CRN's petition sets 180-day deadline for resolution of NAC issue

02-Jun-2021 - Last updated on 02-Jun-2021 at 14:28 GMT

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The Council for Responsible Nutrition has filed a citizen’s petition with FDA requesting that the Agency reverse its decision that the ingredient NAC is not legal for use in dietary supplements. CRN states that FDA’s ruling on the matter, voiced in warning letters, is not legally justified and is having grave economic consequences.

The 10 page petition, signed by CRN president and CEO Steve Mister and Megan Olsen, CRN’s vice president and general counsel, was filed yesterday. It is titled “Citizen Petition Requesting FDA Allow N-acetyl-L-cysteine (NAC) to be Marketed as a Dietary Supplement."

Safety of ingredient not in question

The petition notes that NAC has been on the market since the 1960s, when it was first approved as an inhaled drug for nasal congestion. But the petition notes the substance is naturally occurring, and is found in foods like onions and garlic.

Further, the ingredient has been on the market in supplement form for decades without any substantial safety concerns.

“It is the precursor to the amino acid l-cysteine, which FDA considers to be generally recognized as safe (GRAS).8 The safety of NAC dietary supplements is not in dispute,” the petition stated.

FDA’s position is based on NAC’s prior drug approval. But CRN notes that the Agency is conflating the inhalable form with the ingestible forms used in supplements, which blurs the issue.

“An inhaled substance should not be treated as the same article as an orally consumed substance. To do so would go against FDA’s own significant precedent and guidance. For example, for drug approval FDA would not consider an inhaled drug to be “the same” as an orally ingested drug, as the route of administration and dosage form, among other requirements, are considered by the agency,” the petition read.

Lighting a fire under the Agency

CRN said in the petition that is has had several meetings with the Agency over the issue, including with Cara Welch, PhD, Acting Director of the Office of Dietary Supplement Programs.

“FDA has represented that the agency is considering CRN’s position, but has given no firm timeline for a response,” the petition states.

But CRN noted that time is of the essence. Amazon recently started the process of removing NAC supplements from its sales platform. Hundreds of NAC-containing supplements are on the market, and those companies could be left holding the bag while FDA considers its response.

CRN noted that filing a citizen’s petition starts a regulatory clock. FDA now has an 180-day deadline to respond, and its response can be challenged in court if that proves necessary. Policy decisions outlined in warning letters are not subject to judicial review, the CRN petition noted.