Search results for: cadmium

  • Jocko Fuel (Law360 subscription required) has been sued for allegedly falsely marketing its protein shake products as containing only “premium protein and functional ingredients” that are tested for safety despite being contaminated with or at risk of being contaminated with unsafe levels of cadmium.  
  • According to the complaint, the product’s labels bear statements such as “meets the highest standard” and “Third Party Tested: Integrity is non-negotiable.” In addition, the defendant “specifically lists the ingredients in the Product on the labeling; however, Defendant fails to disclose that the Product contains, or is at risk of containing, cadmium.”
  • The complaint states that independent testing found that the product purchased by the plaintiff is contaminated with cadmium, causing it to be unsafe for consumption. According to the plaintiff, they would not have purchased the protein shakes if they had been aware that they contain cadmium.
  • Keller and Heckman will continue to monitor this and other litigation related to food labeling and safety.
  • 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.
  • On February 11, 2026, Sen. Padilla introduced SB 1033, which would establish new state-level testing and heavy metal disclosure requirements for bulk and packaged protein products sold in California.
  • If passed, commencing on January 1, 2028, manufacturers of bulk protein products or packaged protein products being sold into the state would be required to test a representative sample of each lot of product for heavy metals (arsenic, cadmium, lead, and mercury) and provide results to the California Department of Public Health.  Brand owners would be required to publicly disclose lot-specific heavy metal testing results on their websites.  Additionally, on-package and online statements would be required, directing consumers to the testing information.
  • In Sen. Padilla’s press release, he cites to various reports finding unsafe levels of heavy metals in protein products, noting that, “[d]espite these risks, protein powders and protein beverages remain largely unregulated at the federal level.”  While FDA regulates dietary supplements under the current good manufacturing practice regulations, manufacturers are responsible for ensuring that their products meet specifications before they are released to the market.
  • Keller and Heckman will continue to monitor the legislative process and provide any relevant updates.
  • On February 5, 2026, FDA announced via a letter to food manufacturers that the Agency intends to exercise enforcement discretion regarding certain voluntary claims relating to the absence of certified colors used in foods intended for human consumption.
  • Specifically, FDA does not intend to take enforcement action if the following claims are made on labels or labeling of foods that do not contain colors listed in 21 CFR Part 74:
    • “Made without artificial food colors/colorings”
    • “No artificial color/colors/coloring”
    • “No added artificial color/colors/coloring”
  • This differs from FDA’s prior position in which all color additives, even if derived from natural sources, are considered “artificial,” as described in Compliance Policy Guide Section 587.100 (Label Declaration of Certification-Exempt Color Additives) and Use of the Term Natural on Food Labeling. The new approach is intended to align with FDA’s Make America Healthy Again (MAHA) agenda. According to FDA Commissioner Marty Makary, “calling colors derived from natural sources ‘artificial’ might be confusing for consumers and a hindrance for companies,” so the enforcement discretion will make it “easier for companies to use these colors in the foods our families eat every day.”
  • In addition to the new approach on artificial color claims, FDA announced that the Agency approved two new color additive petitions:
    • The clearance for spirulina extract is being expanded to permit use in foods generally, except for infant formula, certain foods regulated by USDA, and foods subject to a standard of identity unless such use is authorized by the standard. In addition, the specifications for heavy metals are being lowered and a specification for cadmium is being added.
    • Beetroot red will now be permitted for use in foods generally, except for infant formula, certain foods regulated by USDA, and foods subject to a standard of identity unless such use is authorized by the standard
  • Finally, FDA issued an additional letter “reminding manufacturers of their responsibility to ensure color additive safety.”
  • Keller and Heckman will continue to monitor updates related to FDA’s regulation of color additives.
  • On Monday, June 30, 2025, FDA’s Human Food Program published its proposed 2025 guidance agenda (FDA’s news release shown here). The agenda contains possible new topics for guidance documents or revisions to existing guidance documents.
  • The entire list of new guidance topics under the 2025 agenda can be found here. The potential new topics include:
    • New Dietary Ingredient (NDI) Notifications and Related Issues: Identity and Safety Information About the NDI: Guidance for Industry
    • Food Colors Derived from Natural Sources: Fruit Juice and Vegetable Juice as Color Additives in Food; Draft Guidance for Industry
    • Action Levels for Cadmium in Food Intended for Babies and Young Children; Draft Guidance for Industry
  • Importantly, guidance documents do not establish legally enforceable rights or responsibilities (see here). Rather, guidance documents represent FDA’s “current thinking” on a particular topic and serve merely as a resource for businesses and organizations. FDA’s good guidance practices outlined in 21 CFR 10.115 provide, among other things, that the agency will seek public comment on any guidance documents that address more than minor changes in interpretation or policy (Level 1 guidance).
  • Keller and Heckman will continue to monitor developments related to FDA’s forthcoming guidance documents.
  • 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.