FDA Should Call Last Round For OTC Hangover Indication, Cmte. Suggests
This article was originally published in The Pink Sheet
Comments from the Nonprescription Drug and the Drug Safety and Risk Management advisory committees during a joint meeting could push US FDA toward pulling the plug on hangover as a monograph indication.
You may also be interested in...
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.
Bounce Back Drinks sought to establish its bona fides as a registered consumer product provider, but statements referencing ASA, EFSA and MHRA imply the agencies reviewed and approved its product and advertising. Plus, hangover remedy claims are prohibited under UK regulations.
Nonprescription Drug and the Drug Safety and Risk Management advisory committees jointly vote 15-5 that combining antacid with aspirin, acetaminophen or other analgesic ingredients is not a combination that should be allowed under an OTC monograph.