Industry observers have pointed out that this does not signal a new direction for FDA. Warning letters on hangover cures have extended back at least to 2010. In this latest round of enforcement, last week FDA sent warning letters were sent to seven companies marketing botanical-based hangover remedies.
Issue of false sense of confidence
“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.”
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 companies receiving the warning letters were claims such as:
“[A] natural multivitamin specifically designed to reduce alcohol's negative effects in the body . . . Hangovers hinder our work, fitness and family routines, so we embarked on a mission to help health-conscious adults who drink.”
“With Hangover Heaven Nightlife Prep Supplements, you can significantly reduce your changes [sic] of having a hangover.”
One lawyer familiar with the situation said that with the careful attention paid to the content of the message, companies can probably still talk about nutritional support for customers experiencing hangovers without undue fear of a knock on the door from FDA. He cautions companies in particular to avoid using the word ‘hangover.’ But there are a number of companies competing in the niche, he said, and with only periodic enforcement of the stricture, the word starts creeping back into marketing in the meantime, and companies start to feel compelled to talk about hangovers openly lest they be left behind.
Prior drug investigation issue
In addition to the hangover disease-treatment issue, FDA raised another point that might be of much more concern to the industry. Four of the companies, Vita Heaven, Happy Hour Vitamins, LES Labs and Purple Bioscience, were cited for having N-acetyl-L-cysteine (NAC) in their formulas.
The warning letters noted that in the Agency’s view this is not a proper dietary ingredient for use in supplements because it was previously investigated as and approved as a drug. It was approved in 1963 for use as a mucolytic drug for chronic respiratory diseases.
Despite its early use as a respiratory medication, the ingredient has been widely used in finished dietary supplements, frequently as a standalone product. A recent search on Amazon produced more than 400 products for sale mentioning the ingredient, which is usually positioned as a ‘cellular antioxidant,’ or for liver support. Some major brand names in the industry were represented in that search. On the supply end, a search on Alibaba brings up more than 1,000 hits of bulk N-acetyl-L-cysteine (NAC) for sale, with the usual huge range of prices per kilogram that is typical for that portal.
Loren Israelsen, president of the United Natural Products Alliance, said FDA’s apparent renewed emphasis on the provenance of ingredients that have become common in the trade is potentially worrisome.
“I think people should be concerned. For whatever reason FDA has suddenly decided to get serious about some of these ingredients that have these drug exemptions, like NAC and, of course, CBD,” Israelsen told NutraIngredients-USA.
“This signals a renewed effort by FDA to clear the market of dietary ingredients that were formerly investigated as or approved as drugs. NAC is an important ingredient. The big question is, how many more of these are out there?” Israelsen added.