Showing posts with label FDA. Show all posts
Showing posts with label FDA. Show all posts

Sunday, November 8, 2009

are you eating beef that's eating poop?

Lovely:
A coalition of food and consumer groups that includes Consumers Union and the Center for Science in the Public Interest has asked the Food and Drug Administration to ban the practice. McDonald's Corp., the nation's largest restaurant user of beef, also wants the FDA to prohibit the feeding of so-called poultry litter to cattle.

Members of the coalition are threatening to file a lawsuit or to push for federal legislation establishing such a ban if the FDA doesn't act to do so in the coming months.

Farmers feed 1 million to 2 million tons of poultry litter to their cattle annually, according to FDA estimates.

Using the litter -- which includes feces, spilled chicken feed, feathers and poultry farm detritus -- increases the risk of cows becoming infected with bovine spongiform encephalopathy, or mad cow disease, said Michael Hansen, a senior scientist at Consumers Union. full article

Thursday, May 7, 2009

the vaginal sling and slumping FDA efficacy

The failure of ObTape is a reminder of another failure: the FDA.

A vaginal sling inserted under the urethra, ObTape is designed to eliminate urine leakage in women who suffer from urinary incontinence. Turns out, the sling can work its way up into the vaginal wall, create painful and bloody discharge, and must be removed piece by piece through a series of surgeries. One victim is unsure that she will ever live a life without pain, or have enjoyable sex with her husband, ever again.

The New York Times reports:

The lawsuits raise new questions about the process by which the F.D.A. reviews new medical devices. While it “approves” drugs, it merely “clears” medical devices with minimal testing if they are deemed “substantially equivalent” to devices already in use.

The process has been criticized by the agency’s scientists and in a recent Government Accountability Office report concluding that most devices on the market have never been proved safe and effective.

In ObTape’s case, the chain of similarity claims can be traced back to an older product that caused so much harm it was taken off the market. That recall did not stop the F.D.A. from clearing a new generation of vaginal slings whose only claim to safety was their similarity to the flawed device. FULL ARTICLE

Friday, May 1, 2009

Hydroxycut Recalled

Hydroxycut is recalled after reports of liver failure, raising the question as to whether or not the FDA is adequate enough to regulate the supplement industry and protect public health.

At issue is the difference in the way the agency oversees drugs — defined as products that prevent or cure disease — and dietary supplements, which can offer general health benefits but cannot claim to treat specific diseases or symptoms.

Unlike drugs, whose manufacturers must provide safety and effectiveness data before receiving federal approval to sell the products, dietary supplements do not need prior F.D.A. sanction to go on sale. Manufacturers of dietary supplements are themselves responsible for ensuring and documenting the safety and efficacy claims of their products.

According to the law governing dietary supplements, the F.D.A. is empowered to act only in cases when it identifies a harmful or adulterated product that is already on sale. READ FULL ARTICLE