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FDA Issues Draft Guidance on FCN Submissions for Substances Intended to Contact Infant Food

The U.S. Food and Drug Administration (FDA) issued long-awaited draft guidance on December 8, 2016 regarding the preparation of Food Contact Notifications (FCNs) for food-contact substances (FCS’s) that are intended to come into contact with infant formula and/or human (breast) milk (collectively “infant food”).  FDA noted the types of FCS’s that are covered by the draft guidance include materials used in packaging infant formula and in manufacturing baby bottles, including bottle inserts and nipples.   

Although FDA has been restricting the use of FCS’s with infant food for several years now, the draft guidance formally sets out the data and other scientific information that FDA “recommends” notifiers to provide to support a determination that a substance intended for use in contact with infant food is safe for the intended use in accordance with Section 409(h) of the Federal Food Drug and Cosmetic Act.

FDA explains that it has reevaluated its approach to assessing the safety of substances in contact with food for infants to account for scientific advances that point to fundamental biological differences that may influence responses to chemical exposures.  The Agency also notes that infants frequently consume formula and/or human milk exclusively for the first six months of life, and consume a greater volume of food relative to their body weight than adults, leading infants to have a higher intake of food-contact migrants relative to body weight. 

The draft guidance contains detailed chemistry, toxicology, and administrative recommendations for preparing and submitting FCNs for substances intended to contact infant food.  A few notable highlights include FDA’s recommendation that 50% ethanol is an appropriate simulant for assessing potential migration of substances used in contact with dry (powdered) or liquid infant formula or human milk.  (The Agency also recognizes use of a dry food simulant, such as Tenax (Poly(2,6-diphenylphenylene oxide)), to be appropriate for powdered infant formula.)  In addition, FDA’s draft guidance recommends the use of an age-dependent risk evaluation for assessing the safety of potential exposures to carcinogenic constituents in FCS’s used in contact with infant food that takes into account the limited exposure period during infancy on the overall lifetime risk. 

Electronic or written comments on this draft guidance should reference Docket No. FDA-2016-D-1814 and may be submitted through February 7, 2017.    

© 2019 Keller and Heckman LLP


About this Author

Cythia Lieberman Regulation Compliance Lawyer Keller Heckman Law Firm

Cynthia Lieberman is a Partner in the firm’s Washington, DC office. Her practice focuses on providing legal counsel to further the business interests of entities engaged in the manufacture of food and feed additives, food and drug packaging, and medical devices. Ms. Lieberman assists clients with obtaining necessary premarket approvals for products regulated under the U.S. Food and Drug Administration, the European Union’s Plastics Regulation, China’s GB 9685, and MERCOSUR, and with submitting petitions for listings in various EU Member States, such as on Germany’s BfR...

George G. Misko, Food and Drug Lawyer, Keller Heckman Law firm

George Misko is one of the Firm's Food and Drug Practice Group leaders. Mr. Misko's practice focuses on food and drug matters and environmental concerns, including pesticide regulation, right-to-know laws, and toxic substance control regulations. He has extensive experience counseling clients on regulatory requirements relating to chemical substances, plastics and food products in the U.S. and other jurisdictions, including Canada, the European Union, Latin America, and the Pacific Rim. He also represents trade associations, including acting as legal counsel to the Global Silicones Council.

Prior to joining Keller and Heckman, Mr. Misko was Senior Regulatory Counsel for the Chemical Specialty Manufacturers Association (now known as the Consumer Specialty Products Association), where he provided counsel on a broad range of environmental and health and safety issues. Mr. Misko also is an experienced civil trial and appellate litigator, and served as a law clerk to the Honorable Nicholas S. Nunzio, Judge of the Superior Court of the District of Columbia.