Oriental-Tonic

How should FDA enforce NDIs as DSHEA turns 30 years old?

By Published On: June 8, 20246.6 min readViews: 520 Comments on How should FDA enforce NDIs as DSHEA turns 30 years old?

In 2020, I wrote a four-part series of articles that investigated a request to the Food and Drug Administration to enforce against generic forms of beta-alanine being produced in China.

The series, and a subsequent letter from FDA (all republished in this ungated downloadable report), highlighted complexities and controversies over a safety-related premarket notification requirement governing NDIs (new dietary ingredients).

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For me, the series underscored:

  • FDA is reluctant to enforce against unfiled NDIs, especially in the absence of an acute safety hazard, whether due to limited resources, lack of consensus within the various parts of the agency and/or needed cooperation with the U.S. Department of Justice.

  • The agency faces challenges determining if an ingredient is even subject to the notification requirement.

My views haven’t changed as I pack my bags for Salt Lake City to prepare for an industry event focused on the upcoming 30th anniversary of the Dietary Supplement Health and Education Act of 1994 (DSHEA).

In 2024, FDA expressed it is working on finalizing various portions of its new dietary ingredient notification (NDIN) guidance, and the Office of Dietary Supplement Programs (ODSP) has noted this work is a priority. (A final document on NDI notification procedures and time frames was published in March).

Related:Number of unfiled NDIs is hard to pin down in supplement sector

But is it — or should it be — an equally important priority for FDA to enforce against the likely hundreds, or thousands, of unfiled NDINs? As I reported Tuesday, when FDA published a draft guidance on NDI enforcement discretion two years ago, some people thought (or were hopeful) that it signaled a coming wave of crackdowns against unfiled new dietary ingredients in the supplement industry.

After FDA made clear it was prioritizing finalizing the overall NDIN guidance above finalizing its 2022 draft enforcement discretion policy, Pieter Cohen, M.D., of Harvard Medical School told me, “Was the draft guidance truly a sign or signal that the FDA was getting its house in order and planning on actually enforcing the law, or was it yet another delay tactic? Two years later, we have our answer. It was just more smoke and mirrors.”

The present state of affairs leaves me — and others who actually work hands-on in the dietary supplement industry — with the same questions. Will FDA eventually ramp up its enforcement against unfiled NDIs; and if so, when and how? I’ll go so far as to ask if the notification system is irretrievably broken without a rewrite of the law or a revolutionary approach to enforcing it?

Related:FDA ‘enforcement discretion’ on NDIs takes back seat to finalizing overall NDIN guidance

I asked former ODSP official Bob Durkin whether FDA as a matter of course writes to manufacturers, inquiring about their basis for an ingredient not being subject to an NDIN.

FDA has “extremely limited resources relative to the bucket of ingredients we’re talking about here,” responded the Arnall Golden Gregory LLP (AGG) lawyer, who worked for more than 12 years at FDA, including a stint as deputy director of ODSP. “I think if they’re going to do that, they would prioritize based on a safety signal,” or what he described as a “signal of risk.”

Sibyl Swift, Ph.D., another former ODSP official, said FDA’s 2022 draft enforcement discretion policy — proposing an amnesty period for delinquent NDINs — is a “carrot.” She then asked about the “stick.”

FDA’s best chance of getting distributors and manufacturers to submit their NDIs is through enforcement … or at least sending letters to firms the agency believes should have filed but didn’t, she maintained. For example, does the firm have evidence that its dietary ingredient is “old” or grandfathered in — marketed before October 1994 — or does it have documentation that the NDI is exempt from the notification requirement because it is present in the food supply as an article used for food in a nonchemically-altered form? Some describe the latter exemption as the so-called self-GRAS (generally recognized as safe) loophole that has been abused.

Is FDA writing these types of letters today to manufacturers? “I know that [FDA officials] had talked about it previously and never actually hit ‘send’ on them,” responded Swift, who’s chief science officer and VP of regulatory affairs with cbdMD Inc. “From the individuals in the industry [who] I’ve spoken to, I haven’t heard any murmur or anything.”

She added she was doubtful FDA would publicize such an enforcement strategy.

Sidley Austin LLP food and drug lawyer Scott Bass is among the select group of people alive today who helped to craft and negotiate DSHEA. I recently asked him about a letter from FDA to Rep. Jeff Duncan (R-S.C.). Among other things, the letter mentioned FDA’s enforcement discretion draft guidance and a testing program by NOW Foods that has highlighted quality concerns related to dietary supplements sold on e-commerce.

Bass responded that “it’s déjà vu all over again. The same people saying the same things.” He will be speaking on Monday, June 10, at NutraIngredients-USA’s “DSHEA at 30 Summit,” which is being presented in association with the United Natural Products Alliance (UNPA).

Hinting at what he’ll share at the summit, “Without mandatory product listing, none of this is going to work,” said Bass, an early proponent of requiring that all dietary supplement products are listed with FDA. “Just like if people keep playing around with the nonexistent self-GRAS exemption, most products will never be subject to the NDIN process, as they were supposed to be.”

In late 2019, a paper co-authored in The New England Journal of Medicine by Bass and Harvard’s Cohen proposed largely eliminating the food supply exemption to the notification requirement, or what the authors described as a “loophole” that has “swallowed the law.”

DSHEA “was written with the expectation that this exemption would be used infrequently, but its language is not sufficiently clear,” the two men wrote. “The exemption was not meant to apply to new chemicals, combinations or synthetic compounds. Nonetheless, the FDA has appeared to condone the use of this loophole to permit countless substances to be introduced in the absence of submitted safety data.”

Which brings me back to the four-part series of articles that I mentioned at the outset of this column. The GRAS loophole also reared its head in a letter from FDA to a lawyer (AGG’s Kevin Bell) representing Natural Alternatives International Inc. (NAI).

In essentially denying NAI’s request, ODSP director Cara Welch, Ph.D., said in the letter that FDA bears the burden of showing the above-referenced exemption doesn’t apply. Yet, at least as of April 2021, FDA hadn’t reached a final conclusion whether beta-alanine is exempted from the notification requirement based on Section 413(a)(1) of DSHEA. She noted the agency is aware of evidence suggesting the ingredient is present in the food supply in energy drinks, though.

“The presence of beta-alanine in the food supply raises significant questions that would need to be answered before FDA would be in a position to demonstrate that certain imported beta-alanine appears to be adulterated,” Welch wrote to Bell.

It’s not a stretch to believe FDA feels similarly about the burdens of establishing other NDIs found in the conventional food supply are subject to the notification requirement. Which leads many to the conclusion that without an NDI causing, or threatening to cause, death or severe injuries — posing a clear and present harm or substantial risk to human health — the chances of an FDA enforcement action against an unfiled NDI are slim to none.

But does that perceived reality smash to bits the industry’s common narrative that the industry is well regulated and that DSHEA is working as the late Sen. Orrin Hatch and others who negotiated the law intended? For those who are passionate about DSHEA and wish to foster innovation in the industry while safeguarding the public health, these are questions worth pondering.




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