Milky Way Farm – FDA Warning Letter

The FDA issued Warning Letter 10-ATL-13 to Mr. Peeler of scmilkywayfarm.com after reviewing their website and determining they are distributing raw milk in interstate commerce. This violates the Public Health Service Act (PHS Act), 42 U.S.C. §§ 264(a) and 271(a), and 21 CFR 1240.61(a), which prohibits the interstate sale or distribution of unpasteurized milk for human consumption. The letter specifically cites the sale of raw milk through "co-ops," such as one in Augusta, GA.

The FDA emphasizes that this letter is not an exhaustive list of violations and that the company is responsible for ensuring compliance with all PHS Act and Federal Food, Drug, and Cosmetic Act requirements, including proper product labeling. The company must take prompt action to correct the identified deviation and prevent recurrence. Failure to do so could lead to regulatory actions like seizure or injunction without further notice.

The company is required to respond in writing within fifteen working days, detailing specific corrective steps taken and an explanation of how similar violations will be prevented. If corrections cannot be completed within this timeframe, the company must provide a reason for the delay and a timeline for completion. The response should be sent to Serene N. Ackall, Compliance Officer, at the FDA Atlanta District office.