Unusual Supplement Adverse Events Could Be 'Canary' Of Problem
This article was originally published in The Rose Sheet
Post-market surveillance system for dietary supplements should contain a process for identifying sentinel events, or low-incidence and unusual adverse events that can indicate big problems, says a toxicologist speaking during a recent Council for Responsible Nutrition webinar.
You may also be interested in...
Robust dietary supplement adverse event compliance systems can support faster identification of problems and improve products, says Nature’s Bounty Product Vigilance Manager Christina Romano. During a recent CRN webinar, she said distributors, retailers and researchers should be part of the reporting system.
FDA’s OTC Monograph User Fees Are Existential Threat To Small Contract Manufacturers, Cosmetics Brands
OMUFA reauthorization should include small business considerations for the US FDA’s OTC Monograph Drug User Fee Program, which established in 2020 a ‘one-size-fits-all’ facility and monograph order request user fee system which could lead to more contract manufacturer exits, a manufacturing bottleneck for OTC cosmetic products, and fewer product choices, says IBA.
The US Federal Trade Commission is "fully prepared" to bring forward cases after issuing hundreds of penalty offense notices in April regarding health claims substantiation, and it is likely to seek injunctive and monetary relief, said Samuel Levine, director of the FTC’s Bureau of Consumer Protection, at the National Advertising Division’s annual conference in Philadelphia.