fda
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Ingredients and Dietary Supplements Subject to the Requirement for Premarket Notification: Guidance for Industry” (The Draft Guidance).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 ...
ProTab Labs Offers Solutions for Infant Formula Producers Facing Crisis
To tackle the infant formula crisis, producers can rely on Southern California supplement solutions contract manufacturer ProTab Laboratories to blend custom premixes and produce and package infant formula with a rapid turnaround time, the company stated. “ProTab is in the perfect position as a supplement solution manufacturer and packager to prioritize infant formula production with safety and ...
Industry Questions FDA Policy Notice on NDIs
On May 20, FDA’s (U.S. Food and Drug Administration) Center for Food Safety and Applied Nutrition (CFSAN) published a notice in the Federal Register announcing the availability of a draft guidance, “Policy Regarding Certain New Dietary Ingredients and Dietary Supplements Subject to the Requirement for Pre-market Notification.” Under the new policy described in this draft ...
NPA Responds to Report of Increased, Unintentional Pediatric Melatonin Ingestion
Over the past decade and particularly since the beginning of the COVID-19 pandemic, the use of melatonin supplements to address sleep issues has increased significantly by both adults and children. On Thursday, June 3, the Centers for Disease Control and Prevention (CDC) released a 10-year study that found a sharp increase in the use of ...
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