FDA Actions in 2021
Twenty major actions the U.S. Food and Drug Administration took in 2021 on toxic elements in baby food, sodium, food safety, supplements, cosmetics, tobacco and e-cigarettes, breast implants, 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 2021 (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 Requires Boxed Warnings on JAK Inhibitors for Heart Events, Cancer, Blood Clots and Death (2021)
September 2021: after a large safety trial, the FDA required boxed warnings on three JAK-inhibitor arthritis medicines for heart events, cancer, blood clots and death.
Read the full action →FDA and FTC Warn Supplement Sellers Claiming to Treat Depression, Infertility and Diabetes (2021)
February–September 2021: the FDA, joined by the FTC from May, warned 25 supplement sellers claiming their products treat depression, infertility or diabetes, calling them unapproved drugs.
Read the full action →FDA Tightens Hand-Sanitizer Oversight and Warns About Vapors and Eye Injuries (2021)
February–November 2021: the FDA set methanol testing for hand-sanitizer alcohol, ended pandemic shortcuts for making sanitizer and warned about vapors and eye injuries.
Read the full action →FDA's Closer to Zero Plan for Toxic Elements in Baby Food (2021)
March–November 2021: after a House report on metals in baby food, FDA launched Closer to Zero to cut lead, arsenic, cadmium and mercury in children's foods.
Read the full action →FDA Warns That Abuse of the Nasal Decongestant Propylhexedrine Causes Serious Harm (2021)
March 2021: the FDA warned that abusing the over-the-counter decongestant propylhexedrine can cause heart and mental health problems or death, and asked makers to consider redesigns.
Read the full action →FDA Decides to End the In-Person Dispensing Requirement for Mifepristone (2021)
December 2021: after reviewing mifepristone's safety program, the FDA decided to end the in-person dispensing requirement for the abortion pill and to require certified pharmacies.
Read the full action →FDA Commits to Banning Menthol Cigarettes and Flavored Cigars (2021)
April 2021: the FDA granted a citizen petition and committed to proposing bans on menthol cigarettes and all flavored cigars, citing youth use and health disparities.
Read the full action →FDA Grants Accelerated Approval to Aducanumab for Alzheimer's Disease (2021)
June 2021: the FDA granted accelerated approval to aducanumab, the first new Alzheimer's disease treatment since 2003; the approval was withdrawn in November 2024.
Read the full action →FDA Sets a Temporary Impurity Limit as Varenicline Recalls Threaten a Shortage (2021)
July 2021: as a nitrosamine impurity forced recalls of the smoking-cessation drug varenicline, the FDA set a temporary higher limit to prevent a shortage.
Read the full action →FDA Asks Statin Makers to Remove the Strongest Warning Against Use in Pregnancy (2021)
July 2021: the FDA asked statin makers to drop the label's strongest warning against use in pregnancy, while still saying most pregnant patients should stop statins.
Read the full action →FDA Denies Its First Flavored E-Cigarettes, Over 946,000 Products (2021)
August–September 2021: the FDA issued its first marketing denial orders for flavored e-cigarettes, more than 946,000 products whose applications lacked evidence of benefit to adult smokers.
Read the full action →FDA Proposes New Rules for Nonprescription Sunscreens Under the Reformed Monograph System (2021)
September 2021: the FDA proposed new rules for nonprescription sunscreens, finding only zinc oxide and titanium dioxide safe and effective and seeking data on twelve others.
Read the full action →FDA Ends the Use of Lead Acetate in Hair Dyes (2021)
October 2021: the FDA lifted a stay and ended lead acetate's approval in progressive hair dyes as of January 2022, citing no safe level of lead.
Read the full action →FDA Authorizes an E-Cigarette for the First Time (2021)
October 2021: the FDA authorized an e-cigarette for the first time — one maker's device and two tobacco-flavored cartridges — while denying ten of its flavored cartridges.
Read the full action →FDA's Voluntary Sodium Reduction Targets for Processed and Restaurant Foods (2021)
October 2021: FDA issued voluntary 2.5-year sodium targets for packaged and restaurant foods, aiming to lower average intake from about 3,400 to 3,000 mg/day.
Read the full action →FDA Traces a Salmonella Outbreak to Imported Whole Onions (2021)
October 2021: FDA traced a Salmonella Oranienburg outbreak — 1,040 illnesses in 39 states — to whole fresh onions from Chihuahua, Mexico; two suppliers recalled them.
Read the full action →FDA Tests Talc Cosmetics for Asbestos and Finds None in 50 Samples (2021)
October 2021: FDA testing found no asbestos in any of 50 samples of talc-containing cosmetics tested in 2021, and the agency planned 50 more for 2022.
Read the full action →FDA Restricts Breast Implant Sales and Requires a Boxed Warning and Patient Checklist (2021)
October 2021: the FDA restricted breast implant sales to providers who review risks with patients, and required a boxed warning and a patient decision checklist.
Read the full action →FDA and EPA Update Their Advice About Eating Fish (2021)
October 2021: FDA and EPA updated their mercury-based fish advice for pregnancy, breastfeeding and children to incorporate the 2020–2025 Dietary Guidelines for Americans.
Read the full action →FDA Proposes New Pre-Harvest Water Rules for Produce Farms (2021)
December 2021: FDA proposed replacing microbial testing rules for pre-harvest farm water with yearly water assessments and faster fixes for hazards from nearby land.
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