In warning letters to seven companies, FDA on Wednesday 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 Steven Tave, director of FDA’s Office of Dietary Supplement Programs, in a news release. “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. None of the companies immediately returned requests to comment on the warning letters.
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 hangovers.”
- “I am a bartender and always advise my customers to take a couple before beginning their shenanigans for the evening. They always come back and thank me for introducing them to Happy Hour Vitamins. I tell them that is easy to sell, no one wants a hangover!”
“A hangover is a sign or symptom of alcohol intoxication, a disease,” William Correll Jr., director of the Office of Compliance in the Center for Food Safety and Applied Nutrition (CFSAN), wrote in the letters. “Like all poisonings, alcohol intoxication causes dose-related dysfunctioning and damage, ranging from mild impairments to death. Alcohol intoxication causes temporary damage to brain function, causing impairments of judgment, attention, reflexes and coordination.”
Several of the products are marketed on Amazon, the warning letters show. Cecilia Fan, a spokeswoman, did not immediately respond to a request for comment.
Correll 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), which was approved as a new drug in 1963. To FDA’s knowledge, he said, NAC was not marketed as a supplement or food before that date.
FDA requested the companies respond within 15 days, specifying their actions to correct the alleged violations and prevent similar infractions. “Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction,” Correll warned.