Better FDA Act of 2025 | ChamberLight

IN COMMITTEE· 119TH CONGRESS

Senate BillS 3122Health

Better FDA Act of 2025

INTRO NOV 6· LAST ACTION NOV 6

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WHAT THE BILL DOES

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This bill matters because it addresses a long-standing practice in the food industry where companies can self-certify certain ingredients as "Generally Recognized As Safe" (GRAS) without direct FDA review or notification. This means many ingredients currently in our food have not been formally evaluated by the FDA.

If this bill becomes law, it would close that loophole, making it mandatory for companies to notify the FDA about these GRAS ingredients and for the FDA to maintain a public list. This could lead to greater transparency about what's in our food and give the FDA more explicit authority to monitor and potentially question the safety of these substances. Without this bill, the current system of voluntary notification and self-certification for GRAS substances would continue, meaning many ingredients would remain on the market without direct FDA acknowledgement or a publicly accessible record of their use.

KEY PROVISIONS

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PROVISION 01

Requires food manufacturers to notify the FDA about all "Generally Recognized As Safe" (GRAS) substances they use, rather than allowing voluntary notification.

This closes a long-standing loophole that allowed many food ingredients to enter the market without the FDA's direct knowledge or formal review.

PROVISION 02

Establishes a new requirement that after two years, any GRAS substance not on a public FDA list or under active FDA review will be considered unsafe.

This provision creates a strong incentive for companies to comply with the new notification requirements, as non-compliant substances would make food "adulterated."

PROVISION 03

Mandates the FDA to create and maintain a publicly accessible list of all GRAS food substances.

This increases transparency for consumers, allowing them to see which GRAS substances are in their food and have been acknowledged by the FDA.

PROVISION 04

Sets a 180-day deadline for the FDA to respond to a GRAS notification; if no response, the substance is automatically added to the public list.

This ensures the FDA acts efficiently on notifications and prevents companies from being indefinitely held up, while also providing a default path for inclusion.

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ACTION TIMELINE

2 EVENTS

NOV 6

Introduced in Senate

INTROREFERRAL

NOV 6

Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

INTROREFERRAL

BILL INFO

TypeSenate Bill

NumberS 3122

Congress119th

StatusIn Committee

IntroducedNov 6, 2025

Last actionNov 6, 2025

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IN COMMITTEE· 119TH CONGRESS · HEALTH, EDUCATION, LABOR, AND PENSIONS COMMITTEE · INTRODUCED NOV 6, 2025

Senate BillS 3122Health

Better FDA Act of 2025

INTRODUCED NOV 6, 2025· LAST ACTION NOV 6, 2025

PASSAGE CHANCES

—%

READING

10 min

COSPONSORS

COMPLEXITY

Moderate

Call my reps Congress.gov

LEGISLATIVE PROGRESS

STEP 2 OF 8

Introduced

In Committee

Reported

Passed Senate

Passed House

Conference

To President

Became Law

Introduced
In Committee
Reported
Passed Senate
Passed House
Conference
To President
Became Law

WHAT THE BILL DOES

AI-written

KEY PROVISIONS

AI-extracted

high

Requires food manufacturers to notify the FDA about all "Generally Recognized As Safe" (GRAS) substances they use, rather than allowing voluntary notification.

This closes a long-standing loophole that allowed many food ingredients to enter the market without the FDA's direct knowledge or formal review.

high

Establishes a new requirement that after two years, any GRAS substance not on a public FDA list or under active FDA review will be considered unsafe.

This provision creates a strong incentive for companies to comply with the new notification requirements, as non-compliant substances would make food "adulterated."

med

Mandates the FDA to create and maintain a publicly accessible list of all GRAS food substances.

This increases transparency for consumers, allowing them to see which GRAS substances are in their food and have been acknowledged by the FDA.

med

Sets a 180-day deadline for the FDA to respond to a GRAS notification; if no response, the substance is automatically added to the public list.

This ensures the FDA acts efficiently on notifications and prevents companies from being indefinitely held up, while also providing a default path for inclusion.

DEADLINES & DATES

AI-extracted

An AI model extracted this from the bill’s official record and can make mistakes. Check the official text ↗ (opens in new tab)

2 years after enactment of the Better Food Disclosure Act of 2025

Food substance generally recognized as safe (GRAS) will be deemed unsafe unless on a public list or under review.

Not later than 2 years after enactment of the Better Food Disclosure Act of 2025

Deadline for food substances already in interstate commerce and considered GRAS to file notice with the FDA.

Not later than 120 days before the first use

Deadline for food substances first used in food after enactment to file notice with the FDA.

Not later than 2 years after the date of enactment of the Better Food Disclosure Act of 2025

Deadline for the Secretary to promulgate regulations to establish and maintain a publicly accessible list of GRAS food substances.

Not later than 180 days after receiving a notice

Deadline for the Secretary to add a GRAS substance to the list or make a preliminary exclusion determination after receiving a notice.

Not later than 180 days after issuance of a preliminary or removal determination

If a substance is excluded or delisted, deadline for a person using it to submit a reconsideration request, food additive petition, or phase-out plan.

PENALTIES & ENFORCEMENT

AI-extracted

An AI model extracted this from the bill’s official record and can make mistakes. Check the official text ↗ (opens in new tab)

TYPE	AMOUNT	WHO
administrative	The food substance will be deemed unsafe and the food containing it will be deemed adulterated under existing Federal Food, Drug, and Cosmetic Act provisions (Section 402(a)(2)(C)), which can lead to regulatory actions like seizure, injunctions, or recalls.	Any person or company using a GRAS substance that is not included on the FDA's public list or is under review for exclusion.

GLOSSARY

AI-written

Generally Recognized As Safe (GRAS): Refers to a food substance whose use is generally recognized among qualified experts as safe under the conditions of its intended use. Historically, these substances could be used in food without formal FDA approval, based on scientific evidence or common use prior to 1958.
Federal Food, Drug, and Cosmetic Act (FD&C Act): The foundational law granting the Food and Drug Administration (FDA) authority to oversee the safety of food, drugs, medical devices, and cosmetics.
Food Additive: Any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food, unless it is a GRAS substance, a pesticide, or a color additive, among other exceptions. Food additives require premarket approval from the FDA.
Adulterated Food: Food that is considered impure, unsafe, or unhealthy under the law. Selling adulterated food is illegal and can lead to its seizure, product recalls, or other legal actions.
Secretary: Refers to the Secretary of Health and Human Services, who oversees the Food and Drug Administration (FDA).
Interstate Commerce: Refers to commercial trade, transactions, or transportation of goods and services that crosses state lines, making it subject to federal regulation.

ACTION TIMELINE

2 EVENTS

NOV 6, 25

Introduced in Senate

INTROREFERRAL

NOV 6, 25

Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

INTROREFERRAL

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Health, Education, Labor, and Pensions CommitteeReferred

Nov 6, 2025

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Better FDA Act of 2025

LEGISLATIVE PROGRESS

WHAT THE BILL DOES

KEY PROVISIONS

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ACTION TIMELINE

BILL INFO

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Discussion

Better FDA Act of 2025

LEGISLATIVE PROGRESS

WHAT THE BILL DOES

KEY PROVISIONS

DEADLINES & DATES

PENALTIES & ENFORCEMENT

GLOSSARY

ACTION TIMELINE

SPONSORS

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