FDA Never Reviewed More Than 100 Food Chemicals ‘Generally Recognized as Safe’: Report

One of the unreviewed additives, tara flour, was linked to 470 illnesses in 2022, leading to a recall of Daily Harvest products.

According to a new report, dozens of dangerous chemicals are approved for use in the U.S. food supply because of a loophole in federal safety regulations.

On March 3, the Environmental Working Group (EWG) published the results of an investigation into U.S. Food and Drug Administration (FDA) practices, warning that the agency allows food manufacturers to classify certain chemicals in ways that bypass extensive safety reviews, even when there is evidence that the substances may pose risks to human health.

The issue stems from a regulatory exemption created decades ago. In 1958, Congress established the “Generally Recognized as Safe” (GRAS) designation, which allowed companies to label common ingredients such as salt and baking powder as safe without undergoing formal FDA approval. The exemption also permitted companies to determine that certain chemicals qualify as GRAS, allowing them to avoid the agency’s lengthy premarket review process.

However, the report indicates the system has been widely exploited, allowing companies to introduce new substances into the food supply that have never been reviewed by the FDA. EWG states the problem worsened in 1997, when the agency created a voluntary notification system that lets companies decide whether to inform regulators about new chemical ingredients used in food.

According to EWG researchers, this expanded loophole has allowed companies to introduce hundreds of chemicals into cereals, snack bars, sports drinks, frozen foods and other heavily industrialized ultra-processed foods.

Food Additive Approval Problems

Concerns about food additive oversight have been raised by researchers for years. A report compiled by the Global Research Center and published in 2015 concluded that most food additives currently used in the U.S. food supply have not undergone thorough safety testing. The researchers warned that Americans may be routinely exposed to potentially harmful chemicals because regulators have relied on industry safety determinations rather than independent FDA review.

More recently, an August 2024 study by researchers from the NYU School of Global Public Health warned that federal regulators are failing to adequately protect consumers from risky food ingredients.

Those health experts called on the FDA to close regulatory loopholes and take a more active role in determining which additives are allowed in the nation’s food supply.

Secret GRAS

In the new report, researchers from the EWG investigated chemicals labeled as GRAS in the American food supply. They identified 111 food chemicals used in numerous products that they say are unsafe and may be harmful when ingested.

The EWG indicates manufacturers used the GRAS loophole to make their own safety determinations about those chemicals without notifying the FDA, while keeping the details about the safety of the chemicals secret. These chemicals are often known as “secret GRAS.”

Investigators report that companies have added thousands of food additives to the market since 2000, often without notifying the FDA. During the same time frame, the FDA only reviewed 10 new food additive applications and approved only seven through the official pre-market system.

The EWG analysis of voluntary notifications to the agency since 2000 indicates nearly 99% of new food chemicals have exploited the GRAS loophole to be allowed on the market. For example:

• Teavigo is a green tea extract used in more than 900 food products, including water, smoked fish, candy, granola bars and other products.
• Qmatrix is an aloe vera chemical used in more than 400 products including fruit and vegetable juices, tea bags and yogurt.
• BioVin 20 is a grape skin extract used in hundreds of sodas, juices, cooking sauces, candies and salad dressing products.
• Chocamine is a cocoa extract used in brown sugar and powdered sugar, coffee, cereal and cookies.
• Cinsulin is a cinnamon chemical used in honey, cereal, dessert toppings, popcorn, alcohol, powdered drinks, fruit juices and puddings.

Aloe vera is a safe natural ingredient but the FDA banned its use in laxatives in 2002 due to concerns of cancer, kidney injury and other health problems. However, companies continue to use aloe vera chemicals in many food products under the secret GRAS loophole.

In 2022, nearly 500 people became ill after consuming products made with tara flour, an ingredient that had been treated as a secret GRAS substance. The FDA only became aware of the potential danger after consumers reported severe gastrointestinal injuries, liver damage and gallbladder problems, prompting a nationwide Daily Harvest recall in June 2022.

Identifying the source of the illnesses took about a month and required an extensive investigation involving the FDA, the U.S. Centers for Disease Control and Prevention, three independent laboratories, and multiple physicians, microbiologists and toxicologists. The mystery was ultimately resolved when the manufacturer determined that tara flour, which had never undergone an FDA safety review, was the likely cause of the outbreak.

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