December 7, 2021
The Natural Products Association (NPA) on Monday filed a lawsuit against FDA over its position that NAC (N-acetyl-L-cysteine) cannot be marketed in dietary supplements.
In a complaint filed in the U.S. District Court for the District of Maryland, NPA is seeking a declaratory judgment that the so-called drug exclusion provision in the Dietary Supplement Health and Education Act of 1994 (DSHEA) does not retroactively apply to NAC.
The Washington, D.C.-based trade association also is seeking a preliminary and permanent injunction, barring FDA from taking any regulatory action against distributors, manufacturers or sellers of NAC based on the claim that the drug exclusion applies retroactively to NAC.
FDA asserted in 2020 warning letters that NAC was excluded from the definition of a dietary supplement because it was first approved as a drug in 1963. Its assertions drew strong criticism from industry stakeholders who said the ingredient has been on the market for decades in dietary supplements and has posed no acute safety concerns.
NPA’s lawsuit, filed by attorneys with Arnall Golden Gregory LLP (AGG), may force FDA to reckon with NAC on two fronts: in federal court and in a regulatory proceeding where it has requested comments to citizen petitions filed by NPA and the Council for Responsible Nutrition (CRN).
“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 Dan Fabricant, president and CEO of NPA, in a press release announcing the lawsuit. “This is government regulation run amok.”
The complaint names as defendants FDA, the U.S. Department of Health and Human Services, HHS Secretary Xavier Becerra and FDA Acting Commissioner Janet Woodcock.
FDA declined to comment on pending litigation, and HHS did not immediately return a request for comment.
Final agency action
Lawyers previously told Natural Products Insider that a lawsuit filed against FDA based on the NAC warning letters would likely be dismissed since such letters are not “final agency action.”
NPA seems prepared for FDA to raise a defense that the lawsuit is premature and should be dismissed. NPA's complaint cited several examples of what it argued constitute final agency action, including a denial by FDA of export certificates requested by NPA members for NAC-containing products. Its lawsuit also referenced FDA’s position in a criminal case against Blackstone Labs and others that NAC is not lawful in supplements.
The U.S. government in 2017 requested a search warrant for Blackstone Labs and another company, based on a warrant from an FDA special agent with the Office of Criminal Investigations. As noted in NPA’s lawsuit, the agent swore under oath that NAC-containing products were excluded from the definition of a dietary supplement.
"The FDA cannot continue to claim that it has not yet formulated a determination of NAC’s regulatory status–and taken final agency actions based on it, when NPA’s members have sought clarity on this issue," NPA proclaimed in its lawsuit. "In fact, the FDA has taken final agency action as evidenced by its unambiguous representations to the court in the Blackstone case, thereby establishing FDA’s final agency action ripe for review under the Administrative Procedure Act."
DSHEA drug clause: no retroactive effect
DSHEA prohibits an ingredient from being marketed in a dietary supplement if the “article” was first approved or studied as a drug. NPA and others have argued DSHEA does not apply to supplement ingredients on the U.S. market prior to the law’s passage.
Trade associations, including NPA and the American Herbal Products Association (AHPA), have provided FDA evidence to show NAC was on the market before DSHEA’s enactment.
NPA’s lawsuit quoted the legislative history of DSHEA to support its legal position that the drug exclusion provision cannot be applied retroactively. An Oct. 8, 1994 Senate report cited occasions in which an ingredient may appear in both a supplement and active drug product. The Senate report identified L-carnitine as an ingredient that may be used in a dietary supplement, even though it is an active ingredient in an FDA-approved drug product.
“This is an example of exactly why Congress logically intended for supplements and food ingredients that were in the relevant markets prior to DSHEA to continue to be marketed as dietary ingredients … after the effective date of DSHEA, October 15, 1994,” NPA stated in its lawsuit.
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