Minnesota Smoothies And More, LLC. – FDA Warning Letter, Jun 8, 2010

The FDA conducted inspections of Minnesota Smoothies and More, LLC dba Saint Paul Bagelry, most recently on June 8, 2010, verifying the firm manufactures and distributes ready-to-eat bagel products. The inspection revealed several misbranding violations under the Federal Food, Drug, and Cosmetic Act.

Specifically, Asiago Cheese and Jalapeno Cheese bagel products are misbranded because their labels fail to declare milk, a major food allergen, as required by section 403(w) of the Act. All bagel products are misbranded under section 403(i)(2) because they do not list each ingredient by its common or usual name (e.g., "Natural bagel base" instead of "bagel base") and fail to declare all sub-ingredients for multi-component ingredients like "Hi Gluten Flour," "Asiago cheese," "Flour," "Natural bagel base," "mild salsa," and "Pepper jack cheese." Additionally, the bagel products are misbranded under section 403(q)(1) for lacking required nutrition information, and the firm is not exempt from these requirements.

The FDA also noted that "Hi Gluten Flour" contains enriched bleached wheat flour, and if used, all components of enriched flour must be declared. The statement "May contain wheat" is redundant as the products inherently contain wheat.

The firm must take prompt action to correct these violations within 15 working days, providing written