• On April 8, 2021, the U.S. Food and Drug Administration (FDA) unveiled Closer to Zero, a new action plan for reducing exposure to toxic elements from foods eaten by babies and young children to as low as possible.  The plan (announced here) describes FDA’s approach as an iterative process involving four stages: (1) Evaluate the science, (2) Propose action levels, (3) Consult with stakeholders, and (4) Finalize action levels for lead, arsenic, cadmium, and mercury.  A graphic display of the stages shows that FDA’s ongoing research, monitoring, and compliance efforts will continue separately at the center of a cycle of continual improvement.
  • FDA’s Closer to Zero action plan is scheduled to unfold in three phases as follows:
    • Phase 1, which is scheduled for completion by April 2022, will focus on lead and arsenic.  FDA will propose action levels for lead in categories of baby foods (e.g., cereals, infant formula, pureed fruits and vegetables) and other foods commonly eaten by babies and young children, and FDA will consult with stakeholders and federal partners on issues such as feasibility and share best practices for reducing or preventing lead contamination.  With respect to arsenic, FDA will work on the first phase, evaluating the science.
    • In Phase 2, scheduled for April 2022 – April 2024, FDA plans to finalize the action level for lead, propose action levels for arsenic, and begin the evaluation stage for cadmium and mercury.
    • In Phase 3, which is set to begin April 2024 and continue indefinitely, FDA plans to propose action levels for cadmium and mercury, finalize action levels for arsenic, and loop back to the evaluation stage for lead, to assess the feasibility of attaining even lower levels.
  • Closer to Zero follows FDA’s March 5, 2021 announcement of new activities – including a commitment “in the near term” to review current action levels and develop additional action levels for contaminants in key foods – that respond to a February 4, 2021 Congressional report on the finding of heavy metals in baby foods in the U.S.
  • Keller and Heckman will continue to monitor and report on FDA’s regulatory activities, as well as congressional investigation and litigation involving heavy metals in baby food.
  • On March 18, 2021, the U.S. District Court for the Northern District of California granted the U.S. Department of Agriculture’s (USDA) motion for summary judgement and found that USDA did not err in deciding that the Organic Foods Production Act (OFPA) does not prohibit hydroponic systems (where crops are grown without soil) from qualifying for the National Organic Program (NOP). In the same order, the court denied the Center for Food Safety’s (CFS) motion for summary judgement and motion to add materials to the administrative record.
  • The court found that CFS had not provided enough evidence to show that USDA acted arbitrarily and capriciously under the Administrative Procedure Act (APA) such that there was a genuine issue of material fact. Relying on longstanding principles of deference to agencies under the APA, the court held that USDA had reasonably read the OFPA as not prohibiting hydroponics from qualifying as organic if they otherwise meet the NOP’s requirements. It further concluded that CFS had not shown further consideration of comments and information that had been excluded from the administrative record would have changed USDA’s decision.
  • By way of background, CFS submitted a rulemaking petition to USDA in 2019 requesting the agency prohibit organic certification of hydroponics, systems that it views as inconsistent with organic’s primary goal of improving soil fertility. After USDA denied their request, CFS, together with a group of organic farmers and stakeholders, sued to challenge the petition denial (the primary issues in the case are summarized here).
  • CFS has not yet announced its next steps. We will continue to monitor this hotly contested issue for updates.
  • On March 29, 2021, the U.S. Court of Appeals for the Eighth Circuit concluded that that the State of Missouri is not barred from enforcing its 2018 state law that makes it a crime for vegan food producers to imply that their products contain real meat.  However, upon affirming the lower court’s ruling that denied plaintiff Tofurky Company’s (Tofurky) motion for preliminary injunction, the Eight Circuit stated that Tofurky failed to show that the law applies to its products or that Tofurky is at risk of enforcement, as the company already informs consumers that its products are made from plants, rather than from animals.
  • Missouri’s law prohibits persons from “misrepresenting a product as meat that is not derived from harvested production livestock or poultry.”  In the lawsuit, plaintiffs alleged that the Missouri law violates their First Amendment rights, as it criminalizes the word “meat” and unfairly restricts how manufacturers can sell meat alternatives.  After filing the complaint, plaintiffs filed a motion for a preliminary injunction arguing that Missouri’s law could result in criminal charges against Tofurky, which sells “veggie burgers” and other similar products, while the case is being heard in court.
  • The lower court concluded that plaintiffs had not shown a substantial likelihood of success on the merits of their First Amendment claim because the law only prohibits misleading speech, not their commercial speech.  Further, the lower court cited a state guidance document that stated companies are only in violation of the statute if their marketing and labeling do not include “appropriate qualifiers,” such as “plant-based,” “veggie,” “lab-grown,” or “lab-created.”
  • Although the Eighth Circuit denied the injunction, it allowed the suit to move to trial on the merits.  A number of states, including Mississippi and Arkansas, have enacted laws to prohibit marketing a product as “meat” if it is not derived from livestock or poultry.  We will continue to monitor any developments.
  • On April 6, the FDA released a report on the investigation into the Fall 2020 outbreak of E. coli O157:H7 illnesses linked to the consumption of leafy greens. Through the use of a traceback investigation, the FDA identified the outbreak strain in one cattle feces composite sample taken alongside a road approximately 1.3 miles upslope from a produce farm with multiple fields linked to the outbreak. While no direct source or route of contamination was identified, the investigation provided insights into potential sources of contamination, including livestock activities on adjacent land.
  • The report also discussed trends of leafy greens outbreaks linked to the California Central Coast growing region. The FDA analyzed outbreaks that had occurred each fall since 2017 and found three key trends in the contamination of leafy greens by E. coli O157:H7 in recent years: a reoccurring strain, reoccurring region and reoccurring concerns with the potential impacts of  adjacent lands. Based on these findings, the FDA recommended that producers in the California Central Coast growing region participate in the California Longitudinal Study, which is intended to improve food safety through enhanced understanding of the ecology of human pathogens in the environment that may cause foodborne illness outbreaks. FDA also recommended the producers participate in the locally-led, locally-convened California Agricultural Neighbors (CAN) workgroup. In addition, when pathogens are identified through microbiological surveys, pre-harvest or post-harvest testing, the FDA recommended that growers implement industry-led root cause analyses to determine how the contamination likely occurred and then implement appropriate prevention and verification measures.
  • FDA also released an updated version of the Leafy Green Shiga-toxin producing E. coli (STEC) Action Plan which was designed to support an integrated food safety system and help foster a more urgent, collaborative, and action-oriented approach between the FDA and stakeholders in the public and private sectors. According to the FDA, since the initial publication in March 2020, the FDA has made significant progress by enhancing prevention strategies, improving response activities by the FDA and other entities, and identifying and addressing the knowledge gaps that exist around STEC contamination of leafy greens.
  • As we have previously blogged about, in July 2020, the Eastern District of Wisconsin granted summary judgment in favor of Champion Petfoods (“Champion”) in a lawsuit asserting, among other things, that Champion had deceived consumers by labeling pet food products as “biologically appropriate,” even where they contained Bisphenol-A (BPA). The district court concluded that the presence of non-harmful trace amounts of BPA did not constitute deceptive advertising.
  • The plaintiff appealed the decision in November of 2020, arguing that the lower court had inappropriately decided or ignored “numerous disputed issues of material fact and evidence . . . that should have been presented to and weighed by a jury.” Specifically, addressing the BPA-related claims, the plaintiff argued that, contrary to the lower court’s suggestion, it was irrelevant that BPA was unintentionally added, and that the lower court incorrectly considered the potential harm to the defendant or industry if liability was found. Plaintiff further argued that the lower court had ignored the evidence that he had presented demonstrating that Champion’s dog food contained nearly twice as much BPA as other tested dog food products and that BPA had been linked to various health issues.
  • Most recently on April 1, 2021, a pair of 7th Circuit judges expressed skepticism regarding plaintiff’s claims and questioned how plaintiff had demonstrated that BPA was present in an amount that could render the phrase “biologically appropriate” deceptive to a reasonable consumer.
  • Plaintiff’s position ignores the adage and basic toxicological principle that “the dose makes the poison.” And with little evidence apart from his own testimony that a reasonable consumer would be deceived and no evidence that the pet food contains BPA at harmful levels, it appears very likely that the lower court’s ruling will be upheld.  Keller and Heckman will continue to monitor and report on this case and other food-related litigation.

Annie’s Mac And Cheese Uses Harmful Chemical, Suit Says (Subscription to Law360 required)

  • A putative class action complaint was filed in the U.S. District Court for the Eastern District of New York on April 1, 2021 against General Mills’ Annie’s macaroni and cheese products.  The named plaintiff alleges that more than twenty products are mislabeled and falsely advertised as “Made with Goodness!” because the presence of ortho-phthalates is not disclosed on the packages.
  • The complaint notes recent findings of phthalates in the cheese powder of other brands of macaroni and cheese products and alleges that General Mills “has tested its macaroni and cheese products and they do contain phthalates.”  Further, the plaintiff points to the FAQ section of Annie’s website, including the statement, “We are troubled by the recent report of phthalates found in dairy ingredients of macaroni and cheese,” as evidence that the defendant “acknowledges the problem.”  While the Annie’s website notes “the European Food Safety Authority (EFSA) has published risk assessment data which notes a Total Daily Intake of 0.05 mg/kg of body weight” as a threshold for levels of phthalates in food, and indicates that “any trace of phthalates are below the EFSA standard,” the plaintiff alleges that Annie’s products “were not safe or healthy for consumption.”
  • Other courts have dismissed similar false advertising claims on the basis that the failure to disclose trace, non-harmful amounts of a chemical does not constitute misleading advertising where the substance is pervasive in the environment and present in many foods.
  • On April 1, 2021, the Center for Science in the Public Interest (CSPI) joined five consumer and health advocacy organizations (the American Heart Association, American Public Health Association, Center for Digital Democracy, Consumer Federation of America, and Consumer Reports) in a letter urging FDA to draft guidance addressing nutritional labeling requirements for menu items on third-party online platforms (TPPs), like DoorDash, Seamless, Grubhub, and Uber Eats. Specifically, the letter requested that FDA make clear that both covered restaurants and TPPs must comply with the nutrition labeling requirements and highlighted the fact that most TPPs do not currently list calorie information on online menus.
  • Under the Affordable Care Act menu labeling provisions and FDA regulations finalized in 2018, restaurant chains with 20 or more outlets must include calorie information for standard items on menus and provide additional nutritional information upon request.  21 C.F.R. § 101.11(a) specifies that restaurants must include the information on both physical, electronic, and online menus. The consumer groups’ letter argued that TPPs must also comply with the nutritional labeling requirements under the misbranded food provisions in 21 U.S.C. § 331. FDA regulations, however, state that only the restaurants themselves need comply with the rule.
  • In April 2020, FDA announced it would not enforce the nutrition labeling requirements for restaurant menus as a flexibility for the restaurant industry during the COVID-19 pandemic, a policy change that remains in effect for the duration of the public health emergency. We will continue to monitor this issue and report on any developments.
  • On March 29, 2021, the U.S. District Court for the Eastern District of California granted the California Chamber of Commerce’s (CalChamber) preliminary injunction to temporarily bar the State of California and any private litigants from enforcing Proposition 65 against businesses that do not warn consumers that acrylamide in food is known to the State of California to cause cancer.
  • In the lawsuit, CalChamber argued that warnings for acrylamide constitute false and misleading compelled speech that violates the First Amendment of the United States Constitution because there is a lack of reliable scientific evidence suggesting a causal relationship between acrylamide in food and cancer risk.  The court concluded that stating acrylamide is known to cause cancer is not factual or free of controversy, as most studies suggest naturally forming acrylamide in food products does not cause cancer in humans.
  • By way of background, acrylamide is a naturally occurring compound that develops when starches and sugars are cooked at high temperatures.  According to California’s Office of Environmental Health Hazard Assessment, it is present in foods including “French fries, potato chips, fried and baked snack foods, roasted asparagus, canned sweet potatoes and pumpkin, canned black olives, roasted nuts, roasted grain-based coffee substitutes, prune juice, breakfast cereals, crackers, some cookies, bread crusts, and toast.”
  • In its decision, the court stated that “if a business decides not to use the safe harbor warning, it risks expensive and lengthy litigation against private enforcers or the state, and defendants carry heavy evidentiary burdens if they attempt to show their products contain permissibly small quantities of acrylamide.”  The court clarified that the preliminary injunction has no impact on preexisting consent decrees, settlements, or other agreements related to Proposition 65 warning requirements.
  • On March 25, Congressmembers introduced The Baby Food Safety Act of 2021 to amend the Federal Food, Drug, and Cosmetic Act (FDCA) to limit the presence of toxic elements in infant and toddler food. Within a year of the Act coming into effect, manufacturers of infant formula and toddler food for kids up to 36 months would be required to adhere to the following initial maximum levels:
    • Inorganic arsenic: 10 ppb for infant and toddler food (except cereal) and 15 ppb for infant and toddler food that is cereal
    • Cadmium: 5 ppb for infant and toddler food (except cereal) and 10 ppb for infant and toddler food that is cereal
    • Lead: 5 ppb for infant and toddler food (except cereal) and 10 ppb for infant and toddler food that is cereal
    • Mercury: 2 ppb
  • Within 3 years of the date of enactment, the Secretary must set final regulatory limits that are lower than those mentioned above to levels protective of infant and toddler neurological development. Every 5 years afterwards, the established levels must be reviewed, and if needed, lowered by regulation. The Act also permits the Secretary to establish interim action levels and regulatory limits for toxic elements in infant and toddler food.
  • The Act was introduced by Representatives Raja Krishnamoorthi. In an announcement with Representative Tony Cardenas, Senator Amy Klobuchar, and Senator Tammy Duckworth, Rep. Krishnamoorthi stated that the Act was introduced “to dramatically reduce toxic heavy metals in baby food, educate parents about the risks, and invest in cutting edge farming technology to reduce any economic barriers to making baby foods safe for consumption.” As our readers know, the Act follows a February report from the House Oversight and Reform Subcommittee on Economic and Consumer Policy that reported on the levels of heavy metals found in baby foods produced by seven of the largest baby food manufacturers in the U.S.
  • On March 24, 2021, the U.S. District Court for the Northern District of California dismissed (subscription to Law360 required) a consumer class action lawsuit against McDonald’s which had alleged various causes of action relating to McDonald’s sale of vanilla ice cream that the plaintiff alleged derived some portion of its vanilla flavor from vanillin rather than vanilla bean.
  • The Court found that the Plaintiffs had not established that their claim—that consumers were misled by the vanilla flavor labeling—was plausible as required to survive a motion to dismiss. Specifically, the court found that the allegations of consumer deception were merely conclusory and did not establish that it was “probable that a significant portion of the general consuming public or of targeted consumers, acting reasonably in the circumstances, could be misled.” The court noted the labeling regulations that govern the retail sale of vanilla ice cream added no support for Plaintiffs’ claims because they indisputably did not apply to sales at fast-food establishments. Additionally, and serving as an independent grounds for dismissal, the court found that Plaintiffs’ had not established that they had paid a premium for the vanilla ice cream; rather the court found it to be “counter-intuitive” in the market context presented.
  • We have reported on a variety of vanilla flavoring class action lawsuits, many of which have not survived the motion to dismiss stage. This case is another demonstration of the difficulty that plaintiffs have had in convincing the court that consumers expect vanilla flavored products to contain not only the flavor of vanilla but also the ingredient vanilla bean. An amended complaint may be filed within 30 days of the order.