Widely Available Unapproved Hangover Remedies Concern US FDA As Encouraging Overindulgence

Agency Warns Seven Firms In Market Offering Myriad Options

 
• By Malcolm Spicer

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.

Miracoal
MiraCoal marketed by Mind, Body & Coal is among the unapproved hangover remedies the FDA identified recently in warnings.

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.

The agency’s Center for Food Safety Applied Nutrition, apparently beginning an attempt to clear the US marketplace of non-drug products subject to FDA oversight that are promoted or labeled for treating hangovers, has warned seven firms “for illegally selling unapproved products labeled as dietary

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