Food companies across the country may lose their authorization to self-affirm food ingredients, dyes, additives, and stabilizers are safe.
Department of Health and Human Secretary (HHS) Robert F. Kennedy Jr. has directed the Food and Drug Administration (FDA) commissioner to explore revisions to the Substances Generally Recognized as Safe (GRAS) pathway that gives food manufacturers authority to “self-affirm” the safety of new ingredients.
“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,” said Kennedy in a March 10 news release. “Eliminating this loophole will provide transparency to consumers, help get our nation’s food supply back on track by ensuring that ingredients being introduced into foods are safe, and ultimately Make America Healthy Again.”
The directive goes under the auspices of Martin Makary, M.D., who was sworn in as FDA Commissioner on April 1.
Safety Assumption
The public was probably unaware of companies’ ability to self-declare ingredient safety, says Peter McCullough, M.D., MPH, a cardiologist and president of the McCullough Foundation.
“I think Americans were alarmed to find out about this GRAS loophole where the companies would present a new ingredient as being generally recognized as safe based on their own assertion,” said McCullough. “Companies are motivated to have a new entry logged with the FDA with the lowest amount of scrutiny possible. We think this is how these ingredients get on the market.”
Eliminating the loophole would require congressional legislation or an administrative change through the rulemaking process. Kennedy should not rely on Congress, says McCullough.
“I have little or no confidence that our U.S. Congress has the best interest of America’s health in mind,” said McCullough. “During the Health and Human Services confirmation hearings, senators had the opportunity to show whether they care about American health, and one after the other they shut down any inquiry. It’s clear the senators were compromised by Big Food and Big Pharma. Americans saw that on full display.”
Chemical-Laden Food
In 1958, an amendment to the federal Food, Drug, and Cosmetic Act required food companies to get premarket approval of substances added to food unless the product was on the GRAS list. In 1997, the FDA streamlined the process to “eliminate the resource-intensive rulemaking procedures” and “replace the GRAS affirmation petition process with a notification procedure,” states a 2018 document on the FDA’s website.
Today, more than 10,000 chemicals are allowed in American food, most of which have not undergone rigorous third-party testing, according to the EWG watchdog group.
A report by Rep. Chip Roy (R-TX) released in January states “the U.S. actively subsidizes foods that are making us sick, to the tune of $30 billion per year,” and “the U.S. science and regulatory structure is littered with conflicts of interest that promote certain foods and guidelines that are influenced by industry ready to profit.”
“Read any package label and one has to have a degree in organic chemistry to try to understand what they’re eating,” said McCullough. “My general understanding is the reason companies use complex, often petroleum-based, chemical products in food is either they are usually less expensive or more efficient in the manufacturing process, particularly adhesives that hold foods together and may extend the shelf life of products.”
Hungry for More
Removing the loophole would be one way to get unsafe additives out of the American food supply, says McCullough.
“An expert review [of a new ingredient] would probably be a sufficient deterrent for companies,” said McCullough. “With this new normal, companies would have to consider using natural products.”
Ensuring ingredient safety is a federal responsibility, says McCullough.
“I think the states just simply couldn’t effect change with the food supply because of the complexities of food distribution, shipping, inspections; all of those processes have to be at a central level,” said McCullough.
States do control some food programs. In Texas, a bill to increase healthy options in the Supplemental Nutrition Assistance Program is making its way through the legislature.
Katy Talento, an epidemiologist, naturopath, and former Trump administration policy advisor, welcomes Kennedy’s directive to remove the GRAS loophole.
“Congress seems wholly beholden to industry interests and the inertia they demand in ways that states do not,” said Talento. “The good news is … the Secretary can fix this through his own authority.”
Out on the Table
“It’s refreshing to see the absolute corruption of the revolving door in the food industry called out so openly,” said Talento. “The regulatory capture must end. These agencies are supposed to be protecting us against the regulated entities. Instead, they protect the companies against us—against public scrutiny and accountability.”
McCullough told Health Care News the Trump administration should drop the last letter of MAHA (Make America Healthy Again) to make it accurate.
“We have never previously had a healthy food culture that I know of,” said McCullough. “In the 1970s, for example, 50 percent of the adult population smoked. Of my patients who are in their 80s or 90s, 50 years ago none were making choices to enhance their health. They got to be 80 or 90 with no personal investment in diet and fitness.”
Ashley Bateman ([email protected]) writes from Virginia.
