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James Bay Distillers

FDA's surprise $14,000 fees will not apply to us!

on Dec 31 2020
Serial entrepreneur, experienced expat having worked in a dozen countries or more, now living an hour or so from the US/Canadian border.

As you may have seen, on 29 December the FDA published a surprise announcement in a Federal Register Notice (FRN) titled “Fee Rates under the Over-The-Counter Monograph Drug User Fee Program for Fiscal Year 2021.”  We are not affected by that notice.

These fees are being levied under a newly established “OTC monograph drug user fee program,” which has established fees on OTC monograph drug facilities, as well as OTC Monograph Order Requests (OMORs) for FY 2021. The FDA has stated that these fees also apply to facilities, including distilleries, that produced hand sanitizer under the temporary policy during Covid-19. 

The fees impacting distillers are a $14,060 Monograph Drug Facility Fee and $9,373 Contract Manufacturing Organization Facility Fee. The fees for FY 2021 are due on February 11, 2021. 

These fees will NOT apply to us or affect our profitability.  After conferring with legal counsel in early 2020, and noting 1) the FDA's statement that they did not promise not to sue any distillery producing hand sanitizer and 2) the unavailability of key ingredients, we decided not to pursue hand sanitizer at the time.  We devoted our efforts to steering customers and callers to other distilleries we knew had hand sanitizer.  In fact, the FDA now has over 100 law suits against producers.