June 9, 2020
The profound impact of the novel coronavirus (COVID-19) has created a disruptive and ever-changing business and economic climate that presents a host of issues and considerations for businesses, especially those in the food and beverage industries. The importance of these industries has been recognized as “essential” business, and daily headlines remind us of the struggle to put food on the tables of America. The FDA has not been deaf to these struggles, and has provided a number of measures meant to assist these industries in getting food to market without waste.
Foodservice Issues and Retail Package Labeling Flexibility
Social distancing and related public-health rules have caused a shift in where consumers are buying food. Food use in large-scale establishments, such as hotels, restaurants, sports arenas/stadiums and universities suddenly declined, but the demand for food at grocery stores increased. The FDA has issued temporary guidance to provide flexibility in packaging and labeling requirements to support food supply chains and shift foods to the consumer retail marketplace.
The May 22 Guidance, “Temporary Policy Regarding Certain Food Labeling Requirements During the COVID-19 Public Health Emergency: Minor Formulation Changes and Vending Machines” discusses the FDA’s efforts to provide regulatory flexibility to help minimize the impact of COVID-19 supply chain disruptions by using its “enforcement discretion” to turn a blind eye to minor labeling issues caused by supply disruptions or ingredient shortages due to COVID-19. The Guidance allows retail packaged foods companies to utilize foodservice ingredients that would otherwise go to waste by adding flexibility into the labeling laws. These include temporary omissions of non-characterizing ingredients from a formulation without corresponding labeling changes; reductions of minor ingredients in a formulation without a labeling change if the reduction does not significantly change the order of predominance in the ingredient list; temporary substitutions of non-characterizing ingredients, which are generally present at two percent or less, for other safe and suitable ingredients (provided there are no safety or allergen concerns introduced) and other similar adjustments. Moreover, the Guidance indicates that the FDA does not intend to enforce vending machine labeling requirements and caloric information disclosures for operators who own or operate 20 or more vending machines for the duration of the COVID-19 public health emergency, which will allow flexibility for any disruptions to the vended food supply chain and staffing issues, and the temporary relocation of machines to different locations where essential workers are located.
Similarly, as restaurants shift from sit-down to take-out and shift menu offerings to address impacts on operations, they are also creating new or modified online ordering portals and printed menus. In other cases, supply chain disruptions are forcing restaurants to adjust menu offerings based on their food supply options. In response to this shift, the FDA released a “Temporary Policy Regarding Nutrition Labeling of Standard Menu Items in Chain Restaurants and Similar Retail Food Establishments During the COVID-19 Public Health Emergency,” available here. The temporary labeling policy applies to restaurants and similar retail food establishments that are part of a chain with 20 or more locations, doing business under the same name, and offering for sale substantially the same menu items. Similar to the retail labeling Guidance discussed above, this Temporary Policy provides flexibility for nutrition labeling requirements for standard menu items and indicates that the FDA will use its enforcement discretion to temporarily allow deviations from these menu labeling standards for the duration of the public health emergency related to COVID-19.
Is Food Safe and Available?
As the economy starts to open up in some states, consumers rightly want to know if they can become infected with COVID-19 through consuming food purchased either at retail or through a foodservice outlet. Countless stories regarding sick workers at meat packing plants have created a very nervous consuming public, and pressure on industry consumer affairs professionals.
The FDA continues to reiterate that there is no evidence of COVID-19 transmission through foodborne exposure. As such, the FDA has repeatedly stated that it does not anticipate recalls or withdrawals of food products from the market relating to COVID-19, even where individuals working in a food facility (e.g., a food packager) are confirmed to have tested positive for the virus. The FDA issued updated public statements and a series of updated Q&As designed to serve as a resource for industry members and consumers regarding food safety during the COVID-19 pandemic. In these materials, the FDA continues to take the position that COVID-19 poses no significant risk to the food supply, stating that the supply chain has not been disrupted and that, in spite of localized reports of shortages, there are no nationwide food shortages. Instead, this is largely an issue of unprecedented demand – not a lack of capacity to produce, process and deliver – and retailers and manufacturers are working around-the-clock to replenish shelves. These facts are important for consumer affairs professionals and public relations experts to be able to provide to consumers.
Raw Produce Safety Rule Exemption
Raw produce in the United States, with some exceptions and exemptions for “qualified” buyers, is subject to safety controls for growing, harvesting, packing and holding of fruits and vegetables grown for human consumption (the “Produce Safety Rule”). Exemptions from and modified requirements to the Produce Safety Rule are available if sales to certain “qualified end-users” exceed sales to all other buyers. The FDA recognizes that the ability of farms to shift food sales to ALL available buyers during the COVID-19 public health emergency has the potential to help reduce food shortages and food waste and to help support both farms and the U.S. economy. In order to support affected farms in selling food to all available buyers during the COVID-19 public health emergency, under the circumstances described in the Guidance, the FDA stated it does not intend to enforce the criteria for sales to “qualified end-users” during 2020 (and any subsequent years that are affected by the COVID-19 public health emergency) when determining eligibility for the qualified exemption under the Produce Safety Rule. Like the Guidance described above, this enforcement discretion will last for the duration of the COVID-19 public health emergency. The FDA issued the guidance entitled “Temporary Policy During the COVID-19 Public Health Emergency Regarding the Qualified Exemption from the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption” on May 22.
Plant Disruption Reporting
Facilities that manufacture/process, pack or hold food for consumption in the United States must register with the FDA when initially beginning operations and then update that registration on a biennial basis and within 60 days of when certain changes in their operations occur. However, the FDA has recognized that during the COVID-19 pandemic, more rapid and specific notification regarding certain FDA-regulated food establishments that are temporarily closing or reducing production will help the FDA to better understand the current status of the food supply and address challenges facing food producers to help support food production. Further, food establishments may wish to request assistance from the FDA in addressing pandemic-related challenges.
Therefore, the FDA is providing a mechanism for FDA-regulated establishments to voluntarily notify the Agency of temporary closures and significant reductions of production during the pandemic or to request assistance from the FDA regarding issues that may affect continuity of operations during the pandemic. The FDA issued new guidance entitled “Reporting a Temporary Closure of Significantly Reduced Production by a Human Food Establishment and Requesting FDA Assistance During the COVID-19 Public Health Emergency” on May 27.
Establishments that wish to voluntarily report a temporary closure/significant production reduction or request assistance should do so through the FDA’s Center for Food Safety and Applied Nutrition’s (CFSAN’s) Food and Cosmetic Information Center (FCIC). The CFSAN FCIC can be accessed here. Importantly, the FDA stresses that it does not intend to use any of this reported information to target establishments for inspections as a result of temporary closure or reduced production.
The FDA relief measures described in this Alert are aimed at promoting the ability of the food and beverage industry to continue to do its essential work of supplying food and minimizing supply disruption in light of unprecedented circumstances caused by the COVID-19 pandemic. However, it is important to remember that these Guidance documents do not constitute a change in federal law or regulations but instead reflect a new enforcement posture given the extenuating circumstances; these flexibilities are directed at specific circumstances and normal food and beverage rules should still govern whenever possible. Further, food facilities, like other work establishments, need to follow protocols set by local and state health departments, which may vary based on the amount of community spread of COVID-19 in a particular area.
McGrath North’s COVID-19 Response Team continues to monitor federal, state and local government responses to COVID-19. Should you have any questions about this Alert, or if we can be of assistance with your COVID-19 response strategies, please contact Sandra Morar or Rachel Meyer of our COVID-19 Response Team.
Contact information for the complete McGrath North’s COVID-19 Response Team can be found here.
For information regarding additional business-related concerns centered around COVID-19, please visit our COVID-19 Resource Guide here.