Experts Weigh in on FDA's Closer to Zero

By Kaniehtonkie.

On January 24, 2023, the U.S. Food and Drug Administration issued for public comment “Action Levels for Lead in Food Intended for Babies and Young Children: Draft Guidance for Industry.” As the FDA outlined in their ‘Closer to Zero’report, they expect over time for this guidance, together with other activities, to result in the baby food industry to progressively reduce levels of lead in foods to as low as possible. The draft guidance supports the FDA’s goal of reducing dietary exposure to lead, arsenic, cadmium and mercury, and the associated health effects, while maintaining access to nutritious foods.

In 2019 and 2022, Healthy Babies Bright Futures (HBBF) released successive reports on toxic chemicals in homemade and store bought baby food. Healthy Babies Bright Futures (HBBF) is an alliance of scientists, nonprofit organizations and donors working to create and support initiatives that measurably reduce exposures to neurotoxic chemicals in the first one thousand days of development.

The HBBF 2019 report stated they tested 168 foods purchased from major baby food manufacturers. Their analysis found 95% of store-bought baby food contained lead, 73% contained arsenic, 75% contained cadmium and 32% contained mercury. One-fourth of the foods tested that year contained all four heavy metals.

The HBBF’s report triggered a 2021 congressional investigation, which found leading baby food manufacturers knowingly sold products with high levels of toxic metals. Following the congressional report, the FDA to conducted their own research and the result is the Action Levels for Lead in Food Intended for Babies and Young Children: Draft Guidance for Industry.”

In the HBBF 2022 report, they found making baby food at home with store-bought produce isn’t going to reduce the amount of toxic heavy metals in the food your baby eats.

“We found no evidence to suggest that homemade baby foods made from store-bought produce are better than store-bought baby foods when it comes to heavy metal contamination,” said the paper’s coauthor Jane Houlihan, research director for Healthy Babies, Bright Futures.

While any action on the part of the FDA is welcome, the suggested levels of lead are not low enough to move the needle said Houlihan.

“Nearly all baby foods on the market already comply with what they have proposed. The FDA hasn’t done enough with these proposed lead limits to protect babies and young children from lead’s harmful effects. There is no known safe level of lead exposure, and children are particularly vulnerable.”

The director of food policy for Consumers Reports, Brian Ronholm, also expressed concerns. In 2018, Consumer Reports analyzed 50 baby foods and found “concerning” levels of lead and other heavy metals. In fact, “15 of them would pose a risk to a child who ate one serving or less per day,” according to Consumer Reports.

“The FDA should be encouraging industry to work harder to reduce hazardous lead and other heavy metals in baby food given how vulnerable young children are to toxic exposure,” Ronholm said in a statement.

According to the American Academy of Pediatrics, exposure to toxic heavy metals can be harmful to the developing brain of infants and children. “It’s been linked with problems with learning, cognition, and behavior.”

The 2019 HBBF report stated, “Decades of scientific research show that low levels of exposure to these heavy metals harm children’s developing brains with impacts that include IQ loss and other learning and attention deficits. Testing uncovered higher risk foods for neurotoxic harm to be rice- based products, sweet potatoes and fruit juices: safer alternatives are easily accessible and identified in the report. There is no federal safety limit for toxic heavy metals in nearly 9 out of 10 foods tested.

The study tested 168 baby foods spanning 61 brands and found that 95% of baby foods tested are contaminated with one or more of four toxic heavy metals – arsenic, lead, cadmium and mercury. All but nine of the 168 tested baby foods contained at least one of these four toxic metals. And 87% of foods tested contained more than one toxic heavy metal. All four toxic heavy metals were detected in one out of every four foods tested.

Scientific evidence confirms that arsenic, lead, cadmium and mercury are neurotoxic, negatively impacting a child’s healthy brain development. The report cites 23 peer- reviewed studies published in the past seven years that show loss of IQ, attention deficits and other learning and behavioral impacts among children who are exposed. Also, three of the metals (arsenic, lead and cadmium) are human carcinogens.”

An FDA official provided the following comment: “Our goal is to reduce the levels of lead in foods to as close to zero as possible. For all foods, with or without action levels, when the agency finds that the level of lead causes the food to be unsafe, we take action.”

Provided here in its entirety is HBBF statement on FDA’s Closer to Zero new guidelines,

FDA’s New Closer to Zero Action Levels Won’t Get Us Closer to Zero

Healthy Babies Bright Futures’ statement on Closer to Zero’s proposed action levels – after years of FDA’s stalling. January 24, 2023 – The U.S. Food and Drug Administration released draft guidance today as part of their Closer to Zero initiative to limit allowable lead levels in many types of popular baby food. Although the first sentence of the guidance states that “the FDA is committed to reducing lead in food,” today’s proposal does not act on that commitment. For more than two years, Healthy Babies Bright Futures has anxiously awaited the FDA’s Closer to Zero action levels, promised as part of the agency’s plan to to reduce exposure to lead, arsenic, cadmium, and mercury in baby foods. The action levels released today for lead, the first toxic heavy metal the agency is addressing, are not enough to protect the next generation of babies from harmful heavy metals in their food. Children under two years of age lose over 11 million IQ points from exposure to heavy metals in food, according to an analysis commissioned by HBBF and conducted by Abt Associates. One in six children in America has a developmental disability, and exposure to toxic heavy metals causes permanent decreases in IQ, diminished future economic productivity, and lifelong problems with learning and behavior. Healthy Babies Bright Futures’ 2019 study found heavy metals in 95% of baby foods tested. Since then, parents and lawmakers alike have been calling on the FDA to set protective action levels for the food that babies eat. Unfortunately, the Closer to Zero action levels don’t move the needle towards zero. “These proposed action levels don’t do enough to get us closer to zero,” says Charlotte Brody, HBBF’s National Director. “The action levels released by the FDA today for the most part put a rubber stamp on the status quo – signifying that the current levels of lead in baby food are ‘close enough.’ Why has the FDA’s Closer to Zero program spent years to create proposed guidance that won’t do enough to make baby food safer?” Closer to Zero’s proposed number don’t reflect enough progress to protect babies’ brain development from harmful chemicals: Only 16 of over 1,000 baby food tests we’ve assessed exceed FDA’s proposed limits – meaning that the proposed limits would not affect 98% of contaminated foods or make them safer for babies. The FDA didn’t propose any lead limit for puffs and teething biscuits – even though they account for 7 of the 10 highest lead levels in the more than 1,000 food tests HBBF has assessed. One positive element of the proposal is a new limit for sweet potatoes, which often exceed the limit FDA has proposed (20 ppb). But, disappointingly, for all other foods, only rare outlier samples will be affected. In addition, FDA’s proposal does not help families that make their own baby food at home, since it addresses only commercial baby food brands. Our research has shown that homemade baby food is just as likely to be contaminated with heavy metals as store-bought brands. “Nearly all baby foods already meet the action levels FDA lays out in this draft,” says Jane Houlihan, HBBF’s Research Director and the author of our baby food studies. “Grain-based snacks are not even covered, even though they account for 7 of the 10 highest lead levels we’ve seen in over 1,000 tests. If this proposal is finalized, the Closer to Zero promise of continually lowering limits over time will be vital to the health and safety of our babies.”

HBBF used the Abt analysis, baby food test results, and FDA market basket studies to identify which baby foods pose the highest risk to brain development while also offering easily accessible safer alternatives. These safer alternatives have 80% lower levels of toxic heavy metals, on average, than the riskier foods. The results point to five baby foods with higher risk, which include rice-based snacks/meals (puffs snacks, teething biscuits, rice rusks, and infant rice cereal), carrots, sweet potatoes and fruit juices.

Safer alternatives to higher risk foods include rice-free snacks, non-rice cereal (such as multi-grain and oatmeal cereals), other soothing foods for teething (like a frozen banana or chilled cucumber) and serving a variety of vegetables. Organic standards do not address these contaminants, and foods beyond the baby food aisle are equally affected. Parents can find more details about safer alternatives in HBBF’s safer baby foods fact sheet.

Data from the study shows that when FDA has issued a draft guidance or standard, levels have noticeably decreased over time. Despite the evidence that FDA actions can inspire market-wide change, for nearly 9 out of 10 baby foods tested there is no federal safety limit for arsenic, lead and other heavy metals.

“Current arsenic contamination levels in rice cereal and juice are 36% and 75% less, respectively, than the amounts measured a decade ago,” stated Houlihan, “When FDA acts, companies respond. We need the FDA to use their authority more effectively, and much more quickly, to reduce toxic heavy metals in baby foods.” HBBF and its partners have created a petition to the FDA urging them to take action by setting health-based limits that include the protection of babies’ brain development.

Without prompt FDA regulation to limit contamination levels, accelerated action from baby food companies is necessary to reduce toxic heavy metals to safer levels in foods. The newly announced Baby Food Council comprised of leading baby food companies and supported by non-profit organizations including the Environmental Defense Fund (EDF) and HBBF seeks to “reduce heavy metals in the companies’ products to as low as reasonably achievable using best-in-class management practices.”

Dr. Philip Landrigan, a pediatrician and director of the global public health program at Boston College, said in a statement, “Parents can protect their babies today by choosing nutritious and affordable alternatives to the most contaminated foods. And, to protect the babies of tomorrow the food companies and the FDA need to step up and do more. Exposures in early life are especially dangerous. The cumulative impact of exposures is what makes this a significant concern that demands action.”

If you’re interested in making a comment to the FDA regarding “Action Levels for Lead in Food Intended for Babies and Young Children: Draft Guidance for Industry” before the FDA begins work on the final guidance, please submit written or electronic comments by March 27, 2023. Submit comments electronically on Regulations.gov to docket number FDA-2022-D-0278. Submit written/paper submissions to:

Dockets Management Staff (HFA-305)

Food and Drug Administration

5630 Fishers Lane, Rm 1061

Rockville, MD 20852

All submissions received must include the Docket No. FDA-2022-D-0278 for “Action Levels for Lead in Food Intended for Babies and Young Children: Draft Guidance for Industry.”

For more information on HEALTHY BABIES BRIGHT FUTURES and access to their reports go to: http://www.hbbf.org