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"This decision protects children, respects families, and rebuilds trust in public health."

"This [2026] decision recommits HHS to all three [transparency, rigorous science, and respect for families]."

"This decision commits NIH, CDC, and FDA to gold standard science, greater transparency, and ongoing reassessment as new data emerge."

"No family will lose access.This [2026] framework empowers parents and physicians to make individualized decisions based on risk, while maintaining strong protection against serious disease."

"The data support a more focused schedule that protects children from the most serious infectious diseases while improving clarity, adherence, and public confidence."

“I think that a reduced schedule is going to endanger children and lay the groundwork for a resurgence in preventable disease.”

“Changing the pediatric vaccine schedule based on no scientific input on safety risks and little transparency will cause unnecessary fear for patients and doctors, and will make America sicker.”

“There will be more diseases, more infection, more hospitalizations.”

Will Secretary Kennedy's US Childhood Vaccine Schedule Overhaul Risk Public Health?

The U.S. Department of Health and Human Services (HHS) on Monday proposed a rule requiring food and dietary supplement manufacturers to notify the Food and Drug Administration (FDA) whenever it determines an ingredient is Generally Recognized as Safe (GRAS), closing decades of voluntary reporting.

The U.S. Department of Health and Human Services (HHS) on Monday proposed a rule requiring food and dietary supplement manufacturers to notify the Food and Drug Administration (FDA) whenever it determines an ingredient is Generally Recognized as Safe (GRAS), closing decades of voluntary reporting.

The GRAS exemption, established by Congress in 1958, was originally intended to cover common ingredients such as vinegar, flour and spices. But over time it became the primary pathway through which new substances entered the U.S. food supply without independent federal review.

The GRAS exemption, established by Congress in 1958, was originally intended to cover common ingredients such as vinegar, flour and spices. But over time it became the primary pathway through which new substances entered the U.S. food supply without independent federal review.

Under the proposed rule, the FDA would review new ingredient submissions within 45 days to confirm they meet legal requirements, and complete a more substantive review within 180 days, during which it may request additional information or determine a substance has not met GRAS criteria.

Under the proposed rule, the FDA would review new ingredient submissions within 45 days to confirm they meet legal requirements, and complete a more substantive review within 180 days, during which it may request additional information or determine a substance has not met GRAS criteria.

Acting FDA Commissioner Kyle Diamantas said that requiring pre-market approval, which would bar companies from introducing ingredients before FDA sign-off, would require Congress to amend the Food, Drug, and Cosmetic Act of 1938, meaning the proposed rule stops short of that standard.

Acting FDA Commissioner Kyle Diamantas said that requiring pre-market approval, which would bar companies from introducing ingredients before FDA sign-off, would require Congress to amend the Food, Drug, and Cosmetic Act of 1938, meaning the proposed rule stops short of that standard.

HHS and the U.S. Department of Agriculture (USDA) also submitted for final review the federal government's first proposed definition of ultra-processed foods, though no timeline or details were released. Kennedy had previously said the definition would be published in April 2026.

HHS and the U.S. Department of Agriculture (USDA) also submitted for final review the federal government's first proposed definition of ultra-processed foods, though no timeline or details were released. Kennedy had previously said the definition would be published in April 2026.

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The U.S. Department of Health and Human Services on Aug. 10 proposed a rule requiring food and dietary supplement manufacturers to notify the FDA whenever they determine an ingredient is Generally Recognized as Safe, or GRAS, closing a decades-old voluntary reporting loophole.

The U.S. Department of Health and Human Services on Aug. 10 proposed a rule requiring food and dietary supplement manufacturers to notify the FDA whenever they determine an ingredient is Generally Recognized as Safe, or GRAS, closing a decades-old voluntary reporting loophole.

The GRAS exemption, established by Congress in 1958, was originally intended to cover common ingredients such as vinegar, flour and spices, but over time became the primary pathway through which new substances entered the U.S. food supply without independent federal review.

The GRAS exemption, established by Congress in 1958, was originally intended to cover common ingredients such as vinegar, flour and spices, but over time became the primary pathway through which new substances entered the U.S. food supply without independent federal review.

Acting FDA Commissioner Kyle Diamantas said requiring pre-market approval — which would bar companies from introducing ingredients before FDA sign-off — would require Congress to amend the Food, Drug, and Cosmetic Act of 1938, meaning the proposed rule stops short of that standard.

Acting FDA Commissioner Kyle Diamantas said requiring pre-market approval — which would bar companies from introducing ingredients before FDA sign-off — would require Congress to amend the Food, Drug, and Cosmetic Act of 1938, meaning the proposed rule stops short of that standard.

The Consumer Brands Association's coalition, Americans For Ingredient Transparency, said it supports "meaningful, science-based modernization" of the GRAS program but argued the most durable path forward is bipartisan congressional action establishing a uniform national framework.

The Consumer Brands Association's coalition, Americans For Ingredient Transparency, said it supports "meaningful, science-based modernization" of the GRAS program but argued the most durable path forward is bipartisan congressional action establishing a uniform national framework.

HHS and USDA also submitted for final review the federal government's first proposed definition of ultra-processed foods, though no timeline or details were released. Kennedy had previously said the definition would be published in April 2026.

HHS and USDA also submitted for final review the federal government's first proposed definition of ultra-processed foods, though no timeline or details were released. Kennedy had previously said the definition would be published in April 2026.

Food companies have exploited the GRAS loophole for decades, quietly slipping untested chemicals into the food supply without telling the FDA. The proposed rule ending self-certification is a landmark shift — mandatory notification means regulators finally know what's entering human food. Closing this gap exposes the approval networks that let corporations declare their own ingredients safe while turning the public into unwitting test subjects.

Food companies have exploited the GRAS loophole for decades, quietly slipping untested chemicals into the food supply without telling the FDA. The proposed rule ending self-certification is a landmark shift — mandatory notification means regulators finally know what's entering human food. Closing this gap exposes the approval networks that let corporations declare their own ingredients safe while turning the public into unwitting test subjects.

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Sean Spicer

Eliminating self-affirmed GRAS would flood the FDA with thousands of submissions, creating a regulatory bottleneck that could take decades to clear and pulling safe ingredients off shelves alongside genuinely harmful ones. The smarter fix is targeted reform — prioritize high-risk substances using toxicity data, post self-GRAS determinations publicly and protect ingredients with 60-plus years of safe use. Blowing up a system that has functioned since 1958 risks spiking food prices and shrinking options for everyday consumers.

Eliminating self-affirmed GRAS would flood the FDA with thousands of submissions, creating a regulatory bottleneck that could take decades to clear and pulling safe ingredients off shelves alongside genuinely harmful ones. The smarter fix is targeted reform — prioritize high-risk substances using toxicity data, post self-GRAS determinations publicly and protect ingredients with 60-plus years of safe use. Blowing up a system that has functioned since 1958 risks spiking food prices and shrinking options for everyday consumers.

Steve Milloy

HHS Proposes Mandatory FDA GRAS Ingredient Reporting

HHS Proposes Mandatory FDA GRAS Ingredient Reporting

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This is the type of great victory for food safety that Kennedy promised. The GRAS loophole for decades has quietly allowed manufacturers to slip untested chemicals into the food supply without telling the FDA. Mandatory notification means regulators will finally know what's entering the food and the public will no longer be used as unwitting test subjects.

This is the type of great victory for food safety that Kennedy promised. The GRAS loophole for decades has quietly allowed manufacturers to slip untested chemicals into the food supply without telling the FDA. Mandatory notification means regulators will finally know what's entering the food and the public will no longer be used as unwitting test subjects.

The GRAS system has functioned well since 1958 and altering it like this risks spiking food prices and shrinking options for everyday consumers. Not to mention, the FDA will be flooded with thousands of submissions, creating a regulatory bottleneck that could take decades to clear. Kennedy seems determined to ruin the U.S. food supply.

The GRAS system has functioned well since 1958 and altering it like this risks spiking food prices and shrinking options for everyday consumers. Not to mention, the FDA will be flooded with thousands of submissions, creating a regulatory bottleneck that could take decades to clear. Kennedy seems determined to ruin the U.S. food supply.

Win McNamee/Getty Images

Win McNamee/Getty Images

HHS Proposes Mandatory FDA GRAS Ingredient Reporting

HHS Proposes Mandatory FDA GRAS Ingredient Reporting

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