FDA must do more to regulate thousands of chemicals added to your food


You’re careful about every morsel you put into your mouth, exquisitely conscious about the potential impact on your growing baby’s development.

Yet the agency charged with protecting our food from unsafe chemicals — the US Food and Drug Administration — hasn’t been doing the job Congress intended when it passed the 1958 Food Additives Amendment, according to a citizen’s petition filed Wednesday and provided exclusively to CNN in advance.

“The FDA never considers the overall effect of these 10,000 chemicals on people’s health, which is what Congress was after,” said Tom Neltner, the chemicals policy director for the Environmental Defense Fund, a key signatory of the petition.

“And it’s not simply one plus one equals two. We know that synthetic chemicals that harm hormones have what we call additive or synergistic effects,” said Dr. Leonardo Trasande, co-author of the American Academy of Pediatrics’ policy statement on the potential harms of food additives and packaging, which is part of the citizen’s petition.
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The additive effect of low levels of different chemical exposures can impact a baby’s IQ and therefore his or her ability to excel in school and contribute to society at large, said Trasande, who is director of environmental pediatrics at NYU Langone Health.

“We’re talking about each child losing roughly 2% of her lifetime economic productivity on average with the loss of one IQ point, or $20,000,” Trasande said. “You multiply that across four million kids born each year and that’s a lot of zeros and a huge impact on our economy.

“So this is more than a mom and baby story. This is really about the future of our ability to compete in the global economy.”

Consider the cumulative effect

Scientists used to think that it was a baby’s thyroid hormone level that was important to brain development. Studies have now shown that a shift in an expecting mother’s thyroid hormone, “even if it’s so subtle it doesn’t show up on a clinical test,” can have consequences to a child’s future development, Trasande said.

It’s all too easy for a pregnant woman or parent to tip the scales into toxic territory. Take, for example, a dinner of organic vegetables stored in plastic wrap, steamed in nonstick cookware with tap water as a beverage.

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The plastic wrap can contain chlorine, the nonstick cookware is made with perfluoroalkyl and polyfluoroalkyl substances (PFAS), and the vegetables and drinking water may contain nitrates from fertilizers, which often leach into ground water, especially in agricultural areas.
All three of those chemicals are known endocrine disrupters. A review of the last five years of research by Trasande found an “explosion of evidence” about the negative impact on our health of such chemicals in agricultural pesticides and plastic or other containers used in manufacturing that touch our food.

The dangers extend beyond pregnancy. Any negative impact of food additives will be much worse for children of any age, said Dr. Margaret Cuomo, author of “A World Without Cancer,” a book that explores environmental impacts on cancer risk.

“Children are always the most vulnerable especially when it comes to the endocrine disrupters,” Cuomo said, “because their endocrine, neurological and reproductive systems are just developing. And so these chemicals have a much higher impact on their little bodies compared to adults.”

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It’s the FDA’s responsibility to step up and remove the responsibility of avoiding such dangers from consumers, said Dr. Aparna Bole, chair of the AAP’s Council on Environmental Health, who worked on the petition.

“The reason we are asking for greater regulatory support is that it’s really too much to ask a typical parent or pregnant person to purchase their way out of a very confusing system,” Bole said.

“For the average consumer to worry ‘If I purchased this I risk that exposure, and if I store it in this I risk a different exposure. …’ I feel like it’s a landmine.”

Neltner of the Environmental Defense Fund agreed. “We can’t expect every person to become a chemist. We want the FDA and industry to do the job and to think about that core issue. That’s why Congress gave the burden to FDA and industry, right?”

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CNN reached out to the FDA and the American Chemical Council, which represents many food and food product manufacturers. The FDA did not respond before publication.

The American Chemical Council provided the following statement: “FDA regulations are comprehensive and science-based. In addition, through FDA’s ongoing food monitoring, they ensure the safety of the food supply.”

Regulate the class of chemicals

The way the FDA approaches its regulatory job contributes to the problem, experts say.
Take PFAS chemicals, which have been linked to an increased risk of cancer, asthma and thyroid disease, as well as liver damage and decreased fertility. Called “forever” chemicals, because they do not degrade in the environment, PFAS are so widespread that levels have been detected in the blood of 97% of Americans, according to a 2015 report by the US Centers for Disease Control and Prevention.
Even more concerning during the coronavirus pandemic, PFAS chemicals have also been linked to a reduction of antibody responses to vaccines and less resistance to infectious disease.
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While two of the most ubiquitous PFAS — perfluorooctanoic acid (PFOA) and perfluorooctane sulfonate (PFOS) — were removed from consumer products in America in the early 2000s, the industry continuously spawns new versions. More than 4,700 types of PFAS existed in 2018.

The same thing happened with the infamous bisphenol A that was used to create baby bottles, sippy cups and infant formula containers until frightened parents boycotted those products a decade ago. Today there are more than 40 BPA replacements in the marketplace.

Despite the fact that these new products appear to impact the same biological receptor or mechanisms in the body as those that were banned, the FDA does not regulate the entire class of PFAS or BPA chemicals — only one specific chemical at a time.

“The regrettable thing that can happen is we get rid of item A, and then replace it with item A1,” Bole said. “That’s what one of the things this petition is trying to accomplish — for the FDA to look at classes of chemicals as well.”

Pushing chemicals through a loophole

Another part of the problem, according to the petition, is that the agency allows companies to use a loophole in the law called GRAS — “Generally Recognized As Safe.” Written into the original 1958 amendment, it was meant to save companies from FDA review if the new chemical or additive was known to be safe.

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“But they were referring to salt and vinegar and oil. They weren’t referring to brand new synthetic chemicals,” Neltner said. “And this little exemption was stretched beyond recognition so that now, almost any new chemical added to food goes through the GRAS loophole.”

An Environmental Defense Fund analysis of public records found that in the last 23 years, just under 900 GRAS proposals have been voluntarily submitted by companies, Neltner said. A closer review of those 900 of those found only one company had considered the cumulative effect of different chemicals on the body.

When it came to the other other submissions, “we saw no evidence that FDA raised concerns about the notifier’s failure to include the legally mandated information,” the petition states.

And even when the FDA does find concerns, the company can withdraw the GRAS submission and proceed with the use of the chemical, Neltner said.

“We’ve documented cases where the company has gone ahead and used the chemical, despite the withdrawal in the face of agency concern, because the company was convinced it was still safe.”

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Not only that, but the agency has even interpreted “that hole in the law to allow companies to make safety determinations in secret without ever telling the agency,” Neltner added.

In fact, a review of agency documents by the Environmental Defense Fund found “about 1,000 chemicals have been added to food or food packaging without the agency’s knowledge,” Neltner said.

“It takes a long time to reverse these decisions that the companies get so easily,” he added. “Sometimes it takes five to ten years to resolve.”

The Environmental Defense Fund has taken the FDA to court over its interpretation of the GRAS rule, and is currently awaiting a decision by the court.

How can this be done?

Just how can the FDA address a decision that impacts some 10,000 chemicals that are allowed in food or products that touch food?

“The agency actually has a database that it developed back in the ’80s, where it identifies all the health effects for the chemicals it has already approved,” Neltner said. “So it has a starting place.”

By law, the FDA has 180 days to approve, deny, dismiss or give a tentative response to any citizen petition, but that could be simply, “We need more time.”

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The agency will need additional funding to accomplish this goal, experts point out. Compared to the drug approval side of the FDA, the food safety and nutrition divisions are chronically underfunded.

“The executive branch and Congress must recognize the agency cannot carry out the kinds of advances this report has identified without ensuring that it has sufficient authority and resources to do so,” said Cuomo, who is the sister of New York Governor Andrew Cuomo and CNN anchor Chris Cuomo.

“When you’re a public servant in an agency like the FDA, the last thing you want to do is hurt people,” Cuomo added. “And I mean that in all sincerity. We have to show a little respect for the people who dedicate their lives to this kind of work — it’s backbreaking.”

In the end, the process of considering this petition could take years, experts say.

“The first step to fix this problem is to ask the public what they think,” Neltner said. “And to hear from groups like the heart, diabetes, kidney and cancer associations, because they’re the ones that are seeing increases in kidney disease, diabetes and cancer due to these chemicals.”

The petition is currently supported by the Environmental Defense Fund, the American Academy of Pediatrics, the American Public Health Association, Breast Cancer Prevention Partners, the Center for Food Safety, the Clean Label Project, the Consumer Federation of America, Consumer Reports, the Endocrine Society, the Environmental Health Strategy Center, the Environmental Working Group, and Healthy Babies Bright Futures.

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Getting swifter action is up to consumers, Cuomo agreed.

“I cannot overstate the impact and the influence of US public opinion,” she said. “I’m not sure that creating documents like this is going to be effective without a huge public outcry.”

What you can do

While the regulatory process churns on, the AAP suggests consumers do the following to lessen the risk of exposure to food additives.

Prioritize consumption of fresh or frozen fruits and vegetables when possible, and “try to use a variety of fruits and vegetables,” Bole said. That’s one way to minimize the risk in case one type of fruit or veggie is more exposed to food additives.

Avoid processed meats, especially during pregnancy. Sodium nitrite and potassium nitrate are key ingredients in curing meat.

Never run plastics through the dishwasher as that can cause leaching, Bole said, and avoid microwaving food or drinks in plastic (including infant formula and pumped human milk). Use alternatives to plastic, such as glass or stainless steel, when possible.

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Don’t avoid breastfeeding because of concerns over plastic, however.

“Breastfeeding and pumping and feeding is the best, no matter what,” she said. “And remember you can store breast milk in glass, you can feed in glass. It can be convenient because you can pump right into the glass, freeze it and then thaw, heat and feed from the same glass container.”

Look at the recycling code on the bottom of products to find the plastic type, and avoid plastics with recycling codes 3 (phthalates), 6 (styrene), and 7 (bisphenols) unless plastics are labeled as “biobased” or “greenware,” the AAP says. Those labels indicate the plastic is made from corn and does not contain bisphenols.

Always wash hands before handling foods and drinks, and wash all fruits and vegetables that cannot be peeled. “I even encourage washing any food before you peel it,” Bole said.

These tips are particularly focused on food additives, Bole pointed out, and don’t address concerns such as arsenic in rice cereals or pesticides in foods. But there are easy tips parents can use to address those issues, too.

“Fortified cereals can be a healthy first food, just make sure you use a variety of whole grain cereals, not just one,” she said. “For families who eat a lot of rice, be sure to wash the grains first, which helps remove arsenic. And know that brown rice, because it still has the hull, contains more arsenic than white rice.”

Keep all things in perspective, Bole recommended. An exposure to food additives will not be life threatening, and may be a better choice in some situations.

“The bottom line is, I’d rather you eat fresh fruits and vegetables, whatever they’re stored in,” she said. “That’s going to be a better choice than more processed food items that are also bad for your health.”

Correction: A prior version of this story misstated the full number of GRAS proposals.



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