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Following Final NAC Guidance and Marketplace Stabilization, NPA Withdraws FDA Lawsuit
After securing final guidance for N-Acetyl-Cysteine (NAC) through a citizen petition and lawsuit, the Natural Products Association (NPA) dismissed its case against the U.S. Food and Drug Administration (FDA), which preserves legal rights and standing should additional action be necessary. The guidance also initiates the process for export certificates for NAC, which was a primary ...
CRN Disappointed, But Remains Committed to Product Listing for Dietary Supplements
The Council for Responsible Nutrition (CRN) said that it remains committed to its support of Mandatory Product Listing (MPL) despite the advancement of the drug user fee bill, the FDASLA Act of 2022, without including provisions to increase transparency for dietary supplements. In response to the release of the text of the Continuing Appropriations and Ukraine ...
NPA: California Bill Restricting Supplement Access Should Be Vetoed
The Natural Products Association (NPA) has called the passage of a California bill to restrict access to dietary supplements a slap in the face to public health and consumer choice. The California bill, AB 1341, restricts access to dietary supplements and in certain situations requires a prescription to access these health products. While the bill does ...
NJ Labs Underscores Importance of TOC Water Testing Analysis for Cosmetic, Nutraceutical and Pharmaceutical Products
A flood of warning letters from the FDA (U.S. Food and Drug Administration) on water system suitability could pull the plug on the production of food, beverage, cosmetic, nutraceutical, and over-the-counter (OTC) or pharmaceutical products if companies are not conducting total organic carbon (TOC) water testing analysis on a regular basis, reports NJ Labs (New Brunswick, NJ). ...
FDA’s Long-sought Guidance on NAC Follows NPA’s Lawsuit and Citizen’s Petition
Following a Citizen’s petition and lawsuit filed by the Natural Products Association (NPA) against the U.S. Food and Drug Administration (FDA) for a dietary supplement issued enforcement discretion for N-Acetyl-Cysteine (NAC) has resulted in the agency issuing final guidance. “This is a big win but it is bittersweet for sure. Although it was NPA’s leadership ...
CRN President Issues MPL Update to Members
In an open letter to members, Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN), updated the CRN community on the status of the association’s effort to create a dietary supplement registry at the U.S. Food and Drug Administration (FDA). In the letter, Mister reassured members that CRN would continue to advocate ...
NPA, CRN Respond to Research Showing Supplements With Banned Ingredients are Still on the Market
A study recently published in JAMA by Pieter A. Cohen, MD; Bharathi Avula, PhD; and Kumar Katragunta, PhD, et al, has found that supplements with banned ingredients are still on the market despite the companies having received warning letters from the U.S. Food and Drug Administration (FDA). The study stated that “Some dietary supplements are adulterated ...
FDA’s Misguided NDI Amnesty Scheme—But Companies Should Still Comply with the Law
On May 19, 2020, FDA (U.S. Food and Drug Administration) published a proposed Guidance Document announcing its intention to adopt a “Policy Regarding Certain New Dietary Ingredients and Dietary Supplements Subject to the Requirement for Premarket Notification: Guidance for Industry” (The Draft Guidance). This document announced FDA’s intent to consider, pending public comment, a six ...
Government Action: From State to Federal
The panel: Jim Emme, CEO, NOW Health Group, Bloomingdale, IL, www.nowfoods.com Jonathan Emord, President & Principal, Emord & Associates, Clifton, VA, https://emord.com Karen Howard, CEO, Executive Director, Organic & Natural Health Association, Washington, D.C., https://organicandnatural.org Mark LeDoux, Chairman & CEO, Natural Alternatives International, Carlsbad, CA, www.nai-online.com Dan Lifton, President, Maypro Ventures, Port Chester, NY, www.maypro.com ...
Senator Burr Takes Position Against Including Dietary Supplement Provisions in FDA User Fee Bill Package
On July 14, Senator Richard Burr (R-NC), the ranking member of the Senate HELP Committee and a central negotiator in the conference proceedings, introduced a clean reauthorization of FDA User Fee Programs (U.S. Food and Drug Administration), which does not include controversial dietary supplement provisions. Senator Burr cited concerns over the Senate’s ability to pass ...
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