The HHS Secretary has issued a directive to stop a loophole that lets companies approve their own food additives

RFK Jr. Wants to Update Food Additive Safety Rules—How It Could Affect What You Eat Here's what food safety experts think of the change

• A new directive from RFK Jr. aims to close a loophole in FDA rules that lets companies self-approve food additives.
• Experts warned that the current system lacks transparency and may allow unsafe ingredients into food.
• Stronger FDA oversight could improve food safety, experts said, but the agency may lack the funding and staffing to actually implement this change.

A new directive from U.S. Health and Human Services Secretary Robert F. Kennedy, Jr. requires the Food and Drug Administration to explore changes to how new ingredients in food are categorized as safe.

Kennedy's order, issued on March 10, specifically targets rules relating to the Substances Generally Recognized as Safe, or GRAS, designation. Congress created the designation in 1958 to allow substances to bypass FDA review before going to market if they either had a long history of use in food or "information generally available to scientists" assured their safety.

Originally, food companies had to petition the FDA for a GRAS designation if the substance wasn't already approved as GRAS for the specific way the company wanted to use it. However, a 1997 rule allowed manufacturers to self-affirm a substance as GRAS without notifying or sharing their findings with the agency.

Kennedy directed the acting FDA commissioner to take steps to revise GRAS rules and potentially eliminate this loophole.

“For far too long, ingredient manufacturers and sponsors have exploited a loophole that has allowed new ingredients and chemicals, often with unknown safety data, to be introduced into the U.S. food supply without notification to the FDA or the public,” Kennedy said in a press release.

But how will Kennedy’s directive actually affect food safety? And how did we get here, anyway? Here’s what you need to know.

Why Was the GRAS System Created?

The GRAS designation was created as part of the 1958 Food Additives Amendment to the 1938 Federal Food, Drug, and Cosmetic Act. After the amendment’s passage, the FDA published a list of substances considered GRAS—ingredients like salt, pepper, and vinegar—and incorporated it into the Code of Federal Regulations.

But in the late 1960s, new information created safety concerns about cyclamate salts, leading to their removal from the GRAS list. Then-President Richard Nixon directed the FDA to re-examine the safety of substances on the list.

In response, the FDA created a more stringent GRAS designation process, requiring companies to submit scientific data for FDA review before a final GRAS decision. However, the process was time-consuming and eventually created a huge backlog of cases.

In 1997, the FDA changed the rules to streamline the process and created the GRAS Notification Program, which is currently in use. 

What Did the New 1997 Rule Do?

The new rule allowed companies to independently determine, using experts of their choice, whether a substance should be designated as GRAS for its intended use and have it go to market, regardless of whether the companies shared those results with the FDA.

“This is regarded as a GRAS loophole and has become the norm,” Kris DeAngelo, JD, LLM, associate director of the Institute for Food Laws and Regulations at Michigan State University, told Health. “Manufacturers are permitted to determine if substances are GRAS independent of or absent from the FDA’s review or approval as long as the determination aligns” with the agency’s established regulations for determining an additive is safe to be used in a specific way.

The FDA “strongly encourages” companies to submit a notice to the FDA that a substance has been determined as GRAS. If a manufacturer notifies the FDA, it could potentially “lead the agency to question whether use of the substance is GRAS." But the FDA does not require notification.

“Generally speaking, this [rule change] was beneficial for the companies because they could enter the market faster with their food products and ingredients,” Bryan Quoc Le, PhD, a food science consultant, told Health. “Otherwise, by the time the GRAS determination was completed by the FDA, they would have lost the window to be competitive as other companies would find alternatives.”

How Many Substances Have Been Designated GRAS Without Notifying the FDA?

A 2013 Pew Charitable Trust report estimated that companies have designated about a thousand chemicals as GRAS without notifying the FDA. 

Of the notices the FDA does receive, it evaluates an average of 75 a year. You can search through the notices on the agency’s website.

Common additives used under the GRAS definition include bacteria-derived ingredients such as enzymes or natural preservatives, and spices and herbs used for flavorings, according to Quoc Le.

What Does Kennedy Want the FDA to Do?

Kennedy is proposing that the FDA eliminate the self-affirmation pathway and instead require companies to publicly notify the FDA of any intended use of new ingredients, along with underlying safety data, before a substance can be introduced into the food supply.

Eliminating the loophole will provide transparency to consumers and ensure food ingredients are safe, Kennedy said in the release.

In the same release, acting FDA Commissioner Sara Brenner, MD, MPH, said the FDA is “committed to further safeguarding the food supply by ensuring the appropriate review of ingredients and substances that come into contact with food.” 

Would Closing the Loophole Make Food Safer?

DeAngelo agreed there are problems with allowing companies to determine the safety of their products. “The self-approval process creates a fox guarding the hen house scenario,” she said.

The Pew Charitable Trust report found that most additives aren't tested for safety in accordance with the FDA’s established recommendations, as they’re supposed to be. Additionally, the nonprofit discovered ubiquitous conflicts of interest in the GRAS self-designation process. 

“General recognition of additive safety requires consensus in the scientific community,” the report stated. “There can be no such consensus if the chemical's use is unknown to the scientific community and to FDA.”

Quoc Le agreed that a more thorough FDA oversight process is necessary. He said it’s especially important now that food ingredients are increasingly produced using synthetic biology, the safety risks of which scientists are still learning about. 

“I believe it is important for a regulatory body to have the resources and tools to review food ingredients before they enter the market, as there have been historical problems with introducing new substances to consumers that weren’t thoroughly tested,” he said, noting, however, that the issues have cropped up more often in the pharmaceutical industry rather than the food industry.

In addition to more FDA scrutiny from the outset, DeAngelo said she’d like all substances already self-affirmed as GRAS to undergo a more formal approval process. That way, the FDA can revoke an ingredient’s GRAS status if necessary, as it did with artificial trans fats in 2015.

However, DeAngelo and Quoc Le worry that any policy change would create further bottlenecks for an agency already overwhelmed by recent workforce cuts.

It’s possible that the FDA may not even have sufficient staffing to implement potential changes, DeAngelo noted.

“If the self-affirmed GRAS determination were eliminated and the FDA received adequate funding and personnel for all food safety and nutrition operations, both the U.S. and the world would benefit,” DeAngelo said. “However, without sufficiently skilled and educated staff and proper funding, it could simply become another grand gesture aimed at fixing a problem without the necessary people or resources to do so.”

Edited by Health with a background in health, science, and investigative reporting. Previously, she wrote full time about parenting issues for the app Parent Lab. Before that, she worked as a reporter for National Geographic covering wildlife crime and exploitation." tabindex="0" data-inline-tooltip="true"> Jani Hall Jani Hall Jani Hall is a news editor for Health with a background in health, science, and investigative reporting. Previously, she wrote full time about parenting issues for the app Parent Lab. Before that, she worked as a reporter for National Geographic covering wildlife crime and exploitation. learn more

This story originally appeared on: Health News - Author:Cathy Nelson