Monday, April 18, 2022

Trade associations debate mandatory product listing – Natural Products INSIDER

FDA, in its recent budget request to Congress, proposed a mandatory listing of dietary supplement products. If enacted into law, the proposal would require manufacturers list their product labels with FDA and potentially disclose further information to the agency.

In this 30-minute interview hosted by Josh Long, industry trade associations debate the pros and cons of mandatory product listing (MPL) while also discussing the need for “DSHEA 2.0.,” or broader reform to the Federal Food, Drug & Cosmetic Act, the law governing dietary supplements.

This episode of “Short Legal Briefs” also features reactions to a 25-page letter from FDA, which responded to citizen petitions filed by two trade associations relating to a popular ingredient marketed in dietary supplements: NAC (N-acetyl-L-cysteine). In the letter, FDA reaffirmed its position that NAC is excluded from the definition of a dietary supplement. The agency, however, is considering a request for an NAC rulemaking and plans to issue guidance concerning a policy of enforcement discretion.

Long sat down with the following roundtable of experts to weigh in on mandatory product listing, DSHEA 2.0 and NAC:

Michael McGuffin, president of the American Herbal Products Association (AHPA);

Duffy MacKay, senior vice president of dietary supplements with the Consumer Healthcare Products Association (CHPA);

Loren Israelsen, president of the United Natural Products Alliance (UNPA);

Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN; and

Dan Fabricant, president and CEO of the Natural Products Association (NPA).

Check out all episodes at the Short Legal Briefs show page.

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