The Natural Products Association (NPA) recently filed a lawsuit against the U.S. Food and Drug Administration (FDA) over its position that NAC (N-acetyl-L-cysteine) cannot be included in dietary supplements.
In a complaint filed in the US District Court in Maryland, NPA argues that the drug exclusion provision in the Dietary Supplement Health and Education Act of 1994 (DSHEA) doesn’t retroactively apply to the glutathione precursor NAC.
What is NAC?
N-acetyl cysteine (NAC) is an antioxidant that plays important roles in human health. Along with glutamine and glycine, NAC is necessary in replenishing glutathione levels. Glutathione is one of the most important antioxidants in the body, which aids in neutralizing free radicals that can damage tissues and cells in your body.
You can get NAC as a supplement or a prescription drug. As a drug, doctors use NAC to treat acetaminophen poisoning. It can also help break up mucus in individuals with certain lung diseases. On the other hand, as a supplement, some people use NAC to prevent liver problems.
There’s evidence that it can help prevent caused by some medications. NAC has been available in dietary supplement products for several decades now. This is why the recent decision as well as the overall position of FDA on NAC sent shockwaves to the natural products industry.
Where It Began
NAC was originally approved by the FDA as a respiratory drug back in 1963. This was the exact same reason that the regulating agency cited in its 2020 warning letters where it asserted that the law prohibits NAC’s use in supplements because the ingredient was first approved as an inhaled drug.
Therefore, it is, by definition, excluded from the category of dietary supplements. In general, the sale of pharmaceutical ingredients as supplements is illegal.
This isn’t, however, an out of nowhere kind of decision. In fact, the FDA has pushed back on the use of NAC containing supplements since 2010. However, its use has recently ramped up significantly. Some speculate that this is due to new clinical investigations on the use of NAC in preventing COVID-19.
The FDA claims there’s no evidence that NAC was used as a supplement before it was used as a drug. Therefore, including NAC in a supplement makes it an unapproved drug and thus illegal.
Although the 2020 warning letters were only addressed to companies that marketed NAC as a hangover cure, its effect didn’t end there.
In fact, the impact of the warnings were even more amplified when Amazon — citing the FDA’s stand that the ingredient is a drug — banned the sale of all NAC supplement products on its platform.
As a result, product sales have languished.
FDA Requests More Information
In November 2021, just before Thanksgiving, FDA announced a request for additional information on the past use of NAC in products marketed as dietary supplements.
If the industry can prove that there was widespread use of NAC in supplements prior to the Dietary Supplements Health and Education Act (DSHEA) in 1994, the substance would be treated as an “old dietary ingredient,” and would be exempted from the drug exclusion provision.
The agency requested parties to submit information that would support that position by January 25, 2022.
FDA added that it is open to the idea of a rulemaking to make the substance lawful in dietary supplements. Although the FDA hasn’t officially banned NAC containing supplements, the effects of its position — especially when Amazon honored its statement — has definitely hobbled NAC sales.
NPA claims that when FDA applied the Prior Drug Exclusion standard, it acted unlawfully. The complaint called the agency’s actions “arbitrary, capricious, an abuse of discretion, and contrary to law.”
The complaint stated that, “NPA’s members have suffered harm as a direct and proximate result of FDA’s recent final agency actions concluding that the drug exclusion provision of DSHEA applies retroactively to NAC. NPA members who have been selling NAC for years, if not decades, have seen their sales dry up as result of having to preemptively pull products from the shelves by virtue of FDA’s unlawful decisions.”
If the Washington, D.C.-based trade association wins its case, the FDA would be barred from taking any regulatory action against manufacturers, distributors, or sellers of NAC based on the ground that the substance is a pahrmaceutical ingredient.
A Hint Of Irony
There may be a hint of irony in the NPA’s lawsuit. This is because NPA’s CEO and president Daniel Fabricant, PhD, was Director of the FDA’s Division of Dietary Supplement Programs from 2011 to 2014.
Fabricant, however, maintains that his former employer’s actions are way out of line.
“We are very concerned that a safe, legal natural product that has been sold for over thirty years is under what appears to be a regulatory sneak attack by the FDA, and even more concerned if this illegal approach may be used for other ingredients,” said Fabricant in a press release announcing the lawsuit. “This is government regulation run amok.”
“The FDA’s actions against NAC represent a reckless misuse of government resources and will do nothing to protect public health,” he added.
The complaint names the following as defendants:
- U.S. Food and Drug Administration
- U.S. Department of Health and Human Services
- HHS Secretary Xavier Becerra
- FDA Acting Commissioner Janet Woodcock
Fabricant also said that FDA should have either started with rulemaking immediately or denied the NPA’s request instead of asking for additional information on an ingredient that’s been present in dietary supplements for decades already.
“Give us a clear path forward,” he said in an interview. “Is our path through the courts or is our path through rulemaking?”
Renewed Confusion Over NAC
The clash between the industry and FDA creates confusion and emphasizes the huge differences in supplement and drug regulations.
The renewed confusion over the legality of NAC reveals major problems on supplement regulations. The same thing can also be said for another ingredient with confusing legality like CBD. Unlike with medications, there’s no approval process for dietary supplements.
When it comes to a supplement, if it has dietary ingredients that were already used in supplements prior to DSHEA (1994) or established as safe since then, it can be lawfully marketed and sold to consumers.
This is very different from the extensive regulatory process that drugs have to undergo before making it to the market. Those in the industry claim there’s no reason for the FDA to remove products that have been in the market for years with no known safety issues.
As a prescription drug, NAC is generally safe for adults. However, high amounts may cause:
- Chest tightness