•  Many of our readers will recall a February 4, 2021 report by the U.S. House of Representatives subcommittee on Economic and Consumer Policy (summarized here) that raised alarm regarding the levels of heavy metals— including arsenic, lead, cadmium, and mercury— reportedly found in baby foods produced by seven of the largest baby food manufacturers in the U.S.  The Food and Drug Administration (FDA) issued a response on February 16, 2021, as discussed here, outlining the current regulatory activities for assuring that naturally occurring toxic elements in many crops do not reach dangerous levels in food.  Soon after, on March 5, 2021, FDA announced new activities, including a letter to baby food manufactures, increased sampling and other plans (as discussed here) that target reducing the levels of toxic elements in baby food.  On April 8, 2021, FDA released a new Closer to Zero action plan 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.  As discussed here, FDA’s Closer to Zero action plan is scheduled to unfold in phases over several years, with the first phase (proposing action levels for lead in various categories of baby foods) scheduled for completion by April 2022.
  • On September 29, 2021, just seven months after its initial report, the same congressional subcommittee released a new report that adds test results the authors deem concerning for some Plum Organics and Sprout products (not reviewed in the first report), and new information from Walmart (also not discussed in the first report) which the authors characterize as showing a decrease in protective standards.  Summaries of the companies’ responses to the report’s claims are available here.
  • Recommendations in the new report, which is critical of all baby food manufacturers’ handling of toxic elements, as well as FDA’s timeline for publishing draft and final limits for lead, arsenic, cadmium, and mercury in baby foods, include:
    • For FDA to accelerate its proposed timelines for publishing final limits for toxic heavy metals and require baby food manufacturers to test their finished products, and
    • For industry to voluntarily adopt finished product testing, rather than attempt to control levels of heavy metals “based on inaccurate individual-ingredient tests,” and to use appropriate substitutes or phase out products that have high amounts of ingredients that frequently test high in toxic heavy metals, such as rice.
  • 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 April 21, the Attorney General of Washington, DC, Karl A. Racine, filed a lawsuit against Beech-Nut Nutrition Company, one of the largest baby food manufacturers for “misleading parent-consumers about the health and safety of its products.” As stated in a press release, the DC Office of the Attorney General (OAG) alleged that Beech-Nut’s advertising violated the District’s consumer protection laws and misled parents that its baby food underwent the most stringent testing and was safe for babies when the food contained high levels of heavy metals. The OAG’s lawsuit seeks to stop Beech-Nut from engaging in these and similar violations, to obtain restitution damages for parent-consumers and their children, and to obtain civil penalties.
  • The OAG alleged that Beech-Nut violated DC’s Consumer Protection Procedures Act and harmed DC consumers by:
    • Misleading parents about the safety of its baby food;
    • Misrepresenting its testing practices; and
    • Falsely claiming to have high internal safety standards
  • As our readers know, the OAG’s lawsuit comes as a result of the congressional investigative report that found high levels of heavy metals in several brands of popular baby foods. Additionally, several baby food manufacturers have been hit with class action lawsuits that alleged consumer deception claims relating to the presence of heavy metals in baby foods. The FDA has responded with a plan, called Closer to Zero, to reduce exposure to toxic elements in baby foods.
  • Keller and Heckman will continue to monitor and report on any developments with the DC OAG lawsuit and other baby food-related lawsuits.
  • On February 16, the FDA published a response about questions about levels of heavy metals in baby food, as indicated in a Congressional report released on February 4. Our summary of that report is available here. In the response, the FDA states that toxic elements, such as arsenic and lead, are present in the environment and may enter the food supply through soil, water, or air. Thus, they cannot be completely avoided in the fruits, vegetables, or grains that are used in baby foods, juices, and infant cereals. Such elements also cannot be avoided through the use of organic farming practices.
  • The FDA highlighted the following in the response:
    • Consumers should know that FDA scientists routinely monitor levels of toxic elements in baby foods, along with other foods consumed, through the Total Diet Study. Further, the FDA monitors baby food under FDA’s compliance program for Toxic Elements in Food and Foodware, and Radionuclides in Food and through targeted sampling assignments.
    • The FDA takes steps to reduce levels, such as using science to set action levels, making data public, and working with industry on identifying effective mitigation strategies. For example, food manufactures have made progress in arsenic reduction through selective sourcing and testing, as evidenced by FDA sampling of infant rice cereal since 2011. Further, the Agency has published a final guidance that sets action levels for inorganic arsenic in rice cereal for infants. According to the FDA, infant rice cereal is safer than it was a decade ago because of these efforts, and the Agency expects that such levels will continue to be reduced because of emerging science and good manufacturing practices.
    • The FDA has multiple ongoing Import Alerts for toxic elements in food, including arsenic in fruit juice, bottled water, and dietary supplements, in order to prevent foods and dietary supplements with high levels of heavy metals from entering the US.
    • The FDA provides consumers with actionable advice to limit exposure to toxic elements from food. For example, consistent with the Congressional report’s recommendations, the FDA has communicated advice about the importance of feeding infants a variety of foods. Fortified rice cereal is a good source of nutrients for infants, but it should not be the only source.
  • Keller and Heckman will continue to monitor and report on any developments.
  • As some of our readers may know, the U.S. House of Representatives subcommittee on Economic and Consumer Policy released a report on February 4th 2021 which reported on the levels of heavy metals— including arsenic, lead, cadmium, and mercury— found in baby foods produced by seven of the largest baby food manufacturers in the U.S. The baby food manufacturers named in the report were: (1) Nurture Inc. (which sells Happy Family Organics, including baby food products under the brand name HappyBABY); (2) Beech-Nut Nutrition Company; (3) Hain Celestial Group (which sells baby food products under the brand name Earth’s Best Organic); (4) Gerber; (5) Campbell Soup Company (which sells baby food products under the brand name Plum Organics); (6) Walmart Inc. (which sells baby food through its private brand Parent’s Choice); and (7) Sprout Foods, Inc.
  • The report is based on results from the first four of the above-listed companies because the others did not comply with the subcommittee’s requests for internal documentation and test results. While acknowledging that for the majority of heavy metals the FDA has not set thresholds for the level allowed in baby foods (one notable exception is a 100 ppb limit for arsenic in infant rice cereals), it concluded that “commercial baby foods contain dangerous levels of arsenic, lead, mercury, and cadmium . . . [that] pose serious health risks to babies and toddlers.” The report advocates several changes to the regulation of baby foods including mandatory testing of finished products for heavy metals, reporting of heavy metal content on food labels, and new regulations setting limits for heavy metals in baby foods.
  • As expected, the report has instigated the filing of class action lawsuits against the baby food manufacturers named in the report. On February 5th, the day after the report’s release, a pair of consumer class action complaints were filed—one against Gerber in the U.S. District Court for the District of New Jersey (see filing; Law360 subscription required) and the other against Plum, PBC in the U.S. District Court for the Northern District of California.
  • The complaint against Gerber draws heavily from the report’s conclusions and alleges violation of various consumer protection statutes on the theory that Gerber falsely and deceptively failed to disclose the presence of unsafe levels of heavy metals in their baby foods. The complaint against Plum takes a broader approach and alleges that their baby food products were falsely and deceptively advertised because the manufacturer was obligated to disclose (and did not disclose) “any level of Heavy Metals or undesirable toxins or contaminants” (emphasis added). While a court is unlikely accept the latter theory (see our prior post rejecting a similarly broad theory of deceptive advertising in the petfood context), allegations that the levels of heavy metals in the baby food products are unsafe may present viable litigation theories.
  • Keller and Heckman will continue to monitor and report on the outcome of the congressional investigation, including the resulting litigation and any responsive regulatory actions or developments.
  • In November 2018, FDA announced that it had tested 26 kratom products with “disturbingly” high heavy metal levels.  Also known as Mitragyna speciose, kratom grows naturally in Southeast Asia and has opioid-like properties.  The Daily Intake blogged on the topic here.
  • Besides concerns regarding kratom’s opioid-like properties, FDA also has taken action and issued its only mandatory recall order due to Salmonella contamination.
  • On April 3, FDA released a summary of the heavy metal testing – now on 30 products.  In his comment accompanying the data release, Dr. Scott Gottlieb, the outgoing Commissioner of FDA, noted that FDA has “been attempting to work with the companies whose products were found to contain high levels of heavy metals”
  • FDA’s attention on kratom brings to the fore important reminders for all food and dietary supplement producers regarding raw materials testing, supplier verification and validation, and FDA recall authority.
  • In a press announcement released on November 27, 2018, FDA Commissioner Scott Gottlieb revealed that FDA scientists found “disturbingly” high levels of heavy metals in kratom products. Kratom, also known as Mitragyna speciosa, which is a plant that grows naturally in Thailand, Malaysia, Indonesia, and Papua New Guinea. Kratom has opioid properties and stimulant-like effects, and has been marketed in the U.S. to treat muscle pain, diarrhea, and opiate withdrawal.
  • Over the past year, FDA has issued numerous warnings about the serious risks associated with the use of kratom. The agency has also issued an import alert, seized product containing kratom, and issued warning letters to kratom marketers. Most notably, earlier this year, FDA issued a mandatory recall order for all products containing powdered kratom manufactured, processed, packed, or held by Triangle Pharmanaturals LLC, after several tested positive for salmonella.
  • Continuing its actions to address the regulation and enforcement of kratom, the Commissioner’s November 27th statement notes that FDA scientists tested 26 separate kratom products obtained by field investigators. Lead and nickel were found at levels not considered safe for human consumption. In addition to those 26 products, the Commissioner noted FDA’s concern that there may be other kratom products on the market that also contain heavy metals. In light of the current opioid epidemic in the United States, FDA states they will continue to urge consumers not to consume kratom and to seek appropriate medical care from their health care provider.
  •  FDA published a response (discussed here) within two weeks of a Congressional report released on February 4, 2021 on the finding of heavy metals— including arsenic, lead, cadmium, and mercury—in baby foods in the U.S.  FDA’s initial response discussed the Agency’s programs for monitoring levels of toxic elements in baby foods (and other foods), the action levels set for inorganic arsenic in rice cereal for infants, multiple ongoing Import Alerts for toxic elements in food, and consumer education efforts regarding the importance of feeding infants a variety of foods.
  • On March 5, 2021, FDA announced new activities aimed at reducing the levels of toxic elements in baby food including:
    • A March 5, 2021 letter to baby and toddler food manufacturers and processors reminding the industry of their obligations to implement controls to significantly minimize or prevent any identified chemical hazards requiring a control.  FDA’s letter notes that some manufacturers may conduct verification activities like testing the final product for toxic elements.
    • Making a commitment “in the near term” to review current action levels, as well as develop additional action levels for contaminants in key foods, including finalizing the arsenic in apple juice draft guidance and publishing a draft guidance with action levels for lead in juices.
    • Boosting sampling of foods for babies and young children and sharing the results.
    • Increasing inspections and, as appropriate, taking compliance and enforcement actions.
    • Holding a workshop “in the coming year” to bring together stakeholders to share knowledge on the variability of toxic element levels in different foods and the potential impacts, if any, of low exposures on childhood development, and discuss potential mitigation strategies.
  • 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.

 

  • Toxic metals – such as arsenic, lead, cadmium, mercury and others – occur naturally and as environmental pollutants in air, water and soil and they enter the food supply when plants take them up as they grow. The Food and Drug Administration (FDA) actively monitors the levels of these metals in food and established a Toxic Elements Working Group in 2017 to analyze the data and coordinate FDA’s response. Toxic elements are not necessarily more prevalent in food today than in previous generations, but increasingly sensitive detection methods and the wealth of available data may offer ways to reduce the intake of toxic metals, especially by uniquely vulnerable populations such as infants and toddlers.
  • According to its website, Healthy Babies Bright Futures (HBBF) is an alliance of nonprofit organizations, scientists and donors that designs and implements outcomes-based programs to measurably reduce babies’ exposures to toxic chemicals in the first 1,000 days of development. HBBF’s report, What’s in my baby’s food, released October 17, 2019, identifies the levels of lead, arsenic, cadmium, and mercury found in 13 types of baby food: puffs/snacks, teething biscuits, infant rice cereal, other (non-rice) infant cereal, fruit, vegetables, mixed fruits and vegetables, meats, meals, infant formula, apple juice, 100% fruit juice, and other (non-juice) drinks. As widely covered in the popular press, HBBF reported that 94% of the baby foods contained lead, 73% contained arsenic, 75% contained cadmium, and 32% contained mercury, while 26% of the baby foods contained all four toxic metals.
  • Heavy metals may be a future action item for at least one lawmaker. Senator Chuck Schumer (D-NY) is reportedly calling for FDA to respond to HHBF’s report and to establish standards for heavy metals. The HHBF report urges FDA to:
    • Set health-protective standards for heavy metals, prioritizing foods that offer FDA the greatest opportunity to reduce exposure, considering additive effects of the multiple metals detected in foods, and explicitly protecting against neurodevelopmental impacts.
    • Strengthen and finalize standards for arsenic in apple juice and infant rice cereal, and expand the range of foods covered. HBBF supports recommendations for a 3-ppb inorganic arsenic standard and 1-ppb lead standard that apply to all fruit juice, and a health-protective standard for arsenic in infant rice cereal and all other rice-based foods.
    • Implement a proactive testing program for heavy metals in foods consumed by babies and toddlers, similar to the Consumer Product Safety Commission’s program for children’s toys (CPSC 2019).
    • Ensure lead is not present in food contact materials where it could get into food.
    • Establish a goal of no measurable amounts of cadmium, lead, mercury, and inorganic arsenic in baby and children’s food, in recognition of the absence of a known safe level of exposure, and work with manufacturers to achieve steady progress.
  • FDA has not commented on HHBF’s recommendations.
  • 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 8, 2021, Beech-Nut Nutrition Company issued a voluntary recall for one lot of its Beech-Nut Stage 1, Single Grain Rice Cereal (“Cereal”). The rice flour used for the Cereal was tested and confirmed as being below the FDA guidance level, set at a 100 ppb or 100 µg/kg, for inorganic arsenic. However, a routine sampling program by Alaska found that Cereal samples tested above the guidance level for naturally occurring inorganic arsenic set by the FDA in August 2020.
  • As some of our readers may remember, Beech-Nut was named in a congressional report by the U.S. House of Representatives subcommittee on Economic and Consumer Policy with relation to the levels of heavy metals—including arsenic, lead, cadmium, and mercury—found in baby foods. Since that report, Beech-Nut has been involved in two class-action lawsuits for allegedly misrepresenting Beech-Nut baby foods are “real food for babies” and failing to disclose the presence of dangerous levels of heavy metals. Most recently in April 2021, the DC Attorney General filed a lawsuit against Beech-Nut for “misleading parent-consumers about the health and safety of its products.” The New York Attorney General similarly announced an investigation into arsenic levels in infant rice cereal products and the advertising and promotion of such products.
  • In addition to voluntarily recalling the Cereal, Beech-Nut has decided to exit the market for infant rice cereal products, citing concern over the ability to consistently obtain rice flour well-below the FDA guidance level and Beech-Nut specifications for naturally occurring inorganic arsenic.