Milky Way Farm 4/20/10

Department of Health and Human Services	Public Health Service Food and Drug Administration
	Atlanta District Office 60 8th Street, N.E. Atlanta, Georgia 30309

April 20, 2010

 

 

VIA FEDERAL EXPRESS

 

 

L.D. Peeler, Jr.

Milky Way Farm

220 Hidden Hills Road

Starr, South Carolina 29684

WARNING LETTER

(10-ATL-13)

Dear Mr. Peeler:

This is to advise you that the Food and Drug Administration (FDA) has reviewed your website at the Internet address http://www.scmilkywayfarm.com and has determined that you are causing to be delivered, selling, or otherwise distributing raw milk, in final package form for human consumption, in interstate commerce. Such distribution is a violation of the Public Health Service Act (PHS Act), 42 U.S.C. §§ 264(a) and 271(a), and the implementing regulation codified in Title 21, Code of Federal Regulations (CFR), section 1240.61(a). The regulation prohibits the delivery, sale, or distribution in interstate commerce of milk and milk products in final package form for human consumption unless they have been pasteurized.

You cause unpasteurized milk, in final package form for human consumption, to be shipped into interstate commerce through raw milk "co-ops." For example, your raw milk is sold through your co-op in Augusta, GA. For your information, we have enclosed a copy of 21 C.F.R. § 1240.61 as it was published in the Federal Register, 52 FR 29509 (August 10, 1987).

This letter is not intended to provide an all-inclusive list of violations. It is your responsibility to ensure adherence with all requirements of the PHS Act, the Federal Food, Drug, and Cosmetic Act, and implementing regulations. For instance, you should ensure that your products are properly labeled. You should take prompt action to correct the above deviation and prevent any future recurrence. Failure to make prompt corrections could result in regulatory action without further notice. Possible actions include seizure and/or 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.

Please send your written reply to the Food and Drug Administration, Attention: Serene N. Ackall, Compliance Officer at the address noted in the letterhead. If you have any questions about this letter, you can call Ms. Ackall at 404-253-1296.

Sincerely,

/s/

John R. Gridley, Director

Atlanta District

 

Enclosure

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