FDA Issues Draft Guidance on Food Contact Substances for Use with Infant Formula and Human Milk

The U.S. Food and Drug Administration has issued draft guidance to provide additional information on how to prepare Food Contact Notifications (FCNs) for food contact substances that will come into contact with infant formula and human (breast) milk.

Although the FDA evaluates the safety of all packaging materials before they enter the marketplace, the new draft guidance provides more specific advice on how to conduct the safety assessment for food contact substances that would come into contact with infant formula or human milk compared to food contact substances used in packaging of other foods. This guidance applies to material that may be used in infant formula packaging and baby bottles, bottle inserts, nipples and any other products used to collect and store human milk.

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