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July 1, 2020

FDA Update: Key Food Priorities Unrelated to COVID-19

Advisory

Since the Secretary of Health and Human Services declared a public health emergency in response to COVID-19, much of the US Food & Drug Administration's (FDA's) focus and public facing statements related to food have centered on pandemic response activities and temporary flexibilities. In particular, the agency's Center for Food Safety and Applied Nutrition (CFSAN) has worked to ensure the safety, security and continuity of the US food supply through actions such as mechanisms for reporting temporary disruptions in food supplies, flexibility for certain food labeling requirements, and adapting to remote inspections.

Although responding to COVID-19 has claimed much of the spotlight and significant agency bandwidth, FDA has continued to move forward with longer-term agency priorities, such as modernizing food standards of identity and preparing its Blueprint for a New Era of Smarter Food Safety. Meanwhile, other proposed and final rules that would advance agency priorities, such as defining "healthy" and modernizing standards of identity are either parked at the White House Office of Management and Budget (OMB) or have not left the agency. In this advisory, we discuss an issue of immediate relevance to regulated industry—FDA's current approach to inspections, provide a quick preview of FDA's anticipated Blueprint for a New Era of Smarter Food Safety, and briefly highlight anticipated regulatory and deregulatory actions on the horizon that would advance some of the goals set forth in FDA's multi-year Nutrition Innovation Strategy.

INSPECTIONS

COVID-19 related health and safety concerns and travel restrictions have necessitated changes to FDA's approach to overseeing food safety. Although in-person routine domestic and foreign surveillance inspections are on-hold, FDA continues to perform "mission-critical" inspections (those related to an outbreak of foodborne illness, a Class I recall, or COVID-19) and for-cause inspections.1 FDA is also advancing one of the Blueprint targets—exploring new tools such as the use of virtual or remote inspections. Currently, it is performing a limited number of remote inspections in which the agency reviews records submitted by importers that are covered by Foreign Supplier Verification Program (FSVP) requirements.2 Foreign suppliers whose onsite food facility or farm inspections were postponed due to COVID-19 are being prioritized for these remote inspections, and FDA is also planning to conduct previously-assigned foreign routine and follow-up inspections remotely.

FDA is reportedly working with the US Centers for Disease Control to develop principles and processes for resuming on-site inspections per the criteria outlined in the White House Guidelines for Opening Up America Again.3 FDA anticipates this to be a "phased approach driven by scientific data" which prioritizes protecting the health and well-being of agency staff, state contract inspectors, and the health of workers in regulated industry.4 It is important to note that although inspections are a critical tool for the agency to help ensure food safety, they are but one component of the system in ensuring food safety. Adherence to the FDA Food Safety Modernization Act (FSMA) and other food safety requirements are core industry responsibilities, which FDA will continue to police.5

BLUEPRINT FOR A NEW ERA OF SMARTER FOOD SAFETY

A little over a year ago, on April 30, 2019, FDA announced its "New Era of Smarter Food Safety", an initiative aimed at building on the agency's efforts to implement FSMA, while also taking advantage of technological advances to create a more digital, traceable, and safer food system. FDA sought stakeholder input at an October 2019 public meeting on the initiative, and reportedly had planned to unveil the Blueprint for this initiative in March 2020. The pandemic, however, delayed FDA's release of the Blueprint. Ultimately, this delay provided FDA with important new information. The pandemic underscored the importance of food supply chain security, monitoring, and transparency, and accelerated some potentially long-lasting shifts in the food supply chain and consumer behavior that the pandemic accelerated. Apparently, when FDA started considering the New Era of Smarter Food Safety, it anticipated that 20% of groceries would be ordered online by 2023. Frank Yiannas, Deputy Commissioner for Food Policy and Response, observed that this rapidly changed due to the imposition of shelter-in-place orders, and reflects a trend that may not subside after the pandemic has passed.6 FDA's experiences with COVID-19 also showed the type of pressures that the food system experiences during a time of crisis, and the importance of traceability in the food supply chain. FDA has revised the Blueprint to incorporate "lessons learned" over the past few months, and anticipates releasing the Blueprint in the near future.7 A brief summary of the key elements identified in an early June update on the Blueprint follows below:

Enhanced Traceability

Enhancing food traceability, through technologies such as blockchain, and other advanced analytical methods can provide FDA with the ability to track and trace products in the food chain and give the agency more visibility into the food supply chain. Although this prong of the strategy was initially conceived to track and trace contaminated food and respond to public health risks,8 the pandemic showed that traceability and insight could help FDA and industry identify "marketplace imbalances" such as the types of shortages seen in the past few months. By "digitizing" the food system, FDA expects that our food system could become "stronger, more agile, and resilient." Note, CFSAN is prioritizing traceability in other aspects of its food safety work. As part of its "2020 Leafy Greens STEC Action Plan," issued in response to dozens of foodborne outbreaks of Shiga toxin-producing E. coli (STEC) over the past decade, FDA plans to issue a proposed rule for implementing Section 204 of FSMA related to "records required for tracking and tracing designated foods, which may serve as a foundation for traceability throughout the entire food system."9

Smarter Tools for Prevention

"Smarter" tools, such as root cause analyses and predictive analytics are a cornerstone of the forthcoming Blueprint. FDA is also interested in exploring the use of "new" tools, such as virtual or remote inspections, which FDA has started utilizing during the pandemic. Such tools can help FDA identify and assess contamination and other food safety risks.

Protections for Foods Ordered Online

As Deputy Commissioner Yiannas and many Americans have learned during the pandemic, the future of grocery shopping may well be online. Aware of potential longer-term shifts in consumer behavior and in the food supply chain, the Blueprint will focus on the safety of foods ordered online and delivered to consumers.

Establishing and Supporting Food Safety Cultures on Farms, Food Facilities, and at Home

Last, echoing FDA's commitment to a "Quality Culture" in drug manufacturing, the Blueprint is also focused on establishing a "Food Safety Culture" across the food manufacturing industry and at home. FDA emphasized the importance of these stakeholders "accepting responsibility" and owning their roles in promoting food safety.

MODERNIZING FOOD STANDARDS OF IDENTITY

Earlier this year, FDA made incremental progress in advancing a key goal in the agency's multi-year Nutrition Innovation Strategy—modernizing food standards of identity.10 In February, FDA re-opened the comment period on a 2005 proposed rule entitled, Food Standards; General Principles and Food Standards Modernization.11 FDA requested comments on the thirteen principles for establishing, revising, or eliminating a food standard that were proposed in 2005 and on issues pertaining to how to create general principles for establishing new food standards and for revising or eliminating existing food standards. The agency was especially interested in feedback on whether FDA should finalize the proposed rule, whether principles should be added, eliminated, revised, or retained, and the specific revisions that FDA should make to better reflect its modernization goals.12 In April, FDA extended the comment period deadline for 90 days to July 20, 2020.

Other efforts to modernize specific food standards that were announced in the 2019 Unified Agenda appear to still be percolating through the agency and have not progressed to OMB review or publication in the Federal Register. Of note is a final rule to revoke the standards for lowfat yogurt and nonfat yogurt and to amend the standard of identity for yogurt that was slated for submission in May 2020.13 This final rule would modernize the standard of identity for yogurt so as to "allow for technological advances, to preserve the basic nature and essential characteristics of yogurt, and to promote honesty and fair dealing in the interest of consumers."14 Two other proposed deregulatory actions related to standards modernization—revoking the standard of identity regulations for Cherry Pie and French Dressing—were also listed in the Unified Agenda, but have not been published in the Federal Register.15

REGULATIONS ON THE HORIZON: DEFINING "HEALTHY"

Last summer, FDA made significant progress on achieving one of its goals set forth in the 2018 Nutrition Innovation Strategy—modernizing the claim, "healthy." Specifically, in August, 2019, FDA submitted a proposed rule defining the term to OMB for review.16 The proposed rule would update the 1990s-era definition for the implied nutrient content claim, "healthy", to align the definition with current nutrition science and federal dietary guidelines. It would also revise the requirements for when a "healthy" claim may be used in food labeling so that the claim may reflect "current science and dietary guidelines and helps consumers maintain healthy dietary practices."17 Although OMB's website suggested a Nov. 2019 publication date for this non-economically significant rule, the regulation is still under OMB review.

CONCLUSION

While the pandemic has shifted the nation's and FDA's focus, we anticipate that FDA will continue to work on longer-term food priorities, including releasing the Blueprint. We will continue to monitor FDA regulatory and policy developments pertaining to food, and look forward to forthcoming developments.

© Arnold & Porter Kaye Scholer LLP 2020 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.

  1. FDA, FDA's Perspective on Food Safety and Availability During and Beyond COVID-19, A Conversation with Frank Yiannas (Apr. 16, 2020).

  2. FDA, FDA to Temporarily Conduct Remote Importer Inspections Under FSVP Due to COVID-19 (Apr. 3, 2020).

  3. FDA, Coronavirus (COVID-19) Update: FDA Updates on Surveillance Inspections During COVID-19 (May 11, 2020).

  4. Id.

  5. FDA, FDA's Perspective on Food Safety and Availability During and Beyond COVID-19, A Conversation with Frank Yiannas (Apr. 16, 2020).

  6. Id.

  7. FDA, Pandemic Challenges Highlight the Importance of the New Era of Smarter Food Safety (June 2, 2020).

  8. FDA, Getting Smarter About Food Safety: The Pandemic and Lessons Learned (last updated June 23, 2020); FDA, New Era of Smarter Food Safety (last updated June 4, 2020).

  9. FDA, 2020 Leafy Greens STEC Action Plan (last updated March 5, 2020).

  10. FDA has issued over 200 standard of identity regulations that prescribe the composition of a food, mandatory and optional ingredients, proportions of ingredients, and manufacturing methods. Recognizing that many of these standards are outdated, FDA included food standards modernization in its 2018 Nutrition Innovation Strategy.

  11. 85 Fed. Reg. 10107 (Feb. 21, 2020).

  12. These goals include protecting consumers against economic adulteration; maintaining the basic nature, essential characteristics and nutritional integrity of food; and promoting industry innovation by giving manufacturers the flexibility to produce healthier foods.

  13. FDA published a proposed rule on this topic in 2009. See 74 Fed. Reg. 2443 (Jan. 15, 2009).

  14. OMB, Fall 2019 Unified Agenda, Milk and Cream Product and Yogurt Products, Final Rule to Revoke the Standards for Lowfat Yogurt and Nonfat Yogurt and to Amend the Standard for Yogurt.

  15. OMB, Fall 2019 Unified Agenda, Frozen Cherry Pie; Proposed Revocation of a Standard of Identity and a Standard of Quality; OMB, Fall 2019 Unified Agenda, French Dressing; Proposed Revocation of a Standard of Identity.

  16. OMB Regulatory Review, Nutrient Content Claims, Definition of Term: Healthy.

  17. Id.

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