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Report: FDA loophole allows companies to determine safety of new chemicals in foods

The Natural Resources Defense Council says a loophole in a 1958 law allows food manufacturers to bypass federal safety assessments.

Many common foods and drinks contain chemical additives that may have negative health effects.

Too many common foods contain chemical additives that have not been verified as “safe” by the Food and Drug Administration due to a loophole in a 56-year-old law, states a new report.

The report, released Monday by the National Resources Defense Council (NRDC), an environmental advocacy group, details the findings of a recent investigation into the types of chemical additives found in such products as carbonated sodas and nutrition bars.

“All Americans eat food that may or may not have been reviewed by the FDA,” NRDC attorney Tom Neltner, one of the lead authors of the report, said in a press conference Monday.

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Neltner pointed to a 1958 law that exempted common ingredients such as vinegar and vegetable oil from a lengthy FDA approval process because they were “generally recognized as safe” to consume, or GRAS, as the reason for this surreptitious process.

Over the years, however, the exemption “has been stretched so most new chemicals pass through it: the loophole has swallowed the law,” the report says.

Submitting a product for FDA review is optional — an option that some, but not all, companies choose to take.

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“The exemption allows manufacturers to make safety determinations that the uses of their newest chemicals in food are safe without notifying the FDA,” the report states. “The agency’s attempts to limit these undisclosed GRAS determinations by asking industry to voluntarily inform the FDA about their chemicals are insufficient to ensure the safety of our food in a global marketplace with a complex food supply.”

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The NRDC maintains that hundreds of additives have been “self-approved” by manufacturers under this exemption. According to the report,  at least 275 chemicals used by 56 companies have been “put into foods based on an undisclosed safety determination,” said Neltner.

The report highlights four chemicals that biologist Maricel Maffini, senior scientist of NRDC’s Health Program, says are cause for concern:

• Epigallocatechin-3-gallate (EGCG): Determined as safe for use in beverages including teas, sport drinks, and juices, despite FDA’s citation of evidence it may cause leukemia in human and animal fetuses, and may affect the thyroid, testis, spleen, pituitary, liver, and gastrointestinal tract.
• Gamma-amino butyric acid (GABA): Determined as safe for use in beverages, chewing gum, coffee, tea, and candy, despite FDA concerns that estimated exposure was well in excess of what the company itself considered safe.
• Sweet lupin protein, fiber, and flour: Determined as safe for use in baked goods, dairy products, gelatin, meats, and candy, despite FDA-raised questions about whether or not the chemicals would cause serious allergic reactions in those with peanut allergies.
• Theobromine: Determined as safe for use in bread, cereal, beverages, chewing gum, tea, soy milk, gelatin, candy, and yogurt and fruit smoothies, despite FDA’s question about the estimated consumption being five times higher than the safe consumption level reported by the company.

— “Generally Regarded As Secret: Chemicals Added to Food in the United States” (NRDC.org)

Maffini and Neltner were unable to provide specific brand names of product types mentioned in the report, but both urged consumers to do their homework to learn more about the ingredients they ingest.

“There is work to be done by the FDA. There is work to be done by Congress. But consumers need to talk to their favorite brands and their grocers if they want to make a change,” said Neltner.

Maggie Fazeli Fard is Experience Life's staff writer.

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