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 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.
FDA 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.
FDA Action Levels for Lead in Baby Food (2025)
January 2025: the FDA 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 →FDA Proposal for Front-of-Package Nutrition Labels (2025)
January 2025: the FDA 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 →FDA Revokes Red No. 3 in Food and Ingested Drugs (2025)
January 2025: the FDA 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 →FDA Authorizes the First Nicotine Pouches (2025)
January 2025: the FDA 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Read the full action →Menthol, Flavored Cigar and Nicotine Cap Rules Withdrawn (2025)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2025: the FDA proposed capping nicotine in cigarettes, and the final menthol cigarette and flavored cigar bans were withdrawn from White House review; the cap was later listed as withdrawn too.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 →FDA Ends the Semaglutide Shortage and Compounded Copies (2025)
February 2025: the FDA 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 →FDA Moves on Self-Affirmed GRAS and Chemical Reviews (2025)
March–August 2025: HHS directed FDA to explore ending self-affirmed GRAS, and FDA launched a systematic post-market review program for chemicals already in food.
Read the full action →FDA Plan to Phase Out Petroleum-Based Food Dyes (2025)
April–September 2025: HHS and FDA 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 →FDA Action on Ingestible Fluoride Drugs for Children (2025)
May–October 2025: the FDA reviewed unapproved swallowed fluoride prescription products for children, concluded against use under age 3, and notified marketers of enforcement.
Read the full action →FDA Label Change for Extended-Release ADHD Stimulants Under Age 6 (2025)
June 2025: the FDA required all extended-release ADHD stimulant labels to warn of weight loss and higher side-effect rates in children younger than six.
Read the full action →FDA Moves Against Concentrated 7-OH Kratom Products (2025)
July 2025: the FDA 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 →FDA and USDA Seek a Definition of Ultra-Processed Foods (2025)
July 2025: FDA and 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 →FDA Requires New Opioid Labeling on Long-Term Use (2025)
July 2025: the FDA 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 →FDA 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 FDA blocked the firms and first used its import-certification authority.
Read the full action →FDA Crackdown on Misleading Drug Advertising (2025)
September 2025: the FDA 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 →FDA Starts an Acetaminophen-in-Pregnancy Label Change (2025)
September 2025: the FDA began a label change for acetaminophen in pregnancy and told physicians of a possible autism and ADHD association, causation not established.
Read the full action →FDA Moves to Approve Leucovorin for Cerebral Folate Deficiency (2025)
September 2025: the FDA 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 →FDA Reverses Course: NMN Allowed in Dietary Supplements (2025)
September 2025: the FDA concluded NMN is not excluded from the dietary supplement definition, reversing its 2022 position, because NMN was sold as a supplement first.
Read the full action →Infant Botulism Outbreak Linked to Powdered Formula (2025)
November 2025: FDA and 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 →FDA Requests Removal of Hormone Therapy Boxed-Warning Risks (2025)
November 2025: the FDA asked makers of menopausal hormone therapy to drop heart disease, breast cancer and dementia statements from the boxed warning.
Read the full action →