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111 chemicals added to US foods without FDA review

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Investigation finds 111 chemicals added to foods without FDA notification.

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At least 111 chemicals have been added to food, drinks and supplements without the US Food and Drug Administration being notified, according to a new investigation by the Environmental Working Group.

The report claims that manufacturers approved these substances under a rule known as “generally recognized as safe,” or GRAS, without formally informing the FDA.

Under current rules, companies can determine on their own that an ingredient is safe if it meets the GRAS standard. While it is common practice to notify the FDA and provide scientific evidence, doing so is voluntary.

The Environmental Working Group says this has created what it calls “secret GRAS” substances. These are chemicals that companies have approved internally without federal review.

Loophole in the system

Melanie Benesh, vice president for government affairs at the Environmental Working Group, said manufacturers are increasingly using this pathway.

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“Manufacturers now routinely exploit this GRAS loophole — it’s fast becoming more ‘generally recognized as secret’ instead of ‘generally recognized as safe,’” she said.

“Because the government has never reviewed these chemicals, consumers have no way of knowing if they are safe or carry unknown health risks.”

The group noted that a chemical appearing on the list does not automatically mean it is harmful. However, it argues that the lack of oversight raises concerns.

Tara flour case

One example cited in the report is tara flour.

The ingredient had been self certified as safe before hundreds of people became ill in 2022 after consuming products containing it.

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According to reports at the time, nearly 400 people became sick. Some experienced liver and gallbladder problems, and more than 40 people reportedly had their gallbladders removed.

The FDA later investigated and determined that tara flour was not generally recognized as safe. The ingredient was banned from use in food and drink in the United States and from being imported.

Sources: Environmental Working Group report, Food Safety News, U.S. Food and Drug Administration.

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