FDA sends warnings to companies illegally selling hangover supplements
Seven companies selling dietary supplements which illegally claim to treat hangovers have been issued warning letters and have 15 days to respond.
A hangover can occur after alcohol intoxication, which, like all poisonings, can cause dose-related dysfunction and damage, ranging from mild impairments to death.
Under the FD&C Act, products intended to cure, treat, mitigate or prevent disease are considered drugs and are subject to the requirements that apply to drugs. Unlike drugs approved by the FDA, there has been no FDA evaluation of whether these unapproved products are effective for their intended use, what the proper dosage might be, how they could interact with FDA-approved drugs, or whether they have dangerous side effects or other safety concerns.
“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. “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.”
Warning letters were sent to the following companies:
- Double Wood LLC
- Ebnsol Inc.
- Vita Heaven, LLC dba Hangover Heaven
- Happy Hour Vitamins
- LES Labs
- Mind, Body & Coal LLC
- Purple Biosciences LLC.
The FDA has requested responses from the companies within 15 working days stating how they will correct the violations. Failure to correct the violations promptly may result in legal action, including product seizure and/or injunction.