FDA WARNING_LETTER - Minerva Dairy Inc - March 10, 2014

The FDA inspected Minerva Dairy Inc.'s cheese and butter facility in Minerva, OH, from February 28 to March 10, 2014. The inspection and subsequent label review revealed several violations for their "All Natural Ilios Greek Yogurt Butter" and other products, leading to misbranding under 21 U.S.C. § 343 and 21 CFR Part 101.

Key violations include: 1. **Misleading Nutrient Content Claims:** The "All Natural Ilios Greek Yogurt Butter" product is misbranded because it uses implied nutrient content claims like "A Healthy Butter!" and comparative claims such as "15% less fat," "15% less cholesterol," "10% less calories," and "50% less sodium." These claims do not meet the regulatory requirements for "healthy" (e.g., exceeding saturated fat limits, lacking sufficient beneficial nutrients) or for "less fat," "less cholesterol," and "less calories" (e.g., not meeting the 25% reduction threshold). The "less sodium" claim also lacks required comparative quantitative information. 2. **Improper Statement of Identity:** The "Greek Yogurt Butter" label fails to bear the common or usual name of the food. The term "butter" is defined as exclusively from milk or cream, containing at least 80% milk fat, without other ingredients. However, yogurt powder is added to