FDA WARNING_LETTER - Aunt Kitty's Foods, Inc. - August 01, 2008

The FDA conducted an inspection of Aunt Kitty's Foods, Inc. from July 28 to August 1, 2008. The inspection and subsequent analysis of a sample of "(b)(4) Brand Red Clam Italian Style Pasta Sauce" (15 oz, lot VM 61100733331 NOV 2010) revealed two violations.

Firstly, the product is misbranded under Section 403(a)(1) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. § 343(a)(I)] because its label is false or misleading regarding Vitamin C content. The label declared 15% DV (9 mg/serving) of Vitamin C, but analysis showed 50.2% (4.52 mg) and 38.8% (3.94 mg) of the declared amount. FDA regulations (21 CFR §§ 101.9(g)(3) and (4)(ii)) require naturally occurring nutrients to be at least 80% of the declared value, accounting for analytical method variability. Even with a 10% variability allowance, the product should contain at least 6.48 mg Vitamin C per serving, which it did not. A similar Warning Letter (07-NWJ-07) was issued on February 1, 200