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Ingredient notifications to FDA would still pose risks for industry during amnesty period

FDA buildings 2020
A former FDA official highlighted risks of submitting a new dietary ingredient notification to the agency, even during a period of "enforcement discretion."

An FDA policy that is likely to take effect later this year would help dietary supplement firms come into compliance with a safety-related premarket notification requirement without fear of reprisal for failing to timely notify the agency.

In draft guidance published in May, FDA disclosed plans to exercise enforcement discretion for 180 days regarding the requirement to timely file a new dietary ingredient notification (NDIN). This amnesty period would start following publication of a notice in the Federal Register announcing the availability of a final guidance.

However, a former FDA official cautioned a notification submitted during the amnesty period that was met with objections from the agency could establish a firm introduced an adulterated product into U.S. commerce. That could increase a firm's exposure to private litigation or FDA enforcement action.

Bob Durkin, who previously worked as deputy director in FDA’s Office of Dietary Supplement Programs (ODSP), and whose FDA tenure in various positions lasted from 2008 to 2019, highlighted the potential risks of notifying the agency during the 180-day period. He referenced FDA’s 2016 draft guidance regarding NDINs and related issues.

The guidance asserts a dietary supplement containing an NDI is “adulterated,” even if a premarket notification has been provided to the agency, “unless there is a history of use or other evidence of safety establishing that the NDI, when used under the conditions recommended or suggested in the labeling of the dietary supplement, will reasonably be expected to be safe.”

FDA’s 2016 draft guidance and its responses to NDINs show it could find a product is “adulterated,” even after a notification is submitted, warned Durkin, who is of counsel in the FDA and health care practices of the law firm Arnall Golden Gregory LLP (AGG).

If FDA objects to a notification submitted during the amnesty period for an NDI already in commerce, “it will likely establish that the companies put adulterated product on the market, unless there’s another basis for establishing a reasonable expectation of safety outside of the company’s notification,” he said in an interview.

From a “business perspective,” Durkin questioned whether submitting an NDIN during the 180-day window “is the best path forward.” Durkin is not advocating firms circumvent the law. Rather, he asked whether they could meet an exception to the notification requirement in section 413(a)(1) of the Dietary Supplement Health and Education Act of 1994 (DSHEA).

Under section 413(a)(1), an NDI is exempt from the notification requirement if it is present in the food supply as an article used for food in a non-chemically-altered form. Many NDIs in this category have presumably demonstrated their food ingredients are “generally recognized as safe,” either through GRAS notifications to FDA or a GRAS self-determination.

“It might make sense to try to satisfy the NDIN requirement under 413(a)(1) rather than establish that you put an adulterated product on the market,” Durkin said. “If FDA objects [to the notification], unless there’s some basis for safety independent of what’s in the notification, that ingredient in that supplement was on the market as an adulterated product. I don’t know if FDA would take regulatory action, but there may be litigators that would.”

FDA has cited section 413(a)(1) as creating challenges in determining whether an NDI is subject to the notification requirement. The agency has nonetheless estimated it should have received about 4,600 NDINs since enactment of DSHEA, but it has only gotten about 1,200. That’s equivalent to about 26% of the required submissions over the last 28 years.

FDA has faced criticism from industry stakeholders and others for not doing more to enforce against non-compliant NDIs.

In written comments submitted this week to FDA, two lawyers who advise clients in the natural products industry maintained the draft NDI guidance on enforcement discretion “serves no purpose and for FDA to finalize it is a waste of time and resources.”

“In essence, it acknowledges that FDA has failed to enforce the law relating to NDIs for a quarter century, that FDA intends to continue this failure to enforce, and does not even commit FDA to start enforcement at any time in the future,” Marc Ullman and Steven Shapiro, of the law firm Ullman, Shapiro & Ullman LLP, concluded in their written remarks. “FDA should withdraw the draft guidance and begin actual enforcement against violators as soon as possible.”

In a recent interview, ODSP Director Cara Welch said she is hoping “a number of notifications” are submitted to FDA during the 180-day period “because that provides the safety data that we’re looking for.”

“The goal really, though, is the safety data, so we can have a better picture of the safety of those products that are currently on the market,” she told Natural Products Insider.

The more notifications FDA receives “shrinks the pool of those who have not complied with the NDI notification requirement,” she added. “That will help FDA identify those that continue to be in violation, and moving to the next step, facilitating enforcement to uphold the NDI notification requirement.”

Durkin suggested FDA should have finalized a document concerning when a notification is required before announcing plans to exercise enforcement discretion.

“It just seems like there should have been a sequence in going final with the ‘16 draft guidance, or at least significant portions of it should have happened first,” he said. “There’s a lot of confusion right now in the space about when an NDIN is required. FDA has caused a lot of that confusion.”

In January, FDA’s Center for Food Safety and Applied Nutrition (CFSAN) and Office of Food Policy and Response (OFPR) released a list of draft and final guidance topics that are a priority for its Foods Program to complete during the following 12 months. The list included guidance on NDIs and related issues.

 

 

 

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