FDA WARNING_LETTER - Wendy Weihe Storlie, Inc. - March 11, 2011

An FDA and MDA inspection on February 23 and March 11, 2011, found that Wendy Weihe Storlie, Inc. distributed an animal feed product, "(b)(4)," which was adulterated and misbranded. The product was adulterated under section 402(a)(2)(C)(i) of the Federal Food, Drug, and Cosmetic Act (the Act) because it contained deodorizer distillates, an unsafe food additive lacking a food additive regulation, prior sanction, or GRAS status for animal food use.

The product was also misbranded under section 403(i) of the Act because its label, despite being fabricated from multiple ingredients, did not list the common or usual name of each ingredient. Furthermore, the deodorizer distillates sold by the firm were misbranded under section 403(a)(1) of the Act. The firm failed to disclose the material fact that the product's original labeling stated it was "not suitable for animal consumption" when selling it for use in animal feed.

The firm's involvement included working with (b)(4) on product processing, instructing (b)(4) to perform analytical testing on the final product, and directing (b)(4) to (b)(4). The introduction of adulterated or misbranded food into interstate commerce is prohibited under section 301 of the Act.

The firm stated it would no longer sell products