FDA WARNING_LETTER - Twin Oaks Community Foods, Inc - February 11, 2010

The FDA conducted an inspection of Twin Oaks Community Foods, Inc. from December 2009 to February 2010, identifying misbranding violations for their Organic Tofu Extra Firm, Vegetarian Pate, and Vegetarian Sausage Extra Chewy Breakfast Style products.

The Vegetarian Pate and Vegetarian Sausage Extra Chewy Breakfast Style products were misbranded under 21 U.S.C. § 343(r)(1)(A) for using the "saturated fat free" claim without disclosing total fat levels in immediate proximity, as required by 21 CFR 101.62(c). Additionally, the Vegetarian Sausage Extra Chewy Breakfast Style product contained olive oil, an ingredient understood to contain saturated fat, without the required asterisk and explanatory statement per 21 CFR 101.62(c)(1).

All three products were misbranded under 21 U.S.C. § 343(q) due to non-compliant nutrition labeling (21 CFR 101.9). Violations included: serving declarations not in common household measures (21 CFR 101.9(b)(5)); missing caloric content from fat, trans fat, sugars, vitamin A, C, calcium, and iron declarations (21 CFR 101.9(c)); and the Organic Tofu Extra Firm product lacking trans fat information or the "Not a significant source of trans fat" statement