control potential risks.  

“When a manufacturer fails to file a required NDI notification, we do not have the opportunity to assess the manufacturer’s evidence of safety. Therefore, to protect consumers from possibly unsafe NDI-containing dietary supplements, it is important that we receive this safety information,” the agency says.

“While CRN appreciates the intention behind FDA’s enforcement discretion, we question whether the proposed action would lead to increased NDI submissions considering many NDI-related issues remain,” says the CRN.

“FDA estimates that 4,600 NDI notifications should have been submitted and acknowledges receiving 1,200 notifications. CRN is concerned that the agency’s estimate, based on assumptions that 46,000 products were brought on the market since 1994 and 10% of those products required an NDI notification, is not supported by evidence. To avoid misleading the public, FDA should rescind this estimate.” 

The association continues to argue that the FDA should extend the catch-up submission period beyond 180 days and provide a more rapid response to submitters as the timeframe is deemed unrealistic for the FDA and industry players to meet a “common ground.” 

“The uncertainty of when submitters may receive a response from FDA, and whether they may be able to respond to any FDA comments about their notification before public display of the notification’s existence, may discourage submitters,” the CRN notes.

CRN proposes six measuresThe association argues that 180 days are not sufficient for industry and the FDA to meet common ground.
While stressing inconsistencies with the dietary supplement health and education act of 1994 (DSHEA), CRN suggests the FDA to withdraw those parts from the NDI drafted guidelines from 2016. This is causing and keeping industry concerns to remain, even though “a few companies will take advantage of enforcement discretion,” the CRN says.

There is a highlighted need for definitions of “dietary ingredients” and considerations of whether extraction processes are chemically altered and considerations of the food supply, as the FDA “excludes dietary supplements so that prior use in dietary supplements does not constitute presence in the food supply,” CRN notes.

Additionally, CRN argues the industry needs an authoritative list of pre-DSHEA dietary ingredients. The association suggests an NDI master file system established to protect IP, as safety measures when handling data might encourage NDI submissions.

“FDA’s estimate of 4,600 NDI notifications that should have been submitted is not supported by evidence. If FDA moves forward with enforcement discretion, the 180-day grace period should be extended,” says the CRN.

“The NDI filing and enforcement discretion paradox has been a hot-button issue affecting the US$60 billion supplement industry, with popular ingredients like cannabidiol and N-acetyl cysteine, and others falling into the drug preclusion trap.”

FDA in supplement regulation spotlight
Previously, the FDA received criticism for its lack of regulation in the supplements industry. In contrast, they respond that they lack the authority to regulate it, as Congress must step in for a difference in regulatory authority to become a reality. 

The agency has also tried to provide knowledge and transparency in the industry, which also was met by criticism, as too much emphasis was placed on negative aspects of supplements. To implement a mandatory product listing for transparency has previously been suggested by Steve Mister.

By Beatrice Wihlander

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