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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Golden Fleece Products, Inc. 18-Aug-03

Department of Health and Human Services' logo

Public Health Service
Food and Drug Administration

  College Park, Maryland



CERTIFIED MAIL
RETURN RECEIPT REQUESTED
WARNING LETTER
FLA-03-41

August 18, 2003

Mr. Glen E. Norton, President
Golden Fleece Products, Inc.
1500 West Sunturf Street
Lecanto, Florida 34461

Dear Mr. Norton:

The Food and Drug Administration (FDA) has reviewed the label for Golden Fleece Dairy “WHOLE MILK” in 1 gallon bottles. An FDA Investigator collected this label during an inspection at your firm conducted on July 1, 2003.

Our review reveals that the product is misbranded within the meaning of Section 403(a)( 1) of the Federal Food, Drug, and Cosmetic Act because the label containing the statement “No Hormones” is false. This statement is false because all milk contains naturally occurring hormones. Due to the presence of naturally occurring hormones, milk cannot be produced in a way that renders it free of hormones. Therefore, milk cannot be labeled in a manner that falsely indicates that hormones are not present in the product.

The above violation is not meant to be an all-inclusive list of deficiencies on your labels. It is your responsibility to ensure that all of your products are labeled in compliance with the laws and regulations enforced by FDA. You should take prompt action to correct this violation and to prevent its future recurrence. Failure to make prompt corrections could result in regulatory action without further notice. Possible actions include seizure and/or injunction.

Please respond in writing, within fifteen (15) working days from your receipt of this letter. Your response should outline the specific steps you have taken to correct the noted violation.

Copies of the revised label for this product should also be submitted. If corrective action cannot be completed within 15 working days, state the reason for delay and the time within which corrections will be completed.

Your response should be directed to: Mr. Kendall W. Hester, Director of Compliance, U.S. Food and Drug Administration, Florida District, Winderley Place, Suite 200, Maitland, Florida 32751. If you have any questions regarding any issue in this letter, please contact Jimmy Walthall, Compliance Officer, at 407-475-4731.

Sincerely yours,
/s/

David Gallant for Emma R. Singleton
Director, Florida District