| Public Health Service Food and Drug Administration |
| Atlanta District Office 60 8th Street, N.E. Atlanta, Georgia 30309 |
Department of Health and Human Services
July 22, 2010
VIA UNITED PARCEL SERVICE
George E. Deese, Chairman of the Board/CEO
Flowers Foods
1919 Flowers Circle
Thomasville, GA 31757
WARNING LETTER
(10-ATL-18)
Dear Mr. Deese:
On February 09 - 10, 2010, the U.S. Food and Drug Administration conducted an inspection of your Flowers Baking Company of Villa Rica, LLC facility, located at 134 Doyle McCain Drive, Villa Rica, Georgia 30180. During this inspection our investigator collected a sample of Nature's Own Honey Wheat Enriched Bread, manufacturer code 113041, to determine compliance with the Federal Food, Drug, and Cosmetic Act (the Act) and FDA's food labeling requirements (21 CFR Part 101). You can find the Act and FDA regulations through links on FDA's web page at www.fda.gov
FDA analyzed the sample of your Nature's Own Honey Wheat Enriched Bread to determine whether the nutrition information on your Nutrition Facts panel accurately reflects the nutrient content of the product. The product label states one serving (1 Slice/26 grams) contains 0.5 gram of total fat. However, the sample analysis performed by FDA found 0.733 gram of total fat per serving (original analysis) and 0.806 gram of total fat per serving (check analysis). The original analysis was 47% and the check analysis was 61% in excess of the total fat amount declared on your product's label. The analytical worksheets for sample number 512517 are enclosed. Therefore, your product is misbranded under section 403(a)(1) of the Act [21 U.S.C. 343(a)(1)] in that the labeling is false and misleading because the amount of total fat present is greater than 20 percent in excess of the declared value (21 CFR 101.9(g)(5)).
This letter is not intended to be an all-inclusive review of your firm's products and their labeling. It is your responsibility to ensure that your firm and your products comply with the Act and FDA regulations. You should take prompt action to correct the violations. Failure to promptly correct these violations may result in regulatory action without further notice. For instance, we may take further action to seize your product and/or enjoin your firm from operating.
You should notify this office in writing, within 15 working days of receipt of this letter, of any corrective actions, including an explanation of each step being taken to prevent the recurrence of similar conditions. Include any documentation necessary to show that correction has been achieved. If you cannot complete all corrections within 15 working days, state when the corrections will be completed and the reason for your delay.
Please send your reply to Derek C. Price, Compliance Officer, U.S. Food and Drug Administration, 60 8th Street, N.E., Atlanta, GA 30309. If you have any questions about the content of this letter please contact Mr. Price at 404-253-227, derek.price@fda.hhs.gov.
Sincerely
/S/
John R. Gridley
District Director
Atlanta District Office
cc: Mr. Randy Brock, Plant President
Flowers Baking Company of Villa Rica, LLC
134 Doyle McCain Drive
Villa Rica, GA 30180
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