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Self-GRAS is flawed, says ANH-USA, but ditching it would create a massive regulatory bottleneck

Robert F. Kennedy Jr.

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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 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.

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 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.

Kennedy, Trump officials propose new scrutiny of food additives and ingredients

Kennedy, Trump officials propose new scrutiny of food additives and ingredients

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Kennedy, Trump officials propose new scrutiny of food additives and ingredients

Kennedy, Trump officials propose new scrutiny of food additives and ingredients

The Controversies

Jr.

Makary

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Oz

O'Neill

Rivers

Cassidy

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