• Representative Rosa DeLauro has introduced the Toxic Free Food Act to require FDA to “close the ‘Generally Recognized as Safe’ (GRAS) loophole and make chemical food additives subject to FDA approval and oversight.” 
  • According to DeLauro, the GRAS loophole permits companies to determine whether food additives are safe without oversight from FDA through the voluntary GRAS notification system. This allows “potentially dangerous chemicals” to be present in the food supply.
  • The Toxic Free Food Act would require FDA to amend its regulations to prohibit manufacturers from marketing a substance as GRAS without providing notice to FDA, making the GRAS notification system mandatory. Public comment would be required for all GRAS notifications. In addition, newly synthesized or novel chemical substances and carcinogenic substances would not be permitted to be GRAS.
  • Other provisions of the Act would require revisions to FDA’s regulations to:
    • Prohibit reliance on the determination of experts with conflicts of interest when determining whether a substance is GRAS;
    • Incorporate recommendations into the November 2017 draft guidance “Best Practices for Convening a GRAS Panel;”
    • Create a process to systematically reassess any substance that was previously determined to be GRAS if the determination did not meet the revised standards.
  • Finally, FDA would be required to reestablish the Food Advisory Committee to work on the reassessment standards, process, and methods necessary to complete the reassessment of previous GRAS substances.
  • DeLauro has also submitted written comments to FDA urging the agency to close the GRAS loophole, stating that “this loophole and FDA inaction have failed to keep us safe from chemicals added to our food . . . To rebuild consumer confidence, the FDA must take bold action to ban or restrict food chemicals of concern and to reassert its regulatory role and close the loopholes that allow the chemical companies to decide which chemicals are safe for consumers voluntarily.”
  • Given the current political climate, the prospects for this bill are not clear.  As most readers likely know, the option to develop a GRAS position for a food ingredient was added to the Federal Food, Drug, and Cosmetic Act in 1958.  Although the GRAS system has been criticized by various consumer groups in recent years, responsible companies have used it successfully to bring new, safe food ingredients to the market.
  • Nebraska Governor Jim Pillen signed an executive order at the end of August restricting sales of cultivated meat and said he will press state lawmakers to make Nebraska the third state to ban sale of the food products.  Gorvernor Pillen stated at a press conference that the order is the start of a “full blown attack on lab-grown meat and fake meat.”
  • The order bars Nebraska state agencies from buying cultivated meat and requires businesses to contract with the state to attest that they will not discriminate against “natural-meat producers” in favor of cultivated meat producers.  Additionally, Governor Pillen directed the Nebraska Department of Agriculture to develop regulations to make sure any “lab-grown meat products” sold in stores are properly labeled and are not marketed next to natural meat on the same shelves.  A draft hearing on those regulations has been scheduled for October 8, 2024.
  • As we have previously reported, Florida and Alabama have also enacted laws to completely ban the sale of cultivated meat products, adopting frameworks that lay out stiff financial penalties and possible jail time for anyone found in violation.  Iowa approved a law that mandates specific labeling requirements for cultivated meat and bars the sale of such products in public schools and food assistance programs.  Texas has also adopted an aggressive labeling law for cultivated meat products and lawmakers in several other states, including Arizona and Tennessee, have proposed complete bans.
  • Keller and Heckman will continue to monitor and relay the legislative developments addressing cultivated meat.
  • As we previously blogged about, UPSIDE, a manufacturer of cultivated chicken, has sued Florida regarding its ban (SB 1084) on the sale and manufacturing of cultivated meat. The complaint included a request for an injunction (i.e., to block enforcement of the law pending resolution of the case) which the parties finished briefing last month.
  • One of the issues which was briefed was whether SB 1084 is preempted by the federal Poultry Products Inspection Act (PPIA). The PPIA’s preemption provision (21 USC 467e) states in part that “[r]equirements within the scope of this chapter with respect to premises, facilities and operations of any official establishment which are in addition to, or different than those made under this chapter may not be imposed . . . Marking, labeling, packaging, or ingredient requirements (or storage or handling requirements found by the Secretary to unduly interfere with the free flow of poultry products in commerce) in addition to, or different than, those made under this chapter may not be imposed . . .”
  • As a threshold matter, Florida has argued that the PPIA, including its preemption provision, does not apply because cultivated meat cannot be considered a “poultry product” as that term is defined in the PPIA (“any poultry carcass, or part thereof; or any product which is made wholly or in part from any poultry carcass or part thereof, excepting …[ingredients with small proportions of meat exempted by USDA]. 21 USC 453(f). In contrast, UPSIDE argues that it’s product “easily falls within the PPIA’s broad definition of ‘poultry product,’ since it is composed almost entirely of chicken cells.”
  • Florida also argues that the PPIA “contemplates state laws that complement and supplement its regulatory scope” and that it does not violate the preemption provision because that provision does “not set requirements for the particular ingredient in UPSIDE’s quasi-chicken products” nor “require UPSIDE to change its plants, laboratories, production methods, or other operations.” Stated differently, Florida argues that “SB 1084 does not ban anything that PPIA mandates.” In contrast, UPSIDE counters that SB 1084 is preempted “because it imposes ingredient and operational requirements that are not identical to those imposed under federal law.” USDA permits the ingredient that UPSIDE sells while Florida does not.  
  • We will continue to monitor and report on the outcome of this litigation. The case number is 4:24-cv-00316 and was filed in the United States District Court for the Northern District of Florida.
  • FDA’s Human Foods Program is live as of today, October 1, 2024. We have previously blogged about FDA’s internal reorganization to realign functions of the Center for Food Safety and Applied Nutrition, the Office of Food Policy and Response, and key functions of field operations in the Office of Regulatory Affairs into a unified Human Foods Program.
  • The Deputy Commissioner for Human Foods will report directly to the FDA Commissioner and will have authority over all components of the Human Foods Program. Fourteen offices will comprise the Human Foods Program, focusing on one of three functions:
    • Three offices with risk management functions will manage public health risks, including diet-related chronic diseases, health equity, infant formula, pathogen-related foodborne illness, chemical safety, dietary supplement safety, and ingredient innovation.
    • Four offices with strategic management functions will leverage data to prioritize activities and resources based on risk. This will include risk assessment, strategic planning, goal-setting, and business operations.
    • Seven offices with cross-cutting functions will support risk management priorities, including working with state and local regulators, carrying out compliance and enforcement actions, responding to food-related outbreaks and recalls, engaging with stakeholders, setting standards, engaging with international industry and regulatory counterparts, coordinating laboratory operations, and evaluating the effectiveness of programs and processes.
  • Notably, the Office of Nutrition and Food Labeling will retain its name and most of its functions. However, the premarket review team for infant formula will go to the Office of Critical Foods, which is under the Nutrition Center for Excellence.
  • The reorganization is intended to allow “a modernized FDA that optimizes resources to help the agency meet its public health mission; provide employees with clearer priorities and more career opportunities; and comply with recent legislation” establishing the Office of Critical Foods and ensuring the safety of cosmetics products.
  • Keller and Heckman will continue to report on the implementation of the Human Foods Program.
  • On Wednesday, September 25, 2024, FDA held a public meeting inviting stakeholders to speak on the Agency’s development of an enhanced systematic process for the post-market assessment of chemicals in food. The meeting began with Deputy Commissioner Jim Jones explaining that the purpose of updating FDA’s post-market assessment is to ensure that safety determinations hold up over time and to replace the current ad hoc system with a more systematic process.
  • FDA’s updated approach seeks to proactively initiate post-market assessments of GRAS ingredients, food additives, color additives, food contact substances, and contaminants under its new Human Foods Program.
  • The new process will include three stages:
    • (1) Food Chemical Signal Monitoring: FDA will monitor information across many sources including scientific publications and news reports for any new information raising concerns related to food chemical safety.
    • (2) Triage: FDA will conduct a quality and impact assessment of the information using technology and AI to help determine whether to initiate an assessment; and
    • (3) Fit for Purpose Decision: Depending on the quantity and quality of information received, FDA will conduct either a focused or comprehensive assessment.  Focused assessments will be limited in scope in cases where FDA already has safety information on the chemical or a more discreet issue is involved, and will be conducted internally.  A Focused Assessment may also lead to a Comprehensive assessment.  Comprehensive Assessments will be much more resource intensive and may take years to complete, including requests for data from stakeholders.  FDA will publicize the final scientific assessment and initiate any risk management actions as needed, which could include revoking regulations that authorizethe use of a food additive.  Factors that FDA will consider when deciding between a focused or comprehensive assessment include: changes in exposure, susceptible subpopulation exposure, toxicity, new scientific information, and external stakeholder activity.
  • The meeting included presentations from representatives of both industry and consumer advocacy groups and questions and comments from the public in an ongoing effort to increase transparency and public input regarding food chemical safety.  
  • FDA plans to have the new process in place by the end of the calendar year 2025.  Keller and Heckman will continue to monitor the development of the new post-market assessment process. 
  • The U.S. Food and Drug Administration (FDA) has updated the Mycotoxins in Domestic and Imported Foods Compliance Program to include the monitoring of additional mycotoxins of regulatory interest in human foods, specifically T-2/HT-2 toxins and zearalenone.  The update also reflects the transitions by FDA regulatory laboratories to a multi-mycotoxin method for analysis in human foods.  This allows FDA to obtain results for multiple mycotoxins in a single sample analysis.
  • T-2/HT-2 toxins and zearalenone are both mycotoxins produced by Fusarium molds.  They are found in contaminated grains, such as wheat, rye, oat, and barley.  Contamination by T-2/HT-2 toxins may cause human health issues if consumed, such as high fever, gastrointestinal problems, and hemorrhage.  Zearalenone has been linked to reproductive and non-reproductive effects in humans and animals.  Contamination generally occurs when grains are not stored or dried properly.
  • The data gained by the mycotoxins compliance program will support enforcement actions, risk assessments, and international activities, as well as provide information on mycotoxin incidence, the extent of contamination, and co-occurrence.
  • At the end of July Health Canada announced a proposed guidance document on the labeling of plant-based egg alternatives with comments due by October 28, 2024.
  • The guidance is not highly prescriptive and instead applies a flexible approach which evaluates the product labeling as a whole to determine whether the product avoids creating a false or misleading impression by providing sufficient information so that consumers understand what the product is and that it is not an egg product.
  • In determining whether a product complies with this standard, Health Canada will look to information including the product’s common name, any claims or statements made on the label, the list of ingredients, images on the product, and how the product as a whole appears or is represented. 
  • For example, the guidance indicates that a common name such as “‘plant-based omelette’ does not accurately and precisely describe what the food is” and that a more explicit name such as “soybean protein omelette” is preferred. As this example implies, terms associated with egg products are acceptable so long as they are appropriately qualified.
  • Nutrient content claims are permitted so long as they are truthful and not misleading and they meet the specific regulatory requirements for such claims. Negative claims (e.g., egg-free) may also be useful in communicating the nature of the product to consumers, although such claims are only permitted if the product contains no sources of egg allergen. Furthermore, product images and other features contributing to the product’s general appearance which imply that the product is an egg product (e.g., an image of a farm and/or packaging similar to traditional egg products) must be considered and balanced with other complimentary information. 
  • On Sept. 23, 2024, FDA issued an updated guidance document titled “Standards for Growing, Harvesting, Packing, and Holding of Produce for Human Consumption: What You Need to Know About the FDA Regulation: Small Entity Compliance Guide.” The updates to the guidance reflect changes made to the Produce Safety Rule by the May 2024 final rule “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Relating to Agricultural Water” (the agricultural water final rule).
  • The Produce Safety Rule was initially issued in November 2015 and codified at 21 CFR Part 112 to establish science-based minimum standards for the safe growing, harvesting, packing, and holding of fruits and vegetables for human consumption. The agricultural water final rule revised requirements applicable to pre-harvest agricultural water for covered produce (other than sprouts) by:
    • Replacing the microbial quality criteria and uniform testing requirements with new provisions for conducting pre-harvest agricultural water assessments for hazard identification purposes and using the results in making risk management decisions;
    • Including a requirement to test pre-harvest agricultural water in certain circumstances;
    • Adding new options for mitigation measures, providing covered farms additional flexibility in responding to findings from pre-harvest agricultural water assessments;
    • Requiring expedited implementation of mitigation measures for known or reasonably foreseeable hazards related to certain adjacent and nearby land uses;
    • Requiring management review of pre-harvest agricultural water assessments; and
    • Adding new definitions of “agricultural water assessment” and “agricultural water system.”
  • The agricultural water final rule is covered by pages 18-27 of the guidance document. The rule went into effect July 5, 2024. The first compliance date is April 7, 2025, for large farms, followed by small farms on April 6, 2026, and very small farms on April 5, 2027.
  • On September 17, 2024, the U.S. Food and Drug Administration (FDA) released results from retail sampling of dark chocolate and chocolate-containing products labeled as “dairy free” that were collected and tested for unintended milk in 2022 and 2023.  FDA worked in cooperation with the Pennsylvania Department of Agriculture (PDA) and the Michigan State Department of Agriculture and Rural Development (MDARD).  The sampling and testing was conducted to determine whether these products may contain unintended milk at levels that may be hazardous to people with milk allergy.
  • Unlike FDA’s earlier assessment (FY 2018-2019), which focused on chocolate bars and chocolate chips, this recent effort included tested for milk in additional chocolate-containing products, such as chocolate chip cookies, chocolate syrups, and chocolate baking powders that were labeled as “dairy free.”
  • Thirteen of the 210 samples collected by PDA and MDARD tested positive for milk.  Twelve of these 13 samples contained less than 80 parts per million (ppm) of milk, with one sample testing at 1,083 ppm.  Additionally, the 13 products found to contain milk had labeling with milk allergen advisory statements (e.g., “…made in a facility that also processes milk.”
  • The 13 samples at issue were made by three different manufacturing firms.  In response to the findings, two manufacturers removed the “dairy-free” claim from their chocolate products.  The third manufacturer agreed to remove the “dairy-free” claim from its products if the cause of the presence of milk could not be determined and eliminated pending completion of a root cause analysis.
  • On August 30, 2024, Health Canada announced that it had removed brominated vegetable oil (BVO) from its “list of permitted food additives with other accepted uses,” but that in the absence of an acute health risk, industry will have until August 30, 2025 (1 year) to come into compliance.
  • This decision will not come as a surprise to our readers as earlier this year we reported on Health Canada’s proposal to revoke the BVO authorization, as well as FDA’s final rule revoking the authorization for BVO. FDA also has allowed for a 1-year transition period, with implementation beginning on August 2, 2025. California has also adopted its own BVO ban.
  • There appears to be no major pushback from industry on the decision and Health Canada received just 5 comments responding to its initial proposal, all of them supportive of the ban and the transition period.