• An Illinois federal judge has granted Danone Waters of America’s request to dismiss a proposed class action lawsuit alleging that Evian spring water is falsely labeled as “natural” even though it contains microplastics because the claims are preempted by federal law (Law360 subscription required). The lawsuit, which was filed in Illinois state court then removed to federal court in March, alleges violations of various consumer protection statutes, common law fraud, and unjust enrichment.
  • According to the complaint, the plaintiffs and class “paid a premium price for premium products, but instead received non-premium products,” because microplastics are not “natural.” However, the judge held that the terms “spring water,” which is federally regulated, and “natural” are intertwined. As long as the water meets FDA’s standard for “spring water,” then it is, by extension, “natural.”
  • FDA defines “spring water” at 21 CFR 165.110(a)(2)(vi) as “water derived from an underground formation from which water flows naturally to the surface of the earth.” The judge explained that the regulation uses the word “natural” seven times to describe the source of the “spring water.” Therefore, any water that comes from a “natural spring” can be labeled as “natural spring water.” Because the regulation does not impose any further requirement for use of the word “natural,” any claim that imposes such a requirement beyond identification of the water’s source is preempted.
  • There have been multiple other consumer fraud claims based on the presence of microplastics in federally regulated bottled water that have been similarly found to be preempted, including one that we discussed on this blog. However, in those cases, the courts based their reasoning on the fact that the bottled water regulations do not mention microplastics. Here, though, the judge found that it is unnecessary to address any requirement regarding microplastics to determine the scope of the term “natural.” According to the judge, “[w]hether the regulation imposes requirements regarding the content of ‘spring water,’ including whether the presence of microplastics might violate those requirements, is irrelevant to this logic.”
  • Keller and Heckman will continue to monitor litigation related to microplastics and food labeling claims.
  • On November 4, 2024, the U.S. Food and Drug Administration (FDA) and the U.S. Environmental Protection Agency (EPA) announced the registration of the first antimicrobial treatment for pre-harvest agricultural water.  This new treatment, a combination of hydrogen peroxide and Ethaneperoxoic acid, can kill harmful pathogens like Salmonella and E. Coli in the water used to grow crops prior to being harvested.
  • This approval marks a significant step forward in agriculture and food safety practices.  Previously, treatments for pre-harvest agricultural water were limited to managing algae, biofilm formation, or produce rot, with no treatments specifically approved for killing human pathogens.
  • The new registered product aligns with the FDA’s revised rule under the Food Safety Modernization Act (FSMA) on agricultural water.  This rule replaces previous microbial quality criteria and testing requirements with system-based assessments.  Farms must evaluate various factors, including the nature of the water source, water distribution systems, and potential contamination sources from nearby land uses.  The rule also requires farmers to implement appropriate mitigation measures to minimize risks.  Treating water with this new approved antimicrobial treatment aligns with the mitigation requirements under this rule.
  • Products designed to protect humans from disease-causing pathogens are referred to as “public health” pesticide uses, which require a high bar for efficacy data at the EPA, making cross-collaboration between the EPA and the FDA essential in moving this registration forward.  The development and registration of this treatment involved joint collaboration between government agencies, academia and industry, highlighting the importance of joint efforts in advancing food safety.
  • Keller and Heckman will continue to monitor and follow developments in agriculture water safety.
  • Today, the U.S. Food and Drug Administration (FDA) has requested public input regarding its current approach managing FDA certification for the export of human food products. 
  • Companies that export products from the US are often asked by foreign customers and/or governments to supply a certification for products regulated by FDA.  FDA’s export certification provides an official statement concerning a product’s regulatory or marketing status, based on available information at the time of issuance.  To assist US exporters, FDA provides necessary export certification in the form of certificates or export lists.
  • Through FDA’s Request for Information, the agency intends to gather input from all impacted stakeholders to help the Human Food Program (HFP) ensure it is considering the full range of perspectives when planning and resourcing changes and improvements to the export list component of the Export Certification Program.  Specifically, FDA requests comments on the challenges and experiences related to meeting the listing requirements of other countries and FDA’s certification processes for export lists, including suggested approaches for implementing fees to offset the operational costs associated with maintaining a growing number of export lists and potential program enhancements.
  • FDA requests feedback by January 7, 2025.  Keller and Heckman will continue to monitor and relay any updates in the process.
  • We have previously blogged about a lawsuit filed by Upside Foods challenging Florida’s cultivated meat ban. Last month, a district court judge rejected Upside’s request for a preliminary injunction and held that the company had failed to meet its burden to establish that it was substantially likely to succeed on the merits of its express preemption claims.
  • The court addressed the merits of the preemption argument with respect to both the “ingredient requirements” and the “premises, facilities, and operations” provisions in the Poultry Products Inspection Act (21 USC 467e). As to the ingredient requirements provision, the Court found that Plaintiff had identified no statute or regulation which required that cultivated poultry products be permitted and noted that “just because Plaintiff’s product arguably falls within the scope of the PPIA . . . this does not mean that a state is expressly preempted from banning the sale of that particular kind of poultry product.”
  • With respect to the “premises, facilities, and operations” provision, the Court held that (1) Plaintiff did not manufacture cultivated chicken in Florida and so its operations were not directly impacted and (2) that a sales ban did not impose additional or different facilities requirements as compared to federal law.
  • Notably the case is not a final decision on the merits and we will continue to monitor and report on the case.
  • On November 4, 2024, FDA published a Supplement to the 2022 Food Code that incorporates recommendations from regulatory officials, industry, academia, and consumers. The FDA Food Code and its Supplement represent FDA’s best advice to address the safety and protection of food offered at retail and in food service and are intended to be a model for adoption by state, local, tribal, and territorial regulatory bodies.
  • The Food Code and its Supplement are joint projects by FDA, the Centers for Disease Control and Prevention, and USDA’s Food Safety and Inspection Service. The documents provide practical, science-based controls for reducing the risk of foodborne illness.
  • The amendments in the Supplement include:
    • Adding new provisions addressing disinfection of food contact, nonfood-contact, and equipment surfaces;
    • Expanding and clarifying how and when containers can be refilled and reused in a food establishment;
    • Addressing food protection with new provisions that improve awareness of food defense measures;
    • Building on the concept of Food Safety Management Systems and Active Managerial Control by defining the terms, including new provisions that speak to when a Food Safety Management System is required;
    • Updating testing requirements for reinstatement of food employees diagnosed with an illness from STEC, Shigella, or Nontyphoidal Salmonella to include culture-independent diagnostic tests; and
    • Enhancing information regarding sushi rice acidification with a dedicated section in Annex 6 Food Processing Criteria addressing risks and controls.

The Food Code was most recently updated in 2022, as discussed on this blog. The next complete revision will be published in 2026.

  • In October 2023, Governor Newsom signed into law California’s AB 899, which requires that any baby food products sold or made in the state be tested for arsenic, cadmium, lead, and mercury.  This testing requirement became effective January 1, 2024.  Beginning January 1, 2025, the law also requires test results to be posted on the manufacturer’s website. 
  • Manufacturers of baby food (not including infant formula) for sale or distribution in California must test a representative sample of each production aggregate of the final baby food product at least once a month.  Test results must be provided to the California Department of Public Health upon request.
  • Starting January 1, 2025, manufacturers must make publicly available on the manufacturer’s website, for the duration of the product shelf life for a final baby food product plus one month, the name and level of each toxic element present in each production aggregate of a final baby food product.  Baby foods that contain a toxic element at levels higher than the FDA action level can still be sold in the state, but the QR code disclosure is required.
  • On October 23, 2024, The US Food and Drug Administration (FDA) finalized its guidance document on its enforcement policy for animal feed ingredients, following the sunsetting of FDA’s longstanding Memorandum of Understanding (MOU) with the Association of American Feed Control Officials (AAFCO) addressing the review of animal food definitions listed in AAFCO’s Official Publication (OP). 
  • The Association of American Feed Control Officials (AAFCO) is a voluntary organization that guides regulators and has long maintained a list of animal food ingredients and definitions.  Every state, except Alaska, has some version of the AAFCO model bill and regulations codified under their respective state laws.  Historically, FDA participated in the AAFCO ingredient definition request process by providing scientific and technical assistance to AAFCO.  In 2007, FDA and AAFCO entered into an MOU to collaborate on animal ingredient definitions to be listed in the AAFCO Official Publication.  However, the MOU expired in October 2024 and was not renewed.
  • FDA’s guidance document states that the agency does not plan to initiate enforcement actions related to feed ingredients listed in AAFCO’s official Common or Usual Names and Definitions of Feed Ingredients section of chapter six of the AAFCO 2024 OP.   FDA does not plan to initiate action if the ingredient is not an approved animal food additive or GRAS, so long as the ingredient:
    • (1) Is included in the Official Common or Usual Names and Definitions of Feed Ingredients section of chapter six of the 2024 AAFCO OP;
    • (2) Is used according to its intended use, specifications, and limitations listed in the 2024 AAFO OP; and
    • (3) FDA has no questions or concerns about the safety of the ingredients.
  • The agency is currently accepting comments on the guidance submitted to the docket.  Please reach out to Keller and Heckman if you would like assistance in submitting a comment to the Agency
  • Separately, AAFCO announced that it is considering a proposal from Kansas State University’s K-State Olathe Innovation Campus (K-State Olathe) to provide the scientific review for its new animal food ingredient submission pathway.  This proposed pathway would replace AAFCO’s former Ingredient Definition Request process that sunset on October 1, 2024, following the expiration of AAFCO’s MOU with FDA.
  • FDA issued two warnings letters this month for violations of the foreign supplier verification program (FSVP) requirements which are found in section 805 Federal Food, Drug, and Cosmetic Act (codified at 21 U.S.C. 384a) and in the implementing regulations at 21 C.F.R. Part 1, Subpart L.
  • The first warning letter, issued on October 1, 2024 to Paso Real Produce LLC noted the absence of FSVP documentation for the company’s imported products (avocados and limes) and followed FDA’s issuance of Form 483a FSVP Observations following an August 2024 inspection.
  • The second warning letter, issued on October 10, 2024, to Future Best Trading Inc. followed July inspections which were initiated following a positive Listeria monocytogenes sample in the company’s imported fresh Enoki mushrooms. Although the company responded to the Form FDA 483a FSVP Observations issued at the conclusion of the July inspection, FDA stated that the documents did not meet FSVP requirements, in part because their relevance was not explained and there was no indication that the company had reviewed or assessed any of the documents as part of the hazard analysis required by FSVP. The letter also noted the FSVP requirement to take prompt corrective action following the Listeria contamination incident and that while certain relevant steps that had been taken (e.g., the supplier’s food safety improvement plan), the corrective actions taken by the company had not been properly documented and incorporated into a FSVP plan.
  • Both letters warn the companies that continued failure to comply with the FSVP requirements could result in the refusal of admission of food products which appear to violate the FSVP requirements or placement on an import alert list (allowing for detention without physical examination). Import Alert 99-41 includes a list of companies which are not in compliance with the FSVP requirements.
  • An organic food industry advocacy group has asked (Law360 subscription required) the Ninth Circuit to reverse a district court decision upholding USDA’s implementation of the National Bioengineered Food Disclosure Standard, saying that the rule is “arbitrary and capricious” and is “not the uniform standard for consumers that Congress envisioned.”
  • In the original lawsuit, filed in 2020, food advocacy groups claimed USDA’s rule did not deliver on the aims of the National Bioengineered Food Disclosure Act and that portions of the rule violated the First, Fifth, and Tenth amendments by limiting allowed disclosures and preempting state laws requiring additional disclosures. A U.S. District Court judge upheld most of the law but sided with the organic industry groups in ruling that QR codes are not adequate methods of informing shoppers that food is bioengineered. Then, in March, the Consumer Brands Association, the federal government, and sugar industry groups filed amicus briefs in support of the rule, as we discussed on this blog.
  • The appeal, argued by George Kimbrell, the legal director for the Center for Food Safety, is focused on three concerns:
    • USDA’s exemption for highly refined foods with “undetectable” genetically engineered elements is contrary to the Act’s definition of a bioengineered food as one that “contains genetic material that has been modified.” According to one judge on the panel, that is “a difference without a distinction [because] it seems odd to say that something’s there when it’s not detectable.” However, according to Kimbrell, the Agency did not set a level of detection or a threshold for detectability, so there could be two different results with the same product.
    • A requirement that labels use the term “bioengineered” instead of the more commonly known “genetically engineered” or “genetically modified,” which consumers better understand.
    • While the district court found the QR code portion of the rule unlawful, the judge erred by failing to vacate that part of the rule, so there are product packages on the market that use the QR code method to disclose that the food is bioengineered.
  • The federal government argued that a product can include a genetically modified source that is no longer in the product after processing, because some processes degrade DNA to undetectable levels. Further, there are required testing standards for detection of bioengineered material and there was significant science backing USDA’s position in drafting the rule. However, one judge said that the rule leaves it in the hands of the companies to decide if DNA is detectable in the final product, which does not fulfill Congress’s intent.

  • Last week a proposed class action lawsuit was filed against Harris Teeter alleging that the company falsely and deceptively marketed a variety of flavored cereal bars as “naturally flavored with other natural flavors” when in fact the products allegedly contained synthetically produced malic acid.  See Filing (Law360 subscription required).
  • As alleged in the complaint, malic acid is naturally present in certain foods in its L-enantiomeric form, while synthetically produced malic acid contains a mixture of D- and L- malic acid (the D- and L- designations refer to different spatial arrangement of atoms much like the relationship between a left and right hand). Testing commissioned by Plaintiff’s counsel allegedly revealed the presence of D-malic acid which would indicate the presence of synthetically produced (i.e., artificial) malic acid.
  • Products bearing natural or natural flavoring claims and containing malic acid are a frequent target of class action lawsuits. We will continue to monitor and report on this lawsuit and other food litigation.