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July 25, 2012 / Admin

FDA Warns Mead Johnson About Enfamil Packaging

Babies. They’re tiny. They’re cute. They’re fragile. They need to be protected. Luckily, the FDA is taking care of it. On October 26, Reuters reported that the Food and Drug Administration recently warned Mead Johnson Nutrition Company that it had violated federal law in its production of several of its Enfamil powdered infant formula products. In a letter to the company, dated October 18, the FDA explained that Mead Johnson had failed to disclose the specifications for a plastic tub and lid which are part of the packaging for the infant formula. The formula is packaged in a pouch, but labeling on the product suggests it can be stored in the plastic tub. Mead Johnson failed to identify the tubs as a food contact source and failed to provide the FDA with an evaluation of the plastic used to make the tubs and lids. According to the letter, this was a violation of the Food, Drug, and Cosmetic Act and federal regulations.

The Enfamil products identified in the letter include Enfamil Premium Infant, Enfamil Gentlease, and Enfamil A.R. Mead Johnson responded by saying the company recommends keeping the formula in the pouches, but it recognizes consumers may choose to empty the powder into the tub. The label provided instructions on how to do so safely. The company added that the tubs and lids are made with FDA-approved materials and that it was in the process of responding to the FDA.

This illustrates how careful manufacturers have to be when making disclosures to the FDA, especially when it comes to products related to infants. After all, infants don’t choose what they eat or how to store the food that they are fed. Since they can’t look after themselves, everyone else has to be vigilant about what goes in those tiny tummies.


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