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Ignorance is Swiss, at least when it comes to America’s food supply. There are so many holes in a key food safety process that it raises questions about much of what we eat.

Most of the chemicals added to food and beverages — from cheese to chips to chicken soup — are never reviewed by the Food and Drug Administration (FDA) before those products are sold in grocery stores. Sometimes the FDA may not know such chemical ingredients exist unless a company chooses to voluntarily disclose that information. In fact, the FDA may never have even heard of an estimated 1,000 or more chemicals that have been added to foods and beverages, let alone reviewed them for safety.

Responding to a court-approved settlement agreement, the FDA recently issued a final rule on its process for handling substances in food that are “Generally Recognized as Safe,” also known as GRAS. The problem is, generally recognized as safe is an oxymoron. Under the GRAS process, ingredients can bypass FDA safety reviews, and the manufacturers themselves can determine a substance is safe without ever informing the FDA that they are using it in food.


To assess whether a substance is GRAS, companies will often convene their own expert panels and conclude whether the ingredient will pose harm when used as intended. Companies can then decide whether or not to share the results of the assessment with the FDA. That’s like allowing a baseball team’s general manager to also be the coach and umpire.

Even when the FDA has a concern about a chemical ingredient, the substance can still be used in food under the GRAS program. Lupin, for example, is an ingredient found in a variety of baked goods and cereal. It was determined to be safe by a company that voluntarily told the FDA about it. The FDA expressed concern that consumers with an allergy to peanuts may also have an adverse reaction to lupin, ranging from mild hives to anaphylaxis. The FDA asked the company to include a warning label on its product in addition to listing the ingredient on the food label.


The company ultimately withdrew its GRAS notice and stopped selling the lupin-containing food products. But that didn’t stop other companies that never informed FDA of their decisions to use the substance in food from selling products that contain lupin without warning labels.

Conflicts of interest also permeate the GRAS determination procedure. Companies convene expert panels to make a determination on the safety of a new ingredient. But these panels often include company employees, company-paid experts, or experts identified by a consulting firm hired by the company. A 2010 report from the US Government Accountability Office concluded that business or financial affiliations could sway the decisions made on whether an ingredient should be generally recognized as safe. The FDA said it plans to issue guidance to help reduce conflicts of interest in GRAS determinations, though like the GRAS notification process itself, any guidance would also be voluntary.

The health and well-being of the American people depend on a meaningful regulatory policy for food safety, not on a self-designed and self-graded take-home exam that companies can complete to their benefit. The GRAS system is designed in a way that provides the FDA with no ability to credibly vouch for the safety of chemical ingredients in food such as Quorn, a meat substitute, or Olestra, a fat substitute, both of which are known to cause allergic reactions and digestive issues.

By failing to require mandatory reporting of GRAS substances, the FDA missed an important opportunity in its August rule to change the GRAS process. Now it’s time for Congress to work together to create a legislative remedy that will ensure consumers can trust the safety of the food on their tables.

Democratic Senator Edward J. Markey, who represents the state of Massachusetts, is a member of the Senate Environment and Public Works Committee.