FDA WARNING_LETTER - Samuel P. Hostetler (DBA) Hump-Back Dairys - July 29, 2016

On December 19, 2016, the FDA issued a Warning Letter to Samuel P. Hostetler (DBA) Hump-Back Dairys following an inspection from July 27-29, 2016. The inspection revealed the firm distributed unpasteurized raw camel milk and camel milk products in interstate commerce for human consumption, violating the Public Health Service Act (42 U.S.C. § 264(a)) and 21 CFR Part 1240.61(a).

The regulation prohibits the interstate delivery of unpasteurized milk and milk products in final package form for direct human consumption. The inspection found at least four instances between July 11 and July 27, 2016, where unpasteurized camel milk products, labeled as "Whole Raw Camel Milk" or "Cultured Whole Raw Camel Milk," were shipped to customers. The firm confirmed these products were not heat-treated or pasteurized.

The FDA clarified that "milk product," as defined in 21 CFR 1240.3(j), includes lacteal secretions from all healthy milk-producing animals, including camels, despite a non-exhaustive list of examples. Therefore, the pasteurization requirement applies to camel milk products. The letter emphasized the firm's responsibility to comply with all federal laws and FDA regulations, requiring prompt corrective action within fifteen working days to prevent recurrence