What is GRAS – Generally Recognized As Safe?

According to the FDA, GRAS is an acronym for the phrase Generally Recognized As Safe. It means that any substance intentionally added to food is a food additive, subject to premarket review and approval by FDA, unless the substance is generally recognized among qualified experts as having been shown to be safe for its intended use.

There are two main paths to get a food additive into a processed food: premarket approval and an exemption as a GRAS product. Let’s start with premarket approval by the FDA. This is required if the additive is not considered GRAS. A company must submit an application complete with all of the company’s research conducted on the supposed safety of the ingredient and why it should be allowed in the food supply. The FDA then reviews that information and typically signs off on the approval. The inmates are running the asylum. This doesn’t make any sense.

The second path, GRAS, is even worse. GRAS means that a substance added to food is considered safe by experts, and so is exempted from the usual FDA food additive application process discussed above. Guess who determines if an additive is GRAS? That’s right, the company who is selling the ingredient. As disturbingly as that is, it’s only part of the story. The chemical company doesn’t even have to report the newly-dubbed GRAS ingredient to the FDA- there is only a voluntary notification program. You read it correctly. The FDA doesn’t know what these companies are self-approving and putting into the food supply. The FDA has virtually no authority over the additive process. Scary.

Even more nonsensical is once a company determines a food ingredient is safe, it “may market the substance, even if FDA finds that the notice does not provide a sufficient basis for a GRAS” according to the Government Accountability Office (GAO), which has been advocating for a significant overhaul of this process for many years.

So let’s summarize what we’ve learned so far. If a chemical company chooses to go the first route, premarket approval, it provides its own research as to the safety of the product. The FDA then reads the highly-suspect research and approves the additive. If a company goes the second route, they stamp their own approval on their new additive, don’t have to tell the FDA, and even if the FDA becomes aware of the ingredient and determines it is not safe, the company does not have to stop selling it. Are you comfortable with that? I assure you that I am not. The very foundation of our system is broken. These two processes need to be scrapped and replaced with something that puts public safety above the chemical industry’s bottom line.