FDA WARNING_LETTER - Rainbow Acres Farm

On April 20, 2010, the FDA issued a Warning Letter to Mr. Daniel L. Allgyer, Owner of Rainbow Acres Farm, following an investigation. The investigation determined that Rainbow Acres Farm was delivering, selling, or distributing raw milk in final package form for human consumption into interstate commerce. This activity violates the Public Health Service (PHS) Act, Title 42 United States Code, Section 264(a), and its implementing regulation, 21 CFR 1240.61(a). This regulation prohibits the interstate delivery of milk and milk products in final package form for direct human consumption unless they have been pasteurized.

The letter emphasizes that this is not an exhaustive list of violations and that Rainbow Acres Farm is responsible for adhering to all PHS Act, Federal Food, Drug, and Cosmetic Act, and implementing regulations, including proper product labeling. The FDA requires prompt corrective action to address the noted deviation and prevent recurrence. Failure to comply could lead to regulatory actions such as seizure and/or injunction without further notice. Rainbow Acres Farm must notify the FDA in writing within fifteen working days of receiving the letter, detailing the specific steps taken to correct the violations and prevent recurrence. If corrections cannot be completed within this timeframe, the reason for the delay and the new completion timeline must be provided. The reply should be directed to Richard C. Cherry, Compliance Officer.