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The FDA is punishing distillers' good deeds — again – Washington Examiner

More than two years after the Food and Drug Administration solicited distillers to help solve a hand sanitizer shortage at the onset of the deadliest pandemic in a century, the federal agency continues to prove the maxim that “no good deed goes unpunished.”
While large pharmaceutical 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. Many of us took a huge risk, oftentimes taking on debt to purchase the equipment and raw materials needed. Distillers exemplified the exceptional greatness of American small businesses by contributing the essential products needed to combat a public health emergency.
Our story is a huge triumph for free market economics. Unfortunately, big government is incessantly trying to turn this into a tragedy.
Although the FDA assured regulatory leniency for distillers, the agency has since caused nothing but pain for businesses like mine. I practically gave away hand sanitizer to federal agencies such as the FBI and State Department when they reached out their arm in need. But now, the other arm has reached around to slap me in the face for it.
It began in December 2020, half a year after I produced my final batch of hand sanitizer. The FDA “thanked” me by auditing my operations, even though my product never received any consumer complaints. The time-consuming inspection was the last thing I needed while I was struggling to keep my business alive in the face of mandated business closures. While I had the right to charge the agency for the sanitizer samples they took, the inspector added salt to the wound by pressuring me into giving him samples for free so he would have less paperwork to complete. I acquiesced to avoid further complications.
During this audit, I found it odd that the FDA only wanted to know the monetary value of what I had on hand instead of the quantity. If this was about preventing potentially dangerous products from entering the market, wouldn’t the FDA want to know how much was out there?
Weeks later, it all made sense. The agency announced a $14,000 surprise fee on all distillers who made hand sanitizer, regardless of the amount produced, even if it was donated. It was clear the FDA only cared about how big the money pie was so they could get their piece — altruistic small businesses be damned.
After the FDA suffered public backlash due to scathing media coverage, they claimed it was just a mistake. They rightfully rescinded the fee, with then-Health and Human Services chief of staff Brian Harrison heralding us as “heroes.”
It didn’t take long for that sentiment to change.
In June 2022, 18 months after the FDA had taken its samples from me and a year since I donated the last of my remaining inventory to assist in medical efforts after the 2021 Haitian earthquake, I received a letter from the FDA. They alleged that my sanitizer contained unacceptable levels of acetaldehyde, an organic compound naturally found in beverages like spirits, wine, and coffee. Dozens of my fellow distillers also received letters with the same allegations.
The FDA is now demanding a second time-consuming audit and threatening a costly recall of a product that distillers haven’t made for over two years and no longer sell.
The FDA’s fixation on this insignificant impurity is a classic case of government overreach that only discourages innovation. The FDA alleges my sanitizer contains 160 ppm of acetaldehyde — a trace amount. For comparison, a single glass of wine can contain 1,000 times more acetaldehyde than a dose of my hand sanitizer. Moreover, the Occupational Safety and Health Administration permits exposure to acetaldehyde in concentrations of 200 ppm for eight hours.
Perhaps strangest of all, acetaldehyde is listed on the FDA’s “ Generally Recognized As Safe” list for use in food and beverages.
A May 2020 independent study concluded that hand sanitizers with an acetaldehyde content of 1,000 ppm “exposes consumers to levels of acetaldehyde well below both common everyday natural sources, and well within acceptable occupational exposure limits.” It also noted that the danger is virtually nonexistent, as the compound evaporates almost instantly so it has very little skin contact.
I don’t think the FDA truly believes that this amount of acetaldehyde is dangerous. If it did, then why did it wait 18 months to alert me and other distillers?
The FDA plays an important role in protecting U.S. citizens, but if the agency continues to harass and punish those of us who produced sorely needed products that protected many people from a deadly virus, they will destroy many small businesses, as well as their own credibility.
And, most importantly, they will force businesses like mine to think twice before agreeing to give our own resources to help government agencies. Why should we risk retaliation from the bureaucratic regime?
The FDA is disincentivizing small businesses from acting as Good Samaritans when the next disaster strikes. This will affect everyone and is just one of the detrimental social consequences of big government gone wild.
Aaron Bergh is the owner of Calwise Spirits Co., a distillery in Paso Robles, California. In 2020, he ceased spirits production to manufacture over 5,000 gallons of emergency hand sanitizer for first responders, medical professionals, the community, and (regrettably) government agencies.

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