FDA sued over NAC supplement row after industry slams sales hit

08 Dec 2021 --- The Natural Products Association (NPA) has filed a lawsuit against the US Food and Drug Administration (FDA) over a debate on the use of N-acetyl-L-cysteine (NAC) in supplements. 

Currently, the FDA’s stance is that the use of NAC is excluded from the dietary supplement definition after it was approved as a new drug in 1963. 

It has asked for more information to review after the NPA and Council for Responsible Nutrition (CRN) filed citizen petitions over the regulator’s approach. 

“This is government regulation run amok. The FDA has gotten this wrong at every step of the way, and we’ve been left with no choice but to seek relief from the courts,” says Daniel Fabricant, president and CEO of NPA.

On whether this lawsuit may spark any subsequent steps from CRN, the trade association’s president and CEO, Steve Mister, tells NutritionInsight it is “actively considering what further actions it might take.” Companies say the debate is affecting their sales and supply.

Industry hit by debate
A core element of NPA’s lawsuit is that despite the FDA’s stance that NAC should not be included in supplements, “there is nothing in the relevant statute that allows for retroactive application,” which dates from 1963. 

“We are very concerned that a safe, legal natural product that has been sold for over 30 years is under what appears to be a regulatory sneak attack by the FDA, ” notes the NPA.  

Mister also states CRN is in agreement with the NPA that “NAC is a legal dietary ingredient for use in dietary supplements.”

Central to the debate is the interpretation of the 1994 Dietary Supplement Health and Education Act (DSHEA). The stance by CRN is that “DSHEA makes clear that ingredients in use as dietary supplement ingredients prior to its enactment are grandfathered into the supplement marketplace.”

This is also reflected in the lawsuit, which outlines “FDA’s position on NAC was legally erroneous because, among other things, the drug provision of DSHEA was not entitled to be applied retroactively.”

Escalating effects
The FDA told NutritionInsight it does not comment on pending litigation, while Mister noted the question of a course of action by CRN “is squarely on our executive committee and board meeting agendas later this week.”

“Many US citizens count on NAC, and these FDA actions have needlessly interrupted the supply of this safe and legal ingredient without any corresponding benefit whatsoever,” he highlights. 

The issue came to the fore last year when the FDA issued warning letters to seven companies stating that NAC cannot be sold as a dietary supplement because it was first approved as a drug in 1963. This caused a cascade of effects, including Amazon confirming it would be removing NAC from its online marketplace, NPA stresses. The issue came to the fore last year after seven companies received a letter from the FDA.

Both NPA and CRN filed a citizen petition in August, which resulted in the FDA issuing a tentative response last month, asking for additional information. The regulatory body said it was accepting comments until January 25, 2022.  

“NPA members who have been selling NAC for years, if not decades, have seen their sales dry up as a result of having to preemptively pull products from the shelves by virtue of FDA’s unlawful decisions,” notes the lawsuit.

Fears for the future
Beyond the use of NAC in supplements, the industry is also concerned that retroactively applying DSHEA to a product that was marketed as a dietary supplement prior to 1994 may set a precedent. Consequently, this could theoretically extend to other items such as vitamin C, NPA argues. 

Regulatory issues have been observed in other spaces within the industry, such as CBD.

The NPA has previously supported draft legislation from the US Senate that directs FDA to set an upper limit for a safe daily consumption level of CBD products.

UK researchers have also called for “radical” regulation to slash children’s ultra-processed food intake and obesity.

By Andria Kades

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