Search closer to zero

  • 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.
  •  We have reported on developments regarding toxic elements of concern that may be present in the food supply and, in particular, FDA’s “Closer to Zero” plan to reduce the levels of arsenic, lead, cadmium, and mercury in food for babies and young children.  These toxic elements cannot be completely avoided in the fruits, vegetables, or grains that are used in baby foods, juices, and infant cereals because they are present in the environment and may enter the food supply through soil, water, or air.
  • On July 15, 2022, FDA released the Fiscal Years 2018 – 2020 Total Diet Study (TDS) Elements Report on the analytical results for nutrients and toxic elements from 307 foods (including beverages and water), as well as 384 baby food (BF) products, that FDA sampled and analyzed over the 3-year period of the latest TDS and a Supplement (table) that summarizes the data.  Highlights from FDA’s report include:
    • Total arsenic, lead, and mercury were detected in less than half of the FY2018-FY2020 vegetable samples (35%, 10%, and 6% detects respectively); whereas cadmium was detected in 93% of vegetable samples (mean concentrations in vegetables range from: total arsenic, not detect (ND) – 15 ppb; cadmium, ND–222 ppb; lead, ND–12 ppb; mercury, ND – 1.8 ppb)
    • Among the foods with the highest mean concentrations of each analyte:
      • Arsenic (total) was ND in most of the foods tested (i.e., 57%), but was detected in all 27 samples of Baked cod, all 3 samples of Canned Tuna, all 3 samples of Fish sticks, all 27 samples of Baked salmon, and all 27 samples of Pre-cooked shrimp, with the highest reported level of 10,900 parts per billion (ppb) found in Baked cod;
        • Other than seafoods, Crisped rice cereal, BF Rice cereal, and Brown and White rice also had high mean total arsenic concentrations;
        • The results of the subset of samples that were further analyzed for inorganic arsenic ranged from 6.1 to 103 ppb and the highest mean concentration (i.e., 93 ppb) was found at in Crisped rice cereal;
      • Cadmium was ND in only 39% of the foods tested, and was detected in all 3 samples of Sunflower seeds, all 27 samples of Raw spinach, all 3 samples of Potato chips, all 27 samples of Leaf lettuce, and all 27 samples of French fries, with the highest reported level of 400 ppb found in both Raw Spinach and Sunflower seeds;
      • Lead was ND in most foods (86%) but was detected in all 8 samples of BF Sweet potatoes, all 8 samples of BF Teething biscuits, all 3 samples of Sandwich cookies, all 3 samples of White wine, and all 3 samples of Ranch salad dressing (low-calorie), with the highest reported level of 38 ppb found in BF Sweet potatoes; and
      • Mercury was ND in most foods (93%) but was detected in all 3 samples of Canned tuna, all 27 samples of Baked cod, all 27 samples of Baked salmon, all 27 samples of Pan-cooked catfish, and 27 samples of Pre-cooked shrimp, with the highest reported level of 250 ppb found in Canned tuna.
    • For TDS foods with FDA Action Levels, i.e., Apple juice (10 ppb lead, 10 ppb inorganic arsenic), Chocolate and Hard candy (100 ppb lead), and Infant rice cereal (100 ppb inorganic arsenic), or Standards, i.e., Bottled water standards (5 ppb lead, 10 ppb arsenic, 5 ppb cadmium, 2 ppb mercury), all results were below the levels/standards established by FDA.
  • While these new results add significantly to the analytical database for toxic elements of concern, especially for cadmium, which had been the most lacking, FDA has not posted any revisions to its Closer to Zero plan or otherwise provided any updates on establishing interim reference levels (IRLs) since the update in June that is discussed here.  Keller and Heckman will continue to monitor and report on developments impacting the Closer to Zero plan.
  • FDA will hold a webinar on Tuesday, June 14, 2022, at 1:00 pm (ET) to provide an overview of the recent draft guidance that the Agency issued on action levels for lead in juice.
  • As previously reported, the guidance, titled “Action Levels for Lead in Juice; Draft Guidance for Industry,” set action levels of 10 parts per billion (ppb) for lead in single-strength apple juice and 20 ppb for lead in all other single-strength juice types. The new levels are intended to reduce the potential health effects associated with dietary exposure to lead and supports the Agency’s Closer to Zero action plan.
  • During the webinar, FDA will provide an overview of the draft guidance and answer stakeholder questions. To register for the webinar, and to submit questions or comments in advance, please visit the registration page. Questions or comments must be submitted by Tuesday, May 31, 2022. The webinar will also be recorded and posted to FDA’s website.
  • On April 27, 2022, FDA issued a draft guidance providing draft action levels for lead in single-strength apple juice and other single-strength juices. FDA states that the new levels are intended to reduce the potential for negative health effects associated with dietary exposure to lead. The action supports FDA’s Closer to Zero action plan which intends to reduce exposure to toxic elements in foods.
  • The guidance provides draft action levels of 10 parts per billion (ppb) for lead in single-strength apple juice and 20 ppb for lead in all other single-strength juice types. As noted by FDA, the draft action levels in the guidance were determined using FDA’s interim reference level (IRL) for lead. Using this measurement, FDA estimates that a 10 ppb action level in apple juice could result in an estimated 46% reduction in exposure to lead from apple juice in children. For all other juices, an action level of 20 ppb is estimated to result in a reduction of 19% in exposure to lead from the juices in children. The Agency noted that it chose to issue lower draft action levels for apple juice because it is the most consumed juice by young children.
  • FDA is accepting comments on the draft guidance. Comments may be submitted by mail or electronically at Regulations.gov using Docket No. FDA-2019-D-5609.
  • On February 16, New York Attorney General Letitia James issued a demand letter to HolleUSA to stop making false or misleading claims about their baby food products. The demand letter specifically alleges that HolleUSA has been offering for sale various baby foods that are marketed as having “[n]o detectable traces of heavy metals” and as being “lead free.” However, the Office of the Attorney General (OAG) tested several products and found that they do, in fact, contain detectable levels of heavy metals, such as lead, cadmium, and arsenic.
  • The letter orders the removal of all false and misleading claims relating to the products being free of heavy metals from the website, sales materials, and virtual store fronts. It applies to both explicit statements (e.g., “lead free”) as well as any labels or graphics that imply a product is lead free (e.g., “Pb” with a line through it).
  • In terms of federal regulatory requirements, the FDA has not established any lead, arsenic, or cadmium limits for virtually any category of baby food products. However, the FDA’s Closer to Zero action plan, which was published in response to the February 2021 Congressional report on the level of heavy metals in baby foods, will propose action levels aimed at reducing exposure to toxic elements in foods. Notably, the levels of heavy metals that were detected by the OAG in the HolleUSA products did not exceed the EU standards, which is where the brand is based.
  • In a press release announcing the demand letter, Attorney General James stated that “New York parents should never have to second guess the safety of the products meant for their children. […] These false or misleading claims prey upon parents’ concerns about the continuing problem of toxic heavy metals in their children’s food, and they must end. We will continue to hold accountable any company that misrepresents its products to New York consumers.”
  • FDA, in coordination with EPA, has issued updated advice about eating fish for those who might become or are pregnant or breastfeeding and for children ages 1-11 years.
  • While the advice incorporates the Dietary Guidelines for Americans, 2020-2025, overall, it has remained the same and consumption of fish that is low in mercury continues to be recommended. The advice classifies fish into three tiers based on mercury content: “Best Choices,” “Good Choices,” and “Choices to Avoid.” It also identifies a subset of the “Best Choices” fish that are even lower in mercury.
  • Pregnant and breastfeed women are advised to eat two to three 4 ounce servings of “Best Choices” fish or one 4 ounce serving of “Good Choices” fish a week. Children are advised to eat two servings per week from the “Best Choices” fish, although recommended serving size varies between 1 and 4 ounces, depending on age.
  • The advice notes information regarding the following health benefits of fish consumption:
    • Child brain development through provision of omega-3 and omega-6 fats, iron, iodine (during pregnancy), and choline. Choline also supports development of a baby’s spinal cord, and fish can provide iron and zinc which promote immune function.
    • Moderate scientific evidence shows that it can help a baby’s cognitive development.
    • Strong scientific evidence of heart health benefits.
    • Moderate scientific evidence of better bone health, decreased risk of becoming overweight, and decreased risk for colon and rectal cancers when relatively high levels of fish are eaten in combination with other healthy foods.
  • FDA notes that as part of its Closer to Zero action plan, it will evaluate research on mercury consumption by babies and young children, and consider this information in the light of benefits of fish consumption to determine whether further updates to the advice are necessary.
  • On October 21, 2021, a coalition of 23 Attorneys General petitioned FDA to expedite setting heavy metal standards for baby foods. The petition echoes criticism that FDA’s Closer to Zero plan does not include adequately aggressive timelines for reducing heavy metals in baby food.
  • Under FDA’s Closer to Zero plan, FDA would propose guidance on limiting lead in baby food by the middle of 2022, guidance for limiting inorganic arsenic by April 2024, and guidance for limiting cadmium and mercury after April 2024. The AG petition calls on FDA to take the following actions by April 2022:
    • Propose science-based, achievability-focused interim limits for inorganic arsenic, lead, cadmium, and mercury in relevant categories of infant and toddler foods;
    • Propose a lower limit for inorganic arsenic in infant rice cereal than the 100 parts per billion level that is currently set forth in FDA guidance; and
    • Instruct all baby food manufacturers to test their finished products for toxic heavy metals.
  • The AG petition follows a wave of class-action lawsuits against baby food manufacturers and a congressional report  that was released in February 2021.  Keller and Heckman will continue to monitor this matter and report on any developments.
  •  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 May 24, 2021, the consumer protection groups Food & Water Watch and Empire State Consumer Project, Inc. (ESCP) requested (via letter) that the FDA take action to address the allegedly high levels of arsenic and lead found in many vinegar products.
    • ESCP tested 24 samples of major brands of vinegars or vinegar reductions or glazes and found that 11 contained arsenic or lead and 7 contained both. And, of the 11 products, 10 were balsamic products and all were imported from Italy, Greece, or Spain. Arsenic levels in contaminated products ranged from 70 parts per billion (ppb) to more than 1,040 ppb, which means at maximum levels, one tablespoon serving of vinegar would exceed FDA’s maximum allowable level of 0.01 mg arsenic in one liter of drinking water (equivalent to 10 ppb arsenic). Lead levels ranged from 68.6 to 127 ppb, which exceeded the 34 ppb safe harbor level for balsamic vinegars under California’s Proposition 65.
    • Citing to the dangers of arsenic and lead exposure, particularly to developing fetuses, the letter requests FDA to perform product testing and establish limits and warnings addressing lead and arsenic in vinegars and vinegar reductions or glazes.
    • This letter comes in the wake of the fallout from the Congressional report on heavy metals (including arsenic and lead) in baby foods, which has prompted FDA’s Closer to Zero Plan as well as proposed legislation in Congress, both aimed at reducing heavy metals levels in baby foods. Keller and Heckman will continue to monitor any developments in the regulation of heavy metals in food.