December 19, 2016
Ref: CMS # 505741
Mr. Samuel P. Hostetler, Owner
4858 Lawrence 1185
Miller, MO 65707
Dear Mr. Hostetler:
The Food and Drug Administration (FDA) conducted an inspection of your facility located at 4858 Lawrence 1185, Miller, MO 65707 on July 27 – 29, 2016. This inspection revealed that your firm distributed unpasteurized raw camel milk and camel milk products in interstate commerce in finished form for human consumption. Such distribution is a violation of the Public Health Service Act (PHS Act), 42 U.S.C. § 264(a), and the implementing regulation codified in Title 21, Code of Federal Regulations (CFR), Part 1240.61(a). The regulation prohibits the delivery into interstate commerce of milk and milk products in final package form for direct human consumption unless they have been pasteurized. Your products are milk products as defined in 21 CFR 1240.3. Our inspection revealed that no fewer than (b)(4) times between July 11, 2016 and July 27, 2016, you shipped in interstate commerce unpasteurized camel milk and camel milk products. Your shipments were for customers (b)(4), and the products contained (b)(4) labels that bear the statement, “Ingredients: Whole Raw Camel Milk” and “Ingredients: Cultured Whole Raw Camel Milk.” You affirmed that products labeled or identified as raw camel milk in your records are not heat treated or pasteurized. Further, the products that you shipped were in final package form and were for direct human consumption.
We have reviewed the correspondence letter dated September 19, 2016, from Farm-to-Consumer Legal Defense Fund. The letter, which states that it is written on your behalf, raises questions about whether the regulation in 21 CFR 1240.61(a) applies to products such as yours that are made from the lacteal secretions of camels. Under 21 CFR 1240.61(a), the delivery into interstate commerce of “milk” and “milk products” in final package form for direct human consumption is prohibited unless they have been pasteurized. In 1992, FDA amended its regulations by defining “milk” and “milk products” in 21 CFR 1240.3 (57 FR 57343, Dec. 4 1992). Under 21 CFR 1240.3(j), the term “milk product” is defined as “[f]ood products made exclusively or principally from the lacteal secretion obtained from one or more healthy milk-producing animals, e.g., cows, goats, sheep, and water buffalo . . . .” This definition clearly includes the commercial lacteal secretions from all healthy milk-producing animals. Although the definition refers to the examples of cows, goats, sheep, and water buffalo, that list is not exhaustive. The definition thus includes the commercial lacteal secretions from other animals as well, including camels. (See also 57 FR 57343 at 57344, Comment 1). Consequently, the prohibition on interstate delivery in 21 CFR 1240.61(a) applies to products such as yours that are made from the lacteal secretions of camels. We are enclosing a copy of 21 CFR 1240.61(a) and 21 CFR 1240.3 for your information.
The above observation is not intended to be an all-inclusive list of violations that exist in connection with your products. It is your responsibility to ensure that your firm complies with all requirements of federal law and FDA regulations. You should take prompt action to correct the violation cited in this letter. Failure to make prompt corrections could result in regulatory action without further notice, including, without limitation, seizure and injunction.
Please notify this office in writing within fifteen (15) working days of receipt of this letter of the specific steps you have taken to correct the noted violations, including an explanation of each step being taken to prevent the recurrence of similar violations. If corrective actions cannot be completed within 15 working days, state the reason for the delay and the time within which corrections will be completed.
Your response should be directed to Matthew R. Sleeter, Compliance Officer at the above address. If you have any questions regarding this letter, please contact Compliance Officer Sleeter at firstname.lastname@example.org (913) 495-5151.
Cheryl A. Bigham
Kansas City District