• Mondelēz International Inc. has been sued (Law360 subscription required) for allegedly using deceptive sustainability claims regarding its cocoa supply chain. According to the plaintiffs, Mondelēz’s supply chain “really contributes to ‘grievous and unsustainable labor abuses.’”
  • Mondelēz launched its “Cocoa Life” program in 2012 to “help make cocoa sourcing more sustainable in key cocoa-producing countries.” Mondelēz affixes the Cocoa Life logo on its products to represent that those products “protect the planet” and “respect the human rights of people within our own operations and in our value chain.” However, according to the complaint, farms in Mondelēz’s supply chains are linked to unfair labor practices, hazardous child labor, and deforestation; therefore, the products are not responsibly sourced or sustainable, and the Cocoa Life logo is misleading.
  • The product packaging directs consumers to the Cocoa Life website, which explains that the products “help enhance child protection systems” and improve communities and forests. The plaintiffs allege that these misrepresentations are false and deceptive because sustainability and ethical sourcing is important to consumers and “a majority of consumers would stop buying from brands they believe are unethical,” but that Mondelēz hides the unethical practices in its supply chain to sell products at higher prices.
  • This is the second suit this year alleging that Mondelēz “greenwashes” its products with deceptive labeling that “hides evidence of environmental degradation, child labor and child slavery in its supply chain.” The first complaint, filed in January 2024, is set for a dismissal hearing in November.
  • Keller and Heckman will continue to monitor this and other food labeling litigation.
  • French start-up, Gourmey, has submitted the EU’s first application for novel food approval of a cultivated meat product, duck foie gras, which it is offering in both a pâté “semi-cuit” form and as whole pieces ready for frying.
  • The European Commission (EC) will review before asking the European Food Safety Authority (EFSA) for a risk assessment, which the agency will start after verifying that the application contains all the required studies to prove that the product is safe for consumers to eat.
  • While the application should theoretically take about 18 months to review, it will most likely exceed this timeframe, as it is the first cultivated meat product application.
  • An EFSA approval may be controversial.  Italy in particular is opposed to cultivated meat and, in December 2023, banned lab-grown food from the Italian market.  The ban is arguably in breach of European law, since the Meloni government failed to respect EU standstill procedures, adopting the Italian bill before the end of the mandatory comment period, when a measure should be put on hold to allow other EU member states or EC to raise concerns.
  • If the Gourmey foie gras – or any other cultivated meat or fish – is authorized at EU level under the novel foods regulation, the decision will be binding on Italy and the government will have to allow the product on the Italian market.
  • Last week the United States Court of Appeals for the Second Circuit affirmed a grant of summary judgment for Defendants Walgreen Co. and International Vitamin Corporation (IVC) on preemption grounds in a case involving dietary supplement labeling. IVC manufactured and Walgreens sold a glucosamine dietary supplement product which Plaintiffs argued was misleadingly labeled in light of the product formulation.
  • Plaintiff alleged that Defendants should have declared the dietary ingredient as “glucosamine hydrochloride and potassium sulfate” (bold added) and not as “glucosamine hydrochloride potassium sulfate.” This argument hinged on the distinction between glucosamine sold as a single crystal form in contrast to a blended form. The single crystal form consists of a glucosamine-sulfate-potassium-chloride salt, while the blend consists of a mixture of a glucosamine-hydrochloride salt and potassium-sulfate salt. In an aqueous solution (as with the human body), both forms dissociate into the same glucosamine, sulfate, potassium, and chloride constituents.
  • Dietary ingredients like glucosamine for which FDA has not established a Reference Daily Value or a Daily Reference Value must be declared by their common or usual name which, the court stated, is to be determined by testing the ingredient with a validated method of identification. In the absence of appropriate AOAC methods, “other reliable and appropriate analytical procedures” may be used, although FDA has indicated that, where available, it expects official compendial methods such as the U.S. and European pharmacopoeias to be used.
  • It was uncontested that both forms of glucosamine (single crystal and blend) are consistent with the monographs for “Glucosamine Sulfate Potassium Chloride” in the U.S. and European pharmacopoeias. The Federal Food, Drug, and Cosmetic Act (FDCA) contains an express preemption provision which forbids states from establishing food labeling standards that are “not identical” to certain federal food labeling requirements, including the requirement that ingredients be identified by their common or usual names. Therefore, because the dietary ingredient declaration was consistent with the monographs in the pharmacopoeias, and such pharmacopoeias contained “reliable and appropriate analytical procedures” endorsed by FDA, the Court held that “glucosamine hydrochloride potassium sulfate” was the common or usual name under the federal regulations and that the name was insulated from legal challenge based on the FDCA’s labeling preemption provision.
  • On August 16, 2024, FDA issued Edition 2 of the Draft Guidance for Industry: Voluntary Sodium Reduction Goals covering target mean and upper bound concentrations for sodium in commercially processed, packaged, and prepared foods. The Guidance builds on Phase 1, which set initial targets to encourage the food industry to voluntarily reduce sodium levels in various processed, packaged, and prepared foods.
  • The Guidance is intended to provide voluntary goals to “reduce excess population sodium intake, while recognizing and supporting the important roles sodium plays in food technology and food safety.” More than 70% of total sodium intake is from sodium added during food manufacturing and commercial food preparation, with the average daily sodium intake at approximately 3,400 mg/day. The 2020-2025 Dietary Guidelines for Americans, however, advises individuals 14 and older to limit their consumption to 2,300 mg/day. The Guidance sets a goal to help reduce sodium intake to 2,750 mg/day, which, while higher than the Dietary Guidelines recommends, is “intended to balance the need for broad and gradual reductions in sodium and what is publicly known about technical and market constraints on sodium reduction and reformulation.”
  • Excess sodium consumption has been shown to be a contributing factor in the development of hypertension, which is a leading cause of heart disease and stroke. Decreasing population sodium intake is expected to reduce the rate of hypertension and lower blood pressure. Researchers estimate that broadly reducing sodium intake could prevent between 280,000 and 500,000 premature deaths over 10 years.
  • The Guidance sets voluntary goals for baseline, target mean, and upper bound sodium concentrations for several foods and food categories. The baseline is the “state of the market” for each category in 2022 based on information gathered from food labels and menus. The target mean concentration is the “desired average sodium concentration” and the voluntary upper bound is a standard that can be applied to every product in a category.
  • The initiative to reduce sodium is one of many nutrition initiatives FDA is working on to reduce diet-related chronic diseases, including an updated definition of “healthy” and a proposed rule for front-of-pack nutrition labeling.
  • Keller and Heckman will continue to monitor and provide updates on FDA’s sodium reduction goals and other nutrition initiatives.
  • On August 14, 2024, the Federal Trade Commission (FTC or Commission) announced its Final Trade Regulation Rule on the Use of Consumer Reviews and Testimonials (Final Rule) to rein in what it believes is the widespread practice of using fake reviews and testimonials to boost sales of products or services.
  • The long-awaited Final Rule was developed under the provisions of the Magnuson-Moss Warranty Act. Thus, it is the culmination of a two-year process that started in November 2022 with the publication of an Advance Notice of Proposed Rulemaking (ANPR), followed by a Notice of Proposed Rulemaking (NPRM) in July 2023, and a February 2024 informal public hearing.
  • The Final Rule reflects some changes from the proposed rule set out in the NPRM, including clarifications and limitations that were based on feedback received during the public comment period. For example, a previously proposed section addressing reuse of consumer reviews written for one product, so that the reviews appear written for a “substantially different product,” was omitted from the Final Rule following multiple comments, including a comment that raised a disputed issue of material fact.
  • The Commission decided not to finalize this provision at this time and reserved it for potential future rulemaking.
  • To read more, including key provisions of the Final Rule, click here.
  • UPSIDE Foods (UPSIDE), a cultivated meat company, has sued the state of Florida over the state’s ban (SB 1084) on the sale and manufacturing of “cultivated” meat.  The complaint, filed by the Institute for Justice (IJ), contends that the law violates a constitutional prohibition on favoring in-state businesses over out-of-state competitors. 
  • “If some Floridians don’t like the idea of eating cultivated chicken, there’s a simple solution: Don’t eat it,” said Paul Sherman, a senior attorney at IJ. “The government has no right to tell consumers who want to try cultivated meat that they’re not allowed to.  This law is not about safety; it’s about stifling innovation and protecting entrenched interests at the expense of consumer choice.”
  • The complaint reports UPSIDE’s chicken has been given the green light by both the U.S. Food and Drug Administration (FDA) and U.S. Department of Agriculture (USDA), “affirming its safety and quality.  And because it is cultivated in a controlled environment, the process can potentially reduce the risk of foodborne illnesses, contaminations, and other issues in modern animal agriculture.”
  • Florida lawmakers in the past have called cultivated products a threat to their state’s agriculture industries.  Agriculture Commissioner Wilton Simpson, a key supporter of the law, called the lawsuit “ridiculous” and said “lab-grown ‘meat’ is not proven to be safe enough for consumers,” despite FDA and USDA authorization.
  • In 2024, four states (Alabama, Arizona, Florida and Tennessee) have considered legislation that would ban the manufacture, sale, or distribution of cell cultured meat.  Florida and Alabama signed their respective bills into law.   
  • Keller and Heckman will continue to monitor and relay any updates in this litigation.
  • Last month, the National Academies of Science, Engineering, and Medicine (NASEM) released a 401-page report which analyzed the 2022 infant formula shortage, highlighted the vulnerabilities in the infant formula market, and made recommendations to improve the market’s resilience and mitigate the impact of future crises.
  • The vulnerabilities in the infant formula market identified by the report can be broken down into 5 broad categories:
    • Risk management planning. The report discusses failures in the market to implement effective risk management plans at both the facility level and at a sector-wide level.
    • Market concentration. Although the report recognized problems of sales concentration at the state and national levels, it identified production line concentration as the most significant vulnerability to supply disruptions.
    • Ability to support a speedy recovery. The report found that certain aspects of FDA’s lack of authority as well as regulatory requirements inhibiting the import of infant formula slowed restoration of production in times of crisis.
    • Government management of adverse effects on consumers. Inadequate communication with the public, lack of coordination between government and industry, and challenges related to the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) heightened adverse impacts.
    • Protection, promotion, and support of breastfeeding. The report concluded that continued breastfeeding reduced the proportion of families severely affected by the shortage of infant formula.
  • The report offers 14 detailed recommendations to address these challenges. The report follows a Federal Trade Commission (FTC) report released earlier this year which addressed market factors contributing to the infant formula crisis.
  • We will continue to report on infant formula issues, including any government responses to the recommendations made in the report.
  • An Illinois federal judge dismissed a proposed class action (Law360 subscription required) alleging that water labeled as “100% Natural Spring Water” is misleading due to the presence of microplastics. According to the judge, “the complaint doesn’t hold water” and is preempted by FDA’s standard of identity for spring water.
  • The plaintiffs alleged that the labeling of BlueTriton Brands Inc.’s Ice Mountain spring water would lead a reasonable consumer to believe that the water will not contain any synthetic contaminants even though plastic migrated from the bottle into the water. The presence of microplastics in the water, according to the plaintiffs, means that the bottles did not contain 100% spring water. However, according to the opinion, the complaint did not allege that the plaintiffs tested the product for microplastics. Further, “[n]o reasonable consumer would think that ‘100% Natural Spring Water’ is a guarantee at the molecular level, except that it contains hydrogen and oxygen playing together nicely.”
  • According to the judge, the complaint fails whether the plaintiffs argue that the water is not 100% spring water or that it is not 100% natural. FDA’s standard of identity for bottled spring water at 21 CFR 165.110 requires the water to come from a spring in the ground but does not mention any presence of microplastics. Because FDA has defined spring water, the plaintiffs may not rely on state law to “tack on additional requirements.” In addition, although FDA does not generally regulate the use of the term “natural,” the term does appear in the spring water definition, so saying that the spring water is not “natural” is “the same thing as saying that it is not ‘spring water.’” In either case, because FDA has the authority to define the essential characteristics of spring water, the claim is expressly preempted.
  • The judge also said that the “100% Natural Spring Water” label is not a material misrepresentation because the plaintiffs’ interpretation of the claim is unreasonable. The amount of microplastics in a bottle of water is so small that 100% is “close enough.” Consumers would not think microplastics add up to 1% of a water bottle, and a label that says “99.9999999999% natural spring water” is not reasonable. Further, microplastics are inescapable in food and even air, so it is not reasonable to assume that spring water will not contain any microplastics.
  • Keller and Heckman will continue to monitor litigation related to microplastics and food labeling claims.
  • On July 26, 2024, the U.S. Food and Drug Administration (FDA) released findings from its sampling assignment that collected and tested domestic and imported basil, cilantro, and parsley.  FDA sought to estimate the prevalence of Cyclospora, Salmonella, and Shiga toxin-producing Escherichia coli (STEC) in these herbs as part of its ongoing effort to ensure food safety and prevent  contamination.
  • From September 2017 to September 2021, FDA collected and tested 1,383 samples of fresh basil, cilantro, and parsley.  The Agency detected Salmonella in 17 samples, detected Cyclospora in 18 samples, and detected STEC in 1 sample.  The contaminated products were quickly removed from the market.
  • The sampling assignment was conducted in response to food-borne illness outbreaks of Cyclospora, Salmonella, and STEC.  From 2000 through 2016, cilantro was potentially linked to at least three outbreaks in the US.  And since 2017, the US has experienced at least six additional outbreaks involving basil, cilantro, and parsley.  More than 1,200 illnesses and 80 hospitalizations were tied to these outbreaks.
  • Keller and Heckman will continue to monitor and relay updates in food safety.
  • On August 2nd USDA’s Animal and Plant Health Inspection Service (APHIS) Biotechnology Regulatory Service (BRS) announced a new flexibility which permits the reuse of BRS import labels.
  • BRS administers the regulations in 7 CFR Part 340 (“Movement of Organisms Modified or Produced Through Genetic Engineering”). These regulations require a permit when certain types of genetically engineered organisms, including those that are plant pests and organisms that are used to control plant pests and pose a plant pest risk, are “moved.” Movement is defined broadly and includes importing regulated products.
  • BRS import labels are required prior to the import of regulated products. The August 2nd update permitting the reuse of labels avoids the hassle of requesting new labels even when there have been no changes to the underlying permit.
  • Regulated parties use the APHIS eFile system to manage their BRS regulatory compliance obligations.  Guidance on how to use the system is found in the APHIS 2000 Permit Application and Compliance Reporting Job Aid. This document has been updated to reflect the recent change. See p. 52.