Industry accuses FDA of favoring big pharma in NAC row

01 Apr 2022 --- The US Food and Drug Administration (FDA) has rejected industry petitions not to exclude the use of N-acetyl-L-cysteine (NAC) in the definition of dietary supplements. The move has prompted industry to accuse the body of favoring pharma monopolies amid fears of future implications on dietary ingredients.

As a result of the FDA’s decision, NAC is excluded from the dietary supplement definition. Nonetheless, due to the absence of safety concerns, the FDA notes it is “considering exercising enforcement discretion.”

“Today’s extralegal power grab by FDA sets a dangerous precedent for the industry that the agency may sideline other dietary ingredients from the marketplace to the monopolistic favor of pharmaceuticals,” says Steve Mister, CEO and president of the Council for Responsible Nutrition (CRN).

“While the ingredient at issue now is NAC, a broader issue is at stake – FDA’s ability to declare tried and true dietary ingredients off limits to dietary supplements and to confer drug companies with a monopoly over those ingredients, with few options for industry to challenge those actions” he adds.Industry organizations say the long-standing issue has hit sales.

Regulatory limbo?
Citizen petitions were filed by the CRN and the Natural Products Association (NPA). The request relating to the exclusion of the definition was rejected, though NPA’s petition includes an alternative request for the FDA to undertake rulemaking allowing the use of NAC in dietary supplements.

The FDA notes it has not yet reached a decision, and it continues to review the request. 

“CRN is extremely disappointed and unconvinced by FDA’s response today that it has chosen to deny CRN’s citizen’s petition while holding out the possibility that it may open a rulemaking specific to NAC instead,” Mister underscores. 

“Even though FDA has previously acknowledged NAC as a legal and safe supplement ingredient, the agency is attempting to create the power to remove legitimate dietary supplements from the market that the law plainly does not give it.”

Mister also notes that the NAC-specific rulemaking could take years to accomplish, making the situation far more challenging and untenable for industry, retailers and consumers. It can also leave the ingredient in a state of regulatory limbo, he adds. 

Drug use history
The reasoning behind the FDA’s stance is that NAC was approved as a drug in 1963. A subsequent statute, the Dietary Supplement Health and Education Act of 1994 (DSHEA), defines a new dietary ingredient as one not marketed in the US before October 15, 1994. 

It notes the earliest evidence of NAC being marketed as a dietary supplement dates from 1991. 

“Legislative history indicates that Congress believed that allowing an article to be marketed as a dietary supplement after it had been first approved or studied as a drug would not be fair to the pharmaceutical company that brought, or intends to bring, the drug to market,” highlights the FDA. 

“This would serve as a disincentive to the significant investment needed to gain FDA approval of new drugs and would enable manufacturers to escape appropriate safety and efficacy review and FDA oversight by being classified as dietary supplements.”

The CRN’s longstanding position has been that the DSHEA “makes clear that ingredients in use as dietary supplement ingredients prior to its enactment are grandfathered into the supplement marketplace.”Though the NPA has filed a lawsuit, CRN says it is keeping the option on the table.

All options on the table
Though the agency says it will issue guidance on the matter in the near future, products containing NAC in products labeled as dietary supplements, which would have otherwise been lawfully marketed as supplements had the FDA not excluded the ingredient from the definition, will be met with discretion.

“We are guardedly hopeful this announcement gives retailers the assurance they need to continue providing NAC products to consumers. Enforcement discretion and a vague promise of future rulemaking do not provide industry and consumers adequate assurances of future access to this ingredient,” Mister underscores.

Though CRN disagrees with the FDA’s analysis, the industry organization notes it will evaluate all options going forward. 

“We are presently in consultation with our members about next steps, but every option – including immediate legal action – remains on the table.” 

In December, the NPA filed a lawsuit against the FDA over the ongoing debate accusing it of “government regulation run amok.”

By Andria Kades