Believe it or not, the federal Food and Drug Administration (FDA) on Dec. 29 announced that it was going to impose new fees on distilleries and other facilities that rushed to the rescue of a COVID –stricken nation by producing hand sanitizers. The FDA backed off the proposed tax only when the Department of Health & Human Services (HHS) told them to.

HHS explained that only the FDA has the authority to issue such rules. While HHS administration said that the industry should be thanked rather than taxed, it chastised FDA primarily for having failed to go through the proper regulatory processes. The incident is a reminder about the true nature of government and regulatory controls.

Brian Harrison, HHS Chief of Staff, issued a statement that they have withdrawn the Notice published in the Federal Register,  OTC Monograph Drug Facility Fees and directed FDA to cease enforcement of these fees. 

Early in the COVID-19 crisis many small businesses across the country joined the fight to combat the virus which included distilleries that augmented their operations to produce hand sanitizer, an important asset in the battle to deter the spread of COVID.

In March, the FDA issued a guidance document – the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) – which provides flexibility for those entities capable of producing hand sanitizer to rapidly enter the market.