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FDA Warning Wire: Hangover Drinks, Compound Drugs, Fish (Excerpt)

FDA Warning Wire: Hangover Drinks, Compound Drugs, Fish (Excerpt)


Source: Law360

By Sindhu Sundar

November 17, 2015


The U.S. Food and Drug Administration took aim this week at the manufacturer of a beverage meant to cure hangover symptoms, claiming the drink’s purportedly miraculous properties qualify it as a drug rather than a supplement. Also in the FDA’s sights are a drug compounder the agency accused of failing to ensure sterile conditions and a Wisconsin-based cheese company whose ready-to-eat seafood products are allegedly adulterated.


FDA Casts Gimlet Eye on Hangover Antidote


The agency targeted Columbus, Ohio-based Life Support Development Ltd. over its eponymous beverage “Life Support,” which claims to thwart hangovers before they begin. The company touts the instantaneous effect of the product, advising consumers to drink just one glass after their night of drinking.


In a letter dated Sept. 17 and posted online Tuesday, the agency said the product qualifies as a drug that needs FDA approval, rather than just a dietary supplement.


“The therapeutic claims in your product labeling establish that the products are drugs because they are intended for use in the cure, mitigation, treatment or prevention of disease,” the agency said in its letter.


The letter took particular issue with some advertising claims by the company, including that the product’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.”


The company, which was founded in 2012 with the stated mission of finding an effective hangover cure, also advertises the product as being able to protect consumers from liver and brain damage, according to the letter.


The FDA has issued similar warning letters in the past to purveyors of products seeking to cure hangovers, including Florida-based supplement company Bhelliom Enterprises, which was hit with a similar warning letter in June 2014 for the Alcohol-X Hangover Remedy it sold on its website.