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FDA Sends Warning Letters to Seven Companies Illegally Selling Hangover Products

FDA Sends Warning Letters to Seven Companies Illegally Selling Hangover Products

On July 29, 2020, the U.S. Food and Drug Administration (FDA) issued warning letters to seven companies whose products claim to cure, treat, mitigate, or prevent hangovers. A hangover can occur after alcohol intoxication. Alcohol intoxication, like all poisonings, causes dose-related dysfunction and damage, ranging from mild impairments to death. Alcohol intoxication causes temporary damage to brain function, causing impairments of judgment, attention, reflexes, and coordination. The products outlined in these letters, which are labeled as dietary supplements, are unapproved new drugs and have not been evaluated by the FDA to be safe and effective for their intended use.

Dietary supplements that claim to cure, treat, mitigate, or prevent hangovers could potentially harm consumers, particularly young adults, who may be led to believe that using these products, rather than drinking in moderation or not at all, can prevent or mitigate health problems caused by consuming too much alcohol. Consumers should not rely on these products as an alternative to responsibly limiting their consumption of alcoholic beverages.

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

Under the Federal Food, Drug, and Cosmetic Act, products intended to cure, treat, mitigate, or prevent disease are drugs and are subject to the requirements that apply to drugs, even if they are labeled as dietary supplements. 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.

The FDA has requested responses from the companies within 15 working days stating how the companies will correct the violations. Failure to correct the violations promptly may result in legal action, including product seizure and injunction.

July 29, 2020

https://www.fda.gov/

July 30, 2020 / Pharma News
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