• On October 21, a federal judge dismissed a proposed class action complaint against baby and toddler food producer, Sprout Foods Inc. (subscription to Law360 required). In their amended complaint, plaintiffs Samuel and Gillian Davidson alleged that Sprout Foods misbrands its products by declaring impermissible nutrient content claims on foods intended for use by infants and children less than 2 years of age, that those claims mislead buyers into thinking the products provide health benefits, and that the products are actually nutritionally and developmentally harmful for children under 2.
  • U.S. Chief District Judge Richard Seeborg dismissed the amended complaint, however, and found that the plaintiffs still have not plausibly claimed that Sprout Foods’ labeling is misleading or that the products are harmful. Rather, Judge Seeborg stated that the plaintiffs rely on speculative research conclusions and hypothetical scenarios to argue that the products are harmful. For example, plaintiffs allege the products contain harmfully high levels of “free sugars,” but do not explain at what point “high” sugar content crosses into harmful levels.
  • In his opinion, Judge Seeborg noted that the California Court of Appeal has warned against allowing food labeling claims that rely on “inferential leaps and which could ultimately ‘place almost any advertisement truthfully touting a product’s attributes at issue for litigation.’”
  • The amended complaint was dismissed, although plaintiffs are granted leave to amend. Keller and Heckman will continue to monitor and report on this case and other food litigation news.
  • Despite sampling data which indicates that Salmonella contamination in poultry products has decreased (by 50% from 2017 to 2021), the estimated rate of Salmonella infection from food has remained consistent over the past two decades. Accordingly, and in an effort to control Salmonella contamination in poultry and reduce related foodborne illness, on October 14, 2022, USDA’s Food Safety and Inspection Service (FSIS) announced the release of a proposed regulatory framework for Salmonella in poultry products.
  • The three components to the proposed plan are:
    1. Requiring that incoming flocks be tested for Salmonella before entering an establishment;
    2. Enhancing establishment process control monitoring and FSIS verification; and
    3. Implementing an enforceable final product standard. Whether this standard will be a zero tolerance one, or one which is based on factors such as Salmonella serotype, pathogenicity factors, or quantity, remains to be determined.
  • FSIS will hold a public meeting on November 3, 2022 (10 am – 4 pm EST) to discuss and solicit feedback on the proposed standard. FSIS is in particular looking for feedback on the following questions:
    1. What factors should FSIS consider relative to the approaches outlined in each of these components?
    2. How can each component be strengthened?
    3. Where are the gaps in the framework?
  • Comments must be submitted by November 16, 2022.

Gerber Gets Baby Food Heavy Metals Suit Tossed (Law360 Subscription Required)

  • We reported on the April 25, 2022 dismissal by a New Jersey federal judge of a putative class action lawsuit against baby food producer Sprout Foods, Inc. after finding the alleged harm was “simply speculative” without the reported levels of heavy metals in the baby food being linked to any particular harm or risk to the plaintiffs.  In contrast, on January 10, 2022, a California federal judge refused to dismiss similar claims against Plum Organics, finding the claims are not preempted by federal law and that the suit plausibly alleges a reasonable consumer could be induced to pay more by the alleged omission of disclosures of potential toxins in the baby food (subscription to Law360 required).
  • On October 17, 2022, a Virginia federal judge followed the approach in the Sprout Foods case, dismissing claims against Gerber Products Co. by plaintiffs alleging economic harm from having purchased Gerber baby food products that were overpriced because Gerber failed to disclose the risk of containing harmful heavy metals on its packaging, inadequately tested for heavy metals, and failed to adhere to internal standards.  The case was dismissed on grounds of standing and federal preemption.
    • On the issue of standing, the court concluded the baby food products were safe “as to” the plaintiffs, finding the complaint discusses the dangers of heavy metal exposure to human health generally but does not allege the baby food products were adulterated, recalled, or the cause of any reported injuries, or that their children are at imminent risk of developing any specific ailment in the future because they consumed the baby food products.
    • The court also ruled against the plaintiffs on an alternative theory of economic injury based on allegations of having paid a “price premium,” finding the plaintiffs failed to allege any facts substantiating their conclusory allegations that would permit the court to determine the economic value of their alleged lost benefit without resorting to mere conjecture; thus, finding the plaintiff failed to demonstrate they did not get the benefit of their bargain or did not receive the full value of their purchase, the court found the plaintiffs lack standing
    • The court also noted that the plaintiffs have not identified an affirmative duty or legal obligation, under the Federal Food, Drug and Cosmetic Act or any other law, requiring the disclosure of the presence of heavy metals in baby food products.
    • On federal preemption arguments, the court found that FDA has primary jurisdiction to determine whether the amounts of heavy metals in baby food products is harmful.
  • Keller and Heckman will continue to monitor and report on litigation involving heavy metals in baby food, as well as FDA’s regulatory activities following two congressional reports (discussed here) that raised alarm regarding the levels of heavy metals— including arsenic, lead, cadmium, and mercury— reportedly found in baby foods.

 

  • On October 20, FDA issued final guidance that describes the actions, behaviors, and statements by a foreign food establishment or foreign government that the FDA considers to be a refusal of an inspection. As our readers may recall, FDA published its draft guidance concerning refusal of inspections back in December 2017.
  • Food for importation into the United States comes from all over the world.  One way that the FDA protects the U.S. food supply is by conducting inspections of foreign food facilities to identify potential food safety concerns. The Food Safety Modernization Act (FSMA) gives FDA authority to refuse entry of food offered for importation into the United States if the foreign food establishment or foreign government has refused to permit the FDA to inspect the foreign establishment that produced the food. The guidance issued yesterday provides examples of situations that FDA may consider as constituting refusal.
  • A non-exhaustive list of example situations in which FDA would consider a foreign food establishment to have “refused” an inspection include when an operator, agent, or owner in charge:
    • Does not respond to FDA during the 24-hour period after submission by FDA of a written inspection request;
    • Stops communicating with FDA at any time after the owner, operator, or agent in charge initially responds to FDA’s request to schedule an inspection;
    • Agrees to an inspection start date and then requests a later date without giving a reasonable explanation;
    • Refuses to permit entry to the establishment;
    • Sends staff home for the day, without a reasonable explanation, and tells the FDA investigator that the establishment is not producing any product;
    • Does not answer telephone calls from the FDA investigator who is present at the establishment and unable to gain entry to the establishment;
    • Bars the FDA investigator from an area of the establishment where food is grown, harvested, manufactured, processed, prepared, packed, or held;
    • States that direct observation of an establishment, in whole or in part, must be limited to an unreasonably short amount of time;
    • Makes statements, actions, and passive behaviors intended to avoid inspection or to mislead or deceive the FDA investigator in a manner that prevents the investigator from conducting the inspection;
    • Refuses to allow the FDA investigator to collect evidence to document potential violations (e.g., to take photographs as necessary; to collect samples; talk to pertinent staff; or to collect food labels and labeling);
    • Leaves the FDA investigator in a non-production area of the establishment (e.g., conference room) without access to records, to a responsible individual, or to other areas of the establishment that would be subject to inspection for an unreasonable period of time.
  • The final guidance is scheduled to be published in the Federal Register on October 21 and can be reviewed here.
  • On October 17, U.S. Magistrate Judge Donna M. Ryu denied Barilla America Inc.’s motion to dismiss a putative class action lawsuit that accused it of falsely representing its pastas as made in Italy [subscription to Law360 required]. The plaintiffs, Jessica Prost and Matthew Sinatro, allege that the company’s federally trademarked phrase, “Italy’s #1 Brand of Pasta,” which is declared on the principal display panel and is accompanied by green, white, and red colors, is misleading to reasonable consumers and leads them to believe that the pasta products are made in Italy or with ingredients sourced from Italy, when the products are actually made in the United States.
  • According to Barilla, the purpose of the trademark is to identify Barilla to consumers as the entity that made the products, and that it is not misleading to “invoke the Company’s Italian roots through generalized representations of the brand as a whole.” Further, Barilla argues that the plaintiffs lack standing and their complaint fails to state a claim.
  • Judge Ryu did not find Barilla’s arguments persuasive, but found that the plaintiffs’ complaint plausibly alleges that the trademarked phrase supports a reasonable inference that the products were made in Italy or from Italian ingredients. Although Judge Ryu allowed the majority of the plaintiffs’ claims to proceed, she rejected their request for injunctive relief and the arguments that they sufficiently alleged an immediate or actual threat of future harm from being deceived by the trademarked phrase. Judge Ryu stated that the “plaintiffs cannot plausibly allege that they remain unaware that the products are manufactured in the United States from ingredients that are not from Italy or that they reasonable would be misled if they encounter the [trademarked phrase] in the future.”
  • Keller and Heckman will continue to monitor and report on this case and other food litigation news.
  1. On September 30, 2022, a federal Court permanently enjoined Arkansas from enforcing provisions of a state law (Arkansas Code § 2-1-305(2),(5),(6),(8),(9), and (10)) which would have prevented Plaintiff Tofurky from marketing or selling its plant-based meat products in the state with any name that uses a traditional meat term. (Turtle Island Foods SPC v. Soman, Case No. 4:19-cv-00514).
  2. The Court, applying the Central Hudson doctrine for commercial speech, held that the law did not withstand First Amendment scrutiny. In particular, the Court held that the labeling of Tofurky’s products was not misleading because each product featured prominent disclosures which made it clear that the product was plant-based and not animal-based. Therefore, the government could not show that it was directly advancing its stated interest in protecting consumers from false or misleading labeling. Furthermore, the Court found that the ban was more extensive than necessary and amounted to an outright ban on non-misleading speech.
  3. Notably, while Plaintiff was successful in its as-applied constitutional challenge (a challenge to the statute as applied in the particular case), the Court rejected a facial First Amendment challenge because there could be a set of circumstances where the law is valid as applied (i.e., if the law was applied to a company which did not include disclosures indicating that its product was plant based). Nevertheless, the Court’s reasoning makes clear that enforcement of the law against any company marketing plant-based meat products with appropriate qualifiers is unconstitutional.
  •  Dr. Mark Moorman, Director of the Food and Drug Administration’s (FDA) Office of Food Safety, and Stephen Hughes (Prevention Coordinator) published a post on the FDA Voices blog on October 13, 2022 discussing a new series designed to share the latest information on strategies for preventing future foodborne illnesses.
  • FDA’s new series of Prevention Strategies to Enhance Food Safety is developed from investigations of foodborne disease outbreaks.  For food-hazard pairings where emerging patterns can be identified and targeted, FDA will release strategies that contain recommendations for the prevention of future foodborne illness.  These strategies take from the lessons learned from larger initiatives like the Leafy Green STEC Action Plan, while establishing a scalable approach that can be utilized more frequently.  FDA has thus far released two Prevention Strategy documents:
    • Imported Enoki and Imported Wood Ear Mushroom Strategy Document (September 26, 2022) targets Listeria monocytogenes and Salmonella contamination of imported specialty mushrooms and, among other information, includes:
      • Recommendations for further research; and
      • Increased sampling at U.S. ports and retail operations.
    • Bulb Onion Strategy Document (September 26, 2022) targets Salmonella contamination of bulb onions and includes:
      • Recommendations for further research;
      • Prioritized inspections of farms in the U.S. and Mexico;
      • Increased sampling of onions from the State of Chihuahua, Mexico;
      • Support for industry-led efforts to develop and implement best practices for bulb onion production; and
      • Prioritized Foreign Supplier Verification Program inspections of bulb onion importers.
  • FDA experts will be interviewed about foodborne illness prevention strategies on Food Safety Magazine’s Food Safety Matters podcast to be released October 18, 2022.
  • In a 16-page order, U.S. District Judge William H. Orrick dismissed with prejudice customer Angela Kennard’s putative class action she filed last year against Kellogg Sales Co. over its use of the term “veggie” in several of its MorningStar Farms line of meatless products such as its burgers, hot dogs, chicken nuggets, patties, sausage links, bacon stripes, chicken wings and more. As our readers may recall, we reported on the Morningstar Farms “veggie” product labeling suit in April after Kellogg moved to dismiss the amended suit, citing several decisions in similar false labeling suits, such as the opinion issued by the Ninth Circuit in Becerra v. Dr Pepper/Seven Up Inc., where the panel ruled no reasonable customer would believe the company’s use of the term “diet” promised weight loss or management.
  • Plaintiff Kennard alleged Kellogg’s Morningstar Farms “veggie” products mislead consumers because the word “veggie” indicates that the main or only ingredients in the products are vegetables or made from vegetables, adding that customers she surveyed said they largely understood “veggie” to refer to vegetable-based products. Plaintiff accused the food and beverage company of violating California’s False Advertising and Unfair Competition laws, as well as a myriad of federal rules regulating the labeling of food products, and breaching warranties. However, on September 15, the  Northern District of California decided that Kellogg’s use of the term “veggie” on its labels is, at most, ambiguous and could refer to meat substitutes.
  • Judge Orrick said he didn’t think the term “veggie” on the products’ labels was false, misleading or misbranded or that it violates any federal food labeling requirements or state laws. The term “veggie” is ambiguous in the way it is used on the packaging, and the photos and information on the packaging doesn’t convey the product uses any particular vegetables. “I agree that the [Plaintiff’s’] allegations are implausible and do not support a reasonable inference that some significant portion of consumers would be misled into thinking the VEGGIE products are made primarily of vegetables as opposed to being vegetarian meat substitutes made from grains, oils, legumes, or other ingredients,” Judge Orrick maintained. Additionally, the product packaging features items that imitate meat, and consumers can readily identify the actual ingredients in the products on the packaging, the judge said.
  • In recent years, laws have been passed all over the country that restrict the use of the term “meat” in product labeling, including in Missouri, Arkansas, Oklahoma and others. For example, Missouri passed a law in 2018 prohibiting a seller or advertiser from “misrepresenting a product as meat that is not derived from harvested production livestock or poultry.” Similarly, many of these other states’ laws require that only foods derived from food-producing animals may contain labels with terms like “meat, “burger,” “sausage” and the like.
  • In light of these recent labeling lawsuits and related legislation, marketers must be mindful of any representations they are making — whether in words or pictures — that might convey claims about a product’s contents. Keller and Heckman will continue to follow and report developments relating to the growing number of labeling claims challenges.
  • On October 12, 2022, FDA announced that it would be hosting a 4-part webinar series to provide more information regarding the Infant Formula Transition Plan for Exercise of Enforcement Discretion. Each of FDA’s webinars will have a specific focus:
    • October 21, 2022: Infant Formula Enforcement Discretion Transition Guidance Overview
    • November 4, 2022: New Infant Formula Submission Requirements
    • November 10, 2022: Quality Factor Requirement – Sufficient Biological Quality of Protein
    • November 17, 2022: Quality Factor Requirement – Normal Physical Growth
  • By way of background, and as previously reported, on May 16, 2022, FDA released a guidance document with the Agency’s plan to increase the supply of infant formula through the exercise of its enforcement discretion for certain non-compliant formula.  On September 30, 2022, FDA announced a new guidance, the Infant Formula Transition Plan for Exercise of Enforcement Discretion, which details the pathway for manufacturers of infant formula working under the enforcement discretion to market infant formula products as they work toward meeting FDA’s requirements.
  • The webinars begin at 2:00 pm Eastern Time. Registration is required for the webinar and interested parties may register at: https://www.surveymonkey.com/r/MVHQ337. Each webinar will also be recorded and posted to the meeting page.

 

  • On October 11, the FDA announced the launch of an independent study, “The Role of Seafood in Child Growth and Development,” by the National Academies of Science, Engineering, and Medicine (NASEM) on the state of scientific evidence in nutrition and toxicology associations between seafood consumption and child growth and development. The purpose of the study is to obtain the most up-to-date understanding of the science on fish consumption in a whole diet context, which will support the goals of the FDA’s Closer to Zero Action Plan for reducing the exposure of babies and young children to mercury, arsenic, lead, and cadmium from foods.
  • As part of the study, an ad hoc committee of the NASEM will:
    • Evaluate dietary intake and seafood composition data provided by the sponsors (i.e., Department of Commerce, HHS, EPA, and USDA’s Agricultural Research Service);
    • Conduct systematic reviews of the scientific literature covering the areas of seafood nutrition and toxicology associated with seafood consumption and child growth and development;
    • Review existing sources of evidence on maternal and child seafood consumption and child growth and development; and
    • Develop an approach to synthesize the scientific evidence, and utilize that strategy to develop its findings and conclusions (quantitative and/or qualitative) about associations between seafood consumption and child growth and development.
  • FDA intends for the study to help inform whether any updates are needed for the current Advice about Eating Fish for children and those who might become or are pregnant or breastfeeding, and also hopes to gain a better understanding of the science on mercury exposure from food.
  • The FDA is partnering with the National Oceanic and Atmospheric Administration, U.S. Department of Agriculture, and U.S. Environmental Protection Agency on the study, and NASEM will publish the committee’s report after the study is complete in approximately 18 months. The FDA intends to use the study findings to advance policies and programs that support healthy child growth and development.