FDA Shows That It’s Serious About Food Allergen GMPs

By Ricardo Carvajal –      

In a complaint filed on July 1, 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.”

The task of determining what constitutes a failure to take “reasonable precautions” appears to have been made easier in this case by the fact that the defendants are alleged to have repeatedly failed to comply with their own standard operating procedure calling for the use of dedicated equipment for particular products, and to have repeatedly deviated from their own cleaning procedures.  As a result of these and other practices, the government maintains that “there is a reasonable possibility that (a) an allergenic ingredient from one product will be incorporated into other products not intended to contain the allergen, and (b) consuming products cross-contaminated with a food allergen will lead to adverse reactions in susceptible individuals,” thereby giving rise to a violation of section 402(a)(4).

The complaint should be considered required reading for all food and dietary supplement manufacturers.  The case is United States of America v. Quality Formulation Labs., et al., C.A. No. 2:09-CV-03211 (D.N.J. filed July 1, 2009).