Groups Sue FDA Over Exemption for Food Additives

A group of consumer, health and food safety NGOs are suing the US Food and Drug Administration (FDA) over a final rule which they claim allows new food additive chemicals into products, without having their safety properly assessed.

Issued last August, the rule includes criteria defining when a substance in human or animal food is "generally recognised as safe" (Gras). Unlike other food additives, Gras substances are not subject to FDA pre-market approval but, the agency says, must meet the same safety standards. Once a chemical meets the criteria, notifying its use to the FDA becomes voluntary.

The Gras exemption was originally intended for common food ingredients like vinegar and vegetable oil. But the NGOs say industry has stretched it into a loophole that allows new chemicals through without scrutiny.

They claim the FDA is illegally allowing food and chemical manufacturers to decide themselves that food chemicals are safe, without giving notice to the agency, or the public.

The lawsuit was filed in the US District Court for the southern district of New York. Behind it are the Centre for Food Safety, Breast Cancer Prevention Partners, the Centre for Science in the Public Interest, the Environmental Defense Fund and the Environmental Working Group, with legal counsel from the Centre for Food Safety (CFS) and the environmental law group Earthjustice.

This is the second time that the Gras exemption is facing a legal challenge. In 2014, CFS successfully challenged the FDA’s use of an interim rule that initially put the voluntary notification procedure into place.