FDA Actions in 2023
Twenty major actions the U.S. Food and Drug Administration took in 2023 on foods and allergens, supplements and cannabis-derived products, cosmetics, tobacco, mammography, 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 2023 (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.
Sesame Becomes the Ninth Major Food Allergen (2023)
January 2023: under a 2021 law that FDA enforces, sesame became the ninth major food allergen that packaged foods and supplements must declare.
Read the full action →FDA Grants Lecanemab Full Approval for Early Alzheimer's Disease (2023)
January–July 2023: the FDA approved lecanemab under accelerated approval, then converted it to traditional approval after a confirmatory trial showed slower decline in early Alzheimer's.
Read the full action →FDA Says CBD Does Not Fit Food or Supplement Rules and Asks Congress for a New Pathway (2023)
January 2023: the FDA concluded CBD cannot fit the existing food or dietary-supplement rules, denied three petitions seeking a supplement pathway, and asked Congress instead.
Read the full action →FDA Draft Labeling Advice for Plant-Based Milk Alternatives (2023)
February 2023: FDA's draft guidance accepted names like "soy milk" and "almond milk" and proposed voluntary label statements comparing their nutrients with dairy milk.
Read the full action →FDA Restricts Imports of Xylazine, the Animal Sedative in Street Drugs (2023)
February 2023: the FDA put xylazine imports under heightened scrutiny, aiming to stop the veterinary sedative, increasingly found mixed into illicit fentanyl, from reaching illicit markets.
Read the full action →FDA Opens a Public Directory of What It Has Said About Supplement Ingredients (2023)
March 2023: the FDA launched one public directory of supplement ingredients and its actions on each, retiring its rapid-alert advisory list.
Read the full action →FDA Steps to Tighten Infant Formula Safety (2023)
March–September 2023: after the 2022 formula shortage, FDA asked powdered formula makers to report Cronobacter findings, warned three manufacturers and updated its inspection program.
Read the full action →FDA Requires Mammography Reports to Tell Every Patient About Breast Density (2023)
March 2023: the FDA's updated mammography rule required every facility to tell patients whether their breast tissue is dense, in nationally standard wording.
Read the full action →The FDA Begins Carrying Out the 2022 Cosmetics Law: Registration, Product Lists and Injury Reports (2023)
March–December 2023: the FDA built the 2022 cosmetics law's first systems — facility registration, product listing with ingredients, and mandatory serious-injury reporting from December 29.
Read the full action →FDA Approves the First Over-the-Counter Naloxone Nasal Spray (2023)
March 2023: the FDA approved a 4 mg naloxone nasal spray for sale without a prescription, the first opioid-overdose reversal medicine available over the counter.
Read the full action →FDA Withdraws Approval of the Only Drug for Preventing Preterm Birth (2023)
April 2023: the FDA withdrew approval of hydroxyprogesterone caproate injection and its generics for preterm birth after the confirmatory trial failed to show benefit to babies.
Read the full action →FDA Requires New Safety Labeling for All Opioid Pain Medicines (2023)
April–December 2023: the FDA required class-wide label changes for opioid pain medicines, adding an opioid-induced hyperalgesia warning and limits on long and extended-release use.
Read the full action →FDA Requires Updated Boxed Warnings on Prescription Stimulants (2023)
May 2023: the FDA required class-wide updates to the Boxed Warning on prescription stimulants for ADHD, describing misuse, addiction and overdose risks and warning against sharing.
Read the full action →FDA Denies Thousands of Flavored E-Cigarettes and Targets Youth-Appealing Disposables (2023)
May–December 2023: the FDA denied about 6,500 flavored e-cigarette products, warned hundreds of retailers, seized imports, and reported high-school vaping falling from 14.1% to 10%.
Read the full action →FDA Approves the First Nonprescription Daily Birth Control Pill (2023)
July 2023: the FDA approved a norgestrel progestin-only tablet for sale without a prescription, the first daily oral contraceptive available over the counter in the U.S.
Read the full action →FDA Warns That Probiotics Given to Preterm Infants Can Cause Fatal Infections (2023)
September–October 2023: after a preterm infant died of sepsis matched to a probiotic's bacterium, the FDA warned providers and sent warning letters to two sellers.
Read the full action →FDA Investigation of Lead in Cinnamon Applesauce Pouches (2023)
October 2023: FDA warned parents about cinnamon applesauce pouches after children's blood lead rose; the Ecuadorian cinnamon later tested at up to 5,110 ppm lead.
Read the full action →FDA Proposes Revoking Brominated Vegetable Oil (2023)
November 2023: citing new thyroid findings in animals, the FDA proposed revoking the authorization for brominated vegetable oil in drinks, weeks after California's state ban.
Read the full action →FDA Approves Tirzepatide for Chronic Weight Management (2023)
November 2023: the FDA approved tirzepatide, already a type 2 diabetes drug, as a weekly injection for chronic weight management in adults with obesity or overweight.
Read the full action →FDA Investigation of the Cantaloupe Salmonella Outbreak (2023)
November 2023: FDA traced a Salmonella outbreak to imported whole and pre-cut cantaloupe; 407 people fell ill in 44 states, 158 hospitalized, 6 died.
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