• On June 28, 2023, the California Senate Committee on Health approved Assembly Bill 418 (AB 418), which would end the use of certain chemicals in food products sold in California. The bill has already passed California’s lower house and will soon be voted on by the full California Senate. If passed, the bill will go into effect on January 1, 2025.
  • As we have outlined in a previous post, the bill would prohibit manufacturing, selling, delivering, distributing, holding, or offering for sale a food product that contains any of the following substances: 1) brominated vegetable oil, 2) potassium bromate, 3) propylparaben, 4) Red Dye No. 3, and 5) titanium dioxide. The European Union has already imposed restrictions or bans on use of these substances in food. 
  • If passed, AB 418 would be the first law of its kind in the United States. Advocates of the bill argue that these substances have not been adequately reviewed by the U.S. Food and Drug Administration (FDA) and view this bill as a necessary step to remove harmful chemicals from the food supply. However, apart from factual questions regarding the safety of the substances, the bill also raises interesting questions regarding state authority to restrict the use of food additives that have been approved by FDA. 
  • AB 418 has garnered support by various non-governmental organizations, including  Consumer Reports and The Environmental Working Group. Given California’s economic influence, this bill has the potential to significantly impact the food industry well beyond California.  Keller and Heckman will continue to monitor and report on any developments in this area.
  • Today, the European Commission adopted its proposal for a regulation on plants obtained by certain new genomic techniques (targeted mutagenesis and cisgenesis) (‘NGTs’) and derived food and feed products. NGTs permit more targeted genetic changes than conventional breeding or traditional genomic techniques involving the introduction of genetic material from a non-crossable species, permitting rapid development of plant varieties with beneficial characteristics.
  • Reflecting the lower risks of NGTs compared to traditional genomic techniques recognised by the European Food Safety Authority, the proposal lays down a less burdensome EU regulatory framework than currently applicable for both the deliberate release into the environment of plants obtained by NGTs (‘NGT plants’) and the placing on the market of food and feed containing, consisting of, or produced from, those plants (‘NGT food and feed’). 
  • Under the proposal, NGT plants and NGT food and feed are divided into two categories:
    • Following a notification procedure, NGT plants declared to be equivalent to plants obtained by conventional breeding techniques, and their derived NGT food and feed are exempted from the requirements of EU GMO legislation.
    • All other NGT plants and their derived NGT food and feed remain subject to GMO authorization, traceability, and labelling requirements under current EU GMO legislation, subject to certain adaptations, including lighter, more targeted authorization risk assessment requirements. 
  • The proposal constitutes an important element of the European Green Deal and the related Farm to Fork Strategy in establishing a regulatory framework more conducive to promoting innovation in the development of plant and plant products, permitting more sustainable agricultural and food systems. 
  • As currently worded, any finally adopted Regulation would begin to apply in EU Member States two years after its entry into force.
  • On June 22, 2023, FDA announced it had issued warning letters to 189 retailers for selling unauthorized flavored tobacco products manufactured by Elf Bar and Esco Bar brands. This enforcement action comes on the heels of earlier aggressive action by FDA in its issuance of more than 570 warning letters to firms for the manufacture, sale, or distribution of unauthorized tobacco products from January 2021 through May 2023.
  • In its press release, FDA highlighted two studies recently published in the CDC’s Morbidity and Mortality Weekly Report.  The first study found that Elf Bar branded disposable e-cigarettes were the most popular disposable e-cigarette sold in the U.S. in 2022, and the second study showed thousands of e-cigarette exposure cases reported to the U.S. poison control centers in the past year, most of which were among kids younger than five years old.
  • For context, according to the most recent published annual report from the National Poison Data System (NPDS) in 2021, there were 2,527,332 exposures reported to poison centers. The five products most frequently reported were analgesics (11.2%), household cleaning substances (7.49%), cosmetics/personal care products (5.88%), antidepressants (5.61%) and sedatives/hypnotics/antipsychotics (4.73%). Tobacco products (all categories) were identified in 0.51% of exposure cases, with nicotine-containing e-cigarettes representing 0.21% of all exposures.  For children five years and younger, tobacco products accounted for 1.17% of exposures, with e-cigarettes representing 0.47% of all exposures.    
  • As concerns over youth use of disposable ENDS such as Elf Bar continue to rise, the good news is that current (past-30 days) youth vaping rates appear to be falling. A group of public health experts working with Keller and Heckman recently filed a brief with the U.S. Supreme Court noting, among other things, that youth vaping has declined markedly since 2019.
  • To date, FDA has authorized only twenty-three tobacco-flavored e-cigarette products and devices and has either refused or denied Premarket Tobacco Product Applications (PMTAs) for over 26 million products, the vast majority of which are non-tobacco flavored. Only e-cigarettes subject to PMTA Marketing Granted Orders are authorized to be sold in the United States. Sales of unauthorized tobacco products are prohibited by the Food, Drug and Cosmetic Act and are subject to penalties, including warning letters, injunctions, product seizures, and/or civil monetary penalties. 
  • Keller and Heckman will continue to monitor this space. For more information on tobacco and e-vapor products, subscribe to our sister blog, The Continuum of Risk.
  • As our readers know, California’s Proposition 12 is a statewide statutory initiative measure that establishes standards of confinement for certain farm animals. Throughout the course of a series of lawsuits, namely in the state case of California Hispanic Chambers of Commerce v. Ross, the state court had previously stayed the enforcement of Proposition 12 for whole pork meat until July 1, 2023.
  • After the U.S. Supreme Court upheld the constitutionality of Proposition 12, the California Department of Food and Agriculture (CDFA)’s Animal Care Program issued a guidance document that suggested, with respect to noncompliant whole pork meat in inventory that was purchased prior to July 1, 2023, it did not intend to exercise enforcement due to limited implementation resources:
    • What do I do with noncompliant whole pork meat in inventory that was purchased prior to July 1, 2023?
    • We recognize that current inventory is transient and as purchases of compliant products begin to be made after July 1, 2023, pork products in current stocks will eventually be cleared from freezers and retail stores in California. CDFA understands that there will necessarily be a period of transition. CDFA reiterates that for the remainder of 2023, we intend to focus our limited implementation resources, not on covered products already in commerce, but rather on 1) outreach to ensure that all distributors who are required to register do so; 2) accreditation of third-party certifying agents so that when third-party certification is required for producers and distributor registrations beginning on January 1, 2024, producers and distributors have more options; and 3) certification of producers and distributors.
  • In accordance with CDFA’s guidance, that Sacramento County Superior Court issued a June 16 order that states that noncompliant whole pork meat already in the stream of commerce and in the possession of an “end user” or “pork distributor” (both terms which are defined in 3 CCR 1322), or an FSIS-inspected establishment, may be sold, transported, or donated through Dec. 31, 2023.
  • To qualify for the exemption, the end user, pork distributor, or FSIS-inspected establishment must self-certify that it or another end user, pork distributor, or FSIS-inspected establishment possessed the product as of July 1, 2023.
  • As we previously blogged, on January 31, 2023, the U.S. Food and Drug Administration (FDA) proposed a change in the Agency’s structure to create the FDA Human Foods Program following an independent review which, among other things, recommended structural changes within FDA to improve the Agency’s coordinated decision making.
  • The proposed redesign consolidates the Center for Food Safety and Applied Nutrition (CFSAN), Office of Food Policy and Response (OFPR), and certain functions of the Office of Regulatory Affairs (ORA) into the Human Foods Program (HFP). 
  • On June 27, 2023, the FDA announced the following proposals to further enhance the coordination, prevention, and response activities across the FDA:
    • Bestowing oversite control of all budget and resource allocations of HFP and ORA resources to the new HFP Deputy Commissioner;
    • Merging ORA compliance function with HFP;
    • Realigning eight ORA Human and Animal Food laboratories into HFP;
    • Transitioning and merging certain functions under the Office of Security and Emergency Management;
    • Unifying state and local food safety partnership functions and certain aspects of international food safety partnerships into an Office of Integrated Food Safety System Partnerships in the HFP; and
    • Realigning resources and personnel within ORA to support HFP.
  • Finally, the FDA also released graphics of the new proposed structure for ORA and HFP for clarity. 
  • FDA aims to finalize its reorganization proposal for both ORA and the unified HFP this fall.

Keller and Heckman will continue to monitor and report on FDA’s progress in implementing the proposed reorganization.

  • On June 26, 2023, FDA published a set of FAQs, related to the Food Traceability Rule, along with several new tools on its traceability website intended to help educate and inform industry about the Rule.  
  • For context, the Rule is one of the nine major finalized rules intended to implement the Food Safety Modernization Act and thereby reduce the prevalence of foodborne illness. As we have previously blogged about, the Rule, which was issued in November 2022 and has a compliance date of January 20, 2026, is intended to allow for faster identification and removal of potentially contaminated food from the market.  The Food Traceability List (FTL) designates the foods subject to the rule, and manufacturers of such foods must maintain records about critical tracking events in their supply chain.
  • With the compliance date fast approaching, the new FAQs and tools may help those subject to the Food Traceability Rule determine how the Rule applies and prepare them to meet the requirements. Of note, the new tools include: the results for all foods and associated commodity-hazard pairs in the Risk-Ranking Model for Food Tracing (a tool used by FDA to designate the foods on the FTL); additional descriptions on the Food Traceability List to clarify ambiguous terms; new supply chain examples illustrating how the rule is applied in a variety of scenarios; a new Food Traceability Rule fact sheet; a guide to getting started with the Food Traceability Rule; and additional foreign language translations of tools and supply chain examples.
  • Listeriosis is a rare but serious infection, usually caused by eating food contaminated with the bacterium Listeria monocytogenes (Lm).  The disease primarily affects older adults, pregnant women, newborns, and people with weakened immune systems.  As described in a 2013 Technical Report, the United States Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) worked with the Food and Drug Administration (FDA) in consultation with the Centers for Disease Control and Prevention (CDC) on an “Interagency Risk Assessment: Listeria monocytogenes in Retail Delicatessens.”  FSIS incorporated key findings into its 2014 FSIS Best Practices Guidance for Controlling Listeria monocytogenes (Lm) in Retail Delicatessens that outlines steps retailers can take to prevent certain ready-to-eat (RTE) foods prepared or sliced in retail delicatessens and consumed in the home, such as deli meats and salads, from becoming contaminated with Lm and thus a source of listeriosis. 
  • USDA’s June 23, 2023 Constituent Update announces that FSIS has updated its Best Practices Guidance for Controlling Listeria monocytogenes in Retail Delicatessens in response to USDA-FSIS Retail Listeria monocytogenes (Lm) Focus Group Findings and the National Advisory Committee on Meat and Poultry Inspection (NACMPI) recommendations.  Changes include updated references to the FDA Food Code, relocation of a Deli Self-Assessment Tool to the appendices, and a new glossary, as well as edits to improve readability, such as replacing a summary of the Interagency Risk Assessment with a hyperlink to the report itself.  FSIS also added new sections: Sources of Listeria in Retail Firms, Active Managerial Control, and Risk Mitigation of Listeria monocytogenes (Lm) in Retail Firms.  Additionally, reflecting more recent scientific knowledge, the updated guidance no longer includes a recommendation that retailers should rotate (change) sanitizers. 
  • FSIS considers the guidance to be practical recommendations that retailers can follow to control Lm contamination and outgrowth in the deli that will help ensure RTE meat and poultry products in the deli area are handled under sanitary conditions and are not adulterated.  While geared toward assisting small businesses with compliance, FSIS states that deli departments in large supermarkets can benefit from the information in this guideline as well.
  • As our readers know, in March, USDA’s Food Safety and Inspection Service (FSIS) published a proposed rule to amend its regulations to define the conditions under which the labeling of meat, poultry, and egg products, as well as voluntarily-inspected products, may bear voluntary US origin claims. The current FSIS standard allows “Product of USA” or similar claims to be made if the product was processed in the US, even if the source animal were born, raised, and/or slaughtered abroad. FSIS received serval petitions requesting revisions to this standard and in response commissioned a study which found that most consumers did not understand and were misled by the current US origin claims.
  • As a result of the study, FSIS published the proposed rule to resolve the consumer confusion surrounding the current voluntary origin label claims for FSIS-regulated products. Under the proposed rule, a “Product of USA” or “Made in the USA” claim would only be allowed on meat, poultry, and egg products when derived from animals born, raised, slaughtered, and processed in the US. FSIS clarified that, under the proposal, establishments would not need to include these claims on the label, but if they chose to include them, they would need to meet the requirements of the rule.
  • The comment period closed on June 11 and FSIS received over 3,350 comments, the majority of which are in support of the proposed rule. Notably, Farm Action, the Rural Coalition, and the American Grassfed Association issued a joint public comment in support of the proposed rule. In their comment, the organizations stated that the proposed rule “would finally make the ‘Product of U.S.A.’ label a reliable guide for consumers seeking meat, poultry, egg, and other FSIS-regulated products made entirely, or almost entirely, of U.S.-origin ingredients” and “would be a proper exercise of FSIS’s statutory mandate; enable FSIS to efficiently prevent, rather than sanction, the use of misleading U.S.-origin claims; and generate cognizable economic benefits by protecting consumers and markets from deceptive practices.”
  • On June 20, 2023, the U.S. Food and Drug Administration (FDA) released its report on the Occurrence of Foodborne Illness Risk Factors in Fast Food and Full-Service Restaurants.  According to the Centers for Disease Control and Prevention (CDC), more than half of foodborne illness outbreaks that occur each year are linked to food from restaurants.
  • The report summarizes FDA’s findings from the 2017-2018 data collection, and is part of FDA’s 10-year (2013-2022) study on trends in foodborne illness risk factors and food safety behaviors and practices in food service facilities.  The results from the 10-year study are used to develop retail food safety initiatives, policies, and targeted intervention strategies focused on controlling foodborne illness risk factors.
  • Risk factors are food preparation practices that can contribute to outbreaks of foodborne illness, such as inadequate cooking, poor personal hygiene, or using food from unsafe sources.  According to the report, the two most commonly occurring foodborne illness risk factors were improper holding time and temperature, and poor personal hygiene.  However, the study showed that having a well-developed Food Safety Management System (FSMS) is the strongest predictor that these risk factors would be minimized.
  • Findings in this report are likely to guide future changes in FDA’s Model Food Code.