FDA Holds Summit on E-Commerce and Food Safety
The
U.S. Food and Drug Administration (FDA) recently hosted a three-day virtual
summit on e-commerce, which focused on food safety for foods ordered online and
delivered directly to consumers. Because of the increasing number of consumers
ordering their foods online, convening this summit is a goal set in FDA’s New
Era of Smarter Food Safety blueprint. FDA intends to use learnings from the
public meeting to help determine what actions, if any, may be needed to keep
consumers safe.
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
i
86 Fed. Reg. 50130 (Sept. 7, 2021). Summit information and event materials,
including the speaker list and agenda are also available at https://www.fda.gov/food/workshops-meetings-webinars-food-and-dietary-supplements/new-era-smarter-food-safety-summit-e-commerce-ensuring-safety-foods-ordered-online-and-delivered.
ii
New Era of Smarter Food Safety Blueprint, FDA (July 2020), available at https://www.fda.gov/food/new-era-smarter-food-safety/new-era-smarter-food-safety-blueprint.
iii
W.K. Hallman, et al., Online Purveyors of Raw Meat, Poultry, and Seafood
Products: Delivery Policies and Available Consumer Food Safety Information, 35
Food Protection Trends 80 (Mar. 2015), available at https://www.foodprotection.org/files/food-protection-trends/Mar-Apr-15-Hallman.pdf.
WRITTEN BY:
OTHER NEWS
- NOTIFICATION OF FSMA - PCQI TRAINING SCHEDULE MAY 2024
- NOTIFICATION OF FSMA - PCQI TRAINING SCHEDULE APRIL 2024
- NOTIFICATION OF FSMA - PCQI TRAINING SCHEDULE MARCH 2024
- NOTIFICATION OF FSMA - PCQI TRAINING SCHEDULE JANUARY 2024
- NOTIFICATION OF FSMA - PCQI TRAINING SCHEDULE NOVEMBER 2023
- NOTIFICATION OF FSMA - PCQI TRAINING SCHEDULE OCTOBER 2023
- G.O.L COMPANY IS PLEASED TO INTRODUCE TO CLIENTS THE ON-BEHALF OF CLIENT AMS/ACI/ISF/AFR DECLARATION SERVICES
- NOTIFICATION OF FSMA - PCQI TRAINING SCHEDULE SEPTEMBER 2023
- NOTIFICATION OF FSMA - PCQI TRAINING SCHEDULE AUGUST 2023
- NOTIFICATION OF FSMA - PCQI TRAINING SCHEDULE JUNLY 2023
- What is Prior Notice? Note on Prior Notice when sending goods to the US
- Revolutionizing Business Logistics Services: Innovative Solutions for Enhanced Quality
- Navigating FDA 510k: A Comprehensive Guide to Requirements and Exemptions
- FDA AND RELATED REGULATIONS
- FAQ ABOUT ACI EGYPT
- NOTIFICATION OF FSMA - PCQI TRAINING SCHEDULE Jun 2023
- NOTIFICATION OF FSMA - PCQI TRAINING SCHEDULE MAY 2023
- NOTIFICATION OF FSMA - PCQI TRAINING SCHEDULE April 2023
- THE 21ST-ESTABLISHMENT ANNIVERSARY PROMOTIONAL PROGRAM OF GOL CO., LTD (APRIL 3RD, 2002 - APRIL 3RD, 2023)
- NOTIFICATION OF FSMA - PCQI TRAINING SCHEDULE MARCH 2023
- NOTIFICATION OF FSMA - PCQI TRAINING SCHEDULE FEBRUARY 2023
- NOTIFICATION OF FSMA - PCQI TRAINING SCHEDULE JANUARY 2023
- NOTIFICATION OF FSMA - PCQI TRAINING SCHEDULE DECEMBER 2022
- THE PROUDLY AND HAPPY PARTY – G.O.L 20 ANNIVERSARY
- PROMOTION PROGRAM – Celebrating the 20th Anniversary of G.O.L CO., LTD. April 3rd 2002 - 2022
- ANNOUNCEMENT OF FSMA-PCQI TRAINING SCHEDULE IN April 2022
- HAPPY 20TH ANNIVERSARY
- Financial stability, proactive capital by Blockchain technology to create NFT assets
- FDA AND RELATED REGULATIONS
- IMPORTING CARGO INTO THE US AND ENJOYING - THE US E-COMMERCE IMPORT PROGRAM
- Catch up Non-tax benefit clearance solution for E-commerce goods into the USA Market
- Parcel clearance is easier than ever with GOL's US E-COMMERCE IMPORT PROGRAM
- FAQ ABOUT ACI EGYPT
- EGYPT CUSTOMS ANNOUNCEMENT TO STOP SUPPORTING BUSINESSES WITHOUT CARGOX PROFILES FROM February 2022
- ANNOUNCEMENT OF FSMA-PCQI TRAINING SCHEDULE IN MARCH 2022