On September 23, 2020, a coalition of non-governmental organizations and associations announced that they have filed a citizen petition to the US Food and Drug Administration (FDA) requesting the agency to define terms for considering the cumulative effects of chemicals when assessing the safety of a substance. Led by the Environmental Defense Fund (EDF), the petition blames the FDA for not following its own mandate to consider the cumulative effects of substances across the human diet. The petition calls for cumulative effects from any substances that are “a food additive, food contact substance, generally recognized as safe substance [(GRAS)], or color additive” as well as “any chemically- or pharmacologically-related substances in the diet” to be taken into account when assessing safety. EDF analyzed the 877 existing GRAS notifications as of March 2020 and found that only one of them actually considered “the cumulative effect requirement in a meaningful way.” It further found “no evidence that the agency either recognized this single attempt to follow the law or had objected to the omissions in the 876 other notices.”

To address this gap, the petition proposes specific revisions that the FDA should make for existing regulations of color additives, food additives, GRAS substances, food contact substances, and relating to food additive petitions.

The co-authors of the petition spoke with CNN about their concerns and the motivation behind taking this action. Tom Neltner from EDF explained that it is the FDA’s responsibility to protect the public. “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?” Aparna Bole from the American Academy of Pediatrics commented “the reason we are asking for greater regulatory support is that it’s really too much to ask of a typical parent or pregnant person to purchase their way out of a very confusing system.”

The FDA has now published the petition and opened it for public comment. Stakeholders are urging the public to come forward and share their opinion about the issue. “I cannot overstate the impact and the influence of US public opinion,” said environmental health author Margaret Cuomo. “I’m not sure that creating documents like this is going to be effective without a huge public outcry.”

EDF has previously taken the FDA to court over its application of regulation regarding GRAS substances (FPF reported). Experts are reported as saying that it still could take years for this petition to be fully considered by the FDA.

Reference

US Government (September 23, 2020). “Requests that the FDA define key terms essential to consider the cumulative effect of a food additive, food contact substance, generally recognized as safe substance, or color additive, taking into account any chemically- or pharmacologically-related substances in the diet, when assessing safety as required by law.”

Read More

Tom Neltner and Maricel Maffini (September 23, 2020). “FDA’s Failure on Food Chemical Safety Leaves Consumers at Risk of Chronic Diseases.” EDF Health

Sandee LaMotte (September 23, 2020). “FDA must do more to regulate thousands of chemicals added to your food, petitioners say.” CNN health

Endocrine Society (September 23, 2020). “Lack of Key Considerations in FDA Food Chemical Safety Process Leaves Consumers at Risk of Chronic Diseases.”

Share