FDA WARNING_LETTER - Jerusalem Manufacturing Nature Foods & Wholesalers, Inc. - April 17, 2008

An FDA inspection conducted between March 12 and April 17, 2008, at Jerusalem Manufacturing Natural Foods & Wholesalers, Inc. in Dearborn, Michigan, revealed significant violations of the Federal Food, Drug and Cosmetic Act and FDA regulations. The firm's Jerusalem World Pure Foods brand Turnip Pickle was found adulterated under sections 402(c) and 721(a) of the Act, containing the unsafe color additive Rhodamine B, a known carcinogen, which is not approved for food use. Additionally, the Jerusalem brand Pita Bread, Spelt Wheat Free, was misbranded under section 403(w) for failing to declare wheat as a major food allergen, despite containing spelt, a species of wheat. This product was further misbranded under section 403(a)(1) due to false and misleading "SPELT WHEAT FREE" labeling. The Turnip Pickle products in 32 oz. and 20 lb. containers were also misbranded under section 403(e)(2) and 21 CFR 101.105 for incorrect net weight declarations, using a single "NET WT. 20 OZ" label across various sizes. The 20 lb. pails failed to express net weight in required fluid measure subdivisions (21 CFR 101.105(r)), and outer packaging declared incorrect net weights. The FDA emphasized the firm's responsibility for compliance and required prompt corrective actions within fifteen working days, including documentation of revised labels and procedures, to avoid further regulatory actions like seizure or injunction. Additional label comments included proper declaration of sub-ingredients and color additives, foreign language requirements, and nutrition footnote compliance.