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FDA investigators who inspect dietary supplement manufacturing facilities for compliance with cGMPs (current good manufacturing practices) are still often finding the same deficiencies more than a decade after the regulations were adopted. In fiscal year 2018 (FY18), 75 inspections—or about 24 percent of firms that received a Form 483 inspection report for “observations,” or alleged…
The international unit (IU) has been used to measure fat-soluble vitamins—vitamin A, D and E—for decades. The IU is an arbitrary amount based on the amount of a given nutrient needed to produce a biological effect. Different than milligram or microgram, the IU measurement describes something that we cannot see; the potency or biological activity…
The gut flora performs a variety of functions that are important for health. In fact, 70 percent of the body’s immune cells are located in the digestive tract, making gut health critical to overall health. A healthy and well-balanced gut flora facilitates digestion, protects against pathogens, provides vitamins and nutrients, and helps form the immune…
The sports nutrition market continues to see steady growth. Athletes and mainstream users, including exercisers and those leading active lifestyles, are looking for products that support their recreational and lifestyle-driven performance. Both men and women seek sports nutrition products to help improve their nutritional intake, general health, well-being, performance, and muscle growth and recovery from…
FDA on Thursday recognized the benefits of disclosing on labels the number of live microbials in dietary supplements—an issue of interest to marketers of probiotics. FDA stopped short of amending its labeling regulations, denying a request filed by the International Probiotics Association (IPA). However, the agency revealed plans to “exercise enforcement discretion” for companies that…
U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb, MD, released decisions made on citizen petitions to expand and better define what ingredients fall under the legal definition of “dietary fiber.” When in 2016 FDA unveiled a new definition for dietary fiber as part of updating the final rule for the Nutrition Facts label, the…
The Council for Responsible Nutrition (CRN) has unveiled two developments in its collection of proactive, science-based voluntary guidelines and best practices: new recommended guidelines for products containing SARMs and updates to its recommended guidelines for caffeine-containing dietary supplements.These updates coincide with recent FDA action to protect consumers from the potentially harmful effects of selective androgen…
FDA on Monday announced approval of a cannabidiol (CBD)-based drug derived from marijuana, and its top official signaled where the agency will focus its enforcement priorities against companies marketing unapproved CBD products. Epidiolex, the medicine developed by GW Pharmaceuticals plc, was approved by FDA to treat seizures associated with Lennox-Gastaut syndrome and Dravet syndrome in patients…