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Document Type

Article

Abstract

This Article examines the challenges of regulating new areas of food and drug law and promoting industry compliance by considering two case studies: the U.S. regulation of cannabidiol (CBD) products and that of gluten-free items. Gluten-free claims on packaged foods have been subject to a set of U.S. Food and Drug Administ ration rules since those rules became effective in 2014. This new regulatory standard has improved the ability of consumers who need to rely on gluten-free labeling for health reasons to do so. Some concerns remain, however, about the mislabeling of foods that legally cannot be termed as gluten-free based on the ingredients they contain, as well as the gluten-free labeling of foods whose gluten levels exceed legal limits. CBD items are another set of novel products that present regulatory and enforcement challenges with respect to the protection of consumer health and safety. Although the FDA has sent warning letters to many companies selling CBD products that impermissibly claim to treat serious diseases, the widespread sale and marketing of CBD products bearing such claims continues. This Article uses the two case studies described above to explore industry compliance best practices and recommendations for regulatory action in evolving and emerging product areas. It further considers how companies manufacturing, selling, or marketing novel products may anticipate and react to changing law, or conform their operations to existing sets of rules that have the greatest application to their products. This Article also examines how consumer welfare may be best promoted through regulatory action and response. A more robust agency en forcement strategy is warranted with respect to both CBD products and gluten- free labeled items in order to better allow consumers to trust that these types of products on the marketplace fully comply with agency standards. Such increased enforcement would promote and more completely fulfill the purpose of long-existing agency rules, such as those concerning unsupported health claims, or more recent ones, such as the permitted ingredients or quantities of gluten in packaged food items labeled as gluten-free.

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