Search results for: closer to zero

  • As we have previously blogged, FDA announced a three-phase “Closer to Zero” plan in 2021 to reduce the levels of arsenic, lead, cadmium, and mercury that babies and young children are exposed to.
  • In regard to arsenic and cadmium, the plan requires FDA to: (1) develop an interim reference level (IRL) for arsenic in phase 1 of the plan (April 2021 to April 2022); (2) propose a draft action level for arsenic and develop an IRL for cadmium in phase 2 of the plan (April 2022 – April 2024); and (3) finalize the arsenic action level and develop a draft action level for cadmium in phase 3 of the plan (April 2024 and beyond).
  • At a June 14, 2022 webinar on the draft action levels for lead in juice that the Agency recently published (see April 29th post), Conrad Choiniere, Director of the Office of Analytics and Outreach at FDA’s Center for Food Safety and Applied Nutrition (CFSAN), indicated that the Agency has received additional resources to focus on its Closer to Zero plan and that it is likely to release IRLs for both arsenic and cadmium by early 2023 and that draft action levels for both heavy metals would follow in late 2023 to early 2024.  He also reported that an action level for lead in baby food is currently undergoing interagency review and is expected to be released soon.
  • Keller and Heckman will continue to monitor and report on updates to the Closer to Zero Plan.
  • A Consumer Reports study found high lead levels in vegetable puffs made from cassava that are marketed as snacks for young children, with one puff containing more lead than any of the 80 baby foods the group has tested since 2017.
  • Reducing heavy metal contamination in foods for babies and young children is a priority for FDA, as we have previously reported. In January 2023, FDA released draft guidance on action levels for lead in baby foods as part of the Closer to Zero initiative, establishing action levels of 10 parts per billion (ppb) for fruits, vegetables, mixtures, yogurts, custards/puddings, and single ingredient meats; 20 ppb for root vegetables; and 20 ppb for dry infant cereals. The report urges FDA to also consider exposure to lead from baby snack foods.
  • Consumer Reports measures lead as a percentage of California’s maximum allowable dose level (MADL) of 0.5 µg/day, or 0.5 ppb. According to the study, Lesser Evil Lil’ Puffs Intergalactic Voyager Veggie Blend contained 112% of the MADL, and another flavor from the same brand contained 60% of the MADL. Serenity Kids Tomato & Herbs, Bone Broth flavor contained 53% of the MADL. 
  • Cassava is a root vegetable, and because lead occurs naturally in the soil, it can accumulate in a plant’s roots. Lead can be further concentrated when cassava is processed into flour for snack foods. This could also be the case for any root vegetable, such as sweet potatoes, carrots and beets.
  • Keller and Heckman will continue to monitor heavy metals in foods for babies and young children.  
  • On March 4, 2024, FDA updated its list of select chemicals currently under review to include more information about the agency’s assessment of previously approved chemicals in the food supply. FDA first published a list in July 2023 to accompany an inventory of food ingredients that the agency determined through post-market review were not GRAS. The updated list includes food ingredients, food contact substances, and contaminants currently under FDA review, along with information about the status of the post-market assessments and links to public information about post-market actions.
  • For each of the chemicals in the list, FDA will progress through four risk review steps. First, FDA will review scientific information and engage with public health and research stakeholders to determine whether a risk and safety assessment is needed. If so, the agency will assess health effects on consumers, including vulnerable populations, to determine whether the chemical could pose a safety concern. Then, FDA will review the risk data to determine whether action is necessary to protect public health. Finally, FDA will take action, including revoking authorizations and approvals, working with industry on a voluntary market phase-out, developing action levels, issuing alerts, and providing information to consumers and industry.
  • The list is not intended to be comprehensive, but does include some of the contaminants that FDA is focused on through established programs like the Closer to Zero initiative and chemicals that stakeholders have asked FDA to review through citizen petitions. FDA intends to update the list regularly.
  • FDA’s assessment of chemicals in the food supply is part of its commitment to improving food safety under the proposed Human Foods Program. This program would include an Office of Food Chemical Safety, Dietary Supplements and Innovation, which is intended to develop a “systematic and more nimble process for evaluating chemicals in the food supply.”
  • Keller and Heckman will continue to monitor FDA’s post-market review of chemicals in the food supply.
  • James Jones, the newly appointed Deputy Commissioner for Human Foods, released a statement on October 19 outlining his commitment to Commissioner Robert Califf’s framework for the proposed Human Foods Program (HFP). Jones said that he is “committed to upholding and executing this framework guided by the principle of protecting and promoting the health and wellness of all U.S. consumers.” The framework contains three priority areas: preventing foodborne illness, decreasing diet-related chronic disease, and safeguarding the food supply.
  • Under the foodborne illness prevention prong of the framework, FDA is proposing to set up an Office of Critical Foods, which will regulate infant formula and medical foods. This office is intended to work with industry to avoid recalls and shutdowns, particularly in infant formula manufacturing. The HFP will also use FDA’s New Era of Smarter Food Safety blueprint to further progress to regulate the food supply under the Food Safety Modernization Act.
  • To aid in decreasing diet-related chronic diseases, the HFP will prioritize reducing sodium in food, creating more accessible food labels, promoting healthy habits, and supporting innovation. On November 16, the Agency is co-hosting a public meeting with the Reagan-Udall foundation to hear input on front-of-package labeling and from November 6-8 will hold virtual public meeting and listening sessions regarding strategies to reduce added sugar consumption.
  • The HFP will also work to safeguard the food supply by reducing exposure to contaminants and other harmful chemicals in foods. FDA is working on a proposed rule regarding Brominated Vegetable Oil in food, as well as continuing its work on the Closer to Zero initiative, which we have covered previously, to reduce exposure to heavy metals in foods for babies and young children.
  • Keller and Heckman will continue to follow and report on the HFP.
  • 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.
  • 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.

 Plum, Campbell Escape Heavy Metal Baby Food Suit (Law360 Subscription Required)

  • Litigation soon 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 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.  Many of these class action lawsuits have been dismissed for lack of standing, among other reasons.
  • On October 31, 2022, a federal judge dismissed without prejudice plaintiffs’ fraud and consumer protection claims in a New Jersey district class action against Campbell Soup Co. and Plum PBC (formerly a subsidiary of Campbell) that alleged dangerous levels of heavy metals in Plum baby food products.  The court found that plaintiffs have not alleged a “concrete and present harm” that would establish that they have standing.  The plaintiffs’ pleadings were compared to similarly unsuccessful claims involving Sprout and Gerber baby foods and claims in California against Walmart’s Parents Choice baby food that were allowed to proceed.  As compared to the “conclusory allegations” that failed in the other cases, plaintiffs in Kochar v. Walmart, Inc., (N.D. Cal. Apr. 25, 2022) passed the standing test by:
    • Alleging that the levels of heavy metals were above “naturally occurring” levels for the products directly at issue;
    • Outlining the average levels of certain heavy metals in foods regularly consumed by children and infants per FDA testing to provide a comparative baseline necessary for the court to assess risk of harm for standing purposes;
    • Alleging that Walmart was in possession of testing data showing high levels of heavy metals present in its products based on its own internal standards;
    • Articulating a “premium price” economic injury by stating that the plaintiffs had “spent their own time and money dealing with purchasing safer baby food alternatives;” and
    • Alleging that there were costs and expenses incurred related to their efforts to ensure that their babies have not been harmed, as well as costs and expenses for treatments their babies have received.
  • It remains to be seen whether any of the heavy metals lawsuits will ultimately be successful, given the difficulties and uncertainties in determining levels that are both safe and feasible, as outlined in FDA’s Closer to Zero plan (discussed here).  It seems clear, however, that getting to trial will require more than generalized concern and alarm.  Keller and Heckman will continue to monitor and report on any developments with this case or other heavy metal baby food-related lawsuits.
  • On October 11, the FDA announced the launch of an independent study, “The Role of Seafood in Child Growth and Development,” by the National Academies of Science, Engineering, and Medicine (NASEM) on the state of scientific evidence in nutrition and toxicology associations between seafood consumption and child growth and development. The purpose of the study is to obtain the most up-to-date understanding of the science on fish consumption in a whole diet context, which will support the goals of the FDA’s Closer to Zero Action Plan for reducing the exposure of babies and young children to mercury, arsenic, lead, and cadmium from foods.
  • As part of the study, an ad hoc committee of the NASEM will:
    • Evaluate dietary intake and seafood composition data provided by the sponsors (i.e., Department of Commerce, HHS, EPA, and USDA’s Agricultural Research Service);
    • Conduct systematic reviews of the scientific literature covering the areas of seafood nutrition and toxicology associated with seafood consumption and child growth and development;
    • Review existing sources of evidence on maternal and child seafood consumption and child growth and development; and
    • Develop an approach to synthesize the scientific evidence, and utilize that strategy to develop its findings and conclusions (quantitative and/or qualitative) about associations between seafood consumption and child growth and development.
  • FDA intends for the study to help inform whether any updates are needed for the current Advice about Eating Fish for children and those who might become or are pregnant or breastfeeding, and also hopes to gain a better understanding of the science on mercury exposure from food.
  • The FDA is partnering with the National Oceanic and Atmospheric Administration, U.S. Department of Agriculture, and U.S. Environmental Protection Agency on the study, and NASEM will publish the committee’s report after the study is complete in approximately 18 months. The FDA intends to use the study findings to advance policies and programs that support healthy child growth and development.
  • Healthy Babies Bright Futures (HBBF), which is an alliance of non-profit organizations, philanthropies, and scientists that designs and implements projects to reduce babies’ exposure to toxic chemicals, has released a study which found no evidence that homemade baby foods or family brand foods (defined as pre-packaged foods appropriate for the family and not just babies) are any safer with respect to heavy metals (lead, cadmium, mercury, and inorganic arsenic) than commercial store-bought brands. The study is based on HBBS testing of 288 foods, as well as analysis of food testing data from published studies.
  • While some variation was found with respect to the prevalence of particular heavy metals (commercial baby foods were less likely to have arsenic and mercury but more likely to have lead and cadmium), no difference was observed when analyzing for the presence of any detectable heavy metal:  94% of the tested commercial baby foods, and 94% of the tested homemade baby foods and family brand foods contained detectable heavy metals. Food type, and not the maker of the food, was found to be the most important variable. The report categorizes foods into 4 categories based on expected heavy metal levels: (1) “Serve” (lowest heavy metal levels, eat freely), (2) “Limit or Rotate” (moderate heavy metal levels), (3) “Serve rarely” (high heavy metal levels), and (4) “Avoid” (highest heavy metals). Of note, the “Avoid” category consisted entirely of rice products (e.g., rice cakes), which often contain high arsenic levels. Further, the reports recommends that certain otherwise nutritious foods (e.g., carrots and sweet potatoes) be fed less than daily and that different varieties be chosen to avoid potentially high heavy metal levels in these foods.
  • Overall, the report advocates a two-prong strategy. Parents should choose foods that are lower in heavy metals (“The Kitchen Solution”) while FDA should establish protective limits for heavy metals in all foods consumed by babies and young children (“The Country’s Solution”). To date, FDA has only set heavy metal limits in infant rice and juice, although its Closer to Zero plan promises to introduce additional heavy metal limits in baby foods in the coming years. Many, including HBBF, have criticized FDA’s efforts as one which is too slow and which places the burden of risk management on parents.