Friday, July 17, 2009

FDA Serious About Food Allergen GMPs

Ricardo Carvajal calls our attention to FDA’s seriousness about food allergen GMPs, “the government is asking a federal district court to enjoin certain manufacturers of protein powder mixes and dietary supplements from further marketing of products alleged to be adulterated under FDC Act section 402(a)(4) due to the manufacturers’ failure to minimize cross-contact with a major food allergen. The complaint makes clear that FDA interprets section 402(a)(4) and 21 C.F.R. Part 110 to require manufacturers to take “all reasonable precautions. . . to ensure that production procedures do not contribute to contamination from any source, including food allergens.”

Hat tip to Ricardo Carvajal for another great blog.