Food Companies Add 111 Unreviewed Chemicals to Products Without FDA Notification

At least 111 substances of unknown safety have been added to foods, drinks and supplements sold in the United States without alerting the U.S. Food and Drug Administration, a new investigation found. Food companies are deciding on their own to secretly add unreviewed chemical ingredients to products instead of following existing federal guidelines meant to assure food is "generally recognized as safe," or GRAS, according to the Environmental Working Group, a health and environmental health advocacy organization that conducted the investigation published Tuesday.

To meet the GRAS standard, companies must demonstrate a new food ingredient is safe by providing widely accepted scientific evidence that's publicly available. Notifying the U.S. FDA of that safety data is customary and ensures regulatory compliance. It's also voluntary — which means manufacturers can legally self-determine their products to be safe.

The EWG investigation found 49 of the chemicals added by industry in approximately 4,000 products listed in the U.S. Department of Agriculture's FoodData Central database, which provides public access to nutrient and ingredient information. Because the government has never reviewed these chemicals, consumers have no way of knowing if they are safe or carry unknown health risks.

Of the 49 chemicals found in foods, 22 were extracts, according to the investigation. Many appear natural and harmless: aloe vera, cinnamon, cocoa, cranberry seed oil, grape skins, green coffee beans, hemp, lemon balm and mushrooms, to name a few.

Green tea extracts never reviewed by the FDA were found in 901 products in the database, including granola and energy bars, candy and chewing gum, ice cream, sodas, teas, waters and seafood, according to the EWG report. There is a major difference between the antioxidants in green tea you make at home and a purified extract of a green tea antioxidant done in a lab. Loose-leaf green tea may fight cancer-causing inflammation, lower blood pressure and cholesterol, boost brain health, and extend life. Highly concentrated green tea extracts, however, are linked to estrogen disruption and harm to the liver. There are at least 100 established cases of severe liver damage in people using concentrated green tea extracts sold for weight loss and muscle recovery.

Aloe vera extracts that bypassed U.S. FDA review were found in more than 450 products in FoodData Central, a food and nutrient database managed by the USDA Agricultural Research Service, according to the investigation.

The senior vice president of the Consumer Brands Association said CBA was part of a coalition, Americans for Ingredient Transparency, which is advocating for federal legislation establishing national uniformity for ingredient safety and disclosure. The U.S. has one of the safest and most highly regulated food systems in the world, according to the association.