The FDA published final guidance Monday to assist sponsors in identifying appropriate supplement categories for biosimilar prior approval supplements, establishing clear review timelines and creating consistent evaluation standards. The guidance specifies six types of prior approval supplement categories under the Biosimilar User Fee Amendments of 2022, fulfilling a commitment outlined in the BsUFA III commitment […]
The supplement industry is experiencing a paradox. Consumer demand for vitamins, minerals, and dietary supplements continues surging, with the global market projected to reach unprecedented levels. Yet simultaneously, the sector faces more scrutiny than ever before, with class-action lawsuits, safety concerns, and widespread customer dissatisfaction challenging brands to prove their products deliver on promises. This […]
Florida kava bars and kratom tea houses are adjusting to a new regulatory reality following the state's emergency ban on 7-hydroxymitragynine (7-OH), implemented on August 13, 2025. The emergency rule 2ER25-2 reclassified the compound as a Schedule I controlled substance, marking a significant shift for establishments that previously offered kratom-based beverages containing the ingredient. FDA […]
The U.S. Food and Drug Administration (FDA) has announced a nationwide recall of one lot of the dietary supplement MyBladder, manufactured by Purity Products, due to possible contamination with Escherichia coli (E. coli) O7:K1 and 1303. The bacteria can cause serious gastrointestinal and urinary infections, posing particular risks to infants, older adults, and individuals with […]
The U.S. Food and Drug Administration (FDA) has issued a Class 1 recall, the most serious classification available, for a dietary supplement marketed to promote “healthy aging.” The recall involves Dorado Nutrition’s Spermidine Maximum Strength 10mg supplement, which tested positive for undeclared wheat, posing a potentially life-threatening risk to consumers with allergies or sensitivities. Recall […]
The U.S. Food and Drug Administration (FDA) has finalized its investigation into mislabeled dietary supplements sold as tejocote root, revealing alarming results: many products actually contain toxic yellow oleander, a deadly plant known to cause serious neurological and cardiovascular effects. This update underscores an ongoing crisis of transparency and compliance in the supplement industry—one that […]
The Missouri Department of Health and Senior Services issued an urgent public health alert this week. The agency warns residents to avoid 7-hydroxymitragynine, commonly called 7-OH. The chemical compound poses significant health risks despite widespread availability in convenience stores and online retailers. Unregulated Compound Mimics Opioid Potency 7-OH naturally occurs in trace amounts within kratom […]
The Food and Drug Administration reversed its position on nicotinamide mononucleotide (NMN) supplement sales, acknowledging the ingredient was on the market prior to being studied as an investigational new drug. The decision, reported by Nutrition Business Journal, opens the door for continued NMN supplement sales while generating divergent reactions from supplement industry trade associations. The […]
A legal challenge filed by dietary supplement manufacturer Xlear against the Federal Trade Commission could fundamentally reshape how companies market health products in the United States. The lawsuit, reported by KFF Health News, seeks to eliminate the FTC's longstanding requirement that companies provide substantial evidence backing health claims about their products—a standard maintained since 1984. […]
The FDA's September 10, 2025 draft guidance on non-opioid analgesic development marks a pivotal moment for pharmaceutical manufacturers, supplement companies, and the broader landscape of pain management therapeutics. This regulatory initiative doesn't merely offer recommendations—it establishes new pathways that will reshape how companies approach product development, clinical trials, and quality management systems in the chronic […]
