Have you noticed that it has become very difficult to find retailers where you can purchase the antioxidant dietary supplement N-acetylcysteine (NAC)? The reason is that last summer (2020) with no advanced warning the Center for Food Safety and Applied Nutrition (CFSAN) sent out a number of letters advising companies that the U.S. Food and Drug Administration (FDA) was designating NAC as a drug, not a dietary supplement. This sent shock waves throughout the supplement industry, as the FDA had been allowing NAC dietary supplement status for 57 years.

Assuming the policy change would be finalized, some retailers immediately stopped selling any product containing NAC. The Natural Products Industry advised their retailers to continue selling products with NAC, however, as they could not see this policy change being legally upheld. As of the summer of 2021, the matter is still in limbo.

Industry organizations like the Council for Responsible Nutrition have submitted petitions to the FDA outlining the legal rationale against the FDA’s arguments supporting their change in policy against NAC. Senator Mike Lee of Utah has submitted a letter to the FDA requesting explanations for this policy regarding NAC.

As the legal arguments are complex, who knows when this matter will be resolved and whether or not reason or special interests will prevail.

Issue: NAC designation change from dietary supplement to drug

AHHA strives to maintain a neutral position on issues and views knowledge as power. For those interested in this month’s issue, the articles below were selected to support your research into the matter presented. Note that this change has been initiated but not yet finalized by the FDA.

LEGAL OVERVIEW
FDA Invokes the Drug Exclusion Provision with NAC over a 57 Year Old Drug (8/2/21)
by Stan Soper
Soper Law
Law firm presenting similar cases for comparison

PRO
Vita Heaven, LLC dba Hangover Heaven (7/29/20)
U.S. Food & Drug Administration
One of the seven warning letters sent out by the FDA in July 2020

Classification of Products as Drugs and Devices and Additional Product Classification Issues (September 2017)
U.S. Food & Drug Administration
Key document used by the FDA

[Note that we could not locate any explanation materials related to the NAC policy change in the FDA website]

CON
Citizen Petition Requesting FDA Allow N-acetyl-L-cysteine (NAC) to be Marketed as a Dietary Supplement  (6/1/21)
Council for Responsible Nutrition
CRN’s arguments for why FDA needs to reverse its action against NAC

NAC—The Latest Health-Success Story to Become an FDA Target (7/29/21)
by Scott C. Tips
WholeFoods Magazine
A variety of industry reactions to the FDA action against NAC

NAC Letter (7/30/21)
Senator Mike Lee
Video referencing letter he sent to FDA asking for explanation for the change in NAC policy and requesting hearings

We encourage you to post your comments. You are also invited to share additional resources you have found relating to this issue.