How Does the FDA Test to See Whether a New Chemical Causes Cancer?
In October of 2018, the U.S. Food and Drug Administration banned the use of seven artificial flavor-enhancing food additives after environmental and consumer groups threatened a lawsuit. While you may not have heard of methyl eugonol, pyridine, or the other five banned food additives, all of them have been shown to cause cancer in animal laboratory studies. So how were these additives approved by the FDA in the first place?
The FDA Approval Process
For new food additives or the new use of an additive, the manufacturer must petition the FDA and demonstrate that the additive is safe. The FDA looks at the additive’s intended use and the amount used, the amount a person would be likely to consume over time, the effect of long-term consumption of small amounts over time, and studies looking at potential health effects.To determine whether or not a chemical is a carcinogen, scientists generally use a combination of lab and epidemiological studies. Lab studies involve exposing animals to potential carcinogens, while epidemiological studies involve looking at large populations of people to determine what factors might be linked to cancer. The EPA also looks at these studies related to potential food additives, seeking the input of outside experts and the results of long-term laboratory studies using rats and mice. If the FDA has no safety concerns, it establishes any limits necessary for safety.
Animal Lab Studies
These lab studies are particularly important to the FDA process because of a clause contained in the Food, Drugs, and Cosmetic Act of 1938. The “Delaney Clause” prohibits the FDA from approving any food additive that causes cancer in animals or humans. Similarly, if new evidence reveals that a previously approved additive causes cancer in animals, the FDA can ban it from use in food.In the case of the seven additives recently banned by the FDA, manufacturers argued that the additive amount humans are exposed to are minimal compared to the animals in the lab studies. But the FDA banned the additives after consumer and environmental groups threatened to sue the FDA over enforcement of the Delaney Clause.The Madeksho Law Firm has been helping victims of disease due to chemical exposure for nearly fifty years. For a FREE consultation call us at 1-888-910-6376, or contact us here.
