In its letter, CRN takes issue with FDA’s “tentative response” which side-stepped any legal issues raised in the citizen petition.
The Council for Responsible Nutrition (CRN; Washington, D.C.) has sent a letter to FDA in response to the agency’s tentative response to CRN’s Citizen Petition, filed in June of 2021. The petition requested FDA to reverse its position to prohibit the sale of N-acetyl-L-cysteine (NAC) as dietary supplements. FDA argued in several warning letters that the ingredient fell under the drug preclusion clause of the Federal Food, Drug, and Cosmetic Act, making it unlawful for sale as a dietary supplement.
According to the agency, records show that NAC was approved as a new drug in 1963. CRN questions the reliability of these records and argues that the position, suddenly adopted by the agency after decades of the ingredient being safely sold in dietary supplements, violates the well-established presumption against statutory retroactivity. CRN and other stakeholders have also provided FDA evidence that NAC was marketed as a dietary supplement prior to the passage of DSHEA, and is therefore a grandfathered ingredient.
In its letter, CRN takes issue with FDA’s “tentative response” which side-stepped any legal issues raised in the citizen petition. Because of this, CRN believes FDA to be in violation of its own requirements to respond to a citizen petition within 180 days of receipt.
“Over a year after CRN first raised concerns regarding the legality of FDA’s policy reversal on NAC, FDA has failed to substantively respond to CRN’s concerns and, with the announcement in the November 24 Letter, has extended any response date until after January 25, 2022. Meanwhile, dietary supplement companies that have been selling NAC as a dietary ingredient for decades with no objections from FDA are experiencing significant economic harm from FDA’s statements,” states the letter. “CRN has provided FDA with specific examples of this economic harm in multiple documents and meetings, including that the largest U.S. ecommerce retailer, Amazon, stopped selling NAC in spring 2021 in reliance on FDA statements. In the last few months, large payment processing platforms that businesses and consumers have come to rely on for safe and efficient online payment transactions, Paypal and Shopify, have followed Amazon’s lead, and blocked the use of their platforms for NAC dietary supplement sales.”
CRN also takes issue with FDA reviewing a separate citizen petition from the Natural Products Association (NPA; Washington, D.C.) concurrently. This is inappropriate because the two petitions request different actions from the Agency. NPA has since filed suit against FDA for retroactively applying the drug preclusion clause to NAC.
Additionally, CRN expressed concern for FDA’s request for NAC marketing and safety information which the trade association find irrelevant in order for the Agency to respond to the legality of its position. By requesting this information, FDA has pushed back its response date by months, potentially longer. The letter is signed by Steve Mister, CEO of CRN, and Megan Olsen, vice president and associate general counsel for CRN.