Lack of considerations in cumulative effect of food chemicals could have contributed to increased chronic diseases

Today, a group of health, environmental, and consumer organizations challenged the Food and Drug Administration's (FDA) practice of not accounting for the cumulative health effect of chemicals in the diet when allowing new chemicals in food.

Over 60 years ago, Congress passed a law requiring that FDA and industry do just that. Unfortunately, an Environmental Defense Fund investigation of nearly 900 safety determinations found that only one considered the requirement in a meaningful way.

In reviewing the correspondence between FDA and manufacturers, EDF found no evidence the agency raises concerns with this major shortcoming. The analysis also demonstrates that, when evaluating the safety of new additives, FDA and food manufacturers all too often consider one chemical at a time rather than as a class of related substances.

"The collective failure by FDA and the food industry to follow the law may well have contributed to the dramatic increases we have seen in chronic diseases, including obesity, diabetes, and kidney disease in the US in recent decades," said Tom Neltner, Chemicals Policy Director for Environmental Defense Fund.

"Every time we eat highly processed food, we are exposed to chemical additives, and - for the chemicals that cause similar toxic effects - that combined exposure can increase the harm to our health. FDA and industry can and must do better to ensure our food is safe."

"The reality is we are not exposed to a single food additive or contaminant in isolation, so it does not make sense to evaluate their potential effects in isolation. Real-world dietary exposures frequently include a cocktail of endocrine-disrupting and other harmful chemicals that are either deliberately added or leach from food packaging," said Heather Patisaul, PhD, Chair of the Endocrine Society's Advocacy and Public Outreach Core Committee.

"To effectively protect our health, we need to consider how the chemicals in our food affect hormonal, neurological and other systems in combination, particularly when evaluating new additives with similar properties."

"Pediatricians have been urging the U.S. Food and Drug Administration (FDA) to make urgently needed improvements to the food additive regulatory process. Children are uniquely vulnerable to chemical exposures because they eat and drink more, relative to body weight, than adults do."

"For children, studies have suggested that some food additives can have potentially serious health consequences, such as interfering with hormones, impeding growth and development, and increasing the risk of childhood obesity. It is absolutely critical that the FDA evaluate the cumulative effects of food additives across the diet and the lifespan in order to best support children's healthy growth and development." -- American Academy of Pediatrics President Sara "Sally" Goza, MD, FAAP.

"We are pleased to join this important petition calling on the FDA to protect the public's health by fully accounting for the cumulative health effects of the chemicals additives in our food. This call for commonsense protections is essential to preventing disease and improving the nation's health and wellbeing." -- Georges C. Benjamin, MD, Executive Director, American Public Health Association.

"Over 275,000 women are or will be diagnosed with breast cancer this year in the US, and most cases have nothing to do with family history. Science has shown that our exposure to toxic chemicals plays a big role; especially because we are constantly exposed to a mixture of chemicals that impact our health. So it's essential that the FDA fully follow and implement the law when it comes to something as basic and important as the safety of a mixture of chemicals in our food." -- Lisette van Vliet, Senior Policy Coordinator, Breast Cancer Prevention Partners.

"For far too long, FDA has allowed the food industry to regulate itself, while ignoring consumers' concerns," said Jaydee Hanson, Policy Director at Center for Food Safety.

"Instead of requiring food manufacturers to notify FDA whenever new chemical substances are added to our food, FDA allows these manufacturers to self-certify in secret that their additives are safe. Not only does this prevent the public from knowing what is in their food, it prevents FDA from understanding the true cumulative effect of these chemicals on human health. This stands the regulatory process on its head."

"The food safety regulatory framework in America is largely focused on acute exposure to pathogens and microbiological contaminants. Long-term exposure to chemicals of concern including additives can take?years, even decades, to manifest chronic disease."

"We are long overdue to evaluate the cumulative role that additives in food and consumer products play in chronic disease and adapt federal regulatory policies accordingly." - Jaclyn Bowen MPH, MS food and consumer product safety systems engineer and executive director of Clean Label Project.

"FDA is falling short of its mandate to protect consumers so long as it disregards the cumulative effect of food chemicals," said Thomas Gremillion, Director of Food Policy for Consumer Federation of America. "The actions called for by this petition are long overdue."

"Most people are unknowingly exposed to numerous chemicals in food that may have serious adverse effects on their health," said Michael Hansen, PhD, senior scientist for Consumer Reports. "Before approving any new chemical in food, the FDA needs to thoroughly evaluate whether it poses a threat to public health when combined with other related substances already allowed in food."

"When watching what their kids eat, parents know to pay attention to the total amount of sugar from sweets, not just look at an individual candies," said Patrick MacRoy, Deputy Director at the Environmental Health Strategy Center.

"Yet, when it comes to toxic chemicals in our food, the FDA has been doing the equivalent of counting how many Skittles we eat, while ignoring that we also ate a box of M&Ms and a snickers bar or two. It's past time for the agency to follow the law and look at the impact of chemicals that are acting in concert to harm our health."

"For more than 60 years the FDA has brazenly ignored its legal obligations and best scientific practices," said Melanie Benesh, EWG legislative attorney. "We're exposed to multiple chemicals through our food--many of which have been linked to serious health problems like cancer, yet the agency insists on collecting data one chemical at a time. It's appalling that the FDA continues to neglect the cumulative effects of exposure to these chemicals as rates of cardiovascular disease, diabetes, obesity, and other serious health issues continue to rise among Americans."

"The impact of chemicals in our food can add up to harm, especially for pregnant women and their babies. The FDA understands this, but have failed to take proper action to keep our families safe. We urge the FDA to take action to ensure that the cumulative effects of toxic chemicals do not negatively impact moms and babies." -- Charlotte Brody, RN, National Director, Healthy Babies Bright Futures

While not as immediate as adverse drug interactions or food poisoning, the long-term, combined impact of food chemicals on our health can be significant. For example, several food additives and contaminants in common foods - including nitrates, perchlorate, and thiocyanate - all harm the thyroid's ability to use iodine to make a hormone essential to brain development. Exposure to these related chemicals from various foods should be considered together, as a class, to reduce the risk for pregnant women and young children, as the chemicals all harm fetal and infant brain development in the same way."

Maricel Maffini, Consultant, EDF

The citizen petition outlines the necessary steps for FDA to take to ensure that the cumulative effect of a new substance and related substances already in the diet has been adequately evaluated before the new additive is allowed in our food.

Petitioners are asking that the agency update its rules, issue guidance to industry to explain what is needed to conduct a complete safety determination which includes accounting for cumulative effects, and revise its forms for industry to submit notices and petitions.

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

The petitioners ask that the agency immediately put the petition out for public comment. Under its rules, FDA must respond to the petition within 180 days.

Endocrinologists are at the core of solving the most pressing health problems of our time, from diabetes and obesity to infertility, bone health, and hormone-related cancers. The Endocrine Society is the world's oldest and largest organization of scientists devoted to hormone research and physicians who care for people with hormone-related conditions.