FDA Actions in 2022
Twenty major actions the U.S. Food and Drug Administration took in 2022 on infant formula, food chemicals and labels, supplements, tobacco and e-cigarettes, hearing aids, and prescription 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 2022 (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 Warns of Dental Problems With Buprenorphine Dissolved in the Mouth (2022)
January 2022: the FDA required a dental-problems warning for buprenorphine medicines dissolved in the mouth, after 305 reported cases including tooth decay and tooth loss.
Read the full action →FDA Investigation and Recall at a Major Infant Formula Plant (2022)
February 2022: FDA warned parents off powdered formula from one Michigan plant after infant Cronobacter infections; the recall and shutdown triggered a nationwide formula shortage.
Read the full action →FDA Begins Regulating E-Cigarettes Made With Synthetic Nicotine (2022)
March–October 2022: a new law put synthetic-nicotine products under FDA, which set a May deadline, refused over 889,000 products and issued hundreds of warning letters.
Read the full action →FDA Lets NAC Supplements Stay on Shelves While Ruling NAC Is Legally a Drug (2022)
March–August 2022: the FDA confirmed NAC is legally excluded from supplements because it was first approved as a drug, but chose not to enforce against them.
Read the full action →FDA Lowers the Fluoride Limit for Fluoridated Bottled Water (2022)
April 2022: FDA capped added fluoride in bottled water at 0.7 mg/L, down from 0.8–1.7 mg/L, matching the Public Health Service's 2015 tap-water level.
Read the full action →FDA Proposes Banning Menthol Cigarettes and Flavored Cigars (2022)
April 2022: the FDA proposed rules to prohibit menthol as a characterizing flavor in cigarettes and all non-tobacco flavors in cigars, drawing nearly 250,000 comments.
Read the full action →FDA Draft Action Levels for Lead in Juice (2022)
April 2022: under its Closer to Zero plan, FDA proposed lead action levels of 10 ppb for apple juice and 20 ppb for other juices.
Read the full action →FDA Warns Supplement Sellers Over Untested Stimulants and Heart-Disease Cure Claims (2022)
May–November 2022: the FDA warned supplement sellers over pre-workout stimulants such as higenamine and over products claiming to treat heart disease, and launched consumer education.
Read the full action →FDA Approves Tirzepatide, a Dual-Hormone Injection for Type 2 Diabetes (2022)
May 2022: the FDA approved tirzepatide, a once-weekly injection that acts on two gut-hormone receptors, to improve blood sugar control in adults with type 2 diabetes.
Read the full action →FDA Flexibilities to Ease the Infant Formula Shortage (2022)
May–September 2022: during the formula shortage, FDA let safe foreign and domestic formulas onto U.S. shelves case by case, then set compliance deadlines.
Read the full action →FDA Revokes 25 Phthalate and Plasticizer Uses in Food Packaging (2022)
May 2022: FDA removed food-contact authorizations for 23 phthalates and two other plasticizers no longer used, denied a safety petition, and sought data on the rest.
Read the full action →FDA Investigation of Illnesses Linked to Frozen Lentil Crumbles (2022)
June–October 2022: FDA investigated nearly 400 illness reports, many involving the liver, linked to a frozen lentil crumble; its tara flour was later ruled unapproved.
Read the full action →FDA Orders a Leading E-Cigarette Off the Market, Then Pauses Its Own Order (2022)
June–July 2022: the FDA denied marketing for every product of a leading e-cigarette maker over toxicology gaps, then stayed the order twelve days later.
Read the full action →FDA Creates Over-the-Counter Hearing Aids for Adults With Mild to Moderate Hearing Loss (2022)
August 2022: the FDA created a new over-the-counter hearing aid category, letting adults with perceived mild to moderate hearing loss buy without a prescription or exam.
Read the full action →FDA Proposes a New Definition of “Healthy” on Food Labels (2022)
September 2022: FDA proposed rewriting the 1994 "healthy" label claim around food groups and limits on added sugars, saturated fat and sodium.
Read the full action →FDA Approves an Oral Combination Drug for ALS After Two Advisory Meetings (2022)
September 2022: after two advisory meetings, the FDA approved an oral sodium phenylbutyrate–taurursodiol combination for ALS on one 137-patient trial; it was withdrawn in 2025.
Read the full action →FDA's Final Food Traceability Rule (2022)
November 2022: FDA finalized a rule requiring firms handling high-risk foods — fresh-cut produce, eggs, nut butters, cheeses, seafood — to keep tracing records for outbreaks.
Read the full action →FDA Approves Teplizumab to Delay the Onset of Type 1 Diabetes (2022)
November 2022: the FDA approved teplizumab, a 14-day intravenous course that delays the onset of stage 3 type 1 diabetes in high-risk children and adults.
Read the full action →FDA Licenses a Fecal Microbiota Product to Prevent Recurrent C. difficile Infection (2022)
November 2022: the FDA finalized its policy on fecal transplants for hard-to-treat C. difficile and, a day later, licensed a fecal microbiota product to prevent recurrence.
Read the full action →FDA Updates the Label of a Levonorgestrel Emergency Contraceptive on How It Works (2022)
December 2022: the FDA revised a 1.5 mg levonorgestrel emergency contraceptive's labeling, concluding it inhibits or delays ovulation and has no direct effect on implantation.
Read the full action →