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CEO DATELINE Natural Products Association sues FDA over hangover treatment

December 7, 2021 |

The Natural Products Association is suing the Food and Drug Administration over the agency’s decision that an antioxidant can’t be sold as a hangover cure without first determining its potential effects on human health.

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At issue are supplements containing N-acetyl-L-cysteine, or NAC, which is sometimes used by medical professionals to treat Tylenol poisoning, according to the health information website WebMD. Several dietary supplements makers also sell NAC as an alleged cure for hangovers caused by drinking too much alcohol, with some saying the antioxidant can prevent hangovers altogether.

Critics of the supplement industry worry the claims made about NAC could lead to excessive alcohol consumption, particularly among youth. Those criticisms were echoed by the agency in warning letters sent to seven supplement makers in July.

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

Dietary supplements are usually not subject to the same regulatory scrutiny as medications, but because the supplements claimed to treat alcohol poisoning, they are required to be regulated like drugs, according to FDA. There must first be an evaluation of the supplements’ potential effect on human health, both good and bad.

FDA concerns led to online retailer Amazon pulling NAC supplements from its marketplace. NPA sued the agency on Monday, claiming it has not established NAC as a public health risk and ignored its three-decade safety record.

“This is government regulation run amok,” NPA CEO Daniel Fabricant said in a statement. “The FDA has gotten this wrong at every step of the way, and we’ve been left with no choice but to seek relief from the courts.”

The lawsuit was filed in U.S. District Court for Maryland.

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