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FDA Warns Makers of Enfamil

Image via WikipediaThe FDA has warned Mead Johnson Nutrition Co.  about the packaging for some of the company's Enfamil infant formulas.

In a letter dated Oct. 18 that was posted to the agency's website Tuesday, FDA said Mead Johnson didn't give the FDA product specifications about a new plastic tub and lid that is used to store certain types of Enfamil powdered formula.

Earlier this year, Mead Johnson introduced a reusable tub for Enfamil formula that allows consumers to buy refill packages of formula to store in the container.

The FDA said the plastic tub is a "food contact surface." This would require the company to "evaluate the effect of changes in processing conditions that could affect the level of nutrients in the finished product," FDA said.

The FDA said Mead Johnson did notify the agency in February about its plans to start making powdered formula in "multi-serve pouches," but didn't provide an evaluation of the plastic used for the tub and lid.
In a statement, Mead Johnson said the company had believed that it had submitted all required information and had been received a notice from the FDA that indicated the agency had no additional questions.

Source: http://online.wsj.com/article/BT-CO-20101026-713901.html

Full post as published by A Georgia Lawyer on October 28, 2010 (boomark / email).