The manufacturer of a self-proclaimed “anti-hangover” beverage recently received a Warning Letter from the U.S. Food and Drug Administration (FDA), dated September 17 and posted on the FDA’s website earlier this week. The drink, called Life Support, claims to “prevent and relieve headaches, nausea, and grogginess caused by hangovers.” According to its website, the company suggests consuming one of its beverages after your last drink of the evening or first thing the next morning.

The FDA has taken the position that Life Support is not a dietary supplement, but rather is a drug that must be regulated by the FDA, because the company’s advertising includes “therapeutic claims” that the product is “intended for use in the cure, mitigation, treatment, or prevention of disease.” The letter focused on several specific advertising claims by the company, which it identified as evidence that the Life Support product was not a dietary supplement but rather intended for use as a drug:

  • “Hangover Relief”
  • “Tired of Hangovers? Life Support’s cutting-edge formula contains an extract from the fruit of the Japanese Raisin Tree, known specifically to aid in the recovery from alcohol intoxication.”
  • (website) “Life Support can protect the liver and brain from damage . . .”

Because the product is not recognized as safe and effective for these uses, it is considered a “new drug” under 21 U.S.C. § 321(p) and requires FDA approval based on scientific data.

According to its website, Life Support Development Ltd., an Ohio-based company, was founded in 2012 with the mission of finding an effective hangover cure. Its product can be ordered online, or it claims that several major retailers carry it in stores.

This is not the first time the FDA has issued similar warnings to companies purporting to offer hangover cures. In June 2014, the FDA reprimanded the Florida company Bhelliom Enterprises for claims it made related to its “Alcohol-X Hangover Remedy.” One of the claims identified by the FDA as evidence that its product is intended to be used as a drug was: “Acetyls-X is scientifically formulated to not only prevent hangovers, but also to quickly relieve hangovers after they have set in.” Through this repeat action, it is clear that the agency is focusing on the therapeutic claims that companies make in their advertisements, and that the agency has an interest in products seeking to provide “hangover cures.” Companies, especially those making claims regarding hangover cures, should ensure compliance with FDA regulations in order to avoid agency enforcement action.