Distillers’ Pandemic Contribution and FDA’s Subsequent Scrutiny
I helped solve the hand sanitizer – During the height of the 2020 pandemic, hand sanitizer became as scarce as clean water in a drought. When the crisis struck, the Food and Drug Administration (FDA), then led by Secretary Alex Azar, played a pivotal role in addressing the shortage by relaxing stringent regulations on alcohol production. This allowed distilleries to repurpose their whiskey-making facilities into temporary hand sanitizer manufacturing hubs, a grassroots effort that saved countless lives. Yet, as the emergency subsided, the FDA unexpectedly shifted its focus, launching surprise inspections of the very distillers who had aided the nation in its time of need.
My experience with the FDA began on December 8, 2020, when I was subjected to an audit. The consumer safety inspector who visited my facility focused not on the volume of sanitizer produced but on its monetary value. This seemed peculiar, especially since the product had been essential during a global health crisis. During the inspection, the inspector collected samples of my sanitizer, insisting I provide them at no cost. When I asked if there would be a follow-up, he responded with the phrase, “no news was good news,” leaving me uncertain about the next steps.
Just 20 days later, on December 28, 2020, the FDA issued a directive requiring all distillers to pay a $14,060 flat fee for their operations in 2020. The notice also threatened an additional $14,060 charge for 2021 if we hadn’t officially declared our shutdown by year’s end. This came with a three-day deadline, leaving little time to challenge the decision through official channels. Faced with this abrupt reversal, I turned to the public to share our story, hoping to spark awareness and pressure the administration to reconsider.
Within days, the public outcry was significant. The Department of Health and Human Services (HHS) swiftly intervened, halting the rogue FDA administrator’s decision and reimbursing the fees just three days later. HHS chief of staff Brian Harrison issued an apology, acknowledging the distillers’ critical role in the pandemic response. This was a welcome relief, but it didn’t end the scrutiny. As 2021 approached, Xavier Becerra was appointed as FDA administrator, and the agency once again turned its attention toward distillers.
Becerra’s FDA reopened an old dispute, sending threatening letters to distillers like myself who had been previously audited in 2020. The new focus was on an impurity called acetaldehyde, a compound naturally found in fermented products such as alcohol, coffee, and chocolate. While acetaldehyde is a common byproduct, the FDA used it as a justification to demand further audits, suggesting the potential for costly recalls and fines if distillers failed to comply. Despite having stopped production nearly two years prior, the agency targeted us, implying that our earlier efforts were now under question.
My industry group, the American Craft Spirits Association, collaborated to draft a formal letter to Becerra, seeking his support in resolving the issue. However, we received no immediate response. Frustrated by the lack of communication, I reached out to my local congressman, a fellow Democrat from Becerra’s home state of California. While the FDA maintained its stance, citing its policy of not commenting on ongoing investigations, the local representative remained unresponsive as well.
With no resolution forthcoming, I decided to go public once more. This time, the story gained widespread attention, resonating across political lines and even reaching the shores of Haiti, where I had donated my remaining sanitizer to a non-profit medical provider following the 2021 earthquake. The public’s reaction was swift and powerful, highlighting the distillers’ sacrifices during the pandemic and questioning how a government agency could penalize them twice for the same action.
The FDA eventually backed down, dropping its cases against distillers. However, the agency made it clear that it retained the authority to initiate new investigations in the future. While this was a victory, the incident raised important questions about regulatory consistency and the prioritization of enforcement during times of crisis. The distillers who had stepped up to produce hand sanitizer faced not only financial strain but also the erosion of trust in the very agency that had once relied on their efforts.
Reflecting on the events, it’s clear that the FDA’s actions were driven by a shift in policy rather than a direct threat to public health. The initial emergency measures had been a lifeline, but as the situation normalized, the agency tightened its grip. This back-and-forth underscored the challenges of maintaining regulatory flexibility during a crisis while ensuring compliance. For distillers, the experience was a reminder that even well-intentioned efforts can lead to unexpected consequences, especially when oversight changes hands.
The saga of the hand sanitizer shortage and its aftermath illustrates the delicate balance between innovation and regulation. Distillers, once celebrated for their pandemic contributions, found themselves at the center of a political and bureaucratic storm. Their story became a symbol of the broader tensions between government oversight and the agility of small businesses. While the FDA’s reversal was a positive step, the episode left lingering questions about the agency’s decision-making process and its commitment to supporting industries in times of need.
Ultimately, the distillers’ efforts highlighted the importance of adaptability in regulatory frameworks. The initial loosening of rules had been a necessary measure to combat the crisis, but the subsequent audits and fees revealed a lack of foresight. The public’s support, driven by a shared understanding of the situation, played a crucial role in pushing for accountability. As the FDA’s actions evolved, so too did the narrative surrounding its role in the pandemic response, serving as a case study in the complexities of regulatory intervention.
