February 8, 2022
The Natural Products Association (NPA) plans to file an amended lawsuit against FDA in a dispute over the legality of a popular ingredient marketed in dietary supplements.
In response to a joint motion filed by NPA and the U.S. Department of Justice (DOJ), U.S. District Judge Theodore D. Chuang has extended the deadline for the government to file its response to NPA’s complaint.
Feb. 14 was the original deadline for DOJ to file an answer or response to NPA’s original lawsuit. However, the parties jointly requested an extension of the deadline and disclosed NPA intends to file an amended complaint by Feb. 21.
Defendants’ answer will be due within 21 days of service of NPA’s amended lawsuit, Chuang, of the U.S. District Court for the District of Maryland, wrote in an order this week.
NPA sued FDA in December over its position that NAC (N-acetyl-L-cysteine) cannot be marketed in dietary supplements. According to FDA, NAC is excluded from the definition of a dietary supplement because it was first approved as a drug in 1963.
In its original complaint, NPA requested 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 sought 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.
Industry stakeholders have provided FDA evidence that NAC was marketed in nutritional products before passage of DSHEA, and they have argued the drug exclusion provision only applies prospectively to "articles" approved or studied after DSHEA's enactment.
It's unclear how NPA's amended lawsuit will differ from its original complaint against FDA, the U.S. Department of Health and Human Services, HHS Secretary Xavier Becerra and FDA Acting Commissioner Janet Woodcock.
FDA and NPA had no immediate comment on the recently filed court documents.
FDA is reckoning with NAC on two fronts: in federal court and in a regulatory proceeding where it is considering two citizen petitions filed by NPA and the Council for Responsible Nutrition (CRN).
In the regulatory proceeding, consumers, trade associations, other industry stakeholders and pharmaceutical interests have all weighed in on NAC.
In a constituent update in November, after receiving the citizen petitions, FDA requested comments on the past use of NAC in products marketed as dietary supplements.
"If applicable, the FDA will use the information submitted to the public docket and other applicable information to determine if rulemaking to make NAC lawful as a dietary supplement is appropriate," the agency stated in the constitute update.
To date, FDA has received 21 comments. While FDA requested the comments by Jan. 25 in order to be timely in its consideration of them, the docket remains open.
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