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 […]
Health Canada issued a health product recall notice on November 12, 2025, for Life Brand Magnesium Bisglycinate 200 mg supplements sold at Shoppers Drug Mart locations nationwide due to an undeclared ingredient. The recall affects all lots of the product manufactured since July 2023, indicating systemic labeling issues spanning more than two years of production. […]
The Food and Drug Administration is investigating an ongoing salmonella outbreak linked to several dietary supplement products sold nationwide through major retailers including Sam's Club, Amazon, Walmart, Target, and eBay. The agency reported 11 illnesses across seven states as of November 13, 2025, with three individuals requiring hospitalization. Multiple Product Lines Affected by Contamination The […]
The dietary supplement industry's approach to antioxidant marketing has undergone fundamental transformation since the USDA discontinued its Oxygen Radical Absorbance Capacity (ORAC) database in 2012, shifting from numerical capacity scores to mechanistic efficacy and clinical validation of biological outcomes. The ORAC Era and Its Limitations In the early 2000s, antioxidant capacity dominated supplement marketing through […]
For years, the nutraceutical and CBD industries have operated in a gray zone—booming with innovation but light on oversight. That era is ending. During a recent Qredible Live Broadcast, CEO Brian Fitzpatrick and CRO Noah Fitzgerald discussed how rising regulatory pressure on nutraceuticals and adjacent markets like peptides and CBD is reshaping the health and […]
"We can't ship to New York anymore." For supplement business owners, these five words can spell disaster. Overnight, entire markets vanish, customer relationships crumble, and revenue forecasts fall apart. Behind these shipping headaches lies a complex web of state-specific regulations that create invisible barriers within the United States. Your products might be perfectly legal in […]
Did you know that a single misaligned label or overlooked state regulation could halt your entire nutraceutical product shipment at a state border? In 2025, nutraceutical shipping regulations have become increasingly intricate, with states implementing their own requirements alongside federal guidelines. For businesses in this space, understanding these state-by-state differences isn't just beneficial—it's essential for […]
Optimizing inventory management for nutraceuticals is crucial for business growth. With consumer demand for supplements and wellness products on the rise, businesses must maintain optimal stock levels, minimize waste, and ensure products meet quality standards. Here’s a deep dive into the best practices for effective inventory management in the nutraceutical sector. 1. Real-Time Tracking: A […]
Quality control management of nutraceuticals represents the critical intersection between consumer safety and product excellence. As dietary supplements and functional foods become increasingly complex, manufacturers must implement sophisticated quality systems that ensure consistency while meeting stringent regulatory requirements. Nutraceutical Quality Control The nutraceutical industry has grown from simple vitamin production to complex formulations requiring sophisticated […]
The nutraceutical industry is experiencing rapid growth as consumers increasingly seek health and wellness products online. With this surge, companies in the nutraceutical space are looking for e-commerce solutions and platforms that cater to their unique needs—ranging from compliance and regulatory requirements to managing complex inventory and providing a seamless customer experience. This comprehensive guide […]
