Following a notification by the Food and Drug Administration (FDA) that beta-nicotinamide mononucleotide (β-NMN) is not a legal dietary ingredient, Council for Responsible Nutrition (CRN) President and CEO Steve Mister outlined the problems. “CRN is alarmed that, once again, FDA changed its position on whether an ingredient—in this case, beta-nicotinamide mononucleotide (β-NMN)—can...
Washington, D.C.–The Natural Products Association has dropped its lawsuit against the Food and Drug Administration for N-Acetyl-Cysteine (NAC) following guidance issued last month and subsequent market stabilization. FDA's final guidance, issued in August, described enforcement discretion for the sale and distribution of NAC as long as the product does not...
This article has been updated with comments from the industry. Washington, D.C.—The Food and Drug Administration (FDA) has issued Guidance for Industry: Policy Regarding N-acetyl-L-cysteine. The guidance advises dietary supplement manufacturers, distributors, and other stakeholders of FDA's intent to exercise enforcement discretion with respect to the sale and distribution of certain...
Washington, D.C.—The Council for Responsible Nutrition (CRN) has submitted comments in response to FDA’s draft guidance on new dietary ingredient (NDI) filings and enforcement discretion. (Background: CRN Reacts to FDA’s NDI Enforcement Discretion Draft Guidance.) As CRN noted, the NDI filing and enforcement discretion paradox has been a hot-button issue affecting the...
Washington, D.C.—Earlier this year, the Senate Health, Education, Labor, and Pensions (HELP) Committee released a discussion draft of legislation to reauthorize FDA user fees for drugs, biologics, and medical devices—and the legislation includes the Durbin-Braun premarket approval concept. As WholeFoods Magazine reported, the Natural Products Association (NPA) has been cautioning...
Click here to listen. The United States Senate Health, Education, Labor, and Pensions Committee (HELP) has released a discussion draft of its legislation to reauthorize FDA user fees for drugs, biologics, and medical devices package, which includes the controversial Durbin-Braun premarket approval concept and more. The Natural Products Association...
Washington, D.C.—The Senate Health, Education, Labor, and Pensions (HELP) Committee has released a discussion draft of its legislation to reauthorize FDA user fees for drugs, biologics, and medical devices—and the legislation includes the Durbin-Braun premarket approval concept. The Natural Products Association (NPA) is cautioning that this would be damaging to...
We lost Orrin Hatch this year, and with his loss, and his 42-year Senate tenure, the vestige of a bygone era of bipartisanship. Granted, we have been suffering the effects of Congressional dysfunction for quite some time. The death of this Senator, our industry champion, however, lends a feeling of...
Secaucus, NJ—SupplySide East took place on April 12 and 13 this year at the Meadowlands Exposition Center, uniting leaders in the food, beverage, supply, distributor, manufacturing industries, and more to present and discuss new information across their fields. Check out the key takeaways: Research in the spotlight: A focus on...
UPDATE May 15, 2022: The Legal, Regulatory & Compliance Forum on Dietary Supplements on June 29-30, has moved from the Westin Grand Central to the InterContinental Times Square Hotel in New York City. New York, NY—The Council for Responsible Nutrition (CRN) and the American Conference Institute (ACI) have teamed up for Legal, Regulatory,...
