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FDA Imposes Limitations on FCNs Regarding Infant Food Use

February 18, 2014

The U.S. Food and Drug Administration (FDA) now appears to be regularly imposing a limitation on uses of a food contact material with infant food, ingredients, and breast milk unless specifically addressed in a food contact notification (FCN) submission. Review of FDA's Inventory of Effective Food Contact Substances (FCS) Notifications showed that several recently added effective FCNs specifically mention infant formula under the "Limitations/Specifications" section of the FCN listing. The language regarding use of the authorized food-contact substance (FCS) in contact with infant formula differs among various FCNs, however. Examples of language FDA has included in the "Limitations/Specifications" section pertaining to use of the FCS in infant food applications include the following:

  • "The FCS is not intended for use in coatings in contact with infant formula."
  • "Not for use in articles intended for contact with infant food (food for infants 0-6 months of age)."
  • "The FCS may be used in repeated use articles intended for the feeding of infants (e.g., baby bottles and sippy cups). Not for use in infant formula packaging."

FDA says that it has been using adjusted body weights and food consumption values when determining infant exposure to food-contact materials as far back as 2010. (Other than an ion exchange resin cleared by an FCN in 2003, the first infant formula limitations began appearing, albeit sporadically, in 2009 and 2010). Speaking at Keller and Heckman's 14th Annual Food Packaging Seminar on September 18, 2013, Dennis M. Keefe, Ph.D., Director of FDA's Office of Food Additive Safety (OFAS), Center for Food Safety and Applied Nutrition (CFSAN), stated that FDA is now using a 6.3 kg body weight and a food intake level of 900 grams per day to calculate infant exposures.

The new parameters that notifiers are to use in submissions to FDA to address the safety of food-contact substances to infants have not yet been incorporated into either FDA's chemistry of toxicology guidances (see FDA's Guidance on Preparation of Premarket Submission for Food Contact Substances: Chemistry Recommendations and Preparation of Food Contact Substances: Toxicological Recommendations). FDA is updating the 2007 Chemistry Guidance for FCN submissions. As part of the update, FDA is looking at adjusting its exposure analysis for sensitive population groups, such as infants and the elderly, explained Dr. Keefe at the Keller and Heckman Fall, 2013 conference.