Pacific Northwest Tofu, LLC – FDA Warning Letter, Nov 14, 2011

The FDA issued an amended Warning Letter to Pacific Northwest Tofu, LLC on March 23, 2012, following an inspection from October 24 to November 14, 2011, of their tofu manufacturing operation in Portland, Oregon. The letter identifies multiple misbranding violations under section 403 of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 343] and 21 CFR Part 101, concerning their Dae Han Tofu Company brand products. Key violations include non-compliant nutrient content claims for "Low Calorie," "High Protein," and "Reduced Fat" products, which failed to meet specific regulatory requirements (e.g., 21 CFR 101.60(b)(2)(i)(A), 21 CFR 101.54(b), 21 CFR 101.62(b)(4)(ii)(A) and (B)). Additionally, nutrition information was not declared in accordance with 21 CFR 101.9, specifically regarding trans fat declarations and incorrect serving sizes for Kim Chee (Mild). The firm's Soft Tofu Silken Style label also contained an inaccurate business address (21 U.S.C. § 343(e)(1), 21 CFR 101.5(d)). Further deficiencies included packaging tofu in mislabeled soy sauce buckets, inaccurate ingredient declarations (e.g., "nigari"), missing ingredient declarations (e.g., fat/oil for "Stir Fried Tofu"), inconsistent net weight and serving size information, improper serving size declarations (21 CFR 101.9(b)(1), 21 CFR 101.9(b)(5)(iii)), and non-compliant nutrition label formatting (21 CFR 101.9(d)). The FDA requires prompt corrective action and a written response within fifteen working days, detailing steps taken to address violations and prevent recurrence, warning of potential regulatory actions like seizure or injunction if not resolved.