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The FDA Closer To Zero Plan Explained

baby food

In April, the U.S. Food and Drug Administration (FDA) released an action plan to reduce the high levels of toxic heavy metals found in certain baby foods. The FDA’s ‘Closer to Zero’ plan aims to reduce heavy metals in baby foods to levels “as low as possible.”

The plan is a step forward for the government agency. Until recently, the FDA has not acted swiftly or aggressively enough to protect babies and young children from the dangers posed by toxic heavy metals like arsenic, lead, cadmium, and mercury. But while the Closer to Zero plan outlines milestones and deadlines that will help address this issue, the plan is not without flaws, which we will discuss in this blog.

FDA Approval Stamp

What is the Problem with Heavy Metals in Baby Foods?

Babies and infants are vulnerable to the harmful effects of heavy metals because of their smaller body size and metabolism. They consume more food in relation to their body weight and absorb heavy metals more readily than adults by 40 to 90%.

Additionally, the mechanisms needed to metabolize and eliminate heavy metals from the body are comparatively undeveloped in childhood. Babies have weaker detoxifying abilities and poorer immune systems when compared to adults. Linda McCauley, Dean of the Nell Hodgson Woodruff School of Nursing at Emory University, studies environmental health effects. She makes clear the dangers heavy metals pose to babies and infants: “No level of exposure to these [heavy] metals has been shown to be safe in vulnerable infants.”

In February of this year, a government subcommittee report found that certain baby food brands have dangerously high levels of heavy metals, some testing at as much as 129 parts per billion (ppb) arsenic, 352 ppb lead, and over 2 ppb mercury. Furthermore, some baby food products have ingredients that contain as much as 309 ppb arsenic, 200 ppb lead, and 260 ppb cadmium.

The FDA’s maximum allowable levels of heavy metals in bottled water is 10 ppb for inorganic arsenic, 5 ppb for lead, and 5 ppb for cadmium. The U.S. Environmental Protection Agency (EPA) regulates the maximum allowable mercury levels in drinking water at 2 ppb. Without question, the levels of heavy metals in baby foods far exceed these thresholds.

Parents reacted to the report with shock. Some are pursuing lawsuits against several of the leading baby food manufacturers, including Nurture (Happy Family Organics and HappyBABY), Beech-Nut, Hain Celestial Group (Earth’s Best Organic), Campbell Soup (Plum Organics), Walmart (Parent’s Choice), Sprout Foods (Sprout Organic Food), and Gerber. Lawsuits allege exposure to some baby food products substantially contributed to children developing autism and attention-deficit/hyperactivity disorder (ADHD).

What Does the FDA Closer to Zero Plan Do to Help?

According to the FDA, the baby food action plan will:

  • Advance research and evaluate changes in dietary exposures to toxic elements
  • Set action levels with input from stakeholders
  • Encourage industry to adopt best practices to lower levels of toxic elements in agricultural commodities and products
  • Increase targeted compliance and enforcement activities
  • Monitor progress of levels over time

The FDA aims to accomplish these goals using a four-pronged approach:

Evaluate the science to support action levels for heavy metals: The FDA will continue to evaluate data from food testing, toxicological assays, research on chemical analytical methods, exposure and risk assessments, and other scientific information to establish interim reference levels (IRLs) for toxic heavy metals.

Propose action levels: The established IRLs may help inform the FDA’s proposed action levels for heavy metals in certain types of baby foods (for example, infant formula, cereals, and pureed fruits and vegetables).

Consult with stakeholders: The FDA will consult with stakeholders regarding heavy metals in every identified category of baby foods to assess whether the proposed action levels and the timeframes for reaching them are achievable.

Finalize action levels: The FDA will utilize information from stakeholders, updated scientific research, and routine monitoring of data to make adjustments if needed before finalizing action levels.

What the FDA’s Baby Food Action Plan Lacks

In the short term, the FDA’s plan may not move quickly enough to adequately address this very serious health issue. The FDA’s deadline to propose action levels for lead is 2022. For arsenic, the deadline is 2024. The agency has not yet outlined a deadline for cadmium or mercury.

“If the FDA’s timeframe in setting action levels for arsenic in infant rice cereal is any indication of how quickly parents can reasonably expect needed change here, I think there is cause for concern,” says consumer attorney Pedram Esfandiary.

The FDA proposed draft action levels for arsenic in infant rice cereal back in 2013 and only adopted its action level for arsenic in infant rice cereal last year. The process took so long that by the time the FDA adopted the action level, the risk assessment that the draft action level was based on was outdated.

“The FDA cannot let this happen again, especially considering how much medical research supports the dangers heavy metals pose to infants and young children,” Esfandiary adds.

Another issue with the FDA’s plan is that it fails to address the cumulative effect that heavy metals have on babies and children. By staggering the action plan deadlines for each toxic metal separately—and neglecting to set deadlines for cadmium and mercury—the agency is not doing enough to consider the combined effects, which is surprising because the FDA’s own research has found that when mercury is present, the effects of arsenic, cadmium, and lead are worse.

A 2016 study found that that exposure to multiple heavy metals may have synergistic effects on the prevalence of autism spectrum disorder. This finding is significant because children who consume certain baby food products are often exposed to repeated, high doses of multiple heavy metals, which compounds the risk of ASD.

Lastly, the FDA needs to be consistent in its messaging on what exposure to heavy metals is safe for children. When the FDA issued a press release on its Closer to Zero plan, it mentioned the following:

“…the FDA’s testing shows that children are not at an immediate health risk from exposure to toxic elements at the levels found in foods...”

Statements like this are confusing for parents who are naturally concerned about this issue after seeing the baby food report in February. Contrary to the information in the press release, the FDA’s own webpage discussing lead levels in food says:

“…there is no identified safe blood lead level…Lead is especially harmful to vulnerable populations, including infants, young children, pregnant women and their fetuses.”

Consistency and clear definitions are needed when discussing what levels of heavy metals are safe, especially when it comes to children.

In summary, the FDA’s Closer to Zero plan is a positive step in protecting babies and young children from the dangers of toxic heavy metals. However, it will likely take more than what is in this plan to truly meet the challenge of reducing heavy metal levels in food closer to zero.

Heavy Metals in Baby Food Linked to ADHD and Autism

Baum Hedlund Aristei & Goldman baby food attorneys represent hundreds of parents throughout America in lawsuits against certain manufacturers for failing to warn consumers about the dangerous levels of heavy metals in their baby foods.

If your child was diagnosed with ADHD and/or autism after regularly consuming baby foods from the following brands, you may be able to pursue justice and compensation in a lawsuit:

  • Beech Nut
  • Campbell Soup (Plum Organics)
  • Gerber
  • Hain Celestial Group (Earth’s Best Organic)
  • Nurture (Happy Family Organics and Happy Baby)
  • Sprout Foods (Sprout Organic Food)
  • Walmart (Parent’s Choice)

For a free and confidential case evaluation, contact us or give us a call at (855) 948-5098


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