• Earlier this month, Senators Amy Klobuchar and Tammy Duckworth announced the introduction of legislation (the “Baby Food Safety Act of 2024”) intended to increase the safety of certain foods, including baby and toddler foods, with respect to heavy metals and other contaminants.
  • In particular, the legislation calls on FDA to establish, through an administrative order process:
    • Limits for arsenic, cadmium, mercury, and lead in infant and toddler food (defined to include any food marketed for children up to 24 months) as well as food pouches made with fruit or vegetable juice or puree.
    • Limits for arsenic and lead in juice. We note that FDA has previously published draft action levels of 10 ppb lead in apple juice and 20 ppb lead in all other juice.
  • Proposed limits are required to be issued by December 31, 2025, for arsenic and lead, April 30, 2026, for cadmium, and April 30, 2028, for mercury.
  • The legislation would also require facilities manufacturing infant and toddler food, pouches with fruit or vegetable juice or puree, or juice to develop a control program for these contaminants (consistent with HARPC, or HACCP for juice, and with the mitigation against intentional adulteration regulations) and sample and test such contaminants pursuant to a sampling plan, the contours of which are to be set forth in a future FDA guidance (the sampling and testing requirements would not apply until 2 years from the date of enactment). Among the other provisions is a requirement that manufacturers of infant and toddler food develop an environmental monitoring program to monitor for the presence of environmental pathogens and heavy metals.
  • The proposed legislation also includes a broad preemption provision which prohibits any state from implementing legislation which is “different from, or in addition to, or not identical to” the provisions of the legislation.
  • If enacted, this would represent the first mandatory testing requirement for finished food products. We will continue to monitor and report on developments regarding this legislation.
  • The attorneys general from 20 states sent a letter to FDA urging the agency to take official notice of three documents relating to lead in baby food in support of a 2022 petition for reconsideration requesting actions on heavy metals in food for babies and young children. The group of attorneys general filed a citizen petition on October 21, 2021, which FDA denied. The group then filed a reconsideration petition on June 1, 2022. That petition is still pending.
  • The 2021 petition urged FDA to drive down the levels of lead, inorganic arsenic, cadmium, and mercury in food intended for babies and young children, including by issuing guidance on finished product testing. According to the petition, this testing would amount to a “preventive control” that should be performed by food manufacturers. Now, the attorneys general say that a January 2023 guidance document on lead action levels, FDA’s public notices relating to the investigation into elevated lead levels in applesauce, and a December 2023 report on the inspection of the applesauce manufacturer provide additional support for the reconsideration petition.
  • According to the attorneys general, these documents “make it evident that some manufacturers and distributors of baby foods in the U.S. currently lack a clear understanding of the proper way to apply preventive controls to avoid adulteration of finished baby food products.” In the documents, FDA reported that the baby food products contained more than 200 times the maximum acceptable concentration of lead under the proposed action levels, yet there was no finished product testing prior to the recall. The harm to children demonstrated in the documents reinforces the need for required toxic element testing in finished products for babies and young children.
  • The letter requests FDA take official notice of the documents without reopening the administrative record since the documents are official and reliable FDA publications.
  • According to a recent Consumer Reports study, about one-third of chocolate contains high levels of lead and cadmium. The study tested 48 cacao-containing foods, including cocoa powder, chocolate chips, milk chocolate, and brownie, cake, and hot chocolate mixes, and follows a report of heavy metals in dark chocolate bars that we covered last December.
  • Consumer Reports assessed the lead and cadmium by comparing the amount in a serving of each product with the Maximum Allowable Dose Level (MADL) for each metal established under California’s Proposition 65. Sixteen of the 48 tested products contained levels of at least one metal that exceeded the MADL. Dark chocolate tended to have higher levels of both metals, while some of the other products had high levels of lead. The report suggests this is likely because lead and cadmium are concentrated in cocoa solids, and dark chocolate contains more cocoa solids than milk chocolate.
  • Lead and cadmium are of particular concern for pregnant women and young children, as the metals have been linked to developmental delays and learning and behavior problems. According to the report, eating just an ounce of chocolate with high levels of the metals could lead to harm.
  • The National Confectioners Association (NCA) responded to the report, saying that “chocolate and cocoa are safe to eat and can be enjoyed as treats as they have been for centuries.” According to the NCA, the report disregards lead and cadmium levels set in a Consent Judgment by the Superior Court of the State of California set in 2018 that are still in effect, and chocolate makers “remain dedicated to being transparent and socially responsible.”
  • Keller and Heckman will continue to follow and report on this issue.
  • On September 11, 2023, a consumer class action lawsuit against Kroger for selling baby teething wafers with allegedly elevated levels of heavy metals was dismissed with leave to amend (Law360 Subscription required). 
  • Unlike several other heavy metal cases, the Court declined to invoke the “primary jurisdiction” doctrine. The Court found that an underlying reason for the application of primary jurisdiction is a “desire for uniformity,” and that the absence of any regulations on the subject indicated that FDA had not expressed such a desire. As to FDA’s Closer to Zero plan, the Court noted that the plan was announced more than two years ago and that it did not include a timeline for proposed or final regulations.
  • Nevertheless, the Court dismissed the claims. Several of the claims were dismissed for procedural reasons (e.g., failure to specify governing laws), while a claim under the Indiana Deceptive Consumer Sales Act was dismissed because, absent notice to the Defendant (which was not given), the Plaintiffs were required to show that the Defendant acted with an “intent to defraud or mislead.” No such allegations were made.
  • On the count alleging violation of the Washington Consumer Protection Act, which requires (among other things) an unfair or deceptive act or practice and an injury to plaintiff’s business or property, the Court held that no injury to property was shown; on the contrary, the wafers were bought and fed to children, who suffered no ill effects.
  • Notably, on this count, the Court found that Plaintiffs had met their pleading burden to identify an unfair or deceptive act (i.e., the omission of heavy metal warnings) even though Plaintiffs did not “provide actual test results” or “list who conducted the testing or when they conducted it.” The failure to include detailed test results in a complaint has doomed other lawsuits. Nevertheless, this count was dismissed based on the failure to show injury to property.
  • We have observed that uncertainties about the levels of heavy metals in baby foods that are both safe and feasible could pose difficulties for plaintiffs in many of the consumer protection class action lawsuits that followed a February 4, 2021 report and September 29, 2021 supplement (discussed here) by the U.S. House of Representatives subcommittee on Economic and Consumer Policy that raised alarm over the levels of arsenic, lead, cadmium, and mercury reportedly found in U.S. baby foods.  Plaintiffs in personal injury litigation face related challenges in establishing that heavy metals in baby food consumed were sufficient to cause heavy metal toxicity and were a substantial cause of neurological disorders. 
  • In an August 24, 2023 hearing (Law360 subscription required), a California state judge said he would grant defense motions to exclude expert testimony that heavy metals in the baby food eaten by the plaintiffs’ son caused him to develop autism and attention deficit hyperactivity disorders (ADHD).  The judge ruled one expert’s calculation of the child’s exposure to heavy metals from the baby food was inadmissible, finding his methodology was constructed on assumptions.  Specifically, where no heavy metal was detected, the expert assumed the heavy metal was present at the level of detection and where the baby food was not tested, the expert assumed heavy metals were present at the maximum levels specified (whereas the actual levels of heavy metals in the baby food could be zero, or another level less than the assumed amount, in either case).  Other experts’ opinions were excluded because these experts could not have reached their purported opinions without relying on the same faulty heavy metal exposure assumptions. 
  • If problems calculating exposure to heavy metals can be fixed, the plaintiffs will face other causation questions raised by the ubiquity of heavy metals and uncertainties about their role in the development of neurological disorders.  As noted by the judge, “given that the heavy metals at issue here are found widely distributed throughout the environment from many sources — air, food, water, industrial product, and can cross the placenta — it seems a fact that virtually all neo-nates and infants are exposed to and have a dose of these metals in their bodies, yet not all children have these disorders.”  Keller and Heckman will continue to monitor and report on heavy metals baby food litigation and any relevant regulatory actions or developments. 

2nd Circ. Affirms Toss Of Heavy Metal Pet Food Case (Law360 Subscription Required)

  • In May 2017, following a poor rating of its premium-priced dog food by the Clean Label Project, Champion Petfoods released a white paper disclosing the levels of heavy metals in its products and reporting these were well within ranges for arsenic, cadmium, lead, and mercury deemed acceptable for dog foods by the National Research Council and FDA.  Then on October 16, 2018, a proposed class action lawsuit filed in New York federal court alleged that Champion Petfoods’ Acana and Orijen pet foods contain heavy metals known to pose health risks to humans and animals even though the foods are advertised as fit for humans.  The plaintiff did not allege that Champion’s pet foods were unsafe or harmed her pets but maintained that she would not have purchased Champion’s products at their retail prices if she had known that they contained heavy metals.  The district court granted summary judgment for Champion in dismissing all heavy metal fraud-by-omission claims on March 31, 2022.
  • On June 6, 2023, the Second Circuit upheld the trial court’s judgment in an order stating, “the factual record establishes that a reasonable consumer could have discovered that Champion’s pet foods had a material risk of containing some measurable amount of heavy metals” and the plaintiff failed to show that “the business alone possesses” this information, as required under the law.  Further, while acknowledging “the importance of consumer labeling, especially as it relates to food for both humans and pets alike,” the appeals court said that it is up to Congress or a federal agency such as FDA to determine what is disclosed on food labeling. 
  • The appeals court did state that if the plaintiff had claimed that Champion’s pet foods contained quantities of heavy metals in excess of safe thresholds, then that could be information that “the business alone” possessed.  This underscores a significant obstacle in other heavy metals litigation where plaintiffs have been unable to demonstrate that the unavoidable presence of heavy metals in low amounts renders the food inedible or unsafe to consume. 
  • 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.

  • This morning the FDA announced the release of draft guidance entitled “Action Levels for Lead in Food Intended for Babies and Young Children.” The draft guidance, which is part of the Agency’s effort to reduce levels of heavy metals in food, especially in food consumed by babies and young children (the “Closer to Zero” action plan), establishes the following action levels for lead in food intended for babies and children less than two years of age:
    • 10 parts per billion (ppb) limit for fruits, vegetables (excluding single-ingredient root vegetables), mixtures (including grain and meat-based mixtures), yogurts, custards/puddings, and single ingredient meats;
    • 20 ppb for root vegetables (single ingredient); and
    • 20 ppb for dry infant cereals.
  • These action levels reflect the levels of lead at which FDA may regard the food as adulterated. However, FDA considers on a case-by-case basis whether a food that contains a contaminant is adulterated and, when considering whether to bring an enforcement action, the Agency will also consider other factors, including its confidence in measured analytical values. Furthermore, the action levels are not the intended to be the lowest levels for industry to achieve and, consistent with its Closer to Zero action plan, FDA expects industry to “strive for continual reductions [of heavy metals] over time.” 
  • In related news, on January 19, 2023, the U.S. District Court in the Northern District of New York dismissed (Law360 subscription required) a lawsuit against Beech-Nut Nutrition which had made various claims related to allegedly dangerous levels of heavy metals in Beech-Nut’s baby food. The decision, which relies on the primary jurisdiction doctrine, is consistent with dismissals of similar lawsuits against Sprouts Foods and Gerber Products by federal courts in New Jersey and Virginia, respectively, but runs contrary to a decision by a California federal court which refused to dismiss similar claims against Plum Organics.
  • The primary jurisdiction doctrine allows a court to dismiss or stay a lawsuit when it finds that a decision is within “the special competence of an administrative body.” Applying a multi-factored test, the Court held that application of primary jurisdiction was appropriate because (1) the claims were not “garden variety” false advertising cases, but rather required the Court to make a determination as to what constituted dangerous levels of heavy metals, (2) such questions of safety were “within FDA’s authority and discretion,” and (3) a Court’s resolution of the issue without FDA guidance would result (and indeed, has resulted) in inconsistent rulings. 
  • We will continue to monitor and report on news related to heavy metals. Comments to the draft guidance are due by March 27, 2023.
  • On January 12, FDA’s Center for Food Safety and Applied Nutrition (CFSAN) released two press announcements regarding the Agency’s continued effort in addressing heavy metals in foods pursuant to its Closer to Zero Action Plan.  As we have previously blogged, the Closer to Zero Action plan is FDA’s ongoing, multi-phase evaluation of toxic elements present in foods commonly eaten by babies and young children.  FDA’s goal is to make meaningful reductions in exposure to arsenic, lead, cadmium, and mercury from foods through research, setting action levels, and increasing targeted compliance and enforcement activities.
  • First, FDA announced that it will be co-hosting a virtual workshop, “Bridging The Biological And Communication Sciences On Nutrients And Environmental Contaminants In Foods To Support Child Development,” with the National Institute of Health on research in risk communication, environmental contaminants in food, and the role of nutrition in child development.  The workshop will take place on February 9-10, 2023, from 10:30 EST – 4:30 PM EST.  The description of the event provides that the workshop will cover a “wide range” of nutrition and toxicology topics, including the following:
    • Challenges in children consuming adequate nutrients and the role of exposure to environmental contaminants from foods.
    • The important role of nutrients from different foods groups in child development and helping to protect children from the health effects associated with exposure to contaminants.
    • Research opportunities in food, nutrients, and the effects of environmental exposure.
    • Federal agencies’ current and future risk communications.
  • Registration to the workshop is currently available and will close on February 10, 2023.
  • Second, FDA announced that the National Academies Committee is hosting its first public information-gathering session on January 19, 2023, in furtherance of its study “The Role of Seafood Consumption in Child Growth and Development.”  As we have previously blogged, FDA, National Academies of Science, Engineering, and Medicine (NASEM), and EPA have partnered to conduct the study which is focused on assessing the current evidence in nutrition and toxicology associations between seafood consumption and child growth and development with a particular emphasis on mercury in seafood varieties.
  • The session is scheduled to be webcast on January 19, 2023, from 2:00 PM EST – 3:15 PM EST.  
  • Keller and Heckman will continue to monitor and report on developments on the Closer to Zero Action Plan.
  • On December 15, 2022, Consumer Reports published an article in which they report that some dark chocolate bars contain excessive amounts of cadmium and lead. Cadmium and lead are heavy metals that have been linked to adverse health effects.
  • Scientists at Consumer Reports measured the amount of heavy metals in 28 dark chocolate bars from a variety of brands. Cadmium and lead were detected in all of the bars that were tested. Further, the article notes that for 23 of the bars, eating an ounce per day could exceed levels established by public health authorities and Consumer Reports.
  • The article notes that dark chocolate has a reputation for being healthier treat because of its cocoa solids which include antioxidants. However, the cocoa solids also contain the heavy metals. For that reason, the article concludes that dark chocolate is generally higher in heavy metals than milk chocolate.
  • Research shows that lead and cadmium may get into the cacao in different ways – with cadmium being absorbed from the soil during growth and lead getting in after beans are harvested. Thus, Consumer Reports suggests that addressing the contamination will require different solutions for each heavy metal. In the meantime, the article urges consumers to be mindful of the risks and minimize potential harms where possible.