AsWholeFoods previously reported, despite decades on the marker as a dietary supplement, in July 2020, FDA issued multiple warning letters asserting that products containing NAC cannot be marketed as supplements, due to the drug preclusion clause of the FD&C Act, which states that supplements cannot contain articles that FDA has approved as a drug, unless the ingredient was used before it was tested as a drug. WholeFoods legal editor Scott C. Tips addressed the issue in his Legal Tipscolumn, outlining legal arguments that “destroy the FDA’s stance on NAC.” His conclusion: “As NPA has correctly pointed out, there has been no final agency action taken on NAC sales. So, why are so many companies dashing for the exit doors? Stand and fight. And win.” Read the full columnhere.
AHPA joined with other industry groups and experts in questioning FDA's action by submitting comments to each of two dockets created for citizen petitions submitted by CRN in June 2021andby NPA in August 2021. In its comments, AHPA said it cites "extensive legal authority to refute FDA’s apparent position that the so-called prior drug exclusion provision applies retroactively to ingredients that were already in the food supply at the time of DSHEA’s enactment, such as NAC."
Strengthening the industry's stance, AHPA also pointed to several specific NAC-containing dietary supplements that were in the U.S. market prior to enactment of DSHEA.
“AHPA has retained and collated numerous pre-DSHEA records that document actual marketing in the U.S. before 1994 of thousands of ingredients and finished products,” said Michael McGuffin, AHPA President. “We were able to access the extensive records in this AHPA ODI Documents Database to provide affirmative documentation that NAC—just like vitamin C and vitamin D—was already being sold in the U.S. before the prior-drug approval restriction became law.”