• On March 28, FDA released an Immediate National Strategy to Increase the Resiliency of the U.S. Infant Formula Market. The strategy follows a months-long infant formula shortage sparked by the temporary shutdown of Abbot’s facility in Sturgis, Michigan in February 2022 due to positive test results in the facility for Cronobacter sakazakki and an outbreak of food-borne illness among infants who had been exposed to infant formula produced at the facility. To view our past blog posts regarding FDA’s response to last year’s infant formula crisis, please follow this link.
  • As directed by Congress in the Food and Drug Omnibus Reform Act of 2022, FDA devised a national strategy describing the immediate actions the Agency took to address the infant formula shortage and detailing the Agency’s plans for improving the resiliency of the infant formula supply. Among other things, FDA is working to conduct surveillance food safety inspections of all infant formula manufacturers at least annually, use remote regulatory assessments, expand and improve infant formula training for investigators, monitor the infant formula supply and supply chain, expedite review of premarket submissions for new infant formula products to mitigate or prevent shortages, and build a consumer education program.
  • This strategy represents a first step toward issuing, with input from the National Academy of Science, Engineering and Medicine (NASEM), a long-term national strategy in 2024 to improve preparedness against infant formula shortages by outlining methods to improve information-sharing, recommending measures for protecting the integrity of the infant formula supply chain, and preventing contamination.  The long-term strategy will also explore new approaches to help facilitate entry of new infant formula manufacturers to increase supply and mitigate future shortages and recommend other necessary authorities to gain insight into the supply chain and risks for shortages.
  • Keller and Heckman will continue to monitor and report on any developments in this area.
  • Earlier this month, USDA’s Food Safety and Inspection Service (FSIS) issued a proposed rule which would significantly narrow the scope of voluntary U.S. origin claims on FSIS-regulated products (meat, poultry, and eggs).
  • Currently, FSIS’s Food Standards and Labeling Policy Book allows “Product of USA” or similar claims to be made if the product was processed in the U.S., even if the source animals were born, raised, or slaughtered abroad. FSIS received serval petitions requesting revisions to this standard in the last few years and in response commissioned a study which found that most consumers did not understand and were misled by the current U.S. origin claims.
  • Accordingly, FSIS is proposing to authorize “Product of USA” and “Made in USA” only if all FSIS-regulated components of the product are derived from animals born, slaughtered, raised, and processed in the U.S. and (2) all additional ingredients, except for spices and flavoring, are of domestic origin. The proposed rule also allows for qualified origin claims to be made provided that they describe the processing steps which occur in the U.S. (e.g., “Sliced and packaged in the United States using imported pork”). Furthermore, the same criteria would apply to state origin claims (e.g., a “Made in Maryland” meat product would have to be born, raised, slaughtered, and processed in the Maryland).
  • The proposed rule notes that it does not conflict with the country of origin labeling (COOL) regulations for certain imported commodities sold at retail in 7 CFR Part 65 and that such products should continue to comply with those requirements.
  • Comments to the proposed rule are due by May 12, 2023.
  • FDA has long recognized the use in food labeling of Dietary Guidance Statements (e.g., fruits and vegetables are part of a nutritious dietary pattern) as a tool that could help consumers improve their health and decrease the risk of diet-related diseases by making sound dietary decisions.  On November 25, 2003, FDA issued an advance notice of proposed rulemaking (ANPRM) that solicited information and comments on alternatives for regulating qualified health claims and on the appropriateness and nature of dietary guidance statements.  More recently, as covered extensively on our blog, FDA announced a new Nutrition Innovation Strategy (NIS) in March 2018 and held a public meeting on July 26, 2018 to receive input on topics including (1) what types of claims or other nutrition-related labeling statements are most helpful in facilitating product innovation to promote healthful eating patterns and (2) what types of claims and other labeling statements are most helpful to consumers in selecting foods consistent with recommendations in the “Dietary Guidelines for Americans.” 
  • On March 27, 2023, FDA published notice on the availability of a draft guidance for industry titled, Questions and Answers About Dietary Guidance Statements in Food Labeling.  The draft guidance defines Dietary Guidance Statement as “written or graphic material, based on key or principal recommendations from a consensus report, in food labeling that represent or suggest that a food or a food group may contribute to or help maintain a nutritious dietary pattern.”  Dietary Guidance Statements focus on a food or food group in contributing to or maintaining nutritious dietary patterns (e.g., “Eat broccoli as part of a nutritious dietary pattern”) and do not undergo review by FDA prior to use in the marketplace.  They are distinguishable from Health Claims, which focus on the relationship between a particular food substance and reduced risk of a disease or health-related condition (e.g., “Diets low in sodium may reduce the risk of high blood pressure, a disease associated with many factors”) and which generally undergo review by FDA through a petition process, and Nutrient Content Claims which expressly or implicitly characterize the level of a nutrient in a food (e.g., a claim that a food is “low” in fat content or is “healthy”).  
  • The guidance includes recommendations on how to use Dietary Guidance Statements as follows:
    • Identifying an appropriate source of the Dietary Guidance Statement;
    • Ensuring that a product bearing a Dietary Guidance Statement contains a “meaningful amount” of the food or food group or “food group equivalent” that is the subject of the statement;
    • Maximum levels that should be present per Reference Amount Customarily Consumed (RACC) for individual foods bearing a Dietary Guidance Statement, i.e., 15% of the daily value (DV) for sodium (345 milligrams), 10% of the DV for saturated fat (2 grams), and 10% of the DV for added sugars (5 grams), with an exception for saturated fat in seeds and nuts. 
    • Maximum levels that should be present for main dishes bearing a Dietary Guidance Statement, i.e., 30% the saturated fat and sodium DVs per RACC and 20% of the DV per RACC for added sugars.
    • Maximum levels that should be present in meals bearing a Dietary Guidance Statement, i.e., 40% of the saturated fat and sodium DVs per RACC and 30% of the DV per RACC for added sugars. 
  • FDA specifically invites comments on:
    • Use of Dietary Guidance Statements on refined grains that are staples of cultural cuisines that are not high in added sugars, saturated fat, and sodium (since consumption of whole grains is encouraged in the guidance); 
    • Alternative options for calculating “meaningful amounts” or “food group equivalents” of a food or food group that is the subject of the Dietary Guidance Statement;
    • Disclosure statement requirements for situations when a food is recommended by a consensus report as part of a nutritious dietary pattern and the food has a nutrient profile that exceeds the recommended nutrient levels set forth in the guidance;
    • Use of Dietary Guidance Statements on bottles or containers of plain water and other calorie-free beverages ( e.g., flavored carbonated water, coffee, and tea).
  • Comments on the draft guidance that are submitted by June 26, 2023 will be considered before FDA begins work on the final version of the guidance.  FDA will also consider comments received from the 2003 ANPRM that are deemed relevant to the current dietary recommendations. 
  • 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.