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 June 29, 2026, FDA’s Human Foods Program (HFP) released its updated 2026 guidance agenda, which includes priority topics for HFP guidance documents. Subjects of particular interest include:
    • Caffeine content labeling in foods and beverages;
    • Questions and answers regarding the use of “healthy” claims;
    • Action levels for cadmium and inorganic arsenic in food for babies and young children;
    • Fruit juice and vegetable juice as color additives in food;
    • Identity and safety information about new dietary ingredients (NDIs); and
    • Multiple guidances to reduce chemical and microbiological hazards in food
  • While guidance documents do not impose legally enforceable requirements, they represent FDA’s current thinking and interpretation on a specific topic that the industry can use as practical guidance.
  • FDA is accepting comments on the proposed topics at www.regulations.gov, using Docket FDA-2022-D-2088. Keller and Heckman will be happy to assist in drafting comments on behalf of interested companies.

  • On May 26, 2026, Vermont enacted a baby food testing and labeling law targeting heavy metals. Requirements go into effect January 1, 2027.
  • The bill, H536, requires manufacturers of baby food to test a representative sample from each production aggregate of the manufacturer’s final baby food product for heavy metals, including arsenic, cadmium, lead, and mercury. Testing must be conducted by a proficient laboratory at least once a month.
  • The bill also requires manufacturers to publicly disclose the name and level of each heavy metal in the final baby food product. This disclosure must include sufficient information, such as the product name, universal product code (UPC), lot or batch number, and a link to the FDA website that provides the most recent guidance and information on the health effects of heavy metals on children.
  • If the baby food is tested for a heavy metal subject to an action level or regulatory limit, the manufacturer must add a label stating, in a clear, legible manner, that more information about the heavy metal is available by scanning a QR code. The label must include a QR code directing consumers to the manufacturer’s website with the test results for the heavy metal and a URL linking to the relevant FDA website with the most recent guidance on the health effects of heavy metals on children.
  • Keller and Heckman will continue to report on state legislative developments impacting product testing and labeling.
  • On March 6, 2026, California Attorney General, Rob Bonta, issued an enforcement letter to baby food manufacturers, reminding industry of its obligations under AB 899, which requires that any baby food products sold or made in the state be tested for arsenic, cadmium, lead, and mercury.
  • As we previously reported, under AB 899, 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 were also required to 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. 
  • The enforcement letter responds to Consumer Reports’ 2025 article which that found some baby food manufacturers were not making their product testing easily available.  Attorney General Bonta reiterated that “[f]ailure to comply with AB 899’s requirements may constitute a violation of California’s Unfair Competition Law, Business and Professions Code section 17200, and other applicable laws.”
  • Just weeks before the issuance of the enforcement letter, California also introduced AB 2302 in February 2026, which would require heavy metals testing and reporting for infant formula manufacturers. The bill is currently undergoing committee review.
  • Keller and Heckman will continue to relay any developments in baby food and infant formula regulation.
  • On April 29, 2026, the U.S. Food and Drug Administration (FDA) announced the results of the largest and most comprehensive testing program ever conducted on infant formula sold in the United States. As part of Operation Stork Speed and the agency’s broader Closer to Zero initiative, FDA analyzed more than 300 retail products, generating over 120,000 data points across a wide range of potential chemical contaminants. The testing covered powdered, ready-to-feed, and concentrated liquid formulas and included analysis for heavy metals, pesticides, PFAS, phthalates, and other substances that may be present due to environmental or agricultural factors.
  • Overall, FDA’s findings reinforced that all infant formula products on the U.S. market meet a high safety standard, with most samples showing undetectable or very low levels of the contaminants tested. Agency leadership emphasized that these results are encouraging and affirm the general safety of the U.S. infant formula supply.
  • Specifically, all samples tested contained levels of lead, mercury, cadmium, and arsenic that were significantly below U.S. Environmental Protection Agency drinking water standards when prepared for feeding. Pesticides were not detected in 99 percent of samples tested, and none of the 25 out of 30 tested most commonly assessed PFAS compounds were detected in any sample. Among the remaining PFAS analytes, 95 percent of products had total PFAS levels at or below 28 parts per trillion, while 95 percent of samples showed phthalate concentrations at or below 116 parts per billion.
  • FDA plans to continue targeted and routine surveillance, expand testing to additional contaminants, and work with manufacturers to push contaminant levels as low as reasonably achievable. The agency also indicated it will continue developing formal action levels where appropriate.
  • Keller and Heckman will continue to monitor regulatory and policy developments affecting infant formula safety and supply.
  • 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.