A series of infant deaths have been linked to excess arsenic and heavy metals discovered in infant formula. Reported deaths began to be exposed publicly through an October 7, 2010 report by Reuters news about a study released that showed a direct correlation to maternal diet and risk to newborns. The study prompted an FDA investigation that has yielded little conclusive consumer protection action. 

That is until this past February, when a new House committee report was published. The efforts of that study have launched a new outcry against officials under the Trump administration, yet the risk to families has been known, proven, and studied for over a decade with little to no corporate accountability. 

The First Alarm Unheeded
rice imports
U.S. rice imports in 2020/21 projected near-record high, Economic Research Service
U.S. Department of Agriculture

The initial alarm came from a 2010 Reuters Health article, “Prenatal arsenic exposure quintuples infant death risk,”  which focused on Bangladesh and the abnormally high infant mortality rate linked to arsenic in water wells, “Babies born to mothers with high levels of arsenic exposure are five times more likely to die before their first birthday than infants whose mothers we had the least exposure to the toxic mineral, new research shows.”

The link to imported and locally grown rice and high arsenic levels had been correlated far earlier, as studied in 2007, but a warning had not been released to the American public by the Food and Drug Administration until 2013 then revised again in 2016

Arsenic is a natural element which behaves like a metal. It is present in the environment both naturally and due to certain human activities. It has many different forms. It can exist in inorganic or organic form, inorganic arsenic being generally considered more toxic.

Green Facts, Facts on Health and Environment https://www.greenfacts.org/en/arsenic/index.htm Tweet

The link is again making headlines as the House Subcommittee on Economic and Consumer Policy Committee on Oversight and Reform released their staff report on February 4, 2021, “Baby Foods Are Tainted with Dangerous Levels of Arsenic, Lead, Cadmium, and Mercury”. The committee began collecting documentation in November 2020, according to news reports, while no hearing information nor briefings are listed on the Economic and Consumer Policy nor were product recalls or consumer warnings issued during the 116 Congressional session.

 

The only product warning involving baby formula was in September 2020 from an outbreak of products contaminated with Cronobacter bacteria. The Centers for Disease Control issued a statement and guidelines to the public as they had during a prior outbreak in 2011. In neither case was a recall mandated by the FDA or the CDC

As for heavy mental and arsenic contamination, the FDA quietly released their study findings in March 2020, citing:

“The number of samples tested in 2018 that met the FDA’s recommended target of 100 ppb was 76% compared to 36% of samples tested in 2011-2013. Both white rice and brown rice cereals showed improvement in meeting the 100 ppb level, but the improvement was greatest for white rice cereals, which tend to have lower levels of inorganic arsenic overall.”

The agency then published manufacturing guidelines in August 2020, stipulating manufacturing, “not exceed inorganic arsenic levels of 100 ppb in infant rice cereal”.

FDA Guidance for Industry by Date Issued

arsnicreportThe House Subcommittee’s report states that Walmart, Campbell, and Sprout Organic Foods refused to cooperate with the committee’s request for internal records. Nurture (HappyBABY), Hain (Earth’s Best Organic), Beech-Nut, and Gerber did respond and all documents showed arsenic levels above the FDA guideline, with some sampled ingredients topping the 300% ppb mark.

The committee’s report includes a condemnation of these companies inability to “self regulate”. However, the FDA had directed all manufacturers to no more than 100 ppb as far back as 2016 and the U.S. The Government Accountability Office, the regulatory for federal operations authority, outlined regulations in 2018

“GAO is making five recommendations, including that FDA develop a timeline for updating its risk assessment and finalizing its draft guidance and that FDA and USDA develop a coordination mechanism for developing methods to detect foodborne contaminants, including arsenic.”

The issue appears to be a lack of accountability, not published regulatory guidelines. 

The Committee’s Purpose

The Committee’s purpose is clearly outlined:

“Despite the well-known risks of harm to babies from toxic heavy metals, FDA has not taken adequate steps to decrease their presence in baby foods. FDA has not issued thresholds for the vast majority of toxic heavy metals in baby foods and does not require warning labels on any baby food products…” 

Yet, the committee cites the FDA’s limits in their report, ‘100 ppb’. 

However, the FDA has not issued a citation, warning letter, or injunction against any company cited and their actions steadily declined under the Trump Administration.

Illinois Representative Raja Krishnamoorthi (IL-08) served on the 2020 (116 Congress) committee during the November hearing and now serves as the committee chair. The representative was not available for comment as all of Congress is on recess following the impeachment trial. At the time of this writing, no one from the Congressman’s office has responded. 

The companies in the committee report were:

    • Beech-Nut Nutrition Co.
    • Hain Celestial Group Inc., which sells baby food products under the brand name Earth’s Best Organic
    • Gerber
    • Walmart Inc., which sells baby food products through its private brand Parent’s Choice
    • Sprout Foods Inc. which sells baby food under the name (Sprout Organic Foods”
    • Campbell Soup Co., which sells baby food products under the brand name Plum Organics
    • Nurture Inc., which sells Happy Family Organics, including baby food products under the brand name HappyBABY

food_lobbyMajor news outlets covered this issue on February 4, 2021; nearly four months after the House committee began gathering information. One organization to highlight the seriousness of the risk was Food Safety News, a publication sponsored by Marler Clark, ‘The Food Safety Law Firm’ specializing in claims against companies that are responsible for foodborne illness outbreaks.    

Consumer Reports covered this issue in August 2018, “Heavy Metals in Baby Food: What You Need to Know,” that highlighted the risk: 

“That’s why CR’s food safety team analyzed 50 nationally distributed packaged foods made for babies and toddlers, checking for cadmium, lead, mercury, and inorganic arsenic, the type most harmful to health… And annual sales of baby food now top $53 billion and are projected to reach more than $76 billion by 2021, according to Zion Market Research.”

Consumer Reports noted then, and in prior work, that the FDA had not issued guidelines specific to baby food and these toxins for nearly seven years. The most recent guidelines were finally issued August 2020 under FDA-2016-D-1099 to address baby formula and arsenic levels. However, it does not cover other products made with rice. 

The guidelines also come with an FDA disclaimer: 

fdadisclaimer

Prior to this, the FDA merely published studies from 2016 outlining cancer risks for consumers for all products made with rice which contained arsenic and data obtained by scientists in the U.S. Environmental Protection Agency and the National Institute of Environmental Health Sciences under the Obama administration.   

The Trump Administration appears to have declined in limited accountability measures, but the overall lack of accountability for arsenic levels in consumer products began in 2010 and continues to the present day. 

The risk to families was understood and evident under the Obama Administration as evidenced by these same sources cited within the committee’s findings, and reference in the FDA’s own studies.

All that remains now is for members of Congress and the FDA to finally take action based on the science already in their possession.