Certain food businesses have been inadvertently allowed to occupy a regulatory gray airspace and fly under the radar (so to speak), placing consumers' health at risk. In recent years, the food industry has observed a new set of business models rapidly evolve—direct-to-consumer. The pandemic put these developing models on an accelerated course as consumers began to change their ways of selecting and purchasing food. Suddenly, there was a consumer demand to stay inside and order food from the comfort and safety of home. What better solution than "meal kit" delivery? All the ingredients and instructions needed to prepare a family meal delivered right to your doorstep—but at what cost? 

As Business Models Evolve, So Do Concerns

At present, the U.S. Food and Drug Administration's (FDA's) "e-commerce" definition encompasses three different business models: 

  1. Historical retail establishments, such as restaurants and grocery stores
  2. Food delivery services, such as UberEATS, DoorDash, and pizza delivery that delivers food from a restaurant to a consumer
  3. Food businesses that deliver food from a fulfillment center to a customer, such as "meal kits" and certain grocery deliveries, typically requiring transit over 24 hours. 

Under the current regulatory landscape, companies in the third category are regulated through the honor system. Companies self-report to their local food authorities and, in most cases, are regulated under their local food code jurisdictions and inspected by local regulators trained to evaluate the implications of restaurant operations. 

It is important to highlight that e-commerce business models have evolved tremendously over the course of the past five years or so. Startup companies that began in founder's garages with the idea of simple "meal kit delivery" now have complex, multi-state, large-scale facilities. E-commerce companies operate like full-scale manufacturing facilities with large and diverse ingredient volumes, onsite storage and handling, introduction of manufacturing sorting and portioning equipment, packaging equipment, and more. 

What should be defined as an e-commerce business model is vastly different from a restaurant or retail establishment, or a food delivery service. As demonstrated, U.S. e-commerce operations are more appropriately comparable to full-scale food manufacturers. Some cook and package their finished product onsite, while others receive ingredients and portion by hand or with equipment and then distribute their food products via commercial trucks. These commercial trucks range from private and contracted fleets to third-party carriers that historically have not handled food and are exempt from the Sanitary Transportation Rule. 

The crucial fact to examine in determining regulatory needs is the time window of error for proliferation of microbiological organisms, introduction of chemical and physical hazards, and food safety failures. Food delivery services transport food items from restaurant to consumer, and the available time window of error is short—typically less than one hour. Restaurants and retail establishments have limited onsite storage, and time and temperature controlled for safety (TCS) ingredients are delivered and utilized within a relatively short window of time. Assuming the operation is observing local food safety regulations for cooking, thawing, and hot and cold holding, the available time window is about six hours during the cooling process. The model of concern, e-commerce, is much greater, ranging from 24–85 hours or longer. Typically, the packaged food products are shipped on non-temperature-controlled fleets and, in many cases, left on a consumer's doorstep for 8–10 hours.

FDA Summit on E-Commerce

In October 2021, FDA hosted the New Era of Smarter Food Safety Summit on E-Commerce public meeting, wherein the Administration called on regulators and stakeholders to comment on what, if any, regulations should be imposed on these new business models. The industry heard the call and responded with an excellent turnout of attendees from around the world within the private and public sector, as well as consumers. Forty-five total public written comments were submitted; by my account, 37 comments were relevant to the docket. Reading through submissions, one thing is certain—the need for FDA to address these growing and critical food safety risks is top priority among concerned food safety professionals across the world. 

Esteemed professionals throughout the industry expressed dire concern for consumer safety related to the growing risks posed by the complex, inexperienced, and under-regulated e-commerce food business model. High-level concerns included inadequate temperature controls, lack of federal oversight, inappropriate and inadequate regulations, allergen management, nutritional labeling, product integrity, supply chain mapping, food fraud prevention, and the need for appropriate consumer education. During the Summit, it was highlighted that consumer confidence in these companies is high. However, the available data demonstrates that "meal kit" delivery service food products are not safe under existing controls and regulations. 

Summit panelist Dr. William Hallman presented a 2013 U.S. Department of Agriculture-funded study that examined 427 domestic online vendors, measured delivery and food safety parameters of 169 shipments, and examined 684 products for the presence of indicator organisms and specific pathogens. The study also provided recommendations for consumers and industry to improve food safety. The full study can be found here.

Alarming findings from the study included more than 500 U.S. online vendors offering raw meat using FedEx, UPS, and the U.S. Postal Service, with very few barriers to enter the market and subsequently exit without a trace. Under present regulations, there is no central registry of vendors in the event of a foodborne illness outbreak. Most alarming was that nearly half (47%) of the 684 products arrived with a surface temperature exceeding 40 °F. The disaster recipe here is on point with just the right measures of zero federal oversight, misguided consumer confidence in food safety, inadequate temperature controls, inexperienced operations, and the ability to usurp legal responsibilities. 

FDA Food Code cannot ensure consumer safety for these new food business models. With the introduction of the Food Safety Modernization Act (FSMA), FDA has changed its focus to smarter food safety and incident prevention. The industry now waits with bated breath to see if FDA will take this opportunity to require these high-risk e-commerce business models to register with the Reportable Food Registry and observe FSMA.