Search results for: cadmium

  • As You Sow and the National Confectioners Association released a report on August 18, 2022 that determines the predominant sources of lead and cadmium in chocolate products and how best to reduce these levels.  A multi-disciplinary panel of four experts have been investigating the matter for three years.  The report is part of the 2018 settlement agreement reached in As You Sow v. Trader Joe’s, in which the plaintiff alleged that numerous chocolate makers failed to warn the public about levels of lead and cadmium in their products, therefore violating California’s Proposition 65.
  • The report concludes that cadmium can be found in cacao and chocolate due to its presence in tropical soils where it is harvested.  Cadmium contaminates the roots of the plant, where it is then deposited into the nibs of the cacao beans.  The experts concluded a short term solution would be to mix high and low-cadmium cacao beans, whereas long-term reductions could be achieved by changing soil compositions or cacao genetics.
  • The investigation found that lead contaminates the outer shells of the cacao beans, rather than through the roots.  The sticky coating of the outer shells allows lead particles from soil, dust, and power plant air pollution to stick to the cacao beans as they are dried and fermented in open air.  The investigation revealed that, where feasible, minimizing soil contact and optimizing contaminant removal during the cleaning, roasting, and shell removal stages should help reduce lead contamination.
  • In the 2018 settlement, the parties agreed on new threshold levels of lead and cadmium that would trigger product warnings, based on cacao content: products with up to 65% cacao content (0.065 ppm and 0.320 ppm, respectively); products with between 65% and 95% cacao content (0.1 ppm and 0.4 ppm); and products with greater than 95% cacao content (0.2 ppm and 0.8 ppm).  Based on their findings, the experts could not reach an agreement whether it is feasible to lower the agreed upon lead and cadmium thresholds in chocolate.  All experts agreed that the trigger levels for lead were feasible to comply with and that it would be feasible to have a lower standard, but they disagreed with how low a level is feasible.  The majority of the four experts concluded it is not feasible to lower the cadmium thresholds.  Moving forward, the parties will meet to discuss whether or not to change the threshold levels for lead and cadmium put forth in the settlement.  Any party can file a motion with the court to request a change and, if approved, the change would take effect one year later.  If no motions to change threshold levels are made, the levels decided in the settlement will remain in place.
  • The European Commission has again taken aim to reduce the presence of heavy metals in food by setting new limits for lead and cadmium in certain food products. Lead and cadmium, along with other heavy metals like arsenic and mercury, are naturally occurring and can be present in foods, cosmetics, and dietary supplements. Studies have suggested they may pose a health risk, particularly to neurological development in children.
  • In revising its standards for lead, the Commission considered the European Food Safety Authority’s (EFSA) 2010 opinion on lead in food and recent data from the Codex Alimentarius Commission to determine that limits for infant food, salt, and wild fungi merited revision. For cadmium, the Commission considered a 2009 EFSA opinion about health risks of cadmium in food and other new data showing that cadmium levels can be further reduced. The new limits cover a variety of products, including garlic, berries, nuts, fish, and salt. The new measures for lead will take effect on August 30, 2021, and the limits for cadmium will take effect the following day.  Foodstuffs that were lawfully placed on the market before the new limits go into effect may remain on the market until February 28, 2022.
  • Officials in the U.S. have also increased scrutiny on heavy metals in food, particularly in baby foods. In particular, FDA’s Toxic Elements Working Group seeks to identify vulnerable populations, prioritize toxicity concerns, and improve testing for heavy metals in foods. We will continue to monitor and report on updates in this area.
  • A district court judge has granted (Law360 subscription required) Trader Joe’s motion for summary judgment in a class action lawsuit alleging that the company’s dark chocolate bars contain the heavy metals lead, cadmium, and arsenic. In granting summary judgment, the court found that Trader Joe’s “did not have exclusive knowledge that the dark chocolate bars contained or had a material risk of containing heavy metals,” which is a requirement under the applicable state consumer protection laws.
  • In January 2023, Trader Joe’s was hit with 10 class action complaints claiming the company failed to disclose the presence of heavy metals in dark chocolate products. The complaints were consolidated in April 2023, and claims for violations of consumer protection laws in Washington, Illinois, and New York survived a motion to dismiss. Each of the claims under these state laws requires exclusive knowledge of omitted information and excludes claims if that omitted information was reasonably obtainable or easily discoverable by consumers.
  • Trader Joe’s presented articles from as early as 2002 reporting the presence of heavy metals in chocolate products. The judge rejected arguments that the information was not reasonably obtainable because the plaintiffs were not aware that the products contained heavy metals, stating that “[w]hether information on the presence of heavy metals in the products was reasonably obtainable (or easily discoverable) does not depend on what individual plaintiffs were or were not aware of . . . [but] turns on what information was reasonably obtainable or easily discoverable by consumers about the presence of heavy metals in dark chocolate.”
  • The judge did note, however, that if the plaintiffs had alleged that Trader Joe’s failed to disclose a specific amount of heavy metals, high levels of heavy metals, or that the levels exceeded some kind of regulatory threshold, then the information might not be reasonably obtained by consumers.
  • The presence of heavy metals in chocolate has been the subject of studies and lawsuits in recent years, as we have previously blogged. Keller and Heckman will continue to monitor activity related to heavy metals in chocolate and other foods.
  • On January 6, 2025, the U.S. Food & Drug Administration (FDA, or the Agency) issued a final guidance ,“Action Levels for Lead in Processed Food Intended for Babies and Young Children: Guidance for Industry” which aims to regulate lead levels in processed foods for infants and toddlers under two years old.
  • As we have previously blogged, in 2021, FDA initiated its Closer to Zero policy which identified actions the Agency will take to reduce exposure to toxic elements, including lead, to as low as possible while maintaining access to nutritious foods.
  •  As part of this initiative, FDA has also evaluated mercury, cadmium, and arsenic in foods intended for babies and young children, as well as lead in juices.  Under this initiative, FDA has prioritized babies and young children as they are especially vulnerable to lead exposure, which accumulates in the body over time.
  • Lead is naturally present in the environment, but human activities have also released elevated levels of lead, contaminating soil, water, and air.  This contamination can affect crops used in food production.
  • Lead exposures can lead to developmental harm to children by causing learning disabilities, behavioral difficulties, lowered IQ, and may be associated with immunological, cardiovascular, and reproductive and or/developmental effects.
  • To address this concern, FDA established the following action levels in the final guidance for processed foods intended for babies and young children:
    • 10 parts per billion (ppb) 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 single-ingredient root vegetables; and
    • 20 ppb for dry infant cereals.
  • If a processed food intended for babies and young children reaches or exceeds the aforementioned levels of lead, the product will be considered adulterated within the meaning of section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
  • After publishing the final action levels, the Agency will establish a timeframe for assessing industry’s progress toward meeting the action levels and resume research to determine whether the scientific data supports efforts to further adjust the action levels.
  • Keller and Heckman will continue to monitor developments related to heavy metals in foods and the Closer to Zero policy.
  • In October 2023, Governor Newsom signed into law California’s AB 899, which requires that any baby food products sold or made in the state be tested for arsenic, cadmium, lead, and mercury.  This testing requirement became effective January 1, 2024.  Beginning January 1, 2025, the law also requires test results to be posted on the manufacturer’s website. 
  • Manufacturers of baby food (not including infant formula) for sale or distribution in California must test a representative sample of each production aggregate of the final baby food product at least once a month.  Test results must be provided to the California Department of Public Health upon request.
  • Starting January 1, 2025, manufacturers must make publicly available on the manufacturer’s website, for the duration of the product shelf life for a final baby food product plus one month, the name and level of each toxic element present in each production aggregate of a final baby food product.  Baby foods that contain a toxic element at levels higher than the FDA action level can still be sold in the state, but the QR code disclosure is required.
  • 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.
  • The UK Office for Sanitary and Phytosanitary Trade Assurance commissioned the Foods Standards Agency (FSA) to profile the potential risks of importing oysters into the United Kingdom in the hopes of mitigating possible issues.  The study comes after FSA assessed the public health risk of raw oysters earlier this year to help develop risk management options during norovirus outbreaks.
  • Chemical and microbiological hazards were identified, which include heavy metals, natural biotoxins, viral and bacterial pathogens, and persistent organic chemicals.  Allergens and physical hazards were excluded. 
  • The UK currently imports approximately 350,000 kilograms of oysters per year.  The main exporters to the UK include South Korea, France, and New Zealand.  Although consumption surveys indicate that the general population rarely eats oysters, oysters are considered a high risk product.  This is largely due to their filter feeding, which allows bioaccumulation of hazards and likelihood for raw consumption.
  • The main hazards identified in the supply chain were Vibrio parahaemolyticus; marine biotoxins (such as amnesic, paralytic, and lipophilic toxins); hepatitis A virus (HAV), norovirus and Salmonella; heavy metals like cadmium mercury and lead; and diseases caused by other Vibrio species.
  • Control measures at different stages of the supply chain will vary with hazard type.  Control measures during harvest can include suspension of activity, transfer of live animals to cleaner sites, or altering onward processing requirements.  During processing, purification can be achieved through re-immersion in clean water.  At the consumption phase, there are various options to help reduce risk: labeling and traceability, education of workers on cold chain breaches and contamination, and advice on avoiding raw products by vulnerable groups.
  • 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.
  • 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.