FDA WARNING_LETTER - Flowers Baking Company of Villa Rica, LLC - February 10, 2010

On February 9-10, 2010, the FDA inspected Flowers Baking Company of Villa Rica, LLC, at 134 Doyle McCain Drive, Villa Rica, Georgia. The inspection included collecting a sample of Nature's Own Honey Wheat Enriched Bread (manufacturer code 113041) to assess compliance with the Federal Food, Drug, and Cosmetic Act and FDA food labeling requirements (21 CFR Part 101).

FDA analysis of the bread sample revealed a discrepancy in the declared total fat content on the Nutrition Facts panel. The label stated 0.5 gram of total fat per serving (1 Slice/26 grams). However, FDA's original analysis found 0.733 gram of total fat per serving, which is 47% in excess of the declared value. A check analysis further found 0.806 gram of total fat per serving, 61% in excess.

Consequently, the product is deemed misbranded under section 403(a)(1) of the Act [21 U.S.C. 343(a)(1)] because the labeling is false and misleading, as the total fat content exceeds the declared value by more than 20 percent (21 CFR 101.9(g)(5)).

The letter requires prompt corrective action to address these violations. Failure to do so may result in regulatory action, including