In warning letters to several companies, FDA announced targeting products labeled as dietary supplements that claim to cure, treat, mitigate or prevent hangovers. These products are unapproved new drugs in violation of the Federal Food, Drug and Cosmetic Act (FD&C), according to FDA. “Dietary supplements that claim to cure, treat, mitigate or prevent hangovers could potentially harm consumers, especially young adults,” said director of FDA’s Office of Dietary Supplement Programs. “Consumers may get the false impression that using these products can prevent or mitigate health problems caused by excessive drinking. Dietary supplements are not a substitute for responsibly limiting one’s alcohol consumption.”
FDA issued the warning letters to Double Wood LLC, Ebnsol Inc., Vita Heaven LLC (doing business as Hangover Heaven), Happy Hour Vitamins, LES Labs, Mind, Body & Coal LLC and Purple Biosciences LLC.
Among a sampling of the claims targeted by FDA in the letters:
- “PREVENT HANGOVERS – No product is more proven or effective at preventing hangover symptoms including headaches, nausea, brain-fog, and anxiety.”
- “We bring you 3ContRx (ingredient blend in PartyPal), the most effective hangover treatments from 3 different parts of the globe all combined into easy to use tablets that really work!”
- “These supplements contain ingredients that help your body deal with the breakdown products of alcohol, which cause hangover.”
- “I am a bartender and always advise my customers to take a couple before beginning their shenanigan’s for the evening. They always come back and thanks me for introducing them to Happy Hour Vitamins. I tell them that is easy to sell, no one wants a hangover!”
Several of the products are marketed on Amazon, the warning letters show. Director of the Office of Compliance in the Center for Food Safety and Applied Nutrition (CFSAN) cautioned some of the companies that their products are excluded from the definition of a dietary supplement because they contained N-acetyl-L-cysteine (NAC). Sign up with HawkScanner and put those compliance worries behind. On HawkScanner you can upload your inventory and ingredients, get the bad ones out and store active ingredients. With our live monitoring, it allows you to act fast if any bad ingredients come up.