Gate 11 Distillery navigates regulatory maze to deliver hand sanitizer to local first responders
Like many of its craft distillery colleagues, Gate 11 Distillery has been working urgently since early March to produce hand sanitizer liquid to assist in the response to COVID-19. These efforts have included setting up supply chains for raw ingredients and diligently working to assure that their products would be deemed compliant by a host of federal regulatory agencies.
“Finding the raw materials turned out to be the easier challenge, at least initially” said Gate 11 Distiller Bill Lee. “What we didn’t fully appreciate was the difficulty in satisfying the requirements of the Federal Drug Administration to become a sanctioned manufacturer of hand sanitizer products”, he said.
The craft distillery industry has been working in very close coordination with both the FDA and the Federal Tax and Trade Bureau (TTB), the primary federal regulator of the US ethanol industries. As a result of these discussions, TTB and FDA have issued emergency guidance to facilitate rapid expansion of hand sanitizer products.
Gate 11 completed those registrations last week and immediately began production of hand sanitizer. The local distillery is focusing its production on bulk volumes from 5-gallon pails to 250-gallon totes. The distillery delivered its first 250-gallon tote to Hamilton County First Responder on Monday, March 30th. Additional hand sanitizer has been made for the City of Chattanooga for use by many different city departments. Included in the hand sanitizer for the city is product specifically provided to be distributed to the city’s homeless population.
Lee initially sourced raw materials for about three weeks of hand sanitizer production but now, he says, he is finding it difficult to source additional bulk alcohol. “Everyone is scrapping to find industrial-grade alcohol and the producers are maxed out. We intend to continue to support local public health needs with whatever supplies we can muster while we try to source more alcohol”, Lee said.
Gate 11 has also provided quantities of hand sanitizer to area companies including EPB, Blue Cross Blue Shield, UPS, Mapco Express and Chattanooga Labeling Systems. The distillery is still received many requests for additional product as it continues its search for more raw materials.