FDA WARNING_LETTER - Butterfly Bakery Inc - December 08, 2010

On December 8, 2010, an FDA investigator collected samples of Butterfly Bakery Inc.'s No Sugar Added Blueberry Muffins and Sugar Free Double Chocolate Chip Muffins. Analysis revealed multiple violations of the Federal Food, Drug, and Cosmetic Act and 21 CFR Part 101.

Both muffin products were misbranded under Section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] because their labels were false or misleading regarding fat content [21 CFR 101.9(g)(5)]. For the Blueberry Muffins, declared total fat (3.5g) was found to be 9.44g (170% excess) and 10.5g (200% excess) in original and check analyses, respectively. Saturated fat (0.5g) was 2.3g (360% excess). For the Double Chocolate Chip Muffins, declared total fat (3.5g) was 9.64g (175% excess) and 9.95g (184% excess). Saturated fat (0.5g) was 2.72g (444% excess) and 1.84g (268% excess).

Both products were also misbranded under Section 403(w