Mead Johnson Nutrition Company – FDA Warning Letter, Sep 23, 2010

On October 18, 2010, the FDA issued a Warning Letter to Mead Johnson Nutrition Company following an investigation of their infant formula processing facility in Evansville, Indiana, conducted from September 9-23, 2010. The facility blends and packages powdered infant formula.

The FDA concluded that Enfamil Premium Infant, Enfamil Gentlease, and Enfamil AR powdered infant formulas were in violation of the Federal Food, Drug and Cosmetic Act (the Act) and 21 CFR 106 and 107. The primary violation was the failure to provide specifications for the plastic tub and lid assembly used for packaging and marketing pouches of these infant formulas. This constitutes a violation of Section 412(c)(2)(B) of the Act [21 U.S.C. § 350a(c)(2)(B)], which requires notification to the FDA at least ninety days prior to marketing a new infant formula or one with a major change. Failure to comply is a prohibited act under Section 301(s) of the Act [21 U.S.C. § 331(s)].

Specifically, a February 26, 2010, notification regarding blending and packaging infant formula powder in multi-serve pouches did not include specifications for the polypropylene tub and lid. Since product labeling suggests powder transfer to the tub for storage, the tub and lid become