Session Details

Description

NAC (N-acetyl-L-cysteine) was marketed as a supplement before DSHEA (the Dietary Supplement Health & Education Act) passed in 1994, yet FDA sent a batch of warning letters in 2020 to retailers to halt sales of NAC due to its approved drug status. This much delayed use of the drug exclusionary clause—a substance can’t be a supplement if it was first approved as a drug—has left the industry concerned about FDA’s potential next target. This session will review the NAC story, discuss how the agency’s enforcement of this clause may affect other long-standing ingredients and outline ways industry can limit the impact.

Open to all attendees.

• Education Sessions