Not labeled for retail sale, except during the coronavirus pandemic

By Daniel Pessar* (Guest Blogger)

This is the third in a series of occasional posts by Daniel Pessar on regulatory flexibility in the context of food law and the pandemic.

The novel coronavirus pandemic has led to health, economic, and political turmoil around the world. In response to this public health crisis, U.S. federal, state, and local governments have been seeking to contain the impact of the virus while minimizing the collateral economic impact. Although stay at home orders and social distancing rules have had the greatest impact on people, many laws, regulations, and rules have been suspended or relaxed in order to help individuals and organizations—especially those involved in the pandemic response—to be productive during these difficult times.

One agency relaxing regulatory measures is the U.S. Food and Drug Administration (FDA) which has been working to remove obstacles to the flow of essential goods throughout the economy. As supply chains have been disrupted and demand patterns have shifted, the FDA has worked to relax the enforcement of certain regulations which could slow the response of food manufacturers and distributers to the new food business landscape.

In March 2020, the FDA announced that it would relax the enforcement of certain labeling laws that are familiar to many shoppers who purchase packaged goods in bulk. These shoppers know that often the individual beverage containers or snack bags do not have the product’s nutrition information. Instead, they have a label which reads “This unit not labeled for individual sale” or some variation of that announcement. Labeling items within a multi-pack in this way gives manufacturers more flexibility in package aesthetics and design and can help a food business to better control the flow of products for retail sale. Retailers interested in selling these items individually would need to affix a compliant nutrition label on top of the manufacturer’s label to comply with federal law.

In addition to multi-unit packaged goods, FDA nutrition labeling regulations also provide exceptions for food served in most restaurants or in other establishments in which food is served for immediate human consumption (e.g., institutional food service establishments, such as schools, hospitals, and cafeterias; transportation carriers, such as trains and airplanes; bakeries, delicatessens, and retail confectionery stores where there are facilities for immediate consumption on the premises; food service vendors, such as lunch wagons, ice cream shops, mall cookie counters, vending machines, and sidewalk carts…)  21 CFR § 101.9(j)(2)(ii)

These exceptions do not give restaurants a blank check, however. Only food served for immediate human consumption may be served without the inclusion of the necessary nutrition information. Under normal circumstances, these regulations do not limit restaurants—they are in the business of serving food for immediate human consumption after all.

Yet all of the upheaval that has come with the coronavirus pandemic has turned this law into a costly obstacle to offloading excess ingredient inventory. Food establishments with extra meat, flour, or cheese—but fewer customers—might consider selling packages of supplies directly to customers in order to reduce the economic pressures they are facing. However, given that these supplies would not qualify as food for immediate human consumption, the restaurants would need to ensure that an appropriate label be designed and affixed to the food parcels. Further compounding this challenge is the fact that the large packages sent to the restaurants by manufacturers or distributers of food supplies often lack nutrition labeling as well—those companies qualify for a separate exception from nutrition labeling regulations (see 21 CFR § 101.9(j)(2)(v)).

Recognizing that this rule would hurt restaurants while reducing the amount of food being made available to consumers during the pandemic, the FDA stepped in to temporarily relax certain rules. In March 2020, The FDA issued a temporary policy to relax labeling requirements for restaurants seeking to sell these kinds of products. As long as the food was labeled with (1) statement of identity, (2) ingredient statement, (3) name and place of business of the food manufacturer, packer, or distributer, (4) net quantity of contents, and (5) allergen information, the FDA would not object to the product’s sale even if it lacked a Nutrition Facts label.

Other rules have not been suspended, however. Restaurants making nutrient content claims about these food products (“Low fat cheese” or “High fiber beans”) would face other labeling rules that have not been relaxed by the FDA’s temporary policy. In addition, the FDA guidance does not apply to any foods prepared by restaurants. Entrepreneurs interested in developing packaged foods to supplement their restaurant offerings during the pandemic will need to comply with the robust label requirements for packaged foods. But as long as the new guidance stays in effect, restaurants can more easily sell packaged foods—both perishable and non-perishable—from cooking oil and tomato sauce to snack packs and juice pouches.

As restaurants, bars, and bakeries see a dramatic slowdown in business, some are trying to capitalize on their supply chain to maintain some business activity. For example, Fort Defiance, a bar in the Red Hook section of Brooklyn, New York, now sells a range of food supplies online including cheese, tofu, and raw chicken.  The FDA’s new stance facilitates this flexibility.

*Daniel Pessar is a third-year student at Harvard Law School. Before law school, he worked in the real estate investment industry for six years. He is the author of three books and numerous articles. He can be contacted at dpessar@jd20.law.harvard.edu

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