FDA WARNING_LETTER - Blossom Valley Foods Inc - June 13, 2013

An FDA inspection of Blossom Valley Foods, Inc. from June 4-13, 2013, revealed significant deviations from acidified food regulations and issues with dietary supplement labeling. The firm failed to file scheduled processes for all acidified foods, including Crying Tongue Hot Sauce, as required by 21 CFR 108.25(c)(2). Additionally, acidified foods were not manufactured according to their scheduled processes, with discrepancies in filling temperatures and heating parameters (21 CFR 114.80(a)(1)), rendering products adulterated under 21 U.S.C. § 342(a)(4). The firm's 32 oz. Noni Juice product was deemed an unapproved new drug under 21 U.S.C. § 321(g)(1)(B) and § 321(p) due to therapeutic claims like "Noni Juice daily can help prevent certain diseases." Further, its Juice HACCP plan lacked a complete critical limit for pasteurization, missing time parameters. The Noni Juice's "Nutrition Facts" panel also misrepresented it as a conventional food, inconsistent with dietary supplement definitions (21 U.S.C. 321(ff)(2)(B)). The FDA requires prompt corrective actions, including filing scheduled processes, adhering to them, properly handling deviations, removing disease claims, and correcting labeling. A written response detailing these steps is required within 15 working days, with potential regulatory actions like seizure, injunction, or reinspection fees for non-compliance.