FDA probes North County distillery over hand sanitizer production

Aaron Bergh

By JOSH FRIEDMAN

A North County distillery that joined in the emergency hand sanitizer production effort in 2020 has come under investigation by the Food and Drug Administration (FDA) over chemical levels in their product.

Calwise Spirits, located on Ramada Drive south of Paso Robles, produced hand sanitizer early in the COVID-19 pandemic. The distillery’s sanitizer had levels of acetaldehyde that were too high, according to the FDA. 

Acetaldehyde is a chemical compound that occurs naturally in certain food and drinks, such as fruit and juice. However, it is also listed as a carcinogen by the International Agency for Research on Cancer. 

Calwise Spirits owner Aaron Bergh says his hand sanitizer contained 160 parts per million (ppm) of acetaldehyde. The FDA’s limit is 50 ppm, but Bergh disputes that the acetaldehyde level in his hand sanitizer was unsafe.

“This threshold does not make any sense, as the acetaldehyde content of wine and other beverages (which people actually ingest) can well exceed over 200 ppm,” Bergh stated in a tweet on Monday. 

Bergh also claims that Calwise Spirits and other distilleries being probed by the FDA actually followed the agency’s instructions on producing hand sanitizer.

“Every distiller I’ve talked to who was audited by the FDA has also been accused of having acetaldehyde in their sanitizer,” Bergh tweeted. “Since we all used different raw materials, it’s incredibly likely that the problem is the formula the FDA told us to use. In short, acetaldehyde forms through oxidation of alcohol. The formula that the FDA told us to use, aka WHO Handrub formula #1, required us to add hydrogen peroxide to our alcohol — which is a strong oxidant.”

Previously, the FDA and distilleries, including Calwise Spirits, were at odds over a fee the federal agency imposed on the businesses for producing hand sanitizer. The FDA imposed the fee of more than $14,000 in late 2020. Days later, the decision to impose the fee was reversed.

Now, the FDA is again punishing distilleries for making emergency hand sanitizer, Bergh says.

“Large corporations were unable to pivot fast enough to meet the immense demand for hand sanitizer. The nimble, innovative nature of independent distillers allowed us to rise to the occasion. Now the FDA is punishing us,” Bergh tweeted. “The FDA is disincentivizing small businesses from acting as good Samaritans when the next disaster strikes.”

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