FDA WARNING_LETTER - Post Foods LLC dba Post Consumer Brands

On March 10, 2015, the FDA issued a Warning Letter to Post Foods, LLC, regarding their Post Great Grains Digestive Blend (vanilla graham) product. The FDA's review of the product label in September 2014 found it to be in violation of the Federal Food, Drug, and Cosmetic Act, specifically misbranded under section 403(r)(1)(B).

The product label bore unauthorized health claims, characterizing the relationship of whole grains to diseases or health-related conditions like heart disease and diabetes. The specific claim cited was: "By consuming at least 48 g of whole grains per day you can support healthy digestion and reduce the risk of several chronic diseases like heart disease and diabetes. New Great Grains Digestive Blend cereal has 41 g of whole grain which is more than 85% of the daily recommended amount!?"

The FDA stated that this claim was inconsistent with authorized health claims for whole grains and heart disease, which include references to other plant foods and low saturated fat/cholesterol diets. Furthermore, the claim regarding diabetes omitted the required disclosure of "very limited scientific evidence" linking whole grains to a reduced risk of type 2 diabetes, as articulated in FDA's enforcement discretion guidance.

Post Foods, LLC was required to respond within 15 working days, detailing corrective actions taken and steps to prevent future violations. Failure to comply could result in regulatory actions such as seizure or