Food product labels are under intense scrutiny from consumers, regulators, class action lawyers, and non-governmental organizations (NGOs). Demands for more information, as well as changes to or prohibitions on labels' use of certain terminology, are on the rise. But do label-reform advocates fully appreciate the legal and regulatory complexities and burdens food-labeling revisions impose on the industry, especially when those changes involve state-specific rules? This Legal Backgrounder focuses on these complexities and burdens and advocates for alternative, less burdensome solutions that harness technology to inform consumers.
Labeling Regulatory Compliance: A Costly, High Priority
Under the Federal Food, Drug, and Cosmetic Act (FDCA), a food is misbranded if it fails to comply with the myriad requirements that have been established by the Food and Drug Administration (FDA).1 The FDCA prohibits the introduction into commerce or receipt of a misbranded product.2 The Food Safety Inspection Service of the U.S. Department of Agriculture administers similar requirements under other statutes.3 The rules facilitate the flow of consumer information and maintain a level playing field between competitors by preventing companies from gaining an unfair competitive advantage through unlawful practices.
Food-company regulatory-affairs experts spend hundreds of hours scouring finely-detailed labeling regulations and work directly with their marketing departments when developing labels for new products or making label revisions. Regulatory-affairs professionals not only need a comprehensive understanding of the existing rules, but they must stay abreast of emerging mandates as the law changes. Once regulatory affairs officials approve a label, the legal department traditionally conducts a final compliance review.
Legislators and regulators can easily overlook the significant amount of time needed for the regulatory -affairs professionals to read, learn, and understand new requirements so they can be incorporated into the label-review process efficiently and effectively. Consider, for instance, the recently finalized update to the nutrition facts panel (NFP), which prescribes new reference amounts and serving sizes for foods. The preambles to the two final regulations are hundreds of pages and the FDA guidance documents, many of which are still pending, will be similarly voluminous. Review of these documents can take hours, if not hundreds of hours, to fully understand the complexities of the new requirements.
The time regulatory-affairs specialists must invest to learn and keep abreast of new rules is merely one cost of label changes. A new label must be designed by the creative and marketing departments. In many instances months of design testing are needed to make certain the label graphics and claims will resonate well with consumers. Once the new design is finalized, the graphics are shared with the packaging company that will create new plates to make the labels. FDA has estimated there are close to 800,000 universal product codes (UPCs) for conventional food and beverage products that will require changes under the new...