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Monday, January 10, 2011

What Does the New Food Safety Law Mean for You? | FoodSafety.gov

Just before Christmas, the House of Representatives and the Senate passed the FDA Food Safety Modernization Act, which President Obama signed into law on January 4, 2011. Here’s a quick look at some of the provisions in the new law:

Issuing recalls: For the first time, FDA will have the authority to order a recall of food products. Up to now, with the exception of infant formula, the FDA has had to rely on food manufacturers and distributors to recall food voluntarily.
Conducting inspections: The law calls for more frequent inspections and for those inspections to be based on risk. Foods and facilities that pose a greater risk to food safety will get the most attention
Importing food: The law provides significant enhancements to FDA's ability to oversee food produced in foreign countries and imported into the United States. Also, FDA has the authority to prevent a food from entering this country if the facility has refused U.S. inspection.
Preventing problems: Food facilities must have a written plan that spells out the possible problems that could affect the safety of their products. The plan would outline steps that the facility would take to help prevent those problems from occurring.

via foodsafety.gov

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Monday, January 3, 2011

New Drug Approvals Slipped in 2010 - WSJ.com

The Food and Drug Administration approved about 21 drugs in 2010, a relatively modest figure that shows the pharmaceutical industry hasn't yet escaped its drought in recent years.

A few potential blockbusters won approval during the year, but some of the most highly anticipated new products got delayed into next year or beyond. That partly reflects a tougher environment at the FDA, with regulators stepping up their scrutiny of safety issues in drugs for obesity, diabetes and other conditions.

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According to monthly drug-approval reports on the FDA's website, 21 new drugs were approved in 2010, down from 25 in 2009 and 24 in 2008, but higher from a recent low of 18 in 2007.

The final approval figures, as well as the number of applications received by the agency in 2010, won't be available until next month. The approval figures don't include dozens of approvals granted for new formulations or new uses of existing drugs.

Although the 2010 figures are a bit lower than previous years, FDA spokeswoman Sandy Walsh said there's "no systemic change in how the FDA is approaching drug approvals."

The figures include several major biologic drugs, which are created from living cells and represent a growing portion of the pharmaceutical market. Amgen Inc. won approval for Prolia, a drug that is injected twice yearly to treat osteoporosis in postmenopausal women. Roche Holding AG's biotechnology unit, Genentech, won approval for Actemra, a drug that's administered intravenously to treat rheumatoid arthritis.

via online.wsj.com

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Wednesday, November 17, 2010

FDA expected to ban alcoholic energy drinks - Health - Addictions - msnbc.com

WASHINGTON — The Food and Drug Administration is poised to announce a virtual ban of alcoholic energy drinks on Wednesday, even as a leading manufacturer is pulling its products off the market.

The FDA is expected to say that caffeine is an unsafe food additive to alcoholic drinks, a move that would effectively ban them from sale. College students have been hospitalized after drinking the beverages, including the popular Four Loko, and four states have banned the drinks.

Phusion Projects, which manufactures Four Loko, announced late Tuesday that it would reformulate its drinks, removing caffeine. While there is little known medical evidence that the drinks are less safe than other alcoholic drinks, public health advocates say they can make people feel more alert and able to handle risky tasks like driving.

The company's statement said it was removing caffeine from the drinks after unsuccessfully trying to deal with "a difficult and politically-charged regulatory environment at both the state and federal levels."

"We have repeatedly contended — and still believe, as do many people throughout the country — that the combination of alcohol and caffeine is safe," said Chris Hunter, Jeff Wright and Jaisen Freeman, who identify themselves as Phusion's three co-founders and current managing partners.

The statement did not mention several recent incidents in which college students were hospitalized after drinking the beverage. In response to such incidents, four states — Washington, Michigan, Utah and Oklahoma — have banned the beverages. Other states are considering similar action.

Four Loko comes in several varieties, including fruit punch and blue raspberry. A 23.5-ounce can sells for about $2.50 and has an alcohol content of 12 percent, comparable to four beers, according to the company's website.

via msnbc.msn.com

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