FDA

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This Drug Just Got the FDA's OK—and an $89K Price Tag

Marathon Pharmaceuticals to sell deflazacort for $89K

(Newser) - A drug sold for years overseas to treat a rare form of muscular dystrophy was OKed Thursday by the FDA to be sold in the US, but it comes at a high price. The Wall Street Journal reports the now-FDA-approved deflazacort will be offered by Marathon Pharmaceuticals for $89,000... More »

Don't Let Your Pets Near This Skin Cream

Fluorouracil killed 5 dogs who ate it: FDA

(Newser) - A skin cream used to prevent and treat skin cancer should be kept far away from pets after five dogs ate some and died, FDA officials warn. In one case, two dogs simply punctured a tube of fluorouracil—which kills fast-growing cells, including cancer cells, and is sold as Carac,... More »

FDA: Sorry, Camel Milk Is No Miracle Cure

California company gets a warning to tone down claims

(Newser) - One of the latest, pricey health fads is camel milk, and the FDA has made clear that it's none too pleased. That's because California company Desert Farms has been boasting that its product can cure (or at least mitigate) all kinds of ailments, from allergies to Crohn's... More »

FDA Bans Its Second Medical Device Ever

Powdered medical gloves have long been associated with allergies, inflammation

(Newser) - The Food and Drug Administration has banned only the second medical device ever, and it's sort of an unlikely one: powdered medical gloves. Powder has for decades been added to (now a small minority) of latex medical gloves to help healthcare workers put them on and remove them more... More »

GMO Spuds Could Fend Off Another Irish Potato Famine

USDA OKs JR Simplot varieties that include resistance to late blight

(Newser) - Two potato varieties genetically engineered to withstand the bacteria that caused the Irish potato famine could soon be heading to dinner tables. The Department of Agriculture has approved planting of JR Simplot's Ranger Russet and Atlantic varieties of Innate potatoes, reports the AP . The potatoes—which have only potato... More »

Parents Warned to Avoid This Type of Baby Teething Product

FDA says homeopathic tablets, gels may cause medical issues in babies

(Newser) - New parents will do almost anything to relieve their little ones' teething pain—but one thing the FDA says they shouldn't do is give their babies homeopathic teething products, Live Science reports. In a Sept. 30 statement , the FDA warns these "natural" tablets and gels found in some... More »

In 'Perplexing' Move, FDA Approves First Muscular Dystrophy Drug

Drug is controversial, not clear how effective it is

(Newser) - Federal regulators on Monday granted tentative approval to the first drug for muscular dystrophy, following an intense public campaign from patients and doctors who pushed for the largely unproven medication, the AP reports. The approval came despite an internal dispute among Food and Drug Administration officials that ultimately had to... More »

A Banned Chemical May Lurk in Your Toothpaste

Critics question FDA’s decision to forbid triclosan in soap but not in toothpaste

(Newser) - The FDA last week banned the use of a chemical from soap, but not from the nation’s top-selling toothpaste. Why? The New York Times reports it was because Colgate-Palmolive convinced the FDA that the benefits of triclosan are greater than the risks. Toothpaste containing the chemical "demonstrated to... More »

Popular Herbal Supplement Will Be Classified Like LSD

DEA is putting kratom on the list of Schedule 1 drugs

(Newser) - Heroin, marijuana, LSD, and ... kratom? The latter is a plant native to southeast Asia, and it's about to join the others on the most restrictive drug classification list in the US. The DEA said this week that kratom—specifically its active ingredients, mitragynine and 7-hydroxymitragynine—will become a Schedule... More »

FDA: So Long, Antibacterial Soaps

Agency says antibacterial ingredients haven't been proven to be effective, safe

(Newser) - Companies that sell over-the-counter antibacterial soaps will have a year to clean up their acts—namely, to remove those products from shelves and stop marketing them, or take certain ingredients out of their products that the FDA now says are essentially ineffective, NBC News reports. Products containing 19 active ingredients—... More »

FDA Has New Reason You Can't Eat Cookie Dough

It's not the eggs this time, it's the E. coli-tainted flour

(Newser) - The FDA's latest kill-joy for thousands of kids (and their parents) who like to lick the bowl: Don't eat it . And not because of the raw eggs, which can be tied to salmonella poisoning, the Huffington Post notes. This time the culprit is raw flour, which has been... More »

FDA Warns Whole Foods About Filthy Kitchen

Multiple violations found at Mass. facility

(Newser) - The Food and Drug Administration has sent Whole Foods Market a letter over "serious violations" at a Massachusetts kitchen, warning the grocer that food prepared there "may have been contaminated with filth," the AP reports. The FDA's Public Health Service describes multiple inspections conducted during February... More »

Congress Just Passed a Huge Environmental Law

Rules on chemicals get first update in 40 years

(Newser) - It may have gotten lost in all the election news, but a substantial piece of legislation has just managed to clear Congress: A massive overhaul of federal laws regulating chemicals sold in the US is headed to President Obama's desk for his signature—the first such update in 40... More »

Serving Sizes on Snacks Will Soon Be More Realistic

Thanks to makeover for food nutrition labels that's about to be implemented

(Newser) - Nutrition facts labels on food packages are getting a long-awaited makeover, with calories listed in bigger, bolder type and a new line for added sugars, the AP reports. And serving sizes will be updated to make them more realistic (a small bag of chips won't count as two or... More »

FDA Rolls Out Tough New E-Cig Regs

Industry claims it won't be viable for 99% of products to undergo regulatory approval

(Newser) - The FDA regulations on e-cigarettes are here, and not everyone is happy. The agency plans to ban the sale of e-cigarettes, hookah and pipe tobacco, and premium cigars—all of which must carry warning labels—to anyone under 18 within 90 days, reports ABC News . Free samples will also be... More »

Babies Fed Rice Cereal Have Far Higher Arsenic Levels

Move over rice, other grains may become more popular cereal

(Newser) - Feeding infants rice cereals as first foods is taking a new hit from researchers and organizations alike, and now a new study published in JAMA Pediatrics adds to the growing chorus that rice be scaled back or put off altogether. This is because, as researchers report, infants who are fed... More »

That Grated Parm on Your Pasta May Be 9% Wood

Bloomberg tests find some Parmesan cheese contains zero Parmesan

(Newser) - "Your Parmesan cheese products do not contain any Parmesan cheese" is not a letter you want to get from the Food and Drug Administration if you're a company that manufactures Parmesan cheese products. But that's exactly what a 2013 letter from the FDA to Pennsylvania's Castle... More »

US Panel: OK to Make 3-Parent Embryos —Male Ones

But there are still legal roadblocks to controversial process

(Newser) - A US National Academy of Medicine committee said Wednesday the FDA should approve clinical trials for three-parent fertilization in human embryos—with some caveats, Nature reports. In its report , the committee recommended such trials be limited to women at risk of passing along "serious mitochondrial disease" to their kids,... More »

Feds Subpoena Chipotle in Norovirus Outbreak

Looks like that food poisoning in California is leading to all sorts of problems

(Newser) - Sickened customers and employees, bad publicity, and tumbling stock prices were apparently just the beginning of Chipotle's woes. Now the restaurant chain has been slapped with a federal subpoena as part of a criminal investigation into a food poisoning outbreak in August, the AP reports. The subpoena received in... More »

FDA Lifts Ban on Gay Blood Donors

But new policy does come with restrictions

(Newser) - The nation's three-decade-old ban on blood donations from gay and bisexual men was formally lifted Monday, but major restrictions will continue to limit who can donate. The Food and Drug Administration says it is replacing the lifetime ban with a new policy barring donations from men who have had... More »

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