U.S. Food and Drug Administration (FDA) Actions in 2025
Twenty major actions the U.S. Food and Drug Administration took in 2025 on foods, color additives, supplements, tobacco and nicotine products, and prescription and over-the-counter drugs. Each page reports the action from the primary documents — the U.S. Food and Drug Administration (FDA) announcement, the Federal Register notice, the order or letter itself — with what it did, what it did not do, and where it stands as of October 2026.
U.S. Food and Drug Administration Actions in 2025 (20)
In date order, oldest first. The stars rate each action's legal weight: ★★★★★ a final action that changes what is sold or labelled nationwide; ★★★★ a proposed rule or order, or a final action of narrower reach; ★★★ a formal safety review or a final guidance; ★★ a request for information or a public meeting.
U.S. Food and Drug Administration Action Levels for Lead in Baby Food (2025)
January 2025: the U.S. Food and Drug Administration finalized lead action levels for packaged foods for children under two: 10 ppb for most, 20 ppb for root vegetables and cereals.
Read the full action →U.S. Food and Drug Administration Proposal for Front-of-Package Nutrition Labels (2025)
January 2025: the U.S. Food and Drug Administration proposed a front-of-package “Nutrition Info box” rating saturated fat, sodium and added sugars Low, Med or High; still not final.
Read the full action →U.S. Food and Drug Administration Revokes Red No. 3 in Food and Ingested Drugs (2025)
January 2025: the U.S. Food and Drug Administration revoked authorization for the dye FD&C Red No. 3 in foods, supplements and ingested drugs; food makers must stop by January 2027.
Read the full action →U.S. Food and Drug Administration Authorizes the First Nicotine Pouches (2025)
January 2025: the U.S. Food and Drug Administration authorized 20 nicotine pouch products for adults 21 and older, the first pouches cleared through the premarket tobacco pathway, with marketing restrictions.
Read the full action →Menthol, Flavored Cigar and Nicotine Cap Rules Withdrawn (2025)
January 2025: the U.S. Food and Drug Administration proposed capping nicotine in cigarettes, and the final menthol cigarette and flavored cigar bans were withdrawn from White House review; the cap was later listed as withdrawn too.
Read the full action →U.S. Food and Drug Administration Ends the Semaglutide Shortage and Compounded Copies (2025)
February 2025: the U.S. Food and Drug Administration declared the semaglutide injection shortage resolved, ending the shortage basis for compounded copies after grace periods closing in April and May.
Read the full action →U.S. Food and Drug Administration Moves on Self-Affirmed Generally Recognized as Safe and Chemical Reviews (2025)
March–August 2025: U.S. Department of Health and Human Services (HHS) directed U.S. Food and Drug Administration to explore ending self-affirmed generally recognized as safe (GRAS), and U.S. Food and Drug Administration launched a systematic post-market review program for chemicals already in food.
Read the full action →U.S. Food and Drug Administration Plan to Phase Out Petroleum-Based Food Dyes (2025)
April–September 2025: U.S. Department of Health and Human Services and U.S. Food and Drug Administration announced a phase-out of petroleum-based food dyes, approved four colors from natural sources and moved to revoke Orange B.
Read the full action →U.S. Food and Drug Administration Action on Ingestible Fluoride Drugs for Children (2025)
May–October 2025: the U.S. Food and Drug Administration reviewed unapproved swallowed fluoride prescription products for children, concluded against use under age 3, and notified marketers of enforcement.
Read the full action →U.S. Food and Drug Administration Label Change for Extended-Release Attention-Deficit/Hyperactivity Disorder Stimulants Under Age 6 (2025)
June 2025: the U.S. Food and Drug Administration required all extended-release attention-deficit/hyperactivity disorder (ADHD) stimulant labels to warn of weight loss and higher side-effect rates in children younger than six.
Read the full action →U.S. Food and Drug Administration Moves Against Concentrated 7-OH Kratom Products (2025)
July 2025: the U.S. Food and Drug Administration warned seven sellers of concentrated 7-OH products and recommended placing 7-OH under the Controlled Substances Act; natural kratom leaf was not targeted.
Read the full action →U.S. Food and Drug Administration and U.S. Department of Agriculture Seek a Definition of Ultra-Processed Foods (2025)
July 2025: U.S. Food and Drug Administration and U.S. Department of Agriculture (USDA) asked the public for data to build the first uniform federal definition of ultra-processed foods; comments closed October 23.
Read the full action →U.S. Food and Drug Administration Requires New Opioid Labeling on Long-Term Use (2025)
July 2025: the U.S. Food and Drug Administration required class-wide safety label changes for opioid pain medicines, adding long-term addiction and overdose risk data and gabapentinoid interaction warnings.
Read the full action →U.S. Food and Drug Administration Response to Cesium-137 in Imported Shrimp and Spices (2025)
August–October 2025: after detecting radioactive cesium-137 in imported frozen shrimp and cloves, the U.S. Food and Drug Administration blocked the firms and first used its import-certification authority.
Read the full action →U.S. Food and Drug Administration Crackdown on Misleading Drug Advertising (2025)
September 2025: the U.S. Food and Drug Administration sent thousands of warning letters and about 100 cease-and-desist letters over drug ads, and announced rulemaking on broadcast risk disclosure.
Read the full action →U.S. Food and Drug Administration Starts an Acetaminophen-in-Pregnancy Label Change (2025)
September 2025: the U.S. Food and Drug Administration began a label change for acetaminophen in pregnancy and told physicians of a possible autism and attention-deficit/hyperactivity disorder association, causation not established.
Read the full action →U.S. Food and Drug Administration Moves to Approve Leucovorin for Cerebral Folate Deficiency (2025)
September 2025: the U.S. Food and Drug Administration re-approved a withdrawn leucovorin tablet application and began relabeling it for cerebral folate deficiency, a folate-transport disorder with autistic features.
Read the full action →U.S. Food and Drug Administration Reverses Course: Nicotinamide Mononucleotide Allowed in Dietary Supplements (2025)
September 2025: the U.S. Food and Drug Administration concluded nicotinamide mononucleotide (NMN) is not excluded from the dietary supplement definition, reversing its 2022 position, because nicotinamide mononucleotide was sold as a supplement first.
Read the full action →Infant Botulism Outbreak Linked to Powdered Formula (2025)
November 2025: U.S. Food and Drug Administration and U.S. Centers for Disease Control and Prevention (CDC) traced a multistate infant botulism outbreak to one brand of powdered formula; it was fully recalled and 48 infants were hospitalized.
Read the full action →U.S. Food and Drug Administration Requests Removal of Hormone Therapy Boxed-Warning Risks (2025)
November 2025: the U.S. Food and Drug Administration asked makers of menopausal hormone therapy to drop heart disease, breast cancer and dementia statements from the boxed warning.
Read the full action →Connections
- U.S. Food and Drug Administration Actions in 2021
- U.S. Food and Drug Administration Actions in 2022
- U.S. Food and Drug Administration Actions in 2023
- U.S. Food and Drug Administration and Regulation
- U.S. Food and Drug Administration Actions in 2026
- Food Dyes
- Food Additives
- Ultra-Processed Foods
- Dangerous Supplements
- Glucagon-Like Peptide-1 Receptor Agonists
- News