CRN action on NAC
CRN is working to protect consumer access to N-Acetyl-L cysteine (NAC) dietary supplement products following fallout from FDA’s announcement in July 2020 via warning letters that it does not consider NAC to be a legal dietary ingredient.
AUGUST 1, 2022: FDA today announced the availability of a final guidance on its policy regarding products labeled as dietary supplements that contain N-acetyl-L-cysteine (NAC). The guidance explains the agency's intent to exercise enforcement discretion with respect to the sale and distribution of certain NAC-containing products that are labeled as dietary supplements.
“This enforcement discretion policy applies to products that would be lawfully marketed dietary supplements if NAC were not excluded from the definition of ‘dietary supplement’ and are not otherwise in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act).”
APRIL 21, 2022: CRN responds to FDA draft guidance
- CRN welcomes FDA's April 21 draft guidance on NAC to provide retailers, payment platforms, and product marketers with the assurance they have been asking for—that they may continue to sell NAC-containing dietary supplements without threat of enforcement. But clarity on the agency's broader interpretation of the drug preclusion provision is needed going forward. Read more in our press release.
MARCH 31, 2022:
IN THE NEWS—Read up on stakeholders' responses to FDA's decision:
Natural Products Insider, “FDA denies NAC petitions but signals it won’t enforce”
NutraIngredients-USA.com, “FDA signals it won’t go after NAC, but legal issues remain unresolved”
- Vitamin Retailer, "CRN Dismisses FDA Response on N-acetyl-cysteine (NAC)"
MARCH 14, 2022: DOJ filing in NPA's lawsuit
MARCH 2, 2022: FDA letter to CRN
JAN. 26, 2022: CRN Files Comments with FDA, Calls for Swift Agency Response to Citizen Petition on NAC Status
NOV 24, 2021: FDA response letter
Get Involved: Contact your member of Congress and FDA
- Rep. Jeff Duncan (R-SC) requests FDA response to questions surrounding agency's policy change on NAC
- FDA response to Sen. Lee letter acknowledges agency review of CRN NAC Citizen Petition
- Sen. Lee (R-UT) calls for public hearing on NAC.
- CRN urges legislators to tell FDA to stop limiting consumer access to safe, beneficial dietary supplements.
- Learn more about how FDA warning letters are not final agency action or official statements of FDA policy via this legal memo.
CRN's Megan Olsen discussed NAC during "Short legal briefs, with Josh Long" on the SupplySide365 Network. WATCH HERE.
“CRN is firmly committed to protecting our members’ interest in this matter to sell a lawful ingredient. FDA’s warning letters on NAC are not final agency actions, but rather should be viewed as the opening salvo, inviting those with sound legal arguments to respond, which we are doing.”
—Steve Mister, CRN President & CEO, Natural Products Insider, December 2020
JUNE 2021 UPDATE: CRN petition requests FDA reverse position on NAC
As previously reported to our members, several companies are learning that Amazon is removing NAC-containing products from its retail platform.
Here's what CRN has done to address the matter thus far:
- Called on legislators to tell FDA to stop limiting consumer access to NAC
- Filed a submission with FDA in December 2020 challenging the agency's determination that NAC is precluded from use in dietary supplements
- Recently learned Legitscript, an internet and payment compliance company that advises Amazon, identifies NAC on its site as “an impermissible dietary supplement ingredient in the US," relying on FDA warning letters
- Contacted both Amazon and Legitscript and provided a copy of its FDA submission
- Filed a Citizen Petition calling for FDA to recognize N-acetyl-cysteine’s (NAC) status as a lawful dietary ingredient
CRN HAS BEEN PUBLICLY PUSHING BACK SINCE 2020
FDA position on NAC 'invalid on multiple legal grounds,' CRN says
CRN declared “legally invalid” FDA’s new policy prohibiting manufacturers from marketing products containing NAC as dietary supplements under the Federal Food, Drug, and Cosmetic Act (FDCA).
In a letter to FDA Director of Dietary Supplement Programs Steven Tave, CRN called the change, as seen in July 2020 via warning letters, “a sudden and drastic departure from past agency practice" and urged the agency to revert to its longstanding policy of permitting supplement products containing NAC.
It is unclear whether FDCA section 201(ff)(3)(B)(i) applies to NAC, as FDA records of NAC’s drug approval contain unreliable and conflicting information, CRN noted. Additionally, as cited in Nutritional Outlook's coverage of CRN's action, "NAC drugs approved prior to 2016 appear to be comprised of different forms of NAC compared to those found in dietary supplements."
CRN called the policy change "an arbitrary and capricious agency action that is invalid under the Administrative Procedure Act," noting that FDA's new position is not only unenforceable but also violates the "well-established presumption against statutory retroactivity." Read more.
Member Alert and Member Feedback Requested: FDA Targets Sale of NAC Dietary Supplements
Last week FDA sent seven warning letters to companies for allegedly making illegal disease claims that their products could cure, treat, mitigate, or prevent hangovers. CRN is requesting member feedback. CRN members read more.