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FLEXO Magazine : August 2014
Flexible Food Packaging Navigating FDA Compliance Mitzi Ng Clark M icrowaveable retort pouches. Stand up zip bags. Single serving stickpacks. These represent just a few examples of flexible packaging uses found in the U.S . market today. As demand for flexible packag- ing continues its momentum in the food sector, it is imperative that manufacturers have a fundamental understanding of the way in which flexible food pack- aging is regulated in the U.S . AGENCIES & ACTS A discussion of the U.S. regulatory framework for flexible food pack- aging must begin with an understanding of the government agency with jurisdiction over food packaging materials, in this case the Food and Drug Administration (FDA). Under the Federal Food, Drug and Cosmetic Act, food packaging, including flexible food packaging, is prohibited from adulterating food. Adulteration of food can occur if the packaging renders the food unsafe or unfit for consumption, or if the package contains a “food additive” that is not cleared for the intended use by FDA. Significantly, not all substances used in food packaging are properly considered food additives. A food additive is defined in the Act as: “Any substance the intended use of which results or may reason- ably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food (including any substance intended for use in... packing... packaging... or holding food...” 1 The Act excludes from regulation substances that are Generally Rec- ognized as Safe (GRAS) or those that are subject to a prior sanction, discussed later on. By virtue of its definition, the term “food additive” also excludes from regulation any substance that, when used as in- tended, is not reasonably expected to become a component of food. The first step in evaluating the FDA status of a flexible packaging material is to determine if it is already authorized by a food addi- tive regulation or Food Contact Notification (FCN), or subject of a “Threshold of Regulation” (TOR) exemption letter. In terms of clearances under the food additive regulations, these can be found in Title 21 of the Code of Federal Regulations (CFR), § 175–186. Since food additive clearances are generic, anyone may rely on them. However, the clearances can have limitations, so it is important to confirm whether the regulation imposes any restrictions with respect to use levels, foods to be contacted, temperature conditions of use and the like. The FCN program was implemented in 2000 and has become the primary vehicle for obtaining a formal clearance for new food contact substances. The program has largely replaced the food additive 1 Federal Food, Drug and Cosmetic Act, § 201(s), 21 U.S.C . § 321(s). 20 FLEXO | AUGUST 2014 LEGAL WRAP New Feature