Last week, the Food and Drug Administration announced that it will no longer allow seven artificial flavors commonly found in baked goods, ice cream and other foods.
The change sprang from a petition arguing that since megadoses of six ingredients — benzophenone, ethyl acrylate, methyl eugenol, myrcene, pulegone and pyridine — cause cancer in laboratory animals, their use as food additives breaks federal law. The seventh ingredient, styrene, was removed because manufacturers no longer use it.
Yet in its next breath, the FDA issued a major caveat: All the banned ingredients “are unlikely to pose a potential or significant carcinogenic risk for humans at the levels that these synthetic flavoring substances are used in foods.” Translation? We think they’re safe, but the law requires us to ban them anyway.
Only in D.C. will you find contradictions on such a monumental scale.
Indeed, both of the FDA’s premises are true. In a laboratory setting, rats and mice developed more tumors after consuming quantities of these artificial flavors that would make even the most frequent snacker’s head spin. Although some doses reached the human equivalent of consuming as much artificial flavor as you’d find in 366,000 cookies, cancer was detected nonetheless.
At the same time, evidence of cancer at doses analogous to actual human consumption simply doesn’t exist. Human epidemiological studies, where researchers track what participants have eaten over weeks or years, have also come up empty-handed.
The source of the FDA’s conundrum is an outdated law called the “Delaney Clause,” which was added to the Federal Food, Drug, and Cosmetic Act in 1958. It prohibits the agency from approving food additives that have been found to cause cancer in laboratory animals regardless of the probability, or risk, that a human would develop the same cancer.
But what kind of risk are we talking about when it comes to these artificial flavors? According to the data, it’s very, very small.
Scientists believe the majority of the banned flavorings cause cancer in ways that simply aren’t possible in humans. Benzophenone, for example, likely produces kidney tumors in male rats when the animal is also sick with an age-related disease called chronic progressive nephropathy. Humans can’t get this disease, so scientists don’t believe we have the correct biological pathway, called a “mode of action”, that turns benzophenone from a flavor enhancer to a tumor generator.
For methyl eugenol, the only of these artificial flavors with a mode of action that does exist in humans, FDA scientists believe the extremely high doses – 220,000 to 890,000 times higher than the upper estimate of human dietary exposure — were responsible for overloading the animals’ normal functions.
High-dose studies are important for discovering a chemical’s worst-case scenario so that researchers know which small changes to look for once they conduct lower dose studies. Unfortunately, the implications of the initial search are exaggerated all too often by those looking for a quick fix for one of society’s most deadly diseases.
At a surface level, the Delaney Clause appears to be a simple provision: Don’t allow ingredients in our foods if they cause cancer in the laboratory. But it’s this simplistic thinking and the ensuing overreliance on animal testing that puts pharmacologists and toxicologists in a precarious situation when drugs that perform flawlessly in animal studies fail in clinical trials, or when chemicals turn out to be more toxic to humans than previously anticipated.
In fact, as early as 2008, the National Institutes of Health (NIH) and the Environmental Protection Agency (EPA) initiated a joint effort to replace animal testing with more accurate (and less expensive!) technologies: high-speed, automated screening of suspected toxins using human and animal tissues, cells, and molecular targets instead of rats and mice. Their efforts continue today.
It’s no secret that technology has evolved in the past six decades, and chemical toxicity testing is no exception. It’s time for federal law to reflect those changes.
Breanne Kincaid is the research director at the Center for Accountability in Science.
The views and opinions expressed in this commentary are those of the author and do not reflect the official position of The Daily Caller.