FDA Warns Companies for Unlawfully Marketing Hangover Cures and Treatments
Earlier this week, the U.S. Food & Drug Administration (“FDA”) announced that it issued warning letters to seven companies for illegally selling products marketed as dietary supplements claiming to cure, treat, mitigate, or prevent hangovers.
A product that claims its intended use is to cure, mitigate, treat, or prevent a disease is regarded as a drug under the Food, Drug & Cosmetic Act (“FD&C Act”). Drugs, unlike dietary supplements and foods, are subject to pre-approval clinical trials and proof that they are safe and effective for each of their intended uses. Thus, products that FDA interprets as unapproved drugs are considered unsafe for human consumption and may not be lawfully marketed and sold.
FDA routinely looks to see whether product claims comply with the FD&C Act. One of the most common violations that food and dietary supplement statements result in is the marketing of an unapproved drug.
According to FDA, a statement claims to cure, mitigate, treat, or prevent a disease if it claims, explicitly or implicitly, that the product has an effect on the characteristic signs or symptoms of a specific disease or class of diseases. For FDA, a hangover is a sign or symptom of alcohol intoxication, which the agency considers a disease.
FDA inspected the websites of these seven companies and viewed various statements about the products. Notably, FDA also inspected Amazon sale pages and cited those as carrying unlawful drug claims.
Some of the statements resulting in these warning letters include:
- “HELPS AVOID HANGOVERS”
- “KILL YOUR HANGOVER BEFORE IT EVEN STARTS”
- “PUT YOUR HANGOVER TO BED”
- “ULTIMATE HANGOVER RELIEF”
- “YOU’LL WAKE UP FEELING . . . HANGOVER-FREE!”
- “SPECIFICALLY DESIGNED TO REDUCE ALCOHOL’S NEGATIVE EFFECTS ON THE BODY”
- “PROTECT YOUR LIVER AND BRAIN – RESEARCH SHOWS DYCETIN REDUCES ALCOHOL INDUCED DAMAGE TO THE LIVER AND BRAIN”
FDA also cited product reviews and published research as support for its conclusions that the products were unapproved drugs.
While some of the companies cited for these violations published many statements, others published only a few. Even one unlawful product statement claiming to mitigate, cure, prevent, or treat a disease can result in the recall of that product and enforcement action against the product’s marketer or manufacturer.
by Brian Fink
Tags: administrative action, alcohol, dietary supplements, enforcement, fda, hangover, warning letters