Food traceability recordkeeping requirements, major food allergen enforcement, new Prop 65 short-form labeling requirements, and a growing patchwork of state-by-state bans on synthetic chemicals in food packaging are among the top regulatory compliance and legal issues the food industry must address in 2024. And all these developments are happening in tandem with the implementation of the FDA’s new Unified Human Foods Program. 

Food traceability recordkeeping requirements

Companies continue to wrestle with how to meet the compliance timeline for the new recordkeeping requirements under the FDA’s Food Traceability nclick="javascript:window.open('https://www.federalregister.gov/documents/2022/11/21/2022-24417/requirements-for-additional-traceability-records-for-certain-foods', '_blank', 'noopener'); return false;">final rule. Those that manufacture, process, pack, or hold foods designated for inclusion on the FDA’s Food Traceability List (FTL) have until Jan. 20, 2026, to come into compliance, but they will need all that time to prepare.

The rule implements Section 204(d) of the Food Safety Modernization Act (FSMA) and requires companies to maintain nclick="javascript:window.open('https://www.fda.gov/media/163132/download?attachment', '_blank', 'noopener'); return false;">specific “key data elements” (KDEs) associated with certain “critical tracking events” (CTEs) in the handling of food. The KDEs that food companies must keep vary, depending on the CTEs that are performed – from harvesting or food production through processing, distribution, and receipt at retail or other points of service. 

The FDA requires that traceability “lot codes” for FTL foods be assigned, recorded, shared, and linked to other information, identifying foods as they move through the supply chain. Many in the industry have commented that tracing food at the FDA’s expected level will require tracing to the individual product level – a costly and burdensome compliance exercise. 

“The FDA is pushing for electronic solutions for traceability that don’t necessarily exist in the supply chain today,” Cindy Kruger, chief counsel of Food Safety & Regulatory at PepsiCo, told ACI Insights.

A nclick="javascript:window.open('https://www.gao.gov/assets/870/866083.pdf', '_blank', 'noopener'); return false;">report released in January by the U.S. Government Accountability Office (GAO) cited a practical example of a distributor receiving a pallet with products that contain several lot codes. “The distributor would need to track the lot codes at the case level when packing items for shipping to a customer.” 

The OIG report stated that large distribution centers could face additional compliance costs by having “to hire and train additional staff to capture the required data for a large volume of products moving into and out of the centers,” while small businesses and restaurants may have to purchase new technology systems. 

FDA continues to issue new guidance to assist with compliance implementation. Companies seeking further information should refer to the FDA’s website nclick="javascript:window.open('https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-requirements-additional-traceability-records-certain-foods', '_blank', 'noopener'); return false;">here, which provides new traceability plan examples, supply chain examples, FAQs, and more.

Food allergen enforcement

Enforcement of labeling and cross-contact concerning “major food allergens” will continue to be top-of-mind for the FDA in 2024. When the Food Allergy Safety, Treatment, Education, and Research Act took effect on Jan. 1, 2023, it added sesame as the nclick="javascript:window.open('https://www.govinfo.gov/content/pkg/USCODE-2022-title21/html/USCODE-2022-title21-chap9-subchapII.htm', '_blank', 'noopener'); return false;">ninth major food allergen.

Under the Food Allergen Labeling and Consumer Protection Act, manufacturers must declare major food allergens on packaged food labels. With sesame, however, some argue that it is practically impossible to prevent cross-contact with other foods produced in the same facility. Such concerns prompted the FDA in May 2023 to release a nclick="javascript:window.open('https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=117.135', '_blank', 'noopener'); return false;">draft compliance policy guidance addressing the FDA’s enforcement policy regarding major food allergen labeling and preventative controls for cross-contact. 

Relevant to the food industry is a requirement that food facilities establish and implement “a food safety plan that includes a hazard analysis to identify known or reasonably foreseeable hazards that require a preventive control.” According to the guidance, “when a hazard requiring a preventive control is a major food allergen, preventive controls must ensure that the food manufactured, processed, packed, or held by the facility will not be adulterated or misbranded.”

Kruger said the guidance is “revolutionary” in how the FDA expects the industry to treat allergens in their plants and their supply chains, “more akin to how we look at pathogens today.” The regulatory expectations for controlling cross-contact in the supply chain are “new and different and will require more testing labs,” she said. Industry professionals should refer to the guidance as a resource to familiarize themselves with the FDA’s allergen labeling and preventative control expectations.

PFAS regulations

Absent federal efforts, more states are passing laws banning synthetic chemicals in food packaging. States with bans on PFAS include nclick="javascript:window.open('https://dec.ny.gov/environmental-protection/recycling-composting/businesses/pfas-in-food-packaging', '_blank', 'noopener'); return false;">New York, nclick="javascript:window.open('https://leginfo.legislature.ca.gov/faces/billNavClient.xhtml?bill_id=202120220AB1817', '_blank', 'noopener'); return false;">California, nclick="javascript:window.open('https://leg.colorado.gov/bills/hb22-1345', '_blank', 'noopener'); return false;">Colorado, nclick="javascript:window.open('https://www.capitol.hawaii.gov/session/archives/measure_indiv_Archives.aspx?billtype=HB&billnumber=1644&year=2022', '_blank', 'noopener'); return false;">Hawaii, nclick="javascript:window.open('https://mgaleg.maryland.gov/mgawebsite/Legislation/Details/hb0275?ys=2022rs', '_blank', 'noopener'); return false;">Maryland, nclick="javascript:window.open('https://www.rilegislature.gov/pressrelease/_layouts/15/ril.pressrelease.inputform/DisplayForm.aspx?List=c8baae31-3c10-431c-8dcd-9dbbe21ce3e9&ID=372954', '_blank', 'noopener'); return false;">Rhode Island, nclick="javascript:window.open('https://legislature.vermont.gov/statutes/fullchapter/18/033A', '_blank', 'noopener'); return false;">Vermont, nclick="javascript:window.open('https://www.maine.gov/dep/spills/topics/pfas/PFAS-products/', '_blank', 'noopener'); return false;">Maine, nclick="javascript:window.open('https://app.leg.wa.gov/rcw/default.aspx?cite=70A.222.070', '_blank', 'noopener'); return false;">Washington, and nclick="javascript:window.open('https://www.revisor.mn.gov/statutes/cite/325F.075', '_blank', 'noopener'); return false;">Minnesota. 

Colorado, Maryland, Rhode Island, and Minnesota have PFAS bans that took effect this year. Maine’s law will take effect Jan. 1, 2025. Other states’ PFAS bans—including New York, California, Hawaii, and Vermont—have already taken effect. Washington’s PFAS law follows a tiered implementation date by type of food packaging. The first tier took effect Feb. 1, 2023, while the second tier will take effect May 1, 2024.

Some states require certificates of compliance, including New York, Rhode Island, and Vermont. New York State has even published a nclick="javascript:window.open('https://extapps.dec.ny.gov/docs/materials_minerals_pdf/pfaspckgflow.pdf', '_blank', 'noopener'); return false;">flow chart, providing guidance on what food packaging needs to comply and when a certification of compliance must be obtained.

The compliance message: With this growing patchwork of state-law PFAS bans, the burden falls on companies to decipher the scope of each law, when they take effect, and which ones require a certificate of compliance. Prudent companies will want to stay alert of any new state-law PFAS bans. 

Prop 65

In October 2023, the California Office of Environmental Health Hazard Assessment (OEHHA) proposed amendments to Prop 65 that, if implemented, would impose significant new compliance and cost burdens onto companies that sell consumer products in California.

In its current form, Prop 65 requires companies to provide a “clear and reasonable” warning – either in short- or long-form – to consumers about exposures to chemicals determined by the OEHHA to cause cancer or reproductive harm when that exposure exceeds an established safe-harbor level in their consumer products.

“Not requiring a specific chemical or chemicals to be included in the short-form warning has caused its over-use, diluting the impact of legitimate warnings,” the OEHHA nclick="javascript:window.open('https://oehha.ca.gov/media/downloads/crnr/shortformpublichearingtranscript122723.pdf', '_blank', 'noopener'); return false;">said. This prompted proposed changes requiring companies to identify on their short-form warning at least one Prop 65-listed chemical present in their consumer products.

The public comment period, which ended Jan. 1, elicited significant pushback from industry. One nclick="javascript:window.open('https://oehha.ca.gov/media/dockets/20664/20712-consumer_brands_association_california_chamber_of_commerce_and_all_listed_organizations/prop_65_letter_april_2022.pdf', '_blank', 'noopener'); return false;">joint comment letter expressed concern that the Prop 65 amendments would cause “significant disruption and costs on small and large businesses alike because it will necessitate label changes on every product that currently bears a short-form warning.” 

When a product is delivered to a consumer following a website or catalog order, the OEHHA proposes that warnings also be included on or with the product. The letter continued that such changes would “necessitate website, marketplace listing, and catalog updates, as well as communications with all retailers regarding the label changes,” which would necessitate significant time and investments. 

To comply, companies would have to test their products for prohibited chemicals, and product distributors may even have to start requiring Prop 65 certification documents from their downstream suppliers.

nclick="javascript:window.open('https://oehha.ca.gov/media/dockets/21229/21422-fluidra_-_comments_to_notice_of_proposed_rulemaking_and_announcement_of_public_hearing_amendments_to_article_6_clear_and_reasonable_warnings_safe_harbor_methods_and_content/fluidra_comments_to_proposed_rule_making_12202023.pdf', '_blank', 'noopener'); return false;">Another industry commenter said OEHHA’s estimated $4,273 per business compliance cost is “egregiously inaccurate and misrepresentative of the realistic cost of doing business.” A manufacturer with thousands of unique product SKUs could “conservatively” spend an estimated $225,000, the commenter said.

The letter summed up the sentiment expressed by many in the industry: “The lingering effects of the COVID-19 pandemic have all manufacturers struggling with numerous unforeseen challenges such as labor shortages, increased component, material, and freight costs, as well as rising inflation disrupting consumer confidence and spending. We do not feel there is enough value in these proposed amendments to justify the financial burden to California business and consumers.”

FDA Unified Human Foods Program

All of these regulatory developments are happening at the same time of the anticipated launch of the FDA’s new unified Human Foods Program (HFP)—an agency-wide reorganization plan. Under the proposed plan, completed in December 2023, the unified HFP will bring together the Center for Food Safety and Applied Nutrition, the Office of Food Policy and Response, and certain Office of Regulatory Affairs (ORA) functions and will be overseen by a nclick="javascript:window.open('https://www.fda.gov/news-events/press-announcements/fda-names-first-deputy-commissioner-proposed-unified-human-foods-program', '_blank', 'noopener'); return false;">new deputy commissioner.

According to an FDA nclick="javascript:window.open('https://www.fda.gov/news-events/press-announcements/fda-advances-reorganization-proposal-unified-human-foods-program-field-operations-and-additional', '_blank', 'noopener'); return false;">press release, the ORA would be renamed the Office of Inspections and Investigations (OII), tasked with overseeing the FDA’s field-based inspections, investigations, and import operations. Consumer and whistleblower complaints will be received, triaged, and closed under the HFP. Many new offices will be created, while current ones will be merged. 

nclick="javascript:window.open('https://www.fda.gov/about-fda/fda-organization/fdas-proposal-unified-human-foods-program-and-new-model-office-regulatory-affairs', '_blank', 'noopener'); return false;">According to the FDA, the proposed reorganization plan would “strengthen the agency’s ability to oversee and protect the human food supply and other products it regulates.” Following several remaining critical steps, the FDA said it is hopeful implementation will occur this year.