FDA and industry continue to ignore cumulative effects of chemicals in the diet

Tom Neltner, Chemicals Policy Director and Maricel Maffini, consultant

The Food and Drug Administration (FDA) has made no apparent progress to comply with the legal requirement that it consider the cumulative effect of chemicals in the diet that have similar health impacts when evaluating the safety of an additive. A year ago, on September 23, 2020, EDF and 11 other organizations[1] filed a formal petition with the agency documenting the problem and asking it begin complying with the law.

We reviewed FDA and industry actions since the petition was filed and found that both continued to ignore the requirement 100% of the time in:

  • Generally Recognized as Safe (GRAS) notices in which companies were required to consider the cumulative effect as part of their determination that a substance’s use was safe;
  • FDA’s responses to those GRAS notices where it found “no questions” with the flawed safety determinations; and
  • FDA’s revised guidance to industry on use of recycled plastics in food packaging.

The agency’s only response to our petition was a March 2021 letter saying it “has not reached a decision due to competing priorities” and that the “petition is currently under active evaluation by [its] staff.”

From what we can see, FDA and industry continue to make safety determinations about chemical additives without regard to their overall effect on individuals’ health and their legal obligations. Is it any surprise that consumers continue to rate chemicals in food their #1 food safety concern?

GRAS notices and FDA responses failed to even acknowledge requirement

We evaluated 62 GRAS notices voluntarily submitted to FDA by food manufacturers that the agency made publicly available between March 25, 2020 and August 12, 2021. In all the GRAS safety determinations, industry failed to consider the “cumulative effect of the substance in the diet, taking into account any chemically or pharmacologically related substance or substances in such diet” despite it being a key factor in determining safety (per 21 CFR § 170.3(i) and § 170.30).

Briefly, we downloaded all publicly available GRAS notices and FDA responses posted since March 25, 2020. We searched each document for the terms “cumulative effect” and “pharmacologic,” evaluating each result closely. We found:

  • Search term “cumulative effect”: None addressed how the combined effect could impact people’s health. The term was found in just four of 62 GRAS notices; three had it were quoting the language from the definition of safety in the rule. Simply put, they said here are all the things the law requires us to do (including address cumulative effect), then they went to ignore the cumulative effect mandate. The fourth one referred to cumulative exposure of a single substance in food and dietary supplement.
  • Search term “pharmacologic”: It was not addressed either. The term was found in 19 of the 62 notices; one referred to the language from the definition of safety. The others were associated with toxicology or journal names.

We also found that the agency issued letters in response to the GRAS notices saying it had no questions regarding the safety determination even though the company ignored the requirement.

This continues the disturbing track record we uncovered last year when we documented that only one of 877 GRAS safety determination conducted by companies since 1997 considered cumulative impacts in a meaningful way. And FDA did not question any of the failures.

We also reviewed FDA’s guidance for industry that was updated since our petition was filed and found no mention of the search words.

Cumulative effect is important to consider to protect public health from additives

When FDA and industry evaluate a new additive to food for safety, they improperly treat the substance as if it is the only thing that consumers will eat, failing to consider related substances in the diet as the law requires. Yet, we know for a fact that people typically eat multiple chemicals in one day, some of which may potentially harm the same organ.

For example, the thyroid’s ability to make a hormone essential to brain development is harmed by several chemicals in common foods and packaging. These include nitrates (found in some hot dogs and deli meat), perchlorate (found in some dry baby cereal, produce, and processed meats), phthalates (found in some dairy products, fast foods, and boxed mac and cheese), potassium bromate (found in some baked products) and PFAS (found in some takeout containers, plastic bottles, popcorn bags, and disposable bowls and plates). Unfortunately, FDA and manufacturers look at these chemicals one-by-one in a vacuum.

This is an obvious failure by FDA and food manufacturers that has significant consequences for public health, particularly for communities already facing significant health and socio-economic disparities and for children, who are uniquely susceptible to dietary exposures to multiple chemicals.

The American Academy of Pediatrics, one of the dozen organizations who jointly filed the petition, pointed out, “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 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.”

[1] The petitioners are: EDF; 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; Endocrine Society; Defend Our Health (formerly Environmental Health Strategy Center); Environmental Working Group; and Healthy Babies, Bright Futures.

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