The federal loophole that allows food companies to decide what’s safe for you to eat

Watch the CBS Reports documentary “Ultra Processed: How Food Tech Consumed the American Diet” in the video player above.

HENDERSONVILLE, N.C. – Fifteen-year-old Tiara Channer was 13 when she was diagnosed with prediabetes — a condition 1 in 5 American kids faces that causes an increased risk of Type 2 diabetes, chronic kidney disease and cardiovascular disease. She and her mother, Crystal Cauley, blame her diagnosis on a poor diet. 

“[Tiara] actually had to have a neurological consult, because she felt the tingling and the different sensations,” Cauley said. “And it was all linked to prediabetes. So it was a wake-up call, but she took the challenge to do better.”

By transitioning from a diet of ultra-processed foods to healthier whole foods and getting more active, Tiara overcame or shed her prediabetes diagnosis — and lost 50 pounds in the process. But it wasn’t an easy journey for her, given the challenge of understanding what’s healthy and what’s not.

“It is kind of hard when you’re young, you’re trying to figure out what kind of lifestyle change do I want to do? Like, how can I help myself? How can I benefit myself?” the teen said. “It was kind of a little bit difficult, because learning nutrition isn’t that easy.”

Ultra-processed food has consumed the nation’s food supply with its low cost and high convenience. These foods now comprise over half of an average American adult’s diet and two-thirds of an American child’s. 

Lawmakers like Sen. Bernie Sanders say the FDA, the agency that regulates 80% of the country’s food, hasn’t done enough to protect consumers from poor health outcomes associated with these unhealthy ultra-processed foods.

“I think the FDA has been negligent,” Sanders, an Independent from Vermont, told CBS Reports, “and I think we want to make sure that they’re more aggressive in reviewing the products that are getting onto the market.”

An estimated 10,000 food additives are approved for use in the U.S., as opposed to only 411 in the European Union. The FDA commissioner, Dr. Robert Califf, said this is partly due to cultural differences.

“Different societies have different degrees of tolerance for uncertainty, and different laws that determine what the regulators can do as substances are added,” Califf said. “America is a country that likes individual choice and access in general. And I think our laws reflect that sort of national sentiment.”

Almost half of the approved food additives in the U.S. fall under a category known as GRAS —  Generally Recognized As Safe. The designation was created in 1958 to waive FDA review of common, time-tested ingredients like vinegar and baking soda. Companies could petition the FDA to have a substance added to the GRAS list via FDA review and approval.

But in 1997, the FDA loosened the protocol to save resources and created the “voluntary notification” system. It allowed companies themselves to declare substances GRAS, without requiring them to tell the agency of the determination.

The nonprofit Environmental Working Group found 99% of the 766 food chemicals introduced between 2000 and 2021 avoided FDA scrutiny using the GRAS designation. But the number is likely even higher because it does not include the unreported declarations. 

Experts like Emily Broad Leib, the director of Harvard’s Food Law and Policy Clinic, say GRAS has become a loophole that gives companies a provisional green light to put new additives in food. 

“Thousands of substances have entered the food supply using that mechanism,” explained Broad Leib. “FDA can always afterwards say something is no longer generally recognized as safe. They’ve done that with artificial trans fat or partially hydrogenated oils. But there’s so many substances that, you know, it really is, I think, challenging given the resources. FDA has to really be on top of that all the time.”

The FDA told CBS Reports it is committed to overseeing the safety of the food supply and takes action when new research shows an additive causes harm. It is also working on updating its system for assessing food chemicals as part of a larger project to enhance food safety measures. But Califf said the FDA can only do so much. 

“The FDA is more like a referee than it is like the owner of the team,” said Califf. “The rules are written by Congress and dictated by the executive branch of the government. And what the FDA does is to take those rules and then apply them to make decisions based on the rulebook. … The FDA has really got to modernize. But again, we can’t step beyond the rulebook.” 

Sanders is trying to address some of these issues in a bill he is co-sponsoring with Democratic Senators Cory Booker of New Jersey, John Hickenlooper of Colorado and Peter Welch of Vermont, known as the Childhood Obesity Reduction Act of 2024. The bill would, in part, direct the National Institutes of Health to “expand, intensify, and coordinate” research programs on nutrition science, including on the chemicals self-affirmed by manufacturers as generally recognized as safe. 

“There is a growing awareness in the medical community and in the general public that we cannot continue to allow our kids to be addicted to processed foods get sick and die at an earlier age than they otherwise would,” Sanders said. “So the movement is with us. We take on very powerful special interests, but we are gaining every day.”