Food and Drug Administration

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FDA Looks Into Low Levels of Concerning Impurity in Zantac

No recall for now, FDA says

(Newser) - The FDA is evaluating the risk to people who take Zantac and its generic versions after a probable carcinogen was found in the heartburn medication. N-nitrosodimethylamine, also known as NDMA, is the nitrosamine impurity detected in low levels, CNN reports. The agency has been investigating such impurities in blood pressure... More »

FDA Unveils Graphic Cigarette Warning Labels

Tobacco companies blocked them once and are expected to try again

(Newser) - If the Food and Drug Administration gets its way, cigarette labels in the US are about to get pretty graphic. The agency has unveiled 13 proposed warning labels that would be prominently featured on cigarette packs and in cigarette advertising if approved, reports CNBC . The labels go beyond warning of... More »

New Treatment for Deadliest Strain of Tuberculosis Is Massively Successful

FDA approves new 3-drug regimen

(Newser) - Good news for those with the deadliest strain of tuberculosis: It no longer has to mean a death sentence. Scientists have discovered a cure for extensively drug-resistant TB, or XDR-TB, and on Wednesday, the FDA "effectively endorsed" it, the New York Times reports. Just a small percentage of people... More »

Despite 10 Years of Warnings, People Still Drink Dangerous 'Cure'

FDA: Taking sodium chlorite products like Miracle Mineral Solution is basically drinking bleach

(Newser) - It's OK to believe in miracles, but drinking bleach for your ailments isn't going to lead to one. That's effectively what people are doing when they quaff a product known as Miracle Mineral Solution, and other products like it that promise a cure for autism, cancer, HIV,... More »

FDA: Data Manipulated Before Approval of $2.1M Drug

Novartis could face civil, criminal penalties

(Newser) - US regulators want to know why Novartis didn't disclose a problem with testing data until after the Swiss drugmaker's $2.1 million gene therapy was approved. The Food and Drug Administration said Tuesday the manipulated data involved testing in animals, not patients, and it's confident that the... More »

First Postpartum Depression Drug: Effective, Cumbersome

Women felt improvement within 24 hours, but need to get it via IV for 60 hours

(Newser) - A groundbreaking treatment has been approved for what doctors say is a major medical condition that doesn't get talked about enough. The FDA has approved brexanolone, the first treatment specifically targeting postpartum depression, which will be sold as "Zulresso," USA Today reports. Doctors say it is much... More »

Birth Control Pills Recalled Due to Critical Packaging Error

Apotex mistake could lead women to miss pills, or to take placebos instead of active tablets

(Newser) - There's nothing wrong with the tablets themselves, but a nationwide recall of birth control pills has been announced by the Food and Drug Administration due to a packaging goof that could cause women to miss pills or take placebos, possibly leading to pregnancy, People reports. The FDA alert notes... More »

Scott Gottlieb Stepping Down From FDA

After almost 2 years leading the agency

(Newser) - Food and Drug Administration Commissioner Scott Gottlieb is stepping down after nearly two years leading the agency's response to a host of public health challenges, including the opioid epidemic, rising drug prices, and underage vaping. Health and Human Services Secretary Alex Azar announced in a statement Tuesday that Gottlieb... More »

FDA: Beware Letting Robots Operate on You

'Survival benefits to patients when compared to traditional surgery have not been established'

(Newser) - On the plus side: Operations performed using minimally invasive robotic devices can help keep blood loss, pain, and infections to a minimum, reduce scarring, and shorten recovery times. On the minus side, per the Food and Drug Administration: Using these devices for mastectomies and other surgeries for cancers hasn't... More »

Amid Increasing Drug Recalls, FDA Focuses on 2 Factories

Agency: Factories in China, India that made blood pressure drugs have equipment, process problems

(Newser) - With the significant number of drugs and drug ingredients made overseas, it's hard for the FDA to provide airtight oversight. But two plants in China and India that pump out oft-prescribed blood pressure and heart medications are now on the agency's radar after FDA tests revealed trace amounts... More »

Shutdown 'Puts US Food Supply at Risk'

FDA has suspended domestic inspections

(Newser) - The government shutdown has put America's food supply at risk despite the best efforts of the Food and Drug Administration, experts warn. The agency has had to suspend routine testing of most domestic food production facilities, though inspections of imports are continuing. Inspectors working without pay are continuing to... 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 »

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 »

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 »

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 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 »

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