U.S. Food and Drug Administration
NPA Challenges Proposed Restrictions to Nutritional Supplement Access in NJ
On Nov. 14, the Natural Products Association (NPA) called a New Jersey proposal to restrict access to dietary supplements a slap in the face to public health and consumer choice in public testimony against a proposal being considered in the state legislature. A similar proposal in California was recently vetoed by Governor Gavin Newsom. The ...
CRN Responds to FDA Letter Announcing β-NMN Is Not A Dietary Supplement
The Council for Responsible Nutrition (CRN) has responded to U.S. Food and Drug Administration’s (FDA) recent announcement that beta-nicotinamide mononucleotide (β-NMN) is not a legal dietary ingredient. CRN President and CEO Steve Mister expressed his dismay about the ruling. “CRN is alarmed that, once again, FDA changed its position on whether an ingredient—in this case, ...
CRN Responds to Cholesterol Study That Compares Supplements to Prescription Drug
The Council for Responsible Nutrition (CRN) has responded to results of the “Supplements, Placebo, or Rosuvastatin (SPORT)” Study. It was presented at the American Heart Association Scientific Sessions Nov. 6 and published in the Journal of the American College of Cardiology. SPORT, funded by AstraZeneca, the company that markets Rosuvastatin, compared the effect on low-density ...
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 ...
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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