Who's Monitoring Your Food For Safety?

Food companies commonly use additives to flavor food, enhance color, prevent spoilage and more. This includes chemicals used in packaging and food processing equipment that may get into food. It is estimated that out of 10,000 ingredients currently in processed food, the FDA has not reviewed the safety of approximately 3,000.


In August, the Food and Drug Administration issued a final rule defining when chemicals added to or used in making food can be considered “Generally Recognized as Safe,” or GRAS. A growing number of Americans are paying more attention to food labels and are concerned about the chemicals added to their foods. Consumers rely on the FDA to ensure that ingredients in our food have been tested and are safe, but this new ruling is full of loopholes that may make our food supply less safe than before.


For a little background on the ruling, we’ll start at the beginning. In 1958, Congress passed the Food Additives Amendment to the Federal Food, Drug, and Cosmetic Act in response to growing public concern about the increased use of chemicals in food and food processing. The Amendment required the FDA to initiate a formal pre-market review process when a manufacturer petitioned the FDA to approve a new food additive. The Amendment was intended to save time and resources of both food manufactures and the FDA by exempting generally recognized as safe (GRAS) substances from the process. This included such commonly used substances as vinegar, caffeine, black pepper, yeast and corn starch.


However, the number of substances waiting to be evaluated soon became overwhelming, and the FDA did not have the resources to continue this process. So in 1997, the FDA self-imposed a method to streamline the GRAS process. This ruling allowed any person to notify the FDA that use of a substance is generally recognized as safe and did not require formal approval or review by the FDA. The FDA would no longer conduct its own analysis or evaluate the data. Over the past decade, almost all new chemicals added directly to our food have gone through the streamlined GRAS process rather than the formal approval process that was originally intended.


Food companies commonly use additives to flavor food, enhance color, prevent spoilage and more. This includes chemicals used in packaging and food processing equipment that may get into food. It is estimated that out of 10,000 ingredients currently in processed food, the FDA has not reviewed the safety of approximately 3,000.


Due to a 2014 lawsuit brought by the nonprofit Center for Food Safety saying that the current GRAS process was illegal and a threat to public health, the FDA was forced to issue a final ruling to clarify and formalize the GRAS process. Despite hopes that the FDA would strengthen its control over the GRAS process, the final ruling places regulation of GRAS supplements firmly in the hands of food makers.


The new GRAS rules:


Allow the use of chemicals in food without FDA’s knowledge or approval.


Leave in place a completely voluntary notification system, where manufacturers simply tell the FDA they are using a substance that they believe is safe, without any safety review by the FDA.


Weaken the standard for when a substance can be considered GRAS.


Do not address conflicts of interest issues.


Allow the industry to regulate itself.


Do not require public access to documents, thus allowing for secrecy.


Provide for a longer timeframe for the FDA to respond with notifications (180 days instead of 90) and does not specify what action the FDA takes in response.


The FDA explains that the new rule requires manufacturers to provide detailed information in what’s called a “GRAS notice,” which gets posted to the FDA list. The FDA would then issue an opinion but not affirm that a substance is safe. The process is voluntary, although the FDA says it can still take action against ingredients it later deems to be unsafe.


To declare a substance as GRAS, there must be reasonable certainty of no harm under the intended conditions of its use. But the issue of who gets to determine safety or how it is determined isn’t addressed. This allows new chemicals to be introduced into our food supply without any FDA safety review or even awareness. Because many GRAS chemicals do not need to appear in the food label’s ingredient list, consumers now have to rely on the food manufacturer to ensure the ingredients are safe.


Food is too important to our health to allow companies that profit from its sale to determine if it is safe. Reading food labels and not buying foods that have long lists of unpronounceable ingredients is the best thing you can do for your health. If you don’t recognize an ingredient or if a food contains something you wouldn’t find in your own kitchen, you’ll be better off to leave it on the shelf.