CRN staff met with FDA top brass on NAC

FDA buildings 2020

Representatives of the Council for Responsible Nutrition (CRN) met this week via Zoom with the acting commissioner of FDA and about a dozen other officials to discuss areas of agreement and disagreement between the Washington, D.C.-based trade association and the public health agency.

The May 11 talks between CRN’s senior staff and FDA officials—including Dr. Janet Woodcock, acting commissioner of FDA—gave CRN the opportunity to raise its concerns over FDA’s position that NAC (N-acetyl-L-cysteine) cannot be lawfully marketed in dietary supplements.

Steve Mister, president and CEO of CRN, described the nearly hour-long meeting with FDA officials as an extremely “cordial” and “productive” one in which the trade group “covered a lot of territory.”

Among the topics CRN discussed:

  • CRN’s support for a mandatory dietary supplement product listing or registry;
  • Its public education initiatives; and
  • CRN’s support for legislative changes clarifying products marketed as dietary supplements should be subject to enforcement as supplements—even if they don’t contain a dietary ingredient and meet the definition of a supplement under current law.

The meeting with FDA officials, including Dr. Woodcock—whom Mister has known since the 1990s when she worked in the Center for Drug Evaluation and Research (CDER)—provided an opportunity to discuss areas of agreement with the agency, as well as raise topics “we’re not happy about, including the NAC issue,” Mister said in an interview.

The meeting included representatives from the acting commissioner’s office, as well as Office of Chief Counsel, Stakeholder Engagement staff, Office of Dietary Supplement Programs (ODSP) and leadership of the Center for Food Safety and Applied Nutrition (CFSAN), according to a May 12 memo that CRN distributed to its members.

An FDA spokesperson had no comment on the meeting or NAC specifically.

In July 2020 warning letters, FDA stated NAC could not be lawfully marketed in a dietary supplement because the ingredient was first studied as a drug in 1963. The move caused alarm in the industry since NAC had been widely sold in dietary supplements for many years by prominent brands.

In a recent development, Amazon verified it was in the process of removing from its website supplements containing the ingredient, raising concern that other online or brick-and-mortar retailers might follow suit.

During the meeting with FDA officials, Megan Olsen, vice president and associate general counsel of CRN, discussed “the untenable situation created by FDA’s warning letters,” according to CRN’s memo.

CRN summarized its legal arguments outlined in a December 2020 letter that challenged FDA’s position regarding the legality of NAC in supplements. The trade group also “reiterated the uncertainty created among retailers by the agency’s failure to respond to that document and or to provide clarity on the issue,” the memo stated.

Cara Welch, Ph.D., acting director of ODSP, was among the FDA officials on the Zoom call. She recently advised CRN that FDA officials "are closely reviewing" CRN's 2020 letter regarding NAC "and will provide a more substantive response once our evaluation is complete."

CRN said it stressed to FDA officials the urgency of the NAC issue— considering Amazon’s decision and at least one contract manufacturer stopping production of NAC-containing supplements for its customers.

“Although we did not receive a commitment for prompt resolution of the matter, Dr. Woodcock did express interest, asking several questions about the implications of FDA’s position on NAC for other ingredients as well,” CRN disclosed in the memo. “She acknowledged that other dietary supplements coexist with drug counterparts containing the same ingredients.”

 

TAGS: Ingredients
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