NAC | WholeFoods Magazine

CRN Challenges FDA Course on Drug Preclusion

June 2, 2023

The Council for Responsible Nutrition (CRN) has submitted a Citizen Petition to the U.S. Food and Drug Administration (FDA) calling for the agency to reconsider its interpretation of the Drug Preclusion Clause.

Nicotinamide mononucleotide, niacin, anti adeing vitamin. White pills forming shape to NMN alphabet on wooden background, copy space, top view.

NPA, ANH File Citizen’s Petition with FDA on NMN

“Issues surrounding NAC and NMN are glaring examples of the FDA fundamentally failing American consumers and industry," said NPA's Daniel Fabricant, Ph.D.

March 21, 2023

Maggie Jaqua

In November 2022, a notification by the Food and Drug Administration (FDA) declared that beta-nicotinamide mononucleotide (NMN) is not a legal dietary ingredient. In response, the Natural Products Association (NPA), along with the Alliance for Natural Health (ANH), submitted a Citizen’s Petition to FDA.

β-NMN Is Not a Dietary Supplement? CRN Responds

November 29, 2022

Maggie Jaqua

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...

NPA Withdraws FDA Lawsuit, Market Stabilization

November 2, 2022

WholeFoods Magazine Staff

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...

FDA Issues Final Guidance on "Enforcement Discretion" of NAC

August 1, 2022

Maggie Jaqua

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...

CRN: 6 Issues with FDA's NDI Draft Guidance for Dietary Supplements...

July 25, 2022

Maggie Jaqua

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...

Senate HELP FDA Authorization Bill Passes Committee; Industry Groups "Strongly Concerned"

June 15, 2022

WholeFoods Magazine Staff

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...

Senator Durbin is Coming for Your Supplements

May 25, 2022

Steve Lankford and Steve Lankford, host of HealthQuestPodcast.com

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...

Mandatory Product Listing Proposal Included in Draft Legislation; NPA Weighs In

May 19, 2022

Julia Peterman

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...

Pay Homage to the Past with a Promise for the Future

May 11, 2022

Karen Howard

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...