The Food and Drug Administration has announced the availability of a final guidance for industry entitled “Inorganic Arsenic in Rice Cereals for Infants: Action Level.”

“This guidance finalizes FDA’s action level for inorganic arsenic in rice cereals for infants of 100 micrograms per kilogram (μg/kg) or 100 parts per billion (ppb) and identifies FDA’s intended sampling and enforcement approach. The basis for the action level is set forth in the revised supporting document,” according to the agency announcement.

The guidance identifies for industry an action level for inorganic arsenic in rice cereals for infants that is intended to help protect public health and is achievable with the use of current good manufacturing practices. It also describes intended sampling and enforcement approaches. It comes eight years after Consumer Reports (CR) first went public with the problem of the potentially dangerous presence of inorganic arsenic in infant rice cereals.

 CR applauded the FDA for taking the action but did reiterate its concern that limits are still needed on arsenic in other rice-based products and on heavy metals in baby food. And, the Healthy Babies Bright Futures (HBBF) alliance was more blunt, saying the organization’s research shows that FDA’s 100 ppb (parts per billion) “action level” is not a protective, health-based limit for babies.

“We’ve known for years that arsenic is found at troubling levels in infant rice cereals and can pose serious health threats to babies regularly exposed to it,” said Brian Ronholm, CR’s director of food policy.  “The FDA’s action is an important first step, but the agency needs to be far more aggressive in protecting young children from the dangers of arsenic and other heavy metals in food.”

Ronholm is a former deputy undersecretary for food safety at the U.S. Department of Agriculture.

Under the new guidance issued, the FDA has established the limit of 100 ppb for inorganic arsenic in infant rice cereal—not far from the 90 ppb limit recommended by CR. Infants and children are especially vulnerable to exposure to arsenic. It can cause damage to a baby’s developing brain even at low levels, according to CR.   Arsenic has also been proven to increase the risk of developing bladder, lung, and skin cancers, as well as heart disease and type 2 diabetes.

No federal limit exists for inorganic arsenic in most foods.  Since 2012, Consumer Reports has been calling on the FDA to set limits on arsenic in rice and rice products. Tests conducted by CR that year found varying levels of inorganic arsenic in more than 60 rice and rice products, including worrisome levels in infant cereals.

CR found that some infant rice cereals, which are often a baby’s first solid food, had levels of inorganic arsenic at least five times more than has been found in alternatives such as oatmeal. According to federal data, some infants eat up to two to three servings of rice cereal a day.  Eating rice cereal at that rate, with the highest level of inorganic arsenic CR found in its tests, could result in a risk of cancer twice as high as its experts calculated to be acceptable.

Subsequent tests by Consumer Reports in 2014 found that rice cereal and rice pasta can have much more inorganic arsenic than its previous test showed. CR concluded that one serving of either could put children over the maximum recommended amount they should have in a week.

And CR tests in 2018 of other packaged foods for babies and toddlers found troubling levels of inorganic arsenic, cadmium, and lead. CR found that at least two-thirds of the 50 packaged foods it tested had worrisome levels of at least one of these heavy metals. Fifteen of the foods would pose health risks to a child who regularly ate just one serving or less per day. Snacks and products containing rice and sweet potatoes were particularly likely to have high levels of heavy metals.

The risks from heavy metals grow over time, in part because they accumulate in the kidneys and other organs. Regularly consuming even small amounts over a long period of time may raise the risk of bladder, lung, and skin cancer; cognitive and reproductive problems; and type 2 diabetes.

“Parents can take a number of steps to limit their child’s exposure to heavy metals in food, but they should be able to expect that the government is putting public health first,” said Michael Hansen, senior scientist for Consumer Reports. “The FDA should set protective targets for reducing exposure to heavy metals with the goal of having no measurable levels in children’s food.”

For parents concerned about exposure to heavy metals, Consumer Reports recommends talking with a pediatrician to determine whether their child should be tested. Parents can reduce exposure by serving their child a broad array of healthful whole foods, limiting the amount of rice cereal in their diet, and being mindful of how much fruit juice they serve.

Arsenic is strictly regulated in drinking water, but unrestricted until now in infant rice cereals.  Healthy Babies Bright Futures (HBBF), which includes scientists, nonprofit organizations, and interested donors, says FDA has not considered IQ loss and other forms of neurological impact that children may experience from high exposures to arsenic in rice.

”And FDA failed to consider harm from multiple toxic heavy metals—arsenic as wells lead, cadmium, and mercury, that contaminated not only rice but other common baby foods as well—all of which contribute to risks for a baby’s healthy development,” the organization’s statement said.

An HBBF study in 2017 found toxic heavy metals in 95 percent of 168 baby foods tested. They also found rice cereals on average contained 85 ppl of arsenic.

“The FDA’s announcement is a step toward ensuring that babies’ brains are protected from exposure to harmful chemicals, but it is not a large enough step,” said Charlotte Brody,  HBBF’s national director. “When we released our baby food study in 2017, we suggested that the FDA set an enforceable, health-based limit for arsenic in infant rice cereal and other rice-based foods to protect infants from both cancer and neurological harm. Three years later, this newly announced guidance is not the solution. It’s just the first step in the right direction.”

HBBF said the FDA action will do little to lower babies’ risks from toxic heavy metals in rice-based foods. Because of their high levels of heavy metal contamination, 15 foods consumed by children under two years of age account for 55 percent of the risk to babies’ brains. Topping the list are rice-based foods — infant rice cereal, rice dishes, and rice-based snacks. These popular baby foods are not only high in inorganic arsenic, the most toxic form of arsenic, but also are nearly always contaminated with three additional toxic heavy metals, lead, cadmium, and mercury.

Lead and arsenic in rice-based foods account for one-fifth of the more than 11 million IQ points children lose from birth to 24 months of age from dietary sources, according to HBBF,  It says this concentrated risk underscores the need for more clear and protective action from the FDA and baby food companies.

The HBBK statement also says the lack of guidance has also played a role in inequality and racial health disparities, pointing to these findings:

  • Children with celiac disease often eat rice in place of gluten-containing grains. They ingest 14 times more arsenic than other children, on average.
  • National diet surveys show that Hispanic infants and toddlers are 2.5 times more likely to eat rice on a given day than other children.
  • Asian Americans eat nearly 10 times more rice than the national average.
  • Black toddlers are 2 to 3 times as likely to eat arsenic-laden rice snacks.

“Making the food that babies eat safe should be the baseline,” Brody said. “Setting a standard for the maximum amount of arsenic allowed in baby foods is a start to keeping them safe — but 100 ppb is still far too high. No amount of arsenic, lead or other toxic heavy metal is safe for babies.”

(To sign up for a free subscription to Food Safety Website, click here.)