• In February 2023, California Assemblymembers Jesse Gabriel and Buffy Wicks introduced legislation (AB 418) that would prohibit the manufacture or distribution In California of foods containing the additives red dye No. 3, potassium bromate, brominated vegetable oil, titanium dioxide, and propyl paraben.
  • The color additives are commonly found in candies, drinks, and baked goods, including items marketed to children, though some have claimed that they have been linked to cancer, behavioral health problems, and harm to the reproductive system.
  • In the U.S., red dye No. 3 was previously banned in cosmetics in 1990, after studies suggested that it caused thyroid cancer in rats at high doses.  It is already banned in foods in the European Union.  However, industry groups have argued that there is insufficient scientific evidence linking synthetic colors in food to negative health or behavior effects.
  • In October 2022, Consumer Reports, the Center for Science in the Public Interest, and other groups and individuals wrote to the U.S. Food and Drug Administration (FDA) petitioning to “remove Red No. 3 from the permanent list of color additives approved for use in food and dietary supplements… and for use in ingested drugs… because the FDA has found that the additive induces cancer and is unsafe.”  FDA has stated that it will “continue to engage in the scientific and regulatory review of color additives.” 
  • Given that the targeted color additives have been approved by FDA, enactment of the proposed California legislation almost certainly would trigger legal challenges.
  • Keller and Heckman will continue to monitor the developments of AB 418 and will update accordingly.
  • On March 21, the FDA released Activities for the Safety of Imported Seafood, a report which details the approach the Agency’s is taking to ensure that imported seafood consumed in the U.S. meets food safety requirements and the standards of domestically produced seafood. For background on the FDA’s “Strategy for the Safety of Imported Food,” see our February 2019 blog and September 2022 blog regarding FDA’s report for imported produce. 
  • The reports details how established FDA regulation and innovative programs and technology are employed to support each of the four goals that were established in the 2019 strategy document as they relate to imported seafood safety:
    • Goal 1 – Food Offered for Import Meets U.S. Food Safety Requirements
      • FDA objectives include relying on international inspections, using verified foreign suppliers, auditing such as those conducted under FDA’s Accredited Third-Party Certification Program or other programs aligned with FDA produce safety requirements, incentivizing importers to use verified suppliers through the Voluntary Qualified Importer Program (VQIP), leveraging oversight efforts of regulatory counterparts with strong food safety systems, and increasing awareness and training of seafood safety requirements.
    • Goal 2 – FDA Border Surveillance Prevents Entry of Unsafe Foods
      • FDA objectives include enhancing and refining FDA’s import screening and entry review process, optimizing use of sampling of imported seafood, utilizing import alerts and import certifications, improving testing methods and tools to determine admissibility of seafood offered for import, and maximizing surveillance from state and other partnerships.
    • Goal 3 – Rapid and Effective Response to Unsafe Imported Food
      • FDA objectives include maximizing the effectiveness of Agency responses to events involving imported seafood, such as recalls.
    • Goal 4 – Effective and Efficient Food Import Program
      • FDA objectives include a better understanding of the global inventory of seafood facilities and farms and conduction of performance assessments of the effectiveness of import activities.
  • Keller and Heckman will continue to monitor and report on any developments that impact seafood safety requirements.
  • Yesterday a district court dismissed (Law360 subscription required) a class-action lawsuit which alleged that Ferrara Candy Company misled consumers into believing that their Brach Milk Maid caramels were made with milk fat by labeling their caramels with the phrases “Made With Real Milk” and “Rich and Creamy” and depicting a pitcher of milk. As indicated by the ingredient list, the products were made with skim milk, butter oil, and whey, but the primary source of fat was hydrogenated palm kernel oil.
  • The Court held that because the products were made with skim milk, butter oil, and whey, and there were no representations as to the type of milk the products were made with, the claim “made with real milk” was true, and the alleged equivalence between “made with real milk” and “made with real milk fat” was Plaintiff’s own unsupported interpretation. Indeed, although not pivotal to the decision, the Court noted that the milk and milk derived ingredients in the product (e.g., butter oil) would have contributed some milkfat to the product. The Court also cited to cases which held that a labeling claim regarding one ingredient (e.g., milk) does not preclude the presence of other ingredients (e.g., vegetable oil). Additionally, the Court held that the “Rich and Creamy” claim was a subjective description of quality which was not measurable and therefore constituted non-actionable puffery.
  • The case adds to a line of cases construing claims regarding the presence of ingredients narrowly. We will continue to monitor and report on class action lawsuits affecting the food industry.   

US Co. Falsely Marketing ‘French’ Dessert, Class Action Says (Law360 Subscription Required)

  • We have reported on the mixed outcomes in proliferating class action lawsuits that challenge allegedly misleading geographical connotations on various food product labels.  Such lawsuits allege that plaintiff consumers paid premium prices for products after being misled to believe the products were sourced from a specific country or region that they were not.  Judges in such cases must perform a very fact specific analysis to determine whether geographic phrases or images could lead a reasonable consumer to believe a product is made in a particular place. 
  • On March 16, 2023, a proposed class action lawsuit was filed in the Northern District of California against Petit Pot, Inc. alleging the company has misleadingly named its product as “French Dessert” and used misleading French words and imagery to “exploit the intimate relationship between the country of France and its classic dessert, the Pot de Crème.”  The products at issue are various flavors of Pot de Crème made in California.  One of the given examples of allegedly misleading packaging has the words, “Petit Pot, PISTACHIO, ORGANIC & Creamy, FRENCH DESSERT,” and includes a USDA Organic seal, as well as a picture of a green pudding in a glass jar surrounded by cracked pistachios, along with a cartoon image printed beside the brand name ‘Petit Pot’ of a small blue, jar-shaped figure wearing a dark blue striped top and a red beret.  The plaintiff claims to have believed the products were made in France based on the allegedly misleading product name, “French Dessert,” the use of the French words “Petit Pot” (which translates as “Little Pot” in English), the “French” look of the product’s mascot, and the use of a glass jar (characterized as a unique feature of dairy products in France).  The plaintiff also asserts that boxes containing multiple units of the dessert contribute to the deception of the products being made in France by featuring the French word for “magic” in the printed phrase, “A Taste of Magique,” and an image of a shop door with a sign displaying, “Ouvert,” which is French for “Open.” 
  • While the defendant has not yet answered the complaint, they will likely assert that “French” identifies a style rather than a place (i.e., France).  It is not clear what a judge will make of the use of a glass jar and French words interspersed with English words on the product label, however, and if these facts could distinguish the Petit Pot lawsuit from a 2021 case, discussed here, of a yoghurt made in New York where the court found references to “Icelandic” in the “Icelandic Provisions” brand name and the phrase “Traditional Icelandic Skyr” against a snow-covered backdrop on the front label to be akin to “in the style of Iceland,” which signals that the product is not made in the place that is named. 
  • Scientists and experts recently met at the Joint FAO/WHO Expert Meeting on Microbial Risk Assessment (JEMRA) to review recent data and evidence and to provide advice on control measures for Campylobacter jejuni and Campylobacter coli in the poultry meat production chain. 
  • A document summarizing the meeting was released to support updates on related broiler production guidelines by the Codex Committee on Food Hygiene (CCFH).  The full report will be published later as part of the Food and Agriculture Organization (FAO) and World Health Organization (WHO) Microbiological Assessment (MRA) series.
  • The document states that strict biosecurity measures, hygiene practices, and sanitation during primary production can enhance the control of Campylobacter in broiler flocks.  Risk factors for contamination at primary production sites, such as partial depopulation, litter management, proximity to other livestock, and slaughter age can help guide intervention strategies.  Experts suggest various practices to reduce the risk of contamination, including: immersion chilling, irradiation, addition of processing aids (such as chlorine derivatives, peroxyacetic acids, and organic acids) to water during washing, and thorough cooking.
  • Poultry meat is one of the most prevalent food vehicles for Campylobacter infections.  WHO estimates that Campylobacter was the source of more than 95 million illnesses and 21,374 deaths in 2010 alone.
  • WHO and FAO have issued a call for experts to contribute to risk assessment work on both Salmonella, another common contamination of poultry meat, and Campylobacter.
  • On March 10, Hershey Company filed a motion to dismiss a consumer class action suit which claimed that its chocolate contained toxic substances. Hershey maintains that it “never promised, in words or substance, that its products were utterly lead- and cadmium- free,” just that they were safe to consume. See Eva Grausz v. The Hershey Company, case number 3:23-cv-00028, in the U.S. District Court for the Central District of California.
  • Hershey maintained that the plaintiffs failed to show an injury-in-fact, arguing that the suit does not allege that the bars purchased were contaminated; rather, plaintiffs rely on testing reported by the publication Consumer Reports (CR). “That CR detected traces of lead and cadmium in two or three product samples does not indicate that the chocolate bars plaintiff herself purchased contained those contaminants,” said Hershey.  The CR study published in December 2022 tested 28 dark-chocolate bars. All candy tested contained both lead and cadmium, but 23 of them contained more than 0.5 micrograms of lead, more than 4.1 micrograms of cadmium, or both. To read more about the CR study, see our previous blog post here.
  • Hershey claims that the plaintiffs lack standing to bring a claim because CR did not test the particular bars purchased, and the study’s analysis states that results “can vary” from bar to bar. Alternatively, even if the candy consumers bought did contain lead and cadmium at the levels stipulated, they would still lack standing because the presence of heavy metals in low amounts do not render the food inedible or unsafe to consume.
  • Moreover, Hersey maintains, it’s a sad reality of “modern life” that lead and cadmium are omnipresent in the air, water and soil, making it impossible for anyone to make a product “absolutely free” of heavy metals. Accordingly, the company had never made that guarantee but at most implicitly promised the products were safe to consume.
  • Consumers claimed that they frequently purchased Lily’s Extremely Dark Chocolate 85% Cocoa, which is made by Hershey and tested at 143% of the maximum allowable dose level for lead in the state of California and 101% of the maximum allowable dose for cadmium. Other products named in the CR study included Hershey’s Special Dark Mildly Sweet and Lily’s Extra Dark 70% Cocoa.
  • Hershey is not the only company to face recent consumer actions for chocolate products as a result of the CR study. Earlier this month, chocolate makers Mondelez Global LLC, which manufactures Hu-branded chocolate, and Lindt & Sprungli North America Inc. were hit with proposed class actions in New York. See Newman v. Lindt & Sprungli (North America) Inc., case number 1:23-cv-01972, and Newman v. Mondelez Global LLC, case number 1:23-cv-01988, in the U.S. District Court for the Southern District of New York.
  • Keller and Heckman will continue to monitor consumer class actions regarding heavy metals in food products.

  • On March 10, 2023, the U.S. District Court for the Southern District of New York dismissed (Law360 subscription required) an amended complaint which alleged that Wegmans’s vanilla cake mix product was falsely and misleadingly labeled as “naturally flavored” and free of artificial flavors.
  • Per 21 CFR 101.22(i) a product that presents itself as having the characterizing flavor of vanilla may be labeled as “naturally flavored” if it contains natural flavor derived from vanilla bean (the “characterizing ingredient”) and no artificial flavors.
  • The complaint alleges that the product contains artificial ethyl vanillin, and thus that the representations regarding flavoring are incorrect. Plaintiffs support their assertions by citing to a laboratory analysis which purportedly shows the presence of 3.07 part per billion (ppb) of ethyl vanillin.
  • The Court held that the viability of Plaintiffs’ claims depended on their ability to plausibility substantiate the claims that ethyl vanillin is present in the product and that ethyl vanillin is an artificial flavor. The Court held that Plaintiffs failed to substantiate either claim, but it focused on the deficiencies regarding the former. Specifically, the Court held that the pleadings failed to substantiate the presence of ethyl vanillin because no information was included regarding “testing methodology, the date, time, or place of the testing, who conducted the testing, and what the exact product tested was.”
  • The motion to dismiss was granted with prejudice (without leave to amend) because the Court had already put Plaintiffs on notice of the deficiencies in the complaint and given them an opportunity to correct the deficiencies.
  • Yesterday, on March 8, 2023, the U.S. Food and Drug Administration (FDA) sent a letter to manufacturers, packers, distributors, exporters, importers, and retailers involved in the manufacturing and distribution of powdered infant formula, asking for them to share current safety information and to take action to improve processes for the protection of infants.
  • Last year, safety concerns at one of the largest infant formula manufacturing facilities in the U.S. prompted a nationwide recall and temporary pause in production, leading to a national infant formula shortage.  Since then, FDA has issued multiple guidance documents intended to help facilitate the availability of safe and nutritionally adequate infant formula through enforcement discretion.  The Agency has also developed a cronobacter prevention strategy, enhanced inspection activities, increased engagement with the industry, and has pursued regulatory action in some cases.
  • In the recent months, FDA food safety staff have been meeting regularly with the powdered infant formula manufacturers to further develop the prevention strategy to help prevent cronobacter illness.  The letter reflects the information gained during these meetings, as well as the latest available science.
  • In its update, FDA calls on all members of the infant formula industry to use the information in the letter to take prompt action to improve processes and programs for infant protection.  FDA will continue to inspect and work with the industry to advance research and regulatory activities included in the prevention strategy.
  • Keller and Heckman will continue to monitor and report on any developments in this area.
  • On March 3, 2023, Judge Buchwald of the U.S. District Court for the Southern District of New York permanently tossed a proposed class action claiming that Pervine Foods’ FitCrunch protein bars are fraudulently advertised as healthy, ruling that a reasonable consumer wouldn’t look at the label, which features an image of desserts like Oreo cookies, and believe the bars were healthy.  See Cade Seljak et al. v. Pervine Foods LLC, case number 1:21-cv-09561.
  • Plaintiffs argued that they believed the FitCrunch bars were healthy even though the terms “healthy” or “health” do not appear on any of the products’ labels or in any of Pervine Foods’ advertisements. The customers’ sole belief that the protein bars were healthy was entirely premised on the use of the term “fit” in the products’ name which, they argued, is synonymous with “healthy.” Further, the customers claimed they were misled into thinking the bars were healthy when the products actually contain between 8 and 18 grams of fat.
  • According to Judge Buchwald’s opinion granting defendant’s motion to dismiss, Pervine Foods, which sells FitCrunch protein bars and FitBar energy bars, did not falsely advertise its products as “healthy.” The Pervine Foods products contain high levels of protein and come in flavors that sound like desserts, including milk and cookies, chocolate chip cookie dough, apple pie and chocolate peanut butter. The FitCrunch label states that the product is a “whey protein bar” with a “soft cookie center.” Further, the number of calories represented on many of the FitCrunch product labels, which ranges from 190 to 380 calories, is higher than the number of calories found in an average candy bar.
  • “[B]efore even turning to the ingredient label, a reasonable consumer viewing this label simply would not believe that FitCrunch products are ‘healthy’ . . . [i]ndeed, such a belief is plainly inconsistent with the face of the package, and with common sense,” said Judge Buchwald. The judge further concluded that, even assuming that the defendant’s use of the word “fit” could be interpreted to mean “healthy,” the ingredients listed on the back of the product’s wrapper include the bar’s fat content and could easily cure that confusion.
  • Keller and Heckman will continue to monitor consumer class actions regarding misleading product labels.