In December 2022, the U.S. Food and Drug Administration (FDA) issued a final guidance that describes how it intends to prioritize enforcement and regulatory actions for homeopathic drug products marketed in the U.S. without the required FDA approval. FDA's risk-based approach will be used to prioritize enforcement and regulatory actions involving...
Silver Spring, MD—The latest series of warning letters from the U.S. Food and Drug Administration (FDA) were sent to five companies that FDA said is illegally selling products containing cannabidiol (CBD). FDA warning letters were sent to: 11-11-11 Brands Naturally Infused LLC Newhere Inc dba CBDFX Infusionz LLC CBD American...
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.—On Tuesday, October 11, the Natural Products Association (NPA) will present its interactive and educational webinar on Good Manufacturing Practices (cGMPs) regarding identity. The session, titled “GMP’s – Understanding and Mastering the Identity Requirements” will dive into areas such as understanding the mandates for identity and understanding and mastering...
Washington, D.C.—At the invitation of Cara Welch, Ph.D., Director, Office of Dietary Supplement Programs (ODS), the Council for Responsible Nutrition (CRN) provided written feedback on how dietary supplements are presented on FDA's website and its recently released Supplement Your Knowledge content for consumers, health care professionals, and teachers. CRN President and CEO Steve...
Washington, D.C.–The Natural Products Association (NPA), will host an interactive webinar next month that is aimed at providing insight, guidance, and educational support for the dietary supplement industry regarding Good Manufacturing Practices (cGMPs). The event, titled “GMP’s – Understanding and Mastering the Specification Requirements,” will take place on Wednesday, September...
Click here to listen. In this interview, Dr. Douglas Kalman, Senior Vice President of Scientific and Regulatory Affairs for The Natural Products Association (NPA), discusses some of the legal and regulatory issues regarding Delta-8 THC. He will contrast the differences between cannabidiol (CBD) and Delta-8 THC derived from hemp.
Washington, D.C.—The Council for Responsible Nutrition (CRN) released a statement from Steve Mister, President & CEO of the association, regarding progress being made toward passage of federal legislation to enact a product registry for dietary supplements. "I want to reassure you that we continue to advocate for advancing this legislation and honor...
NJ Labs reports on FDA warning letters NJ Labs reported FDA warning letters that will be issued to companies that have failed to validate that their water systems consistently produced water suitable for its intended use. Water system suitability could pull the plug on the production of food, beverage, cosmetic, nutraceutical,...
Washington, D.C.—The 7th annual Dietary Supplements Regulatory Summit, held in Washington D.C. and virtually on July 21, 2022, hosted briefings from the Food and Drug Administration (FDA), toxicologists in the field, legal professionals, and more. Speakers dissected trends in the nutritional supplements market and educated on pressing issues for industry...
