Toxicologists Worried About ‘Patchwork’ of Safety Laws

Call it the “California effect” on food regulation. The California Food Safety Act was passed into law last year, and now food companies and developers across the United States have begun dealing with its implications. California has become a bellwether in this aspect of regulation as in so many other things. And as a state with a population of nearly 40 million, California is a crucial market all on its own.

Two prominent toxicologists recently discussed the new law and its implications during an IFT Lunch and Learn webinar titled “State Level Actions, National Level Impacts.”

The law will prohibit the use of four food additives commonly used in the United States effective Jan. 1, 2027: brominated vegetable oil, potassium bromate, propylparaben, and red dye No. 3. Red dye No. 3 is the most common, used in nearly 3,000 products over a broad range of categories including candy, fruit juices, and cookies. Activists have alleged that the chemicals are associated with health problems such as cancer and nervous system damage.

The act brings the Golden State in line with bans on these ingredients in the European Union as well as in the United Kingdom, Canada, Australia, China, and Japan. “But this sentiment [in California] is driving [legislators] in other states to introduce similar legislation,” including in Illinois, New York, Washington, and Indiana, said James Coughlin, an independent food toxicologist with extensive experience at General Foods and Kraft General Foods.

Toxicologist Craig Llewellyn, who has held leadership roles in both industry and scientific organizations, underscored that the U.S. Food and Drug Administration (FDA) has demonstrated “a long history of concern” for Americans’ food safety, “takes it seriously” and “continues to do so.” He said the U.S. standard for safety is “reasonable certainty” that qualified scientists have found an ingredient not harmful in the conditions of intended use, and noted, “It is impossible to establish with complete certainty the absolute harmlessness of any substance.”

Llewellyn said that a main reason activists have been able to get politicians in California and in other countries to ban these four substances is that “they don’t necessarily stick to the reasonable-certainty-of-no-harm argument and can bring into risk management the ‘precautionary principle.’ In the absence of absolute certainty, they take the action that is contrary to the current knowledge in science.”

Coughlin argued, “We’ve got to start bringing science to bear to counter the conclusions that everything is carcinogenic and toxic and that we have to ban everything that might look and smell like a carcinogen or [toxicant], when in fact, we do toxicology to find that these [concerns] aren’t relevant to humans and there aren’t risks from everyday consumption.”

Otherwise, he said, “If laws pass and there is a patchwork of several states having their own banned additives on a list, that makes it difficult for food manufacturers to sell things in interstate commerce. You can’t prepare foods for just California or Indiana or Illinois. The idea is to put trust in the federal system.”

The two scientists reviewed each of the newly banned substances and concluded, in various ways, that bans on each are uncalled for or irrelevant. Brominated vegetable oil, for instance, hasn’t been in use in its major food application, carbonated soft drinks, for about a decade. Red No. 3 was banned from cosmetics by the FDA in 1990 because of evidence that it caused cancer in lab animals, but it “is not genotoxic and operates by a secondary mechanism of carcinogenesis that is related to toxic effects on hormones,” Coughlin said. “So, you can assume there is a threshold of exposure below which tumors won’t develop, so there is negligible risk [of] human cancers.”ft