FDA

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FDA Narrows Its Romaine Lettuce Warning

Lettuce from outside parts of California not linked to outbreak

(Newser) - The Food and Drug Administration has narrowed its warning not to eat romaine lettuce . The agency now says the only growing areas linked to a recent E. coli outbreak are in the Central Coast region of northern and central California and romaine lettuce grown elsewhere is probably safe, USA Today... More »

Major Restrictions on Flavored E-Cigs Are Coming

FDA plans to rid them from convenience stores, gas stations to protect teens

(Newser) - The expected FDA crackdown on a youth vaping "epidemic" is on the horizon, with the New York Times and Washington Post reporting that most flavoured e-cigarettes will be banned from convenience stores and gas stations across the country as early as next week. Menthol and mint flavors will be... More »

Super-Potent Opioid Wins FDA Approval

Dsuvia will be tightly controlled, the FDA promises

(Newser) - It's called Dsuvia, and the potency of this opioid is hard to fathom: It's up to 1,000 times stronger than morphine and up to 10 times stronger than fentanyl, reports USA Today . Despite the worries of critics that it will add to the nation's opioid problem,... More »

The 'Magic' in 'Shrooms Could Really Help You

New study says it can serve medicinal purposes

(Newser) - Want to quit smoking or alleviate depression? In a few years you might be taking the psychedelic "magic" in magic mushrooms—if the FDA ever agrees, the New York Times reports. Researchers from John Hopkins University suggest the FDA should reclassify psilocybin—the psychedelic drug in hallucinogenic mushrooms—to... More »

FDA May Take Drastic Moves to End Teen Vaping 'Epidemic'

Could ban sales if manufacturers don't comply with new requirement

(Newser) - Youth vaping is an "epidemic," as far as the FDA is concerned, and if manufacturers don't submit "robust" plans to prevent kids from getting their hands on flavored e-cigarettes, the agency will take action—possibly going so far as to order the flavored products off the... More »

New EpiPen Competitor Approved by FDA

Generic alternative should hit the market soon

(Newser) - Parents of children with serious allergies may soon get some relief when shelling out for a epinephrine auto-injector. The FDA has approved a generic alternative to Mylan Pharmaceuticals' widely used EpiPen and EpiPen Jr., reports CNN . While other name-brand injectors exist, this one, produced by Teva, is the first approved... More »

FDA Gives OK to Market Pregnancy- Prevention App

Natural Cycles says its technology is 93% effective, but there has been some controversy

(Newser) - "There's an app for that" is making further inroads in the contraceptives arena. USA Today reports the FDA has approved marketing for the Natural Cycles app, which claims it can help prevent pregnancy by telling a woman what days are best for avoiding sex (marked "red" days)... More »

Tainted Water Blamed for Deadly E. Coli Outbreak

Romaine lettuce outbreak is over, feds say

(Newser) - The worst E. coli outbreak in the US since 2006 is over, with five people dead and more than 200 sickened by tainted romaine lettuce, federal authorities say. The outbreak, which affected people in 36 states and caused at least 96 hospitalizations, was traced to the Yuma region in western... More »

FDA: Teething Remedies Can Have Deadly Side Effects

It wants the products taken off shelves

(Newser) - Federal health officials warned parents Wednesday about the dangers of teething remedies that contain a popular numbing ingredient and asked manufacturers to stop selling their products intended for babies and toddlers. The Food and Drug Administration said that various gels and creams containing the drug benzocaine can cause rare but... More »

Congress Passes 'Right-to-Try' Drug Bill

Law will let terminally ill patients bypass FDA

(Newser) - A "right-to-try" bill that allows terminally ill patients to request medication that hasn't been approved by the Food and Drug Administration has passed Congress and is expected to be signed by President Trump. The bill, which passed the Senate last August, sailed through the House Tuesday with a... More »

FDA Approves Potential Migraine Game-Changer

Monthly injection reduces migraine frequency without major side effects

(Newser) - "Progress, but not a panacea." So proclaims an editorial in journal JAMA on Aimovig, a first-of-its-kind drug purported to prevent chronic migraines without many side effects that was on Thursday approved by the FDA. The drug from Amgen and Novartis, and similar ones in their final stages, "... More »

FDA to E-Cigarette Companies: Stop the Kid-Friendly Packaging

It can lead to accidental ingestion, which can be fatal for children

(Newser) - The Food and Drug Administration is warning companies that make and sell e-cigarette liquid to stop using packaging that appeals to kids after a recent analysis found that more than 8,200 children under the age of 6 were exposed to e-cigarettes or liquid nicotine between January 2012 and April... More »

In a Big First, FDA Issues Mandatory Recall of Kratom

Recalls kratom products due to salmonella outbreak

(Newser) - A Las Vegas company was ordered to pull its herbal supplements off the market because some of its products tested positive for salmonella, part of a nationwide outbreak linked to the ingredient kratom. The Food and Drug Administration said Tuesday that it took the rare step of ordering the recall... More »

FDA Makes 1st Move to Reduce Nicotine in Cigarettes

The goal is 'minimally addictive or nonaddictive' cigarettes

(Newser) - Are nonaddictive cigarettes the future of smoking? The FDA on Thursday made its first move to reduce the nicotine in cigarettes to "minimally addictive or nonaddictive" levels, NPR reports. According to the Washington Post , the FDA was given the power to regulate tobacco in 2009 and first announced plans... More »

FDA Issues Strongest Warning Yet on Kratom

Substance is a dangerous opioid, agency says

(Newser) - Kratom is a deadly opioid, not a safe alternative to opioids or an effective treatment for withdrawal, the Food and Drug Administration said Tuesday in its strongest warning yet against the herbal supplement. The agency said new data shows that the increasingly popular substance has "opioid properties" and has... More »

FDA Warning: 'Bone Treats' Could Kill Your Dog

At least 15 dogs have met that fate

(Newser) - Before you stuff Fido's stocking with edible treats this holiday season, you might want to check the Food and Drug Administration's latest announcement. Per Syracuse.com , the "bone treats" dog owners pick up in the supermarket or pet store could be a health hazard for our four-legged... More »

It's Being Used for Opioid Addiction, but FDA Has Warning

Use of kratom is 'extremely concerning'

(Newser) - The FDA is warning Americans to stay away from kratom, calling its use as an opioid replacement or to treat opioid withdrawals "extremely concerning" and citing 36 deaths connected to the substance, Reuters reports. According to the Verge , kratom is a plant grown in Southeast Asia and used there... More »

Feds Approve Pill With Digital Tracking System

Tiny chip communicates with smartphone app

(Newser) - In an unprecedented step to ensure that patients with mental disorders take the medicine prescribed for them, the Food and Drug Administration has approved the first drug in the United States with a digital ingestion tracking system. The drug Abilify MyCite was developed by Otsuka Pharmaceutical Co., Ltd. Abilify was... More »

It Turns Out Condom Size Has Kind of Been All Wrong

The idea was to make them long enough for almost everyone, and men could roll the excess

(Newser) - Consider these two numbers: 5.57 inches and 6.69. The first is the average erect penile length, according to a study of 1,661 American men . The latter is the minimum length that standard condoms have been required to be. If that seems like a disconnect, well, it is,... More »

Pricey New Cancer Therapy Could Save Thousands

It's the 2nd treatment to turn cells into cancer-killers

(Newser) - The Food and Drug Administration has approved a second "living drug" to fight cancer—a personalized treatment that alters a patient's own cells to turn them into cancer-killers. The new "CAR T-cell therapy" has been approved for non-Hodkins lymphoma patients with few other treatment options, a group... More »

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