The US Food and Drug Administration is considering removing hangover as an indication from its OTC drug monograph, but the potential change isn’t meant as an opportunity for products marketed as dietary supplements to be recognized as overindulgence remedies.
Widely Available Unapproved Hangover Remedies Concern US FDA As Encouraging Overindulgence
Agency Warns Seven Firms In Market Offering Myriad Options
As CFSAN warned seven marketers, supplement products from numerous other businesses advertised as hangover remedies, or as formulations to prevent symptoms associated with overindulgence, remained available to US consumers. Like one business FDA warned, numerous companies are offering OTC intravenous treatments for hangovers, available at locations accepting walk-in or by-appointment customers.
More from Compliance
• By
FDA says “extension affords covered entities the additional time necessary to ensure complete coordination across the supply chain in order to fully implement the final rule’s requirements—ultimately providing FDA and consumers with greater transparency and food safety.”
• By
UK industry association is offering online courses on subjects ranging from UK medicines regulations basics to deep dives on complex topics such as CBD.
• By
Trade group ready to work hand-in-hand with agency and other supplement industry stakeholders on potential regulatory changes or improvements, says president and CEO Steve Mister. “None of them are upsetting the basic balance of things that DSHEA was attempting to do, but there are things with 30 years that we've identified that need to be kind of fixed.”
• By
New Jersey Assembly passed bill amended to expand extensively in defining which products, or ingredients, would be subject to a ban on sales to consumers younger than 18.
More from Policy & Regulation
• By
HBW Insight speaks to AESGP director general Jurate Švarcaite about what's on the agenda for the upcoming 61st AESGP Annual Meeting, which will take place in Warsaw, Poland, between 2-4 June. Highlights include the role of prevention in self-care, discussions about how regulators will ensure the competitiveness of European industry on the world stage and incoming changes to sustainability legislation.
• By
CRN petition argues against general preclusion while NPA petition addressed specifically FDA’s wielding of the provision to prohibit the use of NMN supplements available in US. “FDA has acknowledged that they really can't answer one without answering. The two are inextricably linked,” says CRN CEO Steve Mister.
• By
Eliminating self-affirmation process would require companies to publicly notify FDA of their intended use of ingredients and provide safety data before they’re introduced. Kennedy says the process is “a loophole” for introducing ingredients and chemicals “with unknown safety data.”