How does the FDA approve new food additives?

The Food and Drug Administration (FDA) is an agency within the U.S. Department of Health and Human Services. Part of the FDA’s mission is to protect public health by assuring the safety, efficacy and security of our nation’s food supply.

I started researching the inner workings of the FDA when I learned that in 1958 there were only 800 food additives in our food supply while today there are more than 10,000. I began to wonder what the approval and testing process looked like when a company proposed or introduced a new chemical to ensure its safety and effects on the human population. I’ve always assumed that because an ingredient is in a product or on the market in general, it’s gone through a safety procedures proving and insuring our well-being.

I was surprised to find that when a manufacturer wants to present a new component into our food source, it does not need to notify the FDA. The company alone may determine an ingredient is Generally Recognized as Safe (GRAS), an FDA term meaning there is “reasonable certainty in the minds of competent scientists that the substance is not harmful under the intended conditions of use.”

When a company creates an additive and gives it the GRAS designation, it is exempt from the usual food additive tolerance requirements and does not require pre-market review or approval. The GRAS process was created to give companies a quicker, more efficient method of adding substances to their products.

While not mandatory, a manufacturer can choose to send their GRAS determination to the FDA. If the FDA raises questions about an ingredient received in a voluntary GRAS notice, the producer may easily withdraw their notice and continue to use the ingredient in their products. Additionally, companies may elect to simply bypass the FDA altogether. The FDA’s deputy commissioner for food, Michael Taylor, has been quoted as saying, “We simply do not have the information to vouch for the safety of many of these chemicals.” Furthermore, there are no studies being done on the reactions and complications of the cumulative effects of these additives.

It is important to note the startling conflict of interest as it relates to Michael Taylor. He is the creator of the FDA’s substantial equivalence policy, which is used to justify no safety testing and no labeling of GMOs. Taylor has spent his lengthy career going back and forth from working at the FDA to either legally representing or working in executive functions at Monsanto. Monsanto, the controversial producer of genetically engineered seeds, has been involved in a number of class actions suits where fines and damages have run into the millions of dollars, usually over health issues related to its product.

Organizations are bringing these issues at the FDA to light. In 2010, the Government Accountability Office issued a report criticizing FDA’s GRAS program. In 2013, the Journal of the American Medical Association called into question substances granted GRAS status. The Center for Food Safety, an advocacy group, brought a lawsuit against the FDA last year for failing to protect the public against dangerous additives and because the agency has abandoned its oversight of the additives approval process.

I was disheartened to learn that our hard-earned tax dollars are funding an agency whose protocols and values are questionable. I hope that Americans dissatisfaction over the process demands improvements and accountability.

Samantha Adams lives in Jackson, with her husband, Greg, and her two sons, Gavin and Jackson. She works full-time in medical sales and is working passionately to help to educate our community as it relates to health and wellness. Visit her on Facebook on “If You Seek Nutrition.”

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