FDA WARNING_LETTER - Baker's Breakfast Cookie, Inc. - January 09, 2008

On January 8-9, 2008, the FDA inspected Erin Baker's firm at 4208 Meridian Street, Bellingham, Washington. A sample of "Erin Baker's Homestyle Peanut Butter Granola (12 oz), lot number 'Best Before 092108,'" was collected for compliance with the Federal Food, Drug, and Cosmetic Act (the Act) and FDA's food labeling requirements (21 CFR Part 101).

Analysis revealed the product's Nutrition Facts panel was inaccurate. The label declared 1g saturated fat per serving (45g), but the original analysis found 1.32g (32% in excess), and a check analysis found 1.42g (42% in excess). This misbrands the product under section 403(a)(1) of the Act [21 U.S.C. 343(a)(1)] as the labeling is false and misleading due to the higher actual saturated fat content [21 CFR 101.9(g)(5)].

Additionally, the ingredient statement listed "natural peanut butter" and "pure vanilla extract." These ingredients are subject to standards of identity (21 CFR 164.150 and 21 CFR 169.175) and must be declared as "peanut butter" and "vanilla extract." The