I helped solve the hand sanitizer shortage. Then Xavier Becerra’s FDA came after me.
Distillers who made emergency hand sanitizer during the pandemic were unfairly penalized by the FDA, leading to public outcry and a reversal of the fee, but the FDA under HHS Secretary Xavier Becerra…
Distillers who made emergency hand sanitizer during the pandemic were unfairly penalized by the FDA, leading to public outcry and a reversal of the fe
Read Full Story at The Hill →Why This Matters
The FDA’s abrupt shift from supporting pandemic-era hand sanitizer production to enforcing punitive measures against distillers exposed a critical flaw in regulatory oversight: the agency’s inability to balance long-term compliance with real-time crisis response. This episode underscores how bureaucratic rigidity can undermine public health initiatives, even when they appear to succeed.
Background Context
During COVID-19, the FDA temporarily waived certain manufacturing rules to allow distilleries—unaccustomed to pharmaceutical production—to pivot to hand sanitizer, a move that saved lives and supply chains. Yet months later, the agency reversed course, imposing retroactive fees on these same producers, triggering backlash from industry groups and lawmakers who accused regulators of shifting the goalposts without justification.
What Happens Next
With the fee reversed, distillers may now seek compensation for costs incurred during the FDA’s enforcement blitz, while industry lobbyists push for clearer, permanent guidelines to prevent future overreach. The episode could also prompt congressional scrutiny of the FDA’s post-pandemic regulatory tactics, particularly its treatment of non-traditional manufacturers.
Bigger Picture
This incident reflects a broader tension between agile crisis governance and bureaucratic accountability, a dynamic likely to intensify as agencies navigate the aftermath of emergency protocols. It also highlights how regulatory whiplash—shifting from leniency to enforcement—can erode trust in institutions at a time when public cooperation is essential for public health.
