Seven companies receive warning letters for unapproved dietary supplements

The FDA issued warnings to seven companies for peddling unapproved products intended to treat the symptoms of — or outright prevent — hangovers.

These products, which the companies have labelled “dietary supplements” and which claim to stave off hangover symptoms such as headaches, nausea, brain fog, and anxiety, are unapproved new drugs under the Federal Food, Drug, and Cosmetic Act, the FDA explained in a press release. Most importantly, skirting the approval process has prevented the agency from evaluating the product’s effectiveness, dosages, potential drug interactions, or potentially dangerous side effects.

“Dietary supplements that claim to cure, treat, mitigate, or prevent hangovers could potentially harm consumers, especially young adults,” said Steven Tave, director of the FDA’s Office of Dietary Supplement Programs, in a statement. “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.”

The FDA went on to discourage consumers from trusting medical products that are marketed and sold online along with unproven claims about their ability to treat, prevent, or cure diseases. “The FDA advises consumers to talk to their doctor, pharmacist or other health care professional before deciding to purchase or use any dietary supplement or drug,” the agency wrote. “For example, some supplements might interact with medicines or other supplements. Also, if claims sound too good to be true, they probably are.”

Meanwhile, the seven accused companies — 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 — have 15 days to reply to the FDA to outline plans to correct these violations. Failure to do so, the agency warned, “may result in legal action, including product seizure and/or injunction.”

John McKenna, Associate Editor, BreakingMED™

Cat ID: 151

Topic ID: 88,151,730,192,151,725