FDA WARNING_LETTER - Newman's Own Organics

The FDA issued a Warning Letter to Newman's Own Organics regarding their "NEWMAN'S OWN ORGANICS THE SECOND GENERATION? SPELT PRETZELS" product. The product's label was reviewed and found to be misbranded under section 403(w) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. § 343(w)].

The primary violation is the failure to declare wheat, a major food allergen, on the label, as required by section 403(w)(1). Section 201(qq) of the Act defines "major food allergens" to include wheat, and the FDA considers spelt (Triticum spelta L.) to be a species of wheat. The label does not include a "Contains" statement for wheat or declare spelt as "spelt (wheat)" in the ingredient list. This issue was previously communicated to the firm in a letter dated December 26, 2006, but the label remains non-compliant.

Additionally, the FDA noted concerns that a statement on the back of the package, "While Spelt is a member of the same grain family as oats and wheat, it's an entirely different species," may misleadingly suggest the product does not contain the wheat allergen. Another deficiency is that the net quantity of contents declaration on the principal display panel lacks sufficient contrast with the dark brown background, violating 2