The federal Food and Drug Administration (“FDA”) released two guidance documents to provide restaurants and food manufacturers with additional flexibility in distributing food during the COVID-19 pandemic. Both guidance documents address certain food labeling requirements and should be reviewed carefully by stakeholders prior to implementing any operational changes.
On March 26, 2020, FDA released a guidance document to aid food manufacturers and restaurants in ensuring a continued supply of food to consumers and retail establishments, such as grocery stores. Under the federal Food, Drug, and Cosmetic Act (“FD&C Act”) and FDA regulations, food manufacturers, restaurants, and other establishments that sell packaged foods directly to consumers are often required to provide certain nutrition information to consumers, such as a nutrition facts label. Unlike food packaged directly for consumers, food purchased by restaurants for preparation often lacks complete nutrition information and generally cannot be resold as packaged food to consumers.
As many restaurants and food manufacturers have been forced to alter their operations in response to COVID-19, such as by discontinuing dine-in services, both types of businesses may have stock on hand that does not meet FDA’s consumer nutrition labeling requirements (e.g., food packaged for sale to restaurants, rather than to consumers). To ensure a continuous supply of food products remain available to consumers, FDA’s guidance relaxes the nutrition labeling requirements by allowing restaurants and food manufacturers to sell packaged food directly to consumers or other businesses for resale to consumers, as long as certain limited information is provided (e.g., an ingredient statement, allergen information). FDA’s guidance also provides flexibility to food manufacturers experiencing retail packaging supply chain interruptions, thus allowing manufacturers to continue to produce food labeled for restaurant use that is intended for sale directly to consumers while the supply chain interruptions persist.
Stakeholders should be cautious in implementing FDA’s guidance as several limitations apply. For example, the guidance only applies to packaged foods, rather than foods prepared by restaurants (note that FDA has released similar menu labeling guidance addressed below).
FDA’s second guidance document was released on April 1, 2020 and addresses the menu labeling provisions of the FD&C Act applicable to restaurants and other retail food establishments. Under amendments to the FD&C Act and subsequent rulemaking, many restaurants and similar retail food establishments with twenty or more locations are required to provide nutrition information (e.g., calorie declarations) for standard menu items. In response to COVID-19, however, many of these regulated establishments have altered their operations to comply with governmental directives aimed at curbing the spread of COVID-19, such as by switching to takeout or “to-go” dining formats.
Due to the challenges and disruptions faced by regulated establishments, including temporary business practice changes, FDA’s guidance indicates that the agency will not enforce the menu labeling requirements prescribed by the FD&C Act and accompanying regulations. Prior to making any changes, however, restaurants and other retail food establishments should carefully review FDA’s guidance to understand the scope and limits of FDA’s enforcement discretion.
While FDA has relaxed certain nutrition and menu labeling requirements in light of COVID-19, food manufacturers, processors, and packagers should remain aware of their compliance obligations under the Food Safety Modernization Act, including those requirements related to hazard analysis and preventive controls.
At the same time, stakeholders should monitor additional requirements and recommendations that states and the federal government continue to announce regarding COVID-19, such as the cleaning and safety measures the Pennsylvania Department of Health required in its April 5 Order.