FDA Regulation of Adhesives: Not Necessarily a Sticky Situation
Joan Sylvain Baughan
Manufacturers seeking to establish a suitable U.S. Food and Drug Administration (FDA) regulatory status for an adhesive product intended for food packaging might find it surprisingly easy to adhere to the regulations. In fact, the agency's regulation of adhesives allows some flexibility in establishing a suitable FDA status for an adhesive formulation.
While FDA regulations for indirect food additives tend to focus on the food-contact substance itself, the latitude afforded adhesive manufacturers is based upon the fact that the requirements specified for adhesives place a great deal of the burden of regulatory compliance on the manufacturers of finished food packaging articles that contain adhesive products.
In its food additive regulations, FDA clears the use of various substances that may be used in adhesive formulations intended for the packaging, transporting, or holding of food under 21 C.F.R. § 175.105 ("Adhesives"). A manufacturer of an adhesive formulation, therefore, may use any substance listed under Section 175.105(c) in its adhesive formulation subject, of course, to any limitations on the use of that substance provided in the regulation.
What makes the adhesive regulation somewhat unique, however, is that Section 175.105 also places physical limitations on how the manufacturer of finished food packaging uses adhesive formulations in the finished food contact articles. Specifically, under Section 175.105(a)(2), manufacturers of finished food packaging must ensure that adhesives either:
Substances separated from food by a functional barrier so that they are prevented from migrating to food (as required under Section 175.105) are not reasonably expected to become components of food and, thus, are not properly considered food additives. Judicial confirmation of this well-established position was provided by the U.S. Court of Appeals for the First Circuit in Natick Paperboard v. Weinberger, 525 F.2d 1103 (1st Cir. 1975), cert. denied, 429 U.S. 819 (1976).
In the Natick case, the court addressed the issue of whether polychlorinated biphenyl (PCB) contaminants were impermissible food additives. The court stated that if "the food placed in or to be placed in the paper container is or will be insulated from PCB migration by a barrier impermeable to such migration, so that contamination cannot reasonably be expected to occur, the paperboard would not be a food additive." Id. at 1107-08. Thus, the Natick case affirms FDA's position that substances separated from food by a functional barrier are not food additives and, therefore, are not subject to premarket clearance by FDA.
In August 2001, an article by a Danish journalist drew the attention of many consumers in reporting that unsafe levels of aromatic amines were found in food that had been packaged in plastic. The article attributed the high levels of aromatic amines to the adhesives that were used to create laminated packaging articles. Although the safety of U.S. food was not questioned, Dr. George H. Pauli of the FDA's Office of Premarket Approval (now the Office of Food Additive Safety) noted in an e-mail message to the Flexible Packaging Association that companies "must ensure that the food contact layer is sufficiently nonpermeable or thick to prevent any migration under conditions of use." 1
Pauli's discussion of the functional barrier concept further supports FDA's position with respect to the use of functional barriers with adhesives and demonstrates that it is important for a company to consider the intended conditions of use of the packaging together with the relationship of each component when evaluating whether a material has sufficient barrier qualities to act as a functional barrier. Pursuant to the limitations placed on the use of adhesives under Section 175.105, manufacturers of finished food packaging containing an adhesive meet the requirements of Section 175.105 only if the adhesive is used in a manner that prevents it from becoming a component of food or such that exposure to food does not exceed the de minimis amounts that may occur within the limits of GMP.2 In other words, the adhesive regulation pertains to the use of substances that are not "food additives" under the Federal Food Drug and Cosmetics Act. 3
Consequently, in many cases, adhesive formulations contain substances that are not explicitly listed in Section 175.105 but may still be used as intended, provided that the way in which they are used in the finished food packaging ensures that the adhesive is separated from food by a functional barrier or used in accordance with GMP as prescribed by Section 175.105.
1Available online at: www.flexpack.org/memser/03enviroaromaticamines.asp
2The reason that Section 175.105 was promulgated at all was not due to any concern that the listed material might migrate to food, but simply because the Adhesive Manufacturers Association requested such a listing shortly after enactment of the Food Additives Amendment of 1958.
3The Federal Food, Drug, and Cosmetic Act defines a "food additive" in Section 201(s) as a substance that is reasonably expected to become a component of food under its intended conditions of use. The statute exempts from the definition of "food additive," among other things, substances that are:
(1) not reasonably expected to become a "component" of food;
(2) "generally recognized as safe" (GRAS) among experts qualified by scientific training and experience to evaluate their safety; or
(3) the subject of a sanction or approval issued prior to the enactment of the Food Additives Amendment of 1958.
Pub. L. No. 85-929, 72 Stat. 784 (1958).
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