FDA considers closing approval loophole

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(The Center Square) - U.S. Food and Drug Administrator Marty Makary called on the agency to close a loophole for companies often used to secure product approval.

Makary, who spoke Thursday in the U.S. Department of Health and Human Services’ National Conference on Women’s Health, called for more extensive research on issues that affect an individual’s microbiome.

Makary said ultraprocessed food intake has a large impact on the microbiome – a group of microbes that exist in and around an individual’s body. He pointed to the Trump administration’s new food pyramid for guidance on the right foods to eat.

Makary said he wants to reduce the “GRAS loophole,” a FDA regulatory pathway that allows food companies to implement additives to bypass traditional regulation by affirming a product is “Generally Recognized as Safe.” This can allow companies to tack on ingredients to a product without FDA approval.

“We are challenging this assumption that a company can self-declare a chemical as safe,” Makary said. “Now it’s used for highly engineered and sometimes addictive food chemicals.”

Makary said the microbiome is a sensitive part of the body, with most microbes located in an individual’s intestines. He said 90% of the body’s serotonin production comes from the microbiome.

Suchitra Hourigan, chief of the clinical microbiome unit at the National Institutes of Health, said there is a vast difference in microbiome exposure for someone born via caesarean section compared to vaginal birth. She said babies born via caesarean section have an increased risk of developing chronic inflammatory disease.

“We’re really working on finding interventions for those babies to change their microbiome trajectories and closer to being born of vaginal delivery,” Hourigan said.

Makary also said opening up conversations about food between patients and doctors is necessary to implement healthcare breakthroughs.

“We never talk to somebody about what they’re eating when we’re treating them,” Makary said. “We really don’t talk to them about what increases general body inflammation or what reduces inflammation.”

Additionally, researchers brought up the prevalence of PFAS – chemicals that can come from nonstick cookware and exist in the body for an individual’s entire life. Hourigan said these chemicals can pass from mothers to children during pregnancy.

Makary called for regulators and scientists to challenge long-held assumptions about medical care. He said researchers should more seriously consider using individual experiences as data points in plotting health research.

Makary also called for duplicative research procedures before offering regulations. He pointed to a study about the effect of aspirin that was recently retracted. He said scientific policies during the COVID-19 pandemic had a drastic effect on global understanding of science and policy regulation.

“The harms of taking aspirin outweigh the benefits of taking aspirin,” Makary said. “We need to understand if our assumptions are correct if you do one study and we are recommending something for everyone in the world."

Makary also pointed to recent concerns about the dangers of using selective serotonin reuptake inhibitors during pregnancy, a product the FDA has been seeking to limit in the Trump administration.

He called for companies to reshore healthcare manufacturing in the United States, instead of depending on foreign nations. He said domestic healthcare manufacturing is necessary in the event of a global pandemic.

“We just got burned five years ago shopping for meds and for [personal protective equipment] in China at the beginning of a pandemic,” Makary said. “We’re taking this very seriously. It’s very important.”

Makary called on consumers to use their demand power to influence regulations throughout the industry. He said consumers should demand limited added sugars and increased access to whole foods.

“We speak with our dollars,” Makary said. “We speak with our feet and our going to shop at the right places.”