FDA WARNING_LETTER - Alexia Foods, Inc - November 16, 2011

On November 16, 2011, the FDA issued a Warning Letter to Alexia Foods, Inc., specifically addressing the labeling of their Alexia brand Roasted Red Potatoes & Baby Portabella Mushrooms product. The FDA's review concluded that this product is misbranded under section 403(a)(1) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 343(a)(1)], which prohibits false or misleading labeling.

The violation stems from the "All Natural" claim prominently displayed on the principal display panel. The FDA's policy defines "natural" as a food containing "nothing artificial or synthetic…that would not normally be expected to be in the food." However, the Alexia brand Roasted Red Potatoes & Baby Portabella Mushrooms product contains disodium dihydrogen pyrophosphate, a synthetic chemical preservative. Because of this synthetic ingredient, the "All Natural" claim is deemed false and misleading, rendering the product misbranded.

The FDA recommended that Alexia Foods, Inc. review all their product labels to ensure consistency with FDA policy and prevent further misbranding. The company is required to take prompt action to correct these violations. Failure to do so may result in enforcement actions, including seizure or injunction, without further notice. Alexia Foods, Inc. must respond in writing within fifteen working days, detailing specific corrective actions, including revised labels or other supporting documentation, and explaining any delays.