AGG partner and Dietary Supplements team leader, Kevin Bell, was quoted in a Natural Products Insider article titled “CRN Requests FDA Separately Reviews its NAC Petition — and Soon,” which discussed the FDA’s position that NAC (N-acetyl-L-cysteine) cannot be lawfully marketed in dietary supplements and a lawsuit filed by the Natural Products Association (NPA). Kevin represents NPA in the lawsuit.
NPA is seeking a declaratory judgment that the drug exclusionary provision in the Dietary Supplement Health and Education Act of 1994 (DSHEA) does not retroactively apply to NAC, which was on the market before the passage of the law. The lawsuit also seeks preliminary and permanent injunction, barring FDA from taking regulatory action against distributors, manufacturers, or sellers of NAC based on the claim that the drug exclusion applies retroactively to NAC.
To read the full article, please click here.