Key issues discussed during the meeting include online labeling, last mile traceability, and adequate training and knowledge among shopping and delivery workers. This memorandum provides a summary of the key takeaways from the summit.

FDA is accepting electronically-submitted public comments through November 20, 2021, to docket FDA-2021-N-0929. Please see Appendix A for a list of questions about which FDA seeks comments.

Background & Scope

On October 19-21, 2021, FDA held the New Era of Smarter Food Safety Summit on E-Commerce: Ensuring the Safety of Foods Ordered Online and Delivered Directly to Consumers. The meeting brought together federal, state, and local regulatory partners and a range of stakeholders, including industry, consumers, health organizations, academia, and international regulatory counterparts to discuss food safety concerns and areas of potential improvement for regulatory oversight specific to e-commerce.ⁱ The agency intended the summit to be the beginning of a continuing conversation regarding food safety and e-commerce.

The summit is part of FDA’s New Era of Smarter Food Safety initiative, which seeks to modernize the Agency’s approach to food safety.ⁱⁱ There was a focus on new business models, such as Business to Consumer (“B2C”) e-commerce (e.g., online grocery shopping and food delivery services).

The summit featured speaker presentations followed by roundtable Q&A sessions. Food safety and regulatory challenges related to the following prevalent B2C models were discussed:

• Produce and meal kit subscription and delivery services delivered by mail.
• “Ghost kitchen” facilities that do not have a storefront or dining area and are used only to prepare food for restaurants, other delivery, or catering businesses. Multiple businesses may operate out of a single location.
• “Dark store” fulfilment centers that fulfil delivery and pickup orders without in-store retail services.
• Third-party food delivery services that deliver food in “the last mile” between a restaurant and consumer.

Summit Highlights

Food Safety Risks

The following food safety concerns were discussed during the summit.

• Traceability in the “last mile”: Speakers raised traceability as a top priority, especially concerns with the lack of traceability in last-mile delivery. For example, if adulteration were to occur during delivery and the third-party delivery service is delivering for multiple restaurants or companies, state health agencies noted they would have a difficult time tracing the adulteration to the individual deliverer. As another example, meal-kits containing repackaged ingredients may not carry through labeling with identifying information like lot codes.
• Safe delivery and temperature control of perishable foods: Both industry and government raised concerns about the safe delivery of perishable foods, particularly with respect to ensuring that restaurant foods, grocery deliveries, and kit or produce deliveries are delivered to and received by the consumer at safe temperatures. Concerns raised include the following:
  • Third-party driver deliveries. Speakers raised concerns about third-party drivers delivering groceries and restaurant foods without thermal protection, such as insulated packaging, noting that it is not uncommon for drivers to make several stops before reaching the consumer. Drivers also may have limited means of controlling the temperature of foods during the delivery period.
  • Postal deliveries. Mail-delivered foods that may require cold storage, including produce, meat, poultry, and seafood, present unique challenges for maintaining temperatures during transport and upon delivery. This is especially an issue when foods are left outside after being delivered.
  • The meeting discussed a 2015 study conducted and published by Rutgers University professor William Hallman that analyzed the food safety policies and safety of mail-delivered products from domestic vendors of meat, poultry, seafood, and game products ordered online and delivered by FedEx, UPS, and USPS.ⁱⁱⁱ Nearly half of the 684 products delivered as part of the study arrived at an unsafe temperature (above 40°F).
• Adulteration and cross-contamination: Industry and regulatory officials also raised concerns about intentional and unintentional adulteration and cross-contamination, especially among meal kits and third-party delivery of restaurant foods. For example, meal kits containing ingredients that have been repackaged into recipe-ready portions were said to present risks of cross-contamination. Speakers said that there is little visibility regarding whether adequate controls are in place. As another example, last-mile delivery personnel may be handling a wide variety of foods with little attention to the design and sanitation of delivery containers, which again presents potential risk for both cross-contamination and unintentional adulteration.
• Food tampering: Several industry panelists noted that their companies have implemented proactive measures like sticker seals and stapled bags to discourage tampering with food during last-mile delivery. They also noted, however, that methods are not uniform, and there are no industry-wide recommended best practices. In addition, speakers discussed the possibility that new technologies used for food delivery may be autonomous, so foods may be left unmonitored for a longer period of time. Companies developing pilot programs in this space appear to be taking steps to ensure the autonomous delivery process includes some type of recipient-verification requirement.

Regulatory Framework

FDA sought input on whether B2C e-commerce models may require a different regulatory approach than business-to-business (B2B) commerce and traditional retail settings. The following were raised as potential regulatory gaps and/or areas of uncertainty.

• Kit-food manufacturers: There was some consensus among panelists that most companies in this space appear to be operating under the Retail Food Code. There was a discussion about whether these businesses should be subject to the same FSMA food safety regulations that food manufacturing facilities must follow (e.g., Preventive Controls for Human Food).
• Ghost kitchens: Ghost kitchens may operate under one or more names and on several different online platforms, making it difficult for regulators to identify a single facility’s Food Code violation history. Companies that work with ghost kitchens noted they have internal policies to thoroughly vet their vendor partners and that they emphasize early and ongoing training and audits to ensure compliance with company procedures. Nonetheless, the limited visibility of these operators is a concern to regulators.
• Availability of mandatory labeling information: While many companies currently provide nutrition and allergen information in online postings, there are no uniform practices or methods to provide continuity across sites. Regulators and consumer advocates expressed a need for consumers, including non-English speakers and visually-impaired consumers, to be able to access the essential nutritional and allergen information of foods they order. Dr. Claudine Kavanaugh, Director of FDA’s Office of Nutrition and Food Labeling, noted that the available nutritional information varied greatly when compared across multiple websites often. For example, some information may be presented in image rather than text form, at different areas on the page, or sometimes by a link.
• Food sales on social media: More foods are being sold exclusively through social media platforms by businesses that do not necessarily identify themselves as food retail services. There is general concern that some businesses, especially small businesses new to the food manufacturing space, are unaware of the food safety regulations that apply to them. Speakers from state governments noted that they rely on consumer complaints and reporting to identify social media enterprises that have avoided regulation, but they do not have the capacity to seek out businesses or individuals selling food via social media. Both state and local governments also noted they often have been met with a general unwillingness to cooperate from companies in this space and that there is not often an interest in working towards compliance.
• Food safety training at third-party delivery services: Some panelists suggested that restaurants and kit food or produce delivery firms should verify the third-party services they use and to write food safety and liability provisions into contracts. However, the business structure of delivery services, many of which rely on independent contractors rather than employees, presents challenges to imposing training programs or enforcing food safety measures that may jeopardize the independent contractor status of drivers.
• Pet food companies selling exclusively B2C: It was noted that pet food companies selling B2C may have a different FDA facility registration status than B2B sellers. This could mean that they are not covered by FSMA’s Preventative Controls for Animal Food regulation by virtue of not being an FDA registered facility.

International Perspectives

Day 3 of the summit was dedicated exclusively to gaining insight into international perspectives on retail food safety. Speakers on this day presented perspectives from Brazil, Japan, Germany, and Wales. The presentations showed that the overarching problems with e-commerce are transnational and many of the food safety concerns identified by domestic stakeholders during the summit are also challenges abroad. Presenters also identified that different internet privacy protections can translate into stronger or weaker traceability and enforcement authority. For example, privacy protections in Brazil make it difficult to regulate e-commerce activities, including limiting access to information about website operators and domain information by requiring regulators to request access through the judiciary.

Takeaways & Next Steps

Across all of the summit sessions, industry representatives emphasized they are committed to ongoing dialog with FDA on these issues. Industry and local and state government representatives also expressed a need for guidance from FDA to improve and unify enforcement strategies and information sharing.

FDA emphasized that the summit was only a first step towards improving food safety measures in e-commerce. FDA repeatedly underscored its desire to collaborate with industry to better understand their practices and supply chains. FDA also said that the agency will explore development of regulatory strategies to fill any significant regulatory gaps.* * *

We will continue to monitor FDA’s updates related to this public meeting, as well as other activity generally related to food safety and e-commerce.

Appendix A: Topics for Discussion

FDA is accepting electronically-submitted public comments through November 20, 2021, to docket FDA-2021-N-0929.

FDA has specifically requested comments on the following subjects of interest:

Types of B2C E-commerce Models

• What models other than the existing B2C e-commerce models for human and animal food (e.g., on-line ordering, produce and meal kit subscription services, ghost kitchens, dark stores) currently exist or are being developed?

Food Safety Risks

• Are there unique chemical (including allergen), physical, and/or microbiological that relate to the manufacturing, packaging, labeling, storage, and delivery of human foods sold through B2C e-commerce models? We are particularly interested in the “last mile” of B2C e-commerce to its final destination.
• What, if any, are the unique food safety risks associated with emerging autonomous food delivery models (e.g., drones, parachutes, robots)?
• Are there food safety risks unique to animal food sold through B2C e-commerce compared to animal food sold business to business or in traditional retail settings?

Standards of Care

• What additional practices or standards of care, beyond those used for food sold in traditional manufacturing and retail operations, are being used by industry for human foods sold through B2C e-commerce to manage food safety risks? We are particularly interested in how those risks are managed during the “last mile” of delivery to its final destination using third-party delivery services and autonomous delivery models.
• What technologies are available to help control the food safety risks of human and animal food sold through B2C e-commerce, particularly during delivery?

Regulatory Framework

• Are there unique food safety issues associated with human and animal food sold through B2C e-commerce that require a different regulatory approach than food sold business-to-business or in traditional retail settings?
• What regulatory and compliance gaps and challenges exist with respect to the current federal, state, local, territorial, and tribal (SLTT) regulatory structure for B2C e-commerce businesses that sell human food? What regulatory approaches have been effective and are there lessons learned you can share?
• What additional actions (e.g., training, outreach, guidance, or revisions to the FDA Food Code), if any, could FDA and its SLTT partners undertake to help ensure the safety of human and animal food sold through B2C e-commerce?

Labeling for Online Grocery Shopping Platforms

• What labeling information is being presented to consumers in online grocery shopping platforms, such as websites and mobile applications?
• How is labeling information presented on these platforms (e.g., on the same page as the product, using web links)? When provided, is the nutrition information and other labeling information (e.g., allergen and ingredient labeling) legible and consistent with the label on the actual product?
• What challenges, limitations, or advantages do online grocery retailers, manufacturers and third-party online grocery providers encounter when displaying labeling information online?

What labeling information is important for consumers to have access to when using the online grocery shopping platforms (e.g., nutrition facts label, ingredient declaration, allergen information, food safety information)?

References