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FLEXO Magazine : September 2014
For these reasons, and due to concerns about enhanced sensitivity during crucial stages of development, FDA has recently begun to separately review the safety of new food contact materials for use in applications involving infant formula. MODERN LANGUAGE FDA's new focus on performing separate safety evaluations of pack- aging materials for infant formula becomes apparent when reviewing the Agency's website listings for e ective Food Contact Noti cations (FCN). Many---indeed, most---recent FCN clearances now include language limiting the scope of the clearances to exclude infant formu- la packaging, or to indicate that the safety of the material for use with infant formula has not been evaluated. is type of language should not be read to indicate that the use of the substance poses any safety concerns, however; it is simply indicative of the fact that FDA is applying new factors in evaluating infant exposures and, for the most part, the companies that submitted the recent FCNs were not aware of the new parameters when preparing their FCNs and did not provide the necessary exposure and safety assessment. Going forward, producers of new materials intended for use with in- fant formula will need to estimate dietary exposures using the factors unique to infants and ensure that there is su cient toxicology data to support the safety of the resulting exposures. Indeed, companies developing new food packaging materials are well advised to always consider any special considerations, such as novel sizes or target audi- ences, when performing safety assessments. About the Author: Joan Sylvain Baughan is a partner with the law rm of Keller and Heckman LLP. She practices food and drug law, focusing on U.S. Food and Drug Ad- ministration (FDA) and comparable international regulation of food contact materials, drugs, cosmetics, and medical devices. In addition to practicing in the rm's Washington o ce, Ms. Baughan spent three years counseling foreign and domestic clients from the rm's Brussels, Belgium o ce. While there, she developed an expertise in the regulation of food packaging materials and medicinal products under European Union and Member State legislation. Ms. Baughan has a scienti c background in microbiol- ogy and medical technology, and is frequently a speaker at International Conferences on various FDA and related regulatory topics. SEPTEMBER 2014 | FLEXO 17