• 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.
  • The National Chicken Council (NCC) is calling for an extension to the comment period for the Food Safety and Inspection Service’s (FSIS) proposed rule prohibiting the sale of chicken and turkey contaminated with certain types of Salmonella. The initial comment period was 60 days from when the proposed rule was published, and FSIS has already granted a 30-day extension.
  • As previously discussed on this blog, the proposed rule (published on August 7, 2024) is intended to establish standards to prevent raw poultry products that contain high levels of Salmonella from entering commerce and to require poultry establishments to develop a microbial monitoring program to prevent pathogen contamination through the slaughter system.  
  • In its letter, NCC noted that the proposed rule is “incredibly complex and is based on voluminous technical information” so the current comment period is not adequate to fully review, analyze, and provide feedback. NCC stated that the association and its members had anticipated participating in FSIS webinars would help them to learn more about the proposal and ask clarifying or technical questions, but that “the webinars failed to provide meaningful insights or clarification on most of the clarifying and technical questions asked by participants.” The lack of clarity, according to NCC, impedes the ability to meaningfully comment on the proposal.
  • NCC is requesting at least a 90-day extension of the comment period; the Congressional Chicken Caucus Co-chairs have also asked for an additional 180 days to comment. This would push the deadline to April 4, 2025.
  • Keller and Heckman will continue to monitor and report on this proposed rule.
  • The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS), and the California Department of Food and Agriculture (CDFA) announced that they have eradicated all populations of invasive fruit flies from California. 
  • “Invasive fruit flies are among the most destructive and costly pests globally, threatening more than 400 species of fruits and vegetables, including many of California’s most valuable crops such as oranges, grapes, mangoes, blueberries, and tomatoes,” said USDA Under Secretary for Marketing and Regulatory Programs Jenny L. Moffitt. “The eradication of these pests marks a major victory for California’s agricultural economy.”
  • The joint eradication effort addressed infestations from five introduced species: Oriental (Bactrocera dorsalis), Tau (Zeugodacus tau), Queensland (Bactrocera tryoni), Mexican (Anastrepha ludens) and Mediterranean (Ceratitis capitata) fruit flies.  According to the USDA press release, the 2023 invasive fruit fly outbreak was unprecedented, and was the worst in CDFA’s 100-year history.
  • APHIS deployed hundreds of employees to join forces with CDFA and the agricultural commissioners for trapping, fruit removal, and survey activities.  Eradication strategies included the release of sterile Mediterranean and Mexican fruit flies to disrupt the reproduction of these invasive species.
  • The California legislature passed AB 1830, which is a bill that, if signed into law by Governor Newsom, would require that corn masa flour contain 0.7 mg of folic acid per pound of corn and that wet corn masa products contain 0.4 mg folic acid per pound of end product. The bill would also require that folic acid be declared on the nutrition label and that products declare that they contain corn masa flour or were manufactured through a wet corn masa manufacturing process.
  • Corn masa flour is defined as a “dry-type product made from corn that has been treated with slaked lime or otherwise undergoes a process known as nixtamalization” while wet corn masa product is defined as a “food manufactured by using an alkali solution with corn kernels to transform them into nixtamal.”
  • The bill exempts cottage food operations, food facilities (operations that provide food at the retail level), and grocery stores that offer for retail sale corn masa flour that does not contain folic acid so long as the grocery store also offers corn masa flour that meets the folic acid fortification requirements. Snack foods are also exempted.
  • Folic acid deficiency in pregnant women is a common cause of defects in the neural tube, an embryonic tissue which develops into the brain and spinal cord. The law is intended to reduce the incidence of such disorders, particularly among Latin Americans, many of whom consume corn masa as a dietary staple. Although FDA mandates folic acid in all enriched cereal grain products (see e.g., 21 CFR 137.165(a)), the addition of folic acid in corn masa flour is optional (21 CFR 172.345(i)), and the California law indicates that only 10% of corn masa flour products are fortified with folic acid.
  • If signed into law (as is expected), the provisions of the bill will be implemented starting on January 1, 2026.
  • On September 10, 2024, USDA’s Food Safety and Inspection Service published a Federal Register Notice related to the updated guidelines on substantiating animal-raising or environment-related labeling claims on meat and poultry products, that were released on August 28 and discussed in a previous blog. In the Federal Register Notice, USDA responds to previous comments, and includes information to submit new comments. Changes to the guidelines are related to updated scientific information, sampling data, online questions and answers, public comments, petitions, and stakeholder meetings.
  • Examples of animal-raising claims include “Raised Without Antibiotics,” “Grass Fed,” “Free-Range,” and “Raised Without the Use of Hormones.” Environment-related claims include, among others, “Raised using Regenerative Agriculture Practices,” and “Environmentally Responsible.” These claims are considered “special statements and claims” that trigger the requirement to submit meat and poultry product labels to FSIS for approval before the products may be distributed in commerce. FSIS reviews labels bearing these claims on a case-by-case basis by reviewing the production protocol submitted with the application, which FSIS will approve if:
    • The documentation supports the claim made;
    • The claim is otherwise truthful and not misleading;
    • The claim and any qualifying information is prominently and conspicuously displayed on the label; and
    • The claim does not otherwise render the product misbranded under the Federal Meat Inspection Act and the Poultry Products Inspection Act.
  • FSIS initially published the guidelines in October 2016 and first updated them in December 2019, when the Agency requested comments specifically on the use of the claim “free range” for poultry products in response to a petition. The guidelines are intended to advise establishments on the type of documentation they should submit to substantiate label claims and reduce consumer confusion regarding such claims.
  • In response to comments on the animal-raising and environment-related claims, FSIS stated:
    • It would not be codifying any animal-raising claims because of the constant innovation in animal production practices and evolving consumer expectations, which would make it impractical to maintain a list of allowable claims;
    • It “strongly encourage[s] the use of third-party certifiers to substantiate animal-raising claims;”
    • The kind and amount of supporting documentation depends on the claim and could vary according to circumstances and could include things like detailed written descriptions of processes, signed documents describing how the claim is not false or misleading, and written descriptions of the identification, control, and segregation of non-conforming animals or products;
    • It strongly encourages the use of a routine sampling and testing program to test for the use of antibiotics in animals prior to slaughter or, alternatively, third-party certification to substantiate negative antibiotic use claims; and
    • Establishments are encouraged to provide documentation such as environmental data or studies to substantiate environment-related claims.
  • FSIS further emphasized that it encourages the use of third-party certifiers to substantiate these claims and stated that the Agency is “exploring options to determine whether there are lower-cost third-party certification programs, including those offered by the Agricultural Marketing Service (AMS), that meet the recommended criteria for third-party certifiers included in the revised guideline.”
  • FSIS is accepting comments on the updated guidelines before November 12, 2024, under docket number FSIS-2024-0010.
  • On September 4, 2024, the U.S. Food and Drug Administration (FDA) made available its annual Pesticide Residue Monitoring Program Report for Fiscal Year 2022 (FY 2022), which summarizes findings from FDA testing of human and animal foods for 757 different pesticides and selected industrial compounds from October 1, 2021, through September 30, 2022.
  • FDA’s pesticide residue monitoring program tests FDA-regulated foods shipped in interstate commerce to determine whether they comply with pesticide tolerances, or maximum residue levels, set by the Environmental Protection Agency (EPA).  FDA may take action if it is shown that the amount of pesticide residue on a food is over the tolerance, or when a pesticide is found and there is no tolerance established.  FY 2022 findings show that the levels of pesticide chemical residues in the U.S. food supply are generally in compliance with EPA pesticide tolerances.
  • Out of 2,800 total human food samples, 96.2% of domestic samples and 89.5% of imported samples were compliant were compliant.  No pesticide chemical residues were detected in 42.7% of domestic samples and 44.6% of imported samples.  In determining which products to sample, FDA may consider past problem areas, findings from state and federal monitoring, and foreign pesticide usage data.  Fruits and vegetables accounted for majority (75.5%) of domestic samples.
  • Spencer Sheehan is a Plaintiff’s attorney who has filed hundreds of class action lawsuits against food companies for allegedly deceptive labeling and marketing. A small percentage of these lawsuits survive the motion to dismiss stage, let alone succeed on the merits. Indeed, many of his losses are suffered many times over as he has a practice of refiling essentially identical lawsuits in different jurisdictions, even after unfavorable rulings.
  • His practices have increasingly drawn the ire of the courts, and this summer a United States District Court in Florida issued an order sanctioning him and making him responsible for attorney’s fees in the case.
  • Specifically, the Court applied Florida fee shifting statutes, one mandatory and one discretionary, to hold Plaintiff and Sheehan responsible for the legal fees. However, the Court went further and sanctioned Sheehan for bad faith conduct. The Court noted Sheehan’s practice of re-filing failed lawsuits in other jurisdictions after “collect[ing] consumer plaintiffs through social media advertising.” Particularly troublesome to the Court was the contention that Sheehan was not an attorney of record for the Plaintiff even when his name appeared on the pleadings. The Court found that this was part of a broader practice of flagrantly violating court rules and that Sheehan had not been admitted pro hac vice to any of the twelve cases in which he is involved that are currently pending in the same district.
  • Briefing in case continues as the Court decides on the final monetary award and whether or not to hold the local Florida counsel jointly responsible.
  • On August 29, 2024 (Law360 subscription required), the California State Legislature passed Assembly Bill 2316, the California School Food Safety Act, sending it to the governor. If signed, the bill will prohibit school districts, county superintendents of schools, or charter schools with kindergarten through 12th grade from serving Red 40, Yellow 5, Yellow 6, Blue 1, Blue 2, and Green 3, which researchers have linked to serious health issues.
  • The California Assembly passed the bill in May 2024, finding that it is intended to protect the health and wellbeing of children. The bill was introduced following a 2021 report from the California Environmental Protective Agency that found that “consuming synthetic food dyes can lead to hyperactivity and other neurobehavioral problems in some children.” According to the report, the FDA’s acceptable daily intakes for the dyes are based on outdated studies that did not detect behavioral effects in children.
  • The California Assemblymember who introduced the “first-in-the-nation bill” stated that “California has a responsibility to protect our students from chemicals that harm children and interfere with their ability to learn.” The California State Superintendent of Public Instruction said the bill is “an important step forward to ensure that California’s schools are healthy and equitable learning environments for all.”
  • California Governor Gavin Newsom will have until the end of September to sign or veto the bill. If signed, it will go into effect on December 31, 2027.
  • On August 28, 2024, the U.S. Department of Agriculture (USDA) announced the availability of an updated guideline that makes recommendations to strengthen the documentation that supports animal-raising or environment-related claims on meat or poultry product labeling.  According to USDA, the intent is to protect consumers from false and misleading labels.
  • Animal-raising claims (e.g., “Raised Without Antibiotics,” “Grass-Fed,” “Free-Range”) and environment-related claims (e.g., “Raised using Regenerative Agriculture Practices,” “Climate-Friendly”) are voluntary marketing claims that highlight certain aspects of how the source animals for meat and poultry products are raised or how the producer maintains or improves the land or otherwise implements environmentally sustainable practices.  The documentation submitted by companies to support these claims is reviewed by USDA’s Food Safety and Inspection Service (FSIS) and the claims can only be included on the labels of meat and poultry products sold to consumers after they are approved by the agency.
  • In the updated guideline, FSIS strongly encourages the use of third-party certification and more robust documentation to substantiate animal-raising or environment-related claims.
  • Additionally, the updated guideline recommends that establishments using “negative” antibiotic claims (e.g., “Raised Without Antibiotics” or “No Antibiotics Ever”) implement routine sampling and testing programs to detect antibiotic use in animals prior to slaughter or obtain third-party certification that includes testing.
  • Public comments will be accepted and reviewed for 60 days after publishing in the Federal Register.
  • Keller and Heckman will continue to monitor and report on any rulemaking developments.
  • On August 9, 2024, FDA issued a warning letter to Austrofoods S.A.S., the Peruvian-based manufacturer that produced lead-contaminated apple cinnamon fruit puree pouches that were the subject of a recall last year.
  • The letter follows up on inspections that were conducted in December of last year and which “found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation” in 21 CFR Part 117.
  • The specific violations of these rules that were referenced include:
    • The failure to conduct an appropriate hazard analysis to identify and evaluate lead as a known or reasonably foreseeable hazard requiring a preventive control. FDA noted that lead is often found in spices and that children (the intended consumers) are particularly sensitive to it. Although lead was identified as a hazard, the plan concluded that no preventive control was required based on vague and faulty rationales like “supplier without historical precedents [of lead contamination].”Although the plan concluded that no lead control was required, it nevertheless required that cinnamon be purchased from an approved supplier with certificates of analysis (COA). However, the supplier approval plan was not properly implemented and no on-site audits were conducted. FDA recommended that COAs from labs using scientifically valid methods and procedures document that supplied ingredients (e.g., cinnamon) meet food-grade production standards for every major analytical parameter (e.g., heavy metals).
    • The plan for heavy metal monitoring in the finished product that was provided to FDA did not include critical information like what constituted a representative sample, what method would be used by the test lab, and how the company would assure that the method was properly followed.
  • The warning letter is part of FDA’s continued efforts to reduce the incidence of lead and other heavy metal contamination.