The Food and Drug Administration (FDA) has issued warning letters to 7 companies for selling unapproved products that claim to cure, treat or prevent hangovers.
The Agency stated that the Companies were in violation of the Federal Food, Drug, and Cosmetic Act, as products that are intended to cure, treat, mitigate or prevent diseases are considered drugs, and as such, are subject to the requirements applied to drugs. None of the products mentioned in the warning letters have been evaluated by the FDA for their intended uses.
“Consumers may get the false impression that using these products can prevent or mitigate health problems caused by excessive drinking,” said Steven Tave, director of the FDA’s Office of Dietary Supplement Programs. “Dietary supplements are not a substitute for responsibly limiting one’s alcohol consumption.”
The Companies issued warning letters, as well as the specific product names, include:
- Double Wood LLC; Dycetin
- Ebnsol Inc.; PartyPalTM
- Vita Heaven LLC (doing business as Hangover Heaven); Hangover Heaven Nightlife Prep Supplement
- Happy Hour Vitamins; Happy Hour Vitamins
- LES Labs; DeToxx for Hangovers
- Mind, Body & Coal LLC; Miracoal – Ultimate Hangover Relief and Total Body Detox
- Purple Biosciences LLC; Purple Tree
As well as being sold on proprietary websites, some of these products were also available for order on Amazon. The FDA has requested responses from these Companies within 15 working days, and failure to correct the violations outlined in the letters may result in legal action, including product seizure and/or injunction.
The Agency is reminding consumers to be cautious of products sold online with unproven claims and advises talking to a healthcare professional before making any such purchases. Dietary supplements that claim to cure hangovers have a potential to harm, particularly young adults, who may be led to believe that using these products, rather than drinking in moderation or not at all, can prevent or mitigate health problems caused by drinking too much alcohol.
For more information visit fda.gov.
FDA warns companies illegally selling hangover remedies. https://www.fda.gov/news-events/press-announcements/fda-warns-companies-illegally-selling-hangover-remedies. Accessed on 8/3/20.