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Biden Administration Delays Decision on Menthol Cigarette Ban Amid Pushback

The Biden administration has again delayed enacting a ban on menthol cigarettes following intense lobbying from the tobacco industry.

Along with that pressure, other critics of the ban have warned that it might anger Black smokers, who use menthol cigarettes at far higher rates than whites -- just as President Biden gears up to run for re-election, administration officials told the Wa...

After Salmonella Cases Double in a Week, Cantaloupe Recall Expanded

MONDAY, Nov. 27, 2023 (Healthday News) -- Three more brands of cantaloupe have been recalled by U.S. health officials after salmonella infections linked to the fruit more than doubled in just a week.

The case count now includes nearly 100 people in 32 states, with Arizona, Missouri, Minnesota, Wisconsin and Ohio having the highest number of illnesses reported. Two people have died in Minn...

FDA Looking at Cinnamon as Source of Lead in Fruit Puree Products

FRIDAY, Nov. 17 (Healthday News) -- The U.S. Food and Drug Administration said Friday it has found early evidence that cinnamon may be the source of high levels of lead in fruit puree pouches that have now sickened 34 children.

The agency, in partnership with the U.S. Centers of Disease Control and Prevention, has been investigating illnesses linked to the consumption of Apple Cinnamon Fr...

FDA Moves Against Vape Products That Mimic Toys, Slushies and Appeal to Kids

The U.S. Food and Drug Administration is taking action against e-cigarettes disguised to look like everyday items that appeal to young people.

The FDA sent warning letters Thursday to seven online retailers that were selling unauthorized vape devices that look like drink containers, toys and phones.

The products’ design could appeal to young people and help them conceal e-cigarett...

Babies Are Contracting Salmonella After Handling Pet Food, FDA Warns

FRIDAY, Nov. 10, 2023 (Healthday News) -- Two federal health agencies are investigating a salmonella outbreak linked to dog food that has sickened seven people in seven states, nearly all of them infants.

On Thursday, the U.S. Food and Drug Administration 

  • Robin Foster HealthDay Reporter
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  • November 10, 2023
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    • FDA Approves New Diet Drug Zepbound, a Version of the Diabetes Med Mounjaro

    A second injectable diabetes drug has been approved for weight loss in overweight and obese adults, the U.S. Food and Drug Administration announced Wednesday.

    The weight-loss drug Zepbound contains the same active ingredient, tirzepatide, as the diabetes drug Mounjaro. Both medications are made by Eli Lilly and Co.

    “Obesity and overweight are serious conditions that can be associa...

    FDA Will Pull Vet Drug Used in Pork Industry Over Cancer Concerns for Humans

    WEDNESDAY, Nov. 8, 2023 (Healthday News) -- The U.S. Food and Drug Administration said Tuesday that it plans to pull a veterinary drug used commonly in the pork industry because it might pose a cancer risk to humans wh...

    FDA Investigating Hospitalizations Linked to Counterfeit Ozempic

    The U.S. Food and Drug Administration has received at least three reports of people being hospitalized after taking counterfeit versions of the wildly popular weight-loss drugs known as semaglutides.

    At least one of these reports includes mention of a counterfeit version of the Novo Nordisk medication Ozempic, CBS News reported.

    Ozempic and Wegovy, another semaglutide med...

    FDA Expands Investigation of Pureed Fruit Pouches

    Amid reports of more illnesses and additional product recalls, U.S. health officials have expanded their investigation into potentially lead-tainted pouches of apple cinnamon pureed fruit.

    The U.S. Food and Drug Administration said in an updated alert post...

    Tyson Chicken Nuggets Recalled Over Small Metal Pieces in Product

    Nearly 30,000 pounds of dinosaur-shaped chicken nuggets have been recalled by maker Tyson Foods Inc. after customers discovered small bits of metal in some of the nuggets.

    There has been one reported minor oral injury associated with consumption of the nuggets, which were produced on Sept. 5, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) said in a

    FDA Advisors Say New Gene Therapy for Sickle Cell Disease is Safe

    WEDNESDAY, Nov. 1, 2023 (HealthDay News) -- A new gene therapy for sickle cell disease was deemed safe by a U.S. Food and Drug Administration advisory panel on Tuesday, paving the way for full approval by early December.

    The FDA had already decided that the therapy, known as exa-cel, was effective.

    Developed by Vertex Pharmaceuticals of Boston and CRISPR Therapeutics of Switze...

    FDA Warns WananBana Fruit Puree Pouches May Contain Lead

    TUESDAY, Oct. 31, 2023 (HealthDay News) – Certain pureed fruit pouches from WanaBana may contain dangerous levels of lead, the U.S. Food and Drug Administration has warned.

    Parents and caregivers should not buy or serve WanaBana apple cinnamon fruit puree pouches to children, the agency said in a recent

  • Robin Foster and Cara Murez and Ernie Mundell HealthDay Reporters
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  • October 31, 2023
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    • FDA Warns Eyedrops From Major Brands May Cause Infection

    Federal regulators are warning consumers to stop using eyedrops and gels from several major brands after finding unsanitary conditions in a manufacturing plant.

    Twenty-six eye care products are part of the alert. Contaminated products have the potential to cause eye infection and blindness because drugs applied to the eye can bypass some of the body’s defenses.

    Those concerning th...

    FDA Advisors to Weigh New Gene Therapy for Sickle Cell Anemia

    Patients with sickle cell disease may soon have two new treatments to try.

    On Tuesday, a U.S. Food and Drug Administration advisory committee will weigh the merits of a new gene therapy for the painful, inherited condition, which typically strikes Black people.

    The agency is expected to make a decision on that therapy in early December, and it also plans to decide on a second new tr...

    FDA Proposes Ban on Formaldehyde in Hair Straighteners Over Health Dangers

    The U.S. Food and Drug Administration has proposed a ban on the use of formaldehyde in hair relaxers over concerns about its link to respiratory problems and certain cancers.

    Right now, the FDA only discourages u...

    FDA Moves Closer to Banning Menthol Cigarettes, Flavored Cigars

    A proposed rule from federal regulators that would ban menthol cigarettes and flavored cigars has been sent to the White House Office of Management and Budget for final review.

    The U.S. Food and Drug Administration first announced the

    FDA Warns of Dangers of Compounded Ketamine for Psychiatric Use

    The U.S. Food and Drug Administration is warning consumers about risks of using compounded versions of the drug ketamine, often taken for psychiatric disorders.

    Compounded products are not evaluated by the FDA for safety and effectiveness. They're also not regulated like approved drugs, so they present a greater risk.

    “Although compounded drugs can serve an important medical need ...

    As Menthol Ban Nears, Big Tobacco Is Adding Synthetic Version to Cigarettes Instead

    Cigarette makers are using synthetic menthol substitutes in what appears to be an effort to skirt a looming federal menthol ban, researchers say.

    The menthol flavor appeals to younger and newer smokers, according to investigators at Duke Health in Durham, N.C., and Yale University in New Haven, Conn.

    These new “non-menthol” cigarettes are being introduced in states that have alr...

    FDA Will Begin to Regulate Thousands of Lab Tests

    Faced with growing reports of inaccurate clinical lab tests, the U.S. Food and Drug Administration on Friday announced that it will for the first time regulate these vital diagnostic tools.

    Many Americans might have assumed that the FDA already had oversight of all medical tests; it does not.

    However, FDA Commissioner

  • Ernie Mundell HealthDay Reporter
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  • September 29, 2023
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    • FDA Panel Says No to Experimental ALS Drug

    An advisory panel to the U.S. Food and Drug Administration on Wednesday voted resoundingly against recommending a stem cell-based experimental treatment for ALS.

    Although the FDA isn't bound by the votes of its advisory panels, agency scientists have already penned a scathing review of the drug, called NuOwn.

    Th...

    FDA Adds Warning to Ozempic Label About Risk for Blocked Intestines

    Ozempic, a type 2 diabetes drug that has increasingly been used to help with weight loss, will now be labeled as having the potential to block intestines.

    The U.S. Food and Drug Administration recently made the label update for the drug made by ...

    Pfizer Restarts Production Plant in North Carolina Following Tornado Damage in July

    A Pfizer plant that makes vital drugs, anesthesia and hospital supplies has restarted production after a 10-week shutdown.

    The plant, located in Rocky Mount, N.C., sustained severe tornado damage on July 19, when roofs were ripped off and medications tossed around.

    "This expedited restart is a proud achievement for the Rocky Mount team; however, it is only the first step toward ful...

    Kraft Cheese Slices Recalled Due to Plastic Wrap Choking Hazard

    Kraft Heinz said it is recalling over 83,000 packs of its Kraft Singles American processed cheese slices because of a packaging defect in the plastic that wraps the cheese slices.

    A temporary issue developed on one of the wrapping machines, making it possible for a thin strip of individual film to stay on the cheese slice after the wrapper is removed. Having this film on the cheese could ...

    FDA Must Crack Down on Retailers Selling Tobacco to Teens: Report

    A new government report finds that federal regulators need to do more to help in the battle to keep kids and teens off tobacco.

    Among the report's findings were that the U.S. Food and Drug Administration needs to get tough on retailers selling tobacco to youth and should improve its oversight of online retailers.

    The FDA should also work with the Bureau of Alcohol, Tobacco, Firearm...

    FDA Wants More Data on First Needle-Free Antidote for Severe Allergic Reactions

    In a surprising move, the U.S. Food and Drug Administration (FDA) has opted not to approve a needle-free alternative to the EpiPen for emergency treatment of severe allergic reactions.

    Approval of the Neffy nasal spray was widely anticipated. An FDA advisory panel voted to recommend approval of the drug for children and adults in May. While the FDA is not obligated to follow the advice of...

    Diabetes Drug Maker Sues Over Compounded Versions of Mounjaro

    Another diabetes drug maker is taking legal action against businesses in several states, alleging that they're “fraudulently claiming” that their compounded products are the same as its medication.

    This time, it's Eli Lilly suing certain medical spas, wellness centers and compounding pharmacies over its medication Mounjaro.

    Mounjaro contains the active ingredient tirzepatide an...

    CDC Panel Gives Support to New COVID Booster Shots

    Following on an approval granted Monday by the U.S. Food and Drug Administration, an expert panel from the U.S. Centers for Disease Control and Prevention on Tuesday also signed off on new COVID boosters for Americans.

    Final approval is expected from CDC Director Dr. Mandy Cohen, which would set the stage for the updated vaccines to soon become available.

    The COVID-19 shots from Pf...

    FDA Panel Says Common OTC Decongestant Is Useless

    For decades, sick people have been taking essentially worthless over-the-counter cold remedies to clear their stuffy noses, a key advisory panel for the U.S. Food and Drug Administration said Tuesday.

    The panel voted unanimously that nonprescription oral medications containing phenylephrine -- including Sudafed PE, Vicks Sinex and Benadryl Allergy Plus Congestion -- don't do anything to e...

    FDA Approves New COVID Booster Shots

    The U.S. Food and Drug Administration on Monday gave the green light to new COVID boosters for Americans, setting the stage for the updated vaccines to become available within days.

    The COVID-19 shots from Pfizer and Moderna will join the flu shot and newly approved RSV shots as part of a three-pronged public health strategy to tame the spread of all three viruses this coming winter. The ...

    FDA Approval of New COVID Boosters Could Come by Friday

    New COVID-19 booster shots could soon pass the needed hurdles for vaccinations to begin next week.

    Sources familiar with U.S. Food and Drug Administration plans say boosters could be approved as soon as Friday, NBC News reported.

    The U.S. Centers for Disease Control and Prevention Advisory Committee on Immunization Practices is scheduled to meet on Tuesday. CDC director

    Marijuana Should Be Moved to Lower-Risk Drug Category, U.S. Health Officials Say

    The U.S. Department of Health and Human Services has asked the U.S. Drug Enforcement Agency to reclassify marijuana as a less dangerous drug under the Controlled Substances Act, a move that could potentially expand acceptance of the drug.

    The DEA confirmed receiving an Aug. 29 letter requesting the change and will begin its own review, a spokesperson told Bloomberg News.

    Th...

    Don't Use Dr. Berne's and LightEyez Eye Drops Due to Bacteria, Fungus, FDA Says

    Tainted eye drops are back in the news, with federal regulators warning consumers not to use certain eye drops because of contamination concerns.

    The U.S. Food and Drug Administration on Tuesday

    Don't Use Certain Tests for Pregnancy, Ovulation, UTIs, FDA Warns

    The U.S. Food and Drug Administration has warned that consumers should not use certain pregnancy, ovulation, urine, UTI and breast milk test kits over concerns that the tests may not be safe and effective.

    The tests in question were manufactured by Universal Meditech Inc. (UMI), though they were branded under several names and may not include information about UMI on their packaging, the ...

    Tattoo Regret? Here's Tips on Safely Getting Old 'Ink' Removed

    Whether you got a tattoo on a whim or after much thought, that ink on your body is fairly permanent.

    Tattoo removal is possible, but it comes with risks, according to the U.S. Food and Drug Administration, which regulates tattoo ink and pigment, as well as the laser devices used to remove them. State and local authorities typically oversee tattooing practices.

    The FDA has cleared se...

    FDA Gives Approval to Pill to Ease Postpartum Depression

    The U.S. Food and Drug Administration on Friday approved a new pill, called zuranolone, that may quickly ease severe postpartum depression and help millions of women regain their emotional equilibrium following childbirth.

    Taken as a pill once a day for two weeks, zuranolone (Zurzuvae) showed “rapid, significant and sustained” reductions in depressive symptoms when compared to a place...

    Lawsuit Against Makers of Ozempic, Mounjaro Claim Meds Caused 'Stomach Paralysis'

    A Louisiana woman is suing the makers of two type 2 diabetes drugs used off-label for obesity, saying they failed to adequately warn about the risk of severe stomach problems.

    The lawsuit seeks “very significa...

    Amid Shortages, Federal Agencies Ask Drugmakers to Boost Output of ADHD Meds

    While demand for prescription stimulants is surging, a shortage of the drugs persists, so federal officials have stepped in and asked drug companies to ramp up production of the medications.

    Officials from both the U.S. Food and Drug Administration and the U.S. Drug Enforcement Administration (DEA) made the joint request.

    “The FDA and DEA do not manufacture drugs and cannot requir...

    Pill to Counter Postpartum Depression Looks Good in Trial, May Gain FDA Approval

    All eyes are on the U.S. Food and Drug Administration this week as the agency weighs approval of a new pill that may quickly treat and ease severe postpartum depression.

    Approval of the drug could help millions of women regain their emotional equilibrium following childbirth. The FDA's decision is expected by Friday.

    Taken as a pill once a day for two weeks, zuranolone showed “ra...

    Here's 8 Habits That Could Lengthen Your Life

    Eight healthy habits could add years to your life.

    A new study of more than 700,000 U.S. veterans breaks down the habits that when adopted by middle age, can help someone live substantially longer than folks who don't have these habits.

    These are the big eight:

    • Be physically active.
    • Don't smoke.
    • Don't get addicted to opioids.
    • Don't binge-drink on a...

    Experimental Alzheimer's Drug Slows Thinking Declines in Late-Stage Trial

    Another experimental drug meant to slow the damage of Alzheimer's appears poised to join a growing arsenal of new treatments for this memory-robbing disease.

    In research published online Monday in the Journal of the American Medical Association and presented simultaneously at the Alzheimer's A...

    FDA Approves First Over-the-Counter Birth Control Pill

    The U.S. Food and Drug Administration on Thursday approved the nation's first over-the-counter birth control pill, a move that will likely pave the way for far greater access to contraception for Americans.

    Women will be able to buy the progestin-only oral contraceptive at drug stores, convenience stores and grocery stores, the FDA said. There is no age limit.

    Opill, which is made b...

    FDA Gives Full Approval to Alzheimer's Drug Leqembi

    The U.S. Food and Drug Administration on Thursday gave full approval to the Alzheimer's drug Leqembi, clearing the way for insurance coverage of the pricey drug.

    “The full FDA approval will open the floodgates for people with early Alzheimer's to get this drug. It's a big deal because it's very expensive at $26,500 per year,"

  • Robin Foster HealthDay Reporter
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  • July 6, 2023
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    • FDA Sends Warning to Companies Selling THC Products That Look Like Candy, Cookies

    Several companies are selling copycat food items that have the potential to trick people, including children, into consuming dangerous quantities of cannabis.

    On Wednesday the U.S. Food and Drug Administration and the Federal Trade Commission warned six companies about selling these copycat food products that contain delta-8 tetrahydrocannabinol, also known as delta-8 THC, a substance fou...

    FDA Approves First Blood Test to Predict Preeclampsia in Pregnant Women

    A new blood test approved by the U.S. Food and Drug Administration can predict imminent preeclampsia, helping pregnant women who are at risk of this severe and sometimes deadly form of high blood pressure.

    The test can identify with 96% accuracy which women with sometimes-vague symptoms will develop preeclampsia within the following two weeks, The New York Times reported this wee...

    FDA Approves First Gene Therapy to Treat Duchenne Muscular Dystrophy

    The U.S. Food and Drug Administration on Thursday approved the drug Elevidys, the first gene therapy for the treatment of children with Duchenne muscular dystrophy (DMD).

    The groundbreaking treatment will not be cheap: Drugmaker Sarepta Therapeutics Inc. said it would charge $3.2 million for the one-time IV treatment, the Associated Press reported. Like most medicines in the Unit...

    FDA Approves New Drugs to Treat Type 2 Diabetes in Kids

    The U.S. Food and Drug Administration on Tuesday approved two drugs that have been used in adults with type 2 diabetes for years for use in children aged 10 and up.

    The approvals of Jardiance (empagliflozin) and Synjardy (empagliflozin and metformin hydrochloride) provide a new class of medications for pediatric type 2 diabetes. They join metformin, which has been approved for children wi...

    Novo Nordisk Moves to Stop Businesses From Selling Compounded Versions of Wegovy, Ozempic

    The maker of three popular drugs that treat weight loss and diabetes said Tuesday that it has begun legal proceedings against businesses that are selling compounded versions of its products that are not approved by the U.S. Food and Drug Administration.

    In a sta...

    FDA Advisers Say Next Round of COVID Booster Shots Should  Target an XBB Variant

    An advisory panel to the U.S. Food and Drug Administration voted unanimously on Thursday to recommend that COVID booster shots be updated for the fall to protect solely against one of the three XBB variants that have taken hold in the United States.

    Those three XBB variants, which are all sublineages of the Omicron variant, are XBB.1.5, XBB.1.16 and XBB.2.3, CNN reported. What wi...

    FDA Proposes Tougher Rules for Tattoo Providers to Curb Contaminated Inks

    Regulators want your next tattoo to be as safe as it is trendy.

    The U.S. Food and Drug Administration has issued a draft of new guidance aimed at helping manufacturers and distributors of tattoo inks prevent microbial contamination.

    “Wit...

    FDA Advisers Meet to Decide Next COVID Booster Shot

    COVID-19 boosters may be offered this fall, but first scientists need to determine what strains to target and who should receive the shots.

    Advisers to the U.S. Food and Drug Administration are slated to meet Thursday to discuss plans for fall, a decision with a deadline because drugmakers will need to have the time to manufacture the shots, NBC News reported.

    The process i...