FDA warns Mead Johnson over infant formula packaging

In a warning to the global infant formula maker, the agency said the company hadn’t provided the specifications for the plastic tub and lid assembly in which pouches of its Enfamil Premium Infant, Enfamil Gentlease, and Enfamil A,R, infant formula pouches are packaged and marketed.

“Failure to notify the FDA at least 90 days prior to marketing a new infant formula or formula with a major change is in violation of the Federal Food, Drug, and Cosmetic Act,”​ said FDA Detroit district director Joann M Givens in the letter to Mead Johnson CEO Stephen W Golsby on 18 October.

Food contact surfaces​

The FDA sent the reprimand saying Mead Johnson was in breach of food contact regulations after carrying out an eight-day investigation at the company’s plant in Indiana last month.

Mead Johnson had notified the FDA in February 2010 that it would begin blending and packaging infant formula powder in pouches at its Evansville facility but had failed to include specifications for the polypropylene tub and lid which is used for packaging the infant formula pouches. Labelling on the infant formula suggested the powder could be transferred from the pouch into the plastic tub for storage purposes. If this occurred the tub and the lid would both become food contact surfaces, said the food watchdog.

It points out that under the Code of Federal Regulations, Mead Johnson is obliged to “evaluate the effect of changes in processing conditions that could affect the level of nutrients in the finished product”.​ The company’s notification neither identifies the tub or lid as food contact materials, nor provides an evaluation of the plastic used, it added.

FDA-approved materials​

The FDA told the company it had 15 working days to lay out how it intended to take corrective action to comply with the federal rules and how it would prevent their reoccurrence.

"Our label recommends that parents keep the powder in the pouch,"​ Mead Johnson spokesman Chris Perille told Reuters. "However, we recognize that consumers may choose to empty the pouch into the tub, and we therefore provided instructions on the label on how to do so safely."​

He added the tubs and lids are made with FDA-approved materials and that the company was in the process of responding to the FDA.

The firm says it markets 70 products in 50 countries around the world and has offices in the Netherlands, Thailand and Mexico.