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After Baby Formula Scandal, FDA Announces New Unit Focused on Food Safety

Stung by recent food safety scandals -- most notably last year's infant formula shortage, the U.S. Food and Drug Administration announced Tuesday that it is creating a new unit devoted to food safety.

The newly dubbed Human Foods Program will wield wide-ranging powers.

"We’re proposing the creation of a unified, newly envisioned organization, called the Human Foods Program, that ...

FDA Could Ease Blood Donation Rules for Gay Men

Longstanding restrictions on blood donations from gay or bisexual men could soon shift towards a more nuanced policy, where such men are asked about sexual partners and practices instead, the U.S. Food and Drug Administration announced Friday.

Specifically, gay men who are in monogamous relationships will no longer be required to abstain from sex for any period of time before donating to ...

FDA Says No to Regulating CBD Products as Supplements

The U.S. Food and Drug Administration said Thursday it can't regulate CBD supplements because there isn't enough evidence on their safety. The agency also called on Congress to create new rules for what has become a burgeoning industry.

"The use of CBD raises various safety concerns, especially with long-term use," FDA Deputy Commissioner

  • Cara Murez and Robin Foster HealthDay Reporters
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  • January 27, 2023
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  • Updated Booster Shots, Not Original COVID Vaccines, Should Be Standard: FDA Panel

    The U.S. Food and Drug Administration's vaccine advisory panel on Thursday voted unanimously to recommend that the agency phase out original versions of COVID vaccines for use in the unvaccinated, in favor of updated bivalent booster shots.

    Committee members also weighed a proposal to streamline the dosing schedule for COVID vaccines by turning them into annual shots that would likely be ...

    Top FDA Official Involved in Baby Formula Debacle Resigns

    A U.S. Food and Drug Administration official who has led the agency’s food policy efforts since 2018 announced his resignation on Wednesday.

    Frank Yiannas was also among the top officials leading the agency response to last year’s infant formula shortage.

    "Today, I informed [FDA] Commissio...

    FDA Wants to Lower Lead Levels in Baby Food

    The U.S. Food and Drug Administration has proposed stricter limits on levels of lead in infant food products.

    The agency announced draft guidance for manufacturers that would lower allowable lead levels in processed foods meant for infants and children 2 years and younger.

    The change could reduce dietary exposure to lead, which can cause neurological and developmental harm, the FDA ...

    U.S. Proposes to Make COVID Shot Annual, Much Like Flu Shot

    The U.S. Food and Drug Administration on Monday asked its vaccine advisory panel to weigh a proposal to turn COVID vaccines into an annual shot for most Americans.

    The committee will weigh the proposal at its Jan. 26 meeting.

    Such a move would simplify future vaccination efforts, a critical point given the fact that efforts to get people to get COVID booster shots have fallen far sh...

    New USDA Rules Ramp Up Oversight of Organic Food

    FRIDAY, Jan. 20, 2023 (HealthDay News) – Organic food will soon have to comply with stricter labeling rules under new requirements announced Thursday by the U.S. Department of Agriculture (USDA).

    In what the Organic Trade Organization (OTA) called the biggest change since the USDA’s organic program was first founded in 1990, the

  • Cara Murez HealthDay Reporter
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  • January 20, 2023
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  • FDA Approves New 2-Drug Combo Medicine for Asthma

    Adults with asthma now have a new rescue medication to turn to after the U.S. Food and Drug Administration approved Airsupra on Wednesday.

    The drug is the first approved to combine albuterol (a beta-2 adrenergic agonist) and budesonide (a corticosteroid).

    It's mea...

    FDA Approves Second Alzheimer’s Drug, Despite Safety Concerns

    The U.S. Food and Drug Administration on Friday approved a second Alzheimer's drug, lecanemab, despite reports of rare brain bleeds linked to use of the drug in some patients.

    However, the FDA pointed to the drug's benefits, as well.

    “Alzheimer’s disease immeasurably incapacitates the lives of those who suffer from it and has devastating effects on their loved ones,” Dr. Bill...

    Patients, Doctors Await FDA Decision on Experimental Alzheimer’s Drug

    Lecanemab: It's an experimental medication that's been shown in trials to slow cognitive decline in people with Alzheimer’s disease.

    It's also up for accelerated approval by the U.S. Food and Drug Administration, with a decision expected by Jan. 6.

    However, the drug has also been linked to two deaths from brain bleeds among people who’ve used it in trials, so safety concerns c...

    Drug Approved to Help Young Patients Battle a Rare Cancer

    Children and adults with a rare type of soft tissue cancer will now have a new treatment option that could have a big impact.

    The U.S. Food and Drug Administration has approved the immunotherapy drug atezolizumab (Tecentriq) for use in p...

    Congressional Report Slams FDA, Drugmaker Over Approval of Alzheimer's Drug Aduhelm

    The U.S. Food and Drug Administration's approval process for the controversial Alzheimer's drug Aduhelm was "rife with irregularities," despite lingering doubts about the power of the pricey medication to slow the disease down, a Congressional report released Thursday claims.

    Actions the agency took with Biogen, maker of Aduhelm, "raise serious concerns about FDA's lapses in protocol," th...

    Buyer Beware: Bogus Flu Meds Are Out There

    With flu rampant in the United States, the U.S. Food and Drug Administration is warning consumers to be wary of over-the-counter products that promise to cure you of influenza, prevent it or reduce its severity.

    Sellers offering these products may make claims that are not accurate or safe, the FDA cautions.

    "These products can be found online, including popular marketplac...

    Tough New Labeling Law for Sesame Prompts Companies to Add It to Their Products

    Call it a good idea that seems to have backfired: A tough new labeling law that requires even the smallest amount of sesame be listed on food products has instead spurred some companies to add it to their products.

    The new federal law goes into effect on Jan. 1, adding sesame to the list of major al...

    FDA's Tobacco Unit Overloaded and Lacking Direction, Panel Says

    The U.S. Food and Drug Administration's tobacco unit is “reactive and overwhelmed,” an expert panel reviewing its work reported Monday.

    In addition, the panel blamed the FDA's inconsistent regulation efforts for the spread of unauthorized e-cigarettes that are appealing to teens, among other problems.

    Commissioned by FDA chief

  • Cara Murez HealthDay Reporter
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  • December 20, 2022
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  • FDA Approves Gene Therapy for Tough-to-Treat Bladder Cancer

    Patients with a high-risk bladder cancer now have a new option to treat it.

    The U.S. Food and Drug Administration on Friday approved a gene therapy called Adstiladrin, which is designed to work for patients who have what's called high-risk non-muscle-invasive bladder cancer (NMIBC) that hasn't responded to the standard treatment, Bacillus Calmette-Guérin (BCG), but hasn't spread. BCG is ...

    Cats Now Have an FDA-Approved Pill to Treat Their Diabetes

    Owners whose cats have diabetes now have a new option to care for the condition in their otherwise healthy pets.

    The U.S. Food and Drug Administration on Thursday approved the first pill to improve control of diabetes in some cats.

    The drug, call...

    FDA OKs Bivalent COVID Boosters for Kids 6 Months and Older

    The updated bivalent COVID-19 boosters are now approved for use in children as young as 6 months of age, the U.S. Food and Drug Administration announced today.

    Children can receive either a Moderna or Pfizer-BioNTech bivalent booster shot, although the rules differ depending on their age and what type of vaccine they got as their primary series, the FDA said.

    Kids 6 months to 5 year...

    Lasik Surgery Should Carry Warnings of Possible Complications, FDA Says

    Lasik eye surgery is a common vision-correcting procedure that many Americans view as safe and effective, but the U.S. Food and Drug Administration has now drafted guidance that warns of potential complications.

    Although many patients are happy with the results after surgery, the recommended new guidance says complica...

    Is a Ban on Menthols Enough to Thwart Big Tobacco?

    A proposed U.S. federal ban on menthol cigarettes doesn't go far enough and needs to include other menthol products, from pipe tobacco to cigarette tubes, researchers say.

    New evidence shows both the appeal and the addiction potential of these substitutes in adults who smoke menthol cigarettes, said scientists from Rutgers University Center for Tobacco Studies in New Brunswick, N.J., and...

    FDA's Food Safety Program Needs a Revamp: Panel

    The U.S. Food and Drug Administration's foods program is in “constant turmoil” and needs stronger leadership, a panel said Thursday.

    The Reagan-Udall Foundation, a group with close ties to the FDA, released a 51-page report Tuesday noting the need for a clear mission in the program ...

    Banning Flavored Vapes Didn't Spur Folks to Quit

    When the U.S. Food and Drug Administration banned fruit-flavored vaping products in early 2020, the idea was to reverse the rapid rise in electronic cigarette use among youths.

    Now, a new survey of adult e-cigarette users finds that instead of quitting e-cigarettes, most vapers switched to flavored products not covered by the ban, or even went back to smoking traditional ciga...

    Pfizer Asks FDA to Approve Tweaked COVID Booster as Third Shot for Kids Under 5

    Infants and young children could soon receive an updated COVID-19 vaccine as part of their three-dose series.

    Pfizer Inc. on Monday asked the U.S. Food and Drug Administration to have the vaccine that targets the Omicron subvariants BA.4 and BA.5 replace the third dose in the series for children aged 6 months through 4 years old. Children in that age group would still receive two doses o...

    First FDA-Approved Fecal-Based Treatment Helps Fight a Tough Superbug

    The U.S. Food and Drug Administration on Wednesday approved the first fecal microbiota treatment, aimed at helping adults battling tough-to-treat Clostridium difficile (C. diff) infections.

    "Today's approval of Rebyota is an advance in caring for patients who have recurrent C. difficile infection [CDI]," said

  • Cara Murez HealthDay Reporter
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  • December 1, 2022
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  • FDA Moves to Ease Restrictions on Gay Men Giving Blood

    U.S. Food & Drug Administration policies that have limited blood donations from men who have sex with men may soon ease.

    At the moment, FDA policy does not allow blood donation from men who have had sex with other men in the past three months. That's already a shorter timeframe than in the past, when the agency required a one-year gap.

    The agency is now considering switching to ques...

    Berry Good for You: Some Foods Can Strengthen Your Brain

    Eating more berries and drinking tea may help slow mental decline as you age, new research suggests.

    In a study of more than 900 adults, researchers found that foods like these -- containing antioxidant flavonols -- delivered brain benefits to older adults. Flavonols are found in fruits like berries, green leafy vegetables, tea and wine.

    For example, people who ate a serving o...

    A Gene Therapy for Hemophilia That Costs $3.5 Million Gets FDA Approval

    People with one form of the genetic blood disorder hemophilia now have a one-time treatment with a $3.5 million price tag.

    The U.S. Food and Drug Administration approved the new gene therapy Hemgenix on Nov. 22. Soon after, drugmaker CSL Behring revealed its cost.

    The company said its drug would ultimately reduce health care costs because patients with the genetic disorder would ne...

    FDA Approves First Drug to Delay Onset of Type 1 Diabetes

    The U.S. Food and Drug Administration on Thursday approved the first drug that could delay the development of type 1 diabetes (T1D).

    Teplizumab (Tzield) targets the autoimmune issues that drive the disease, rather than its symptoms, making the medication a game changer.

    “Today's approval of a first-in-class therapy adds an important new treatment option for certain at-risk patient...

    Using an Online Pharmacy to Buy Meds? It's Buyer Beware, FDA Says

    It might be tempting to buy prescription medication online, but buyers should beware, the U.S. Food and Drug Administration warns.

    While some pharmacy websites operate legally and can offer convenience, privacy and lower costs, others may be selling unapproved, counterfeit and unsafe medications, the

  • Cara Murez HealthDay Reporter
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  • November 18, 2022
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  • FDA Approves First Lab-Grown Meat Product

    Americans could soon be eating chicken that's grown in a lab from cultured animal cells, rather than raised at a farm or facility.

    The U.S. Food & Drug Administration announced Wednesday that the environment-friendly chicken made by California-ba...

    FDA Moves Toward Making Overdose Antidote an Over-the-Counter Drug

    The U.S. Food and Drug Administration appears poised to approve certain naloxone products for over-the-counter use, a move that would help fight the nation's opioid epidemic.

    Naloxone (Narcan, Evzio) can save lives when administered soon after the first signs of an overdose from opioids such as heroin, fentanyl, oxycodone or morphine.

    On Tuesday, the FDA

  • Cara Murez HealthDay Reporter
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  • November 16, 2022
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  • FDA Warns of Animal Tranquilizer in Illicit Drugs

    The U.S. Food and Drug Administration on Tuesday warned health care workers to look out for patients who may have been exposed to a potentially deadly animal sedative, possibly through illicit drug use.

    The veterinary medication xylazine is sometimes added to fentanyl, heroin or other drugs, after either being diverted from the legal animal supply or illicitly produced, the FDA said.

    ...

    FDA Warns of Amoxicillin Shortage

    It could be harder to fill a prescription for the widely used antibiotic amoxicillin because of a shortage that appears to be linked to an ongoing surge in RSV infections across the United States.

    Supplies of amoxicillin oral solution, which is typically used in children, are low, the U.S. Food and Drug Admin...

    What Parents Need to Know About Cronobacter Bacteria in Baby Formula

    Cronobacter sakazakii has been in the news as the cause of infant infections and the reason for a U.S. baby formula recall and resulting shortage this year.

    Infections are rare and the bacteria is harmless for most people. Yet it can be dangerous or even life-threatening for infants, especially those who ar...

    Dove, Tresemme Dry Shampoos Recalled Due to Possible Carcinogen

    Unilever announced Monday that it has recalled certain dry shampoo sprays because they may contain elevated levels of benzene.

    The propellant used in the products, which are sold under the brand names Dove, Nexxus, Suave, TIGI (Rockaholic and Bed Head) and TRESemmé, appears to be the source ...

    FDA Panel Votes for Removal of Drug Meant to Prevent Preterm Births

    A U.S. Food and Drug Administration advisory committee on Wednesday voted to recommend that a controversial drug meant to prevent premature births be pulled from the market.

    FDA officials have said they want to withdraw...

    FDA, Company Square Off in Hearing Over Drug Meant to Prevent Preterm Births

    In a three-day hearing that began Monday, a U.S. Food and Drug Administration advisory committee will give the maker of a drug meant to prevent premature births a chance to show why its drug should not be pulled off the market.

    FDA officials have

  • Cara Murez
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  • October 17, 2022
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  • FDA Approves New Bivalent COVID Booster for Use in Children

    The new bivalent COVID-19 booster is now approved for children as young as 5 years old, the U.S. Food and Drug Administration announced Wednesday.

    The bivalent booster shot includes one part that protects against the original strain of the COVID-19 coronavirus, and another part that targets the hi...

    FDA Approves New ALS Drug Despite Uncertain Data

    The U.S. Food and Drug Administration on Thursday gave its approval to a new drug for ALS (amyotrophic lateral sclerosis), also known as Lou Gehrig's disease.

    But appro...

    Less Salt, More Whole Grains: FDA Updates Food Label Definition of 'Healthy'

    Salmon can't be labeled a "healthy" food under existing federal regulations, because it contains high levels of fat.

    But sweetened cereals can bear the "healthy" label on their packaging if they tick specific boxes related to individual nutrients -- even though they might be loaded with added sugars.

    These contradictions fly in the face of modern nutrition science and common sense,...

    Nutrition Labels to Move to Front of Packaging Under Biden Plan

    To help consumers ascertain the nutritional value of foods more easily, the Biden administration said Tuesday it will propose putting nutrition labels on the front of packaging instead of on the back.

    The proposal will be paired with an update on criteria for wha...

    FDA Warns of Cybersecurity Risk With Certain Medtronic Insulin Pumps

    The U.S. Food and Drug Administration is warning patients who use a particular insulin pump system that unauthorized people could access it and change how much insulin a patient receives.

    The pump at the center of the FDA alert is the Medtronic MiniMed 600 Series Insulin Pump S...

    FDA Approves Botox Competitor That Lasts Longer

    People wanting to keep wrinkles at bay will soon have a new option now that the U.S. Food and Drug Administration has approved the first competitor for Botox in decades.

    Daxxify, made by Revance Therapeutics Inc. in Nashville,...

    Dogs Have Died After Licking a Common Chemotherapy Cream, FDA Warns

    Your dog may like to lick your hand or face, but if you're using a chemotherapy cream that treats certain skin conditions, you should not allow it, the U.S. Food and Drug Administration advises.

    The medication fluorouracil is fatal to dogs when ingested. People who keep the cream on a nightstand or counter sh...

    CDC's Expert Panel OKs Omicron-Specific Booster Shots From Pfizer, Moderna

    A vaccine advisory panel to the U.S. Centers for Disease Control and Prevention voted on Thursday to recommend updated boosters from Pfizer and Moderna that target Omicron variants, paving the way for the shots to get into American arms within days.

    All that is needed now is for CDC Director Dr. Ro...

    FDA Warns of Dangers From Skin Lightening Creams

    Skin lightening products can be dangerous for consumers when they contain harmful ingredients that are illegal for over-the-counter sales, the U.S. Food and Drug Administration warned Wednesday.

    The potentially harmful ingredient...

    FDA Approves Omicron-Specific Booster Shots From Pfizer, Moderna

    The U.S. Food and Drug Administration on Wednesday gave the green light to updated COVID booster shots from both Pfizer and Moderna that target Omicron variants, paving the way for the shots to get into American arms within a few days.

    “The FDA has been planning for the possibility that the composit...

    Could Black Tea Lengthen Your Life?

    A cup of tea can soothe your spirit, but drinking a couple of cups each day may also lower your chances of dying early, new research suggests.

    In the study of nearly 500,000 men and women who took part in the U.K. Biobank, researchers found that compared with people who didn't drink tea, those who drank two or more cups a day lowered their risk of dying by 9% to 13%. And it made no differ...

    Thousands of U.S. Patients Got COVID Treatments Rejected as Useless by FDA

    U.S. doctors administered more than 150,000 doses of useless monoclonal antibody treatments to COVID-19 patients early this year, spending loads of cash on therapies that had been deemed of no benefit, a new study has found.