Fda

When is a fish not a fish but a drug? When government regulators take old laws and twist themselves into knots trying to apply them to new technology. In the emotionally charged battle over the safety and appropriateness of genetically modified foods, people on both sides agree that the way the government oversees genetically modified plants and animals is patchy, inconsistent and at times just plain bizarre. Soon, analysts say, the system may be stretched to the breaking point.

The Food and Drug Administration is cracking down on a second Southern California firm it says is using misleading ads to promote Lap-Band weight-loss surgery. The FDA sent a letter to the owners of Lap-Band VIP, warning them to change their billboard and television marketing or face disciplinary action. The allegations were similar to those the agency made in December against 1-800-GET-THIN, another company that marketed Lap-Band weight-loss surgery. Lap-Band VIP, based in Tarzana, has promoted its weight-loss surgery on television, the Internet and freeway billboards throughout Southern California.

Americans spend billions on hair-care products each year, a remarkable investment for a part of the body with no real function. We clean it, nourish it and style it -- and we definitely mourn its loss. Lots of products and procedures promise to restore thinning or disappearing hair. One especially intriguing option is the HairMax LaserComb, a hand-held laser device that supposedly revives hair follicles.

WASHINGTON – Following a spike in reported complications, the Food and Drug Administration released an updated advisory Wednesday about a surgical mesh implanted in women to strengthen vaginal tissue that can become weakened, especially after childbirth. In its report, the FDA says a review of industry literature and the adverse event reports has shown little evidence that the device, which is implanted vaginally or abdominally, improves pelvic organ prolapse, where a woman's uterus, bladder, or rectum can slip out of place.

Regarding "Longtime Drug's New Troubles," July 23: This was the first article in any U.S. newspaper that I have seen which accurately reflects the tenor of the FDA letter to the makers of Synthroid in denying its petition to escape regulation. Even better, this article is the only one I have seen to note that the organizations speaking out in favor of allowing Synthroid to continue to be sold are all funded by the makers of Synthroid. The FDA does not get everything right, but this latest effort to regulate thyroid medications should be applauded.

The Food and Drug Administration has approved marketing of the weight-loss drug lorcaserin, the first prescription anti-obesity medication to win the FDA's blessing since the agency approved orlistat in 1999. Once it is cleared by the Drug Enforcement Administration, the drug will be marketed in the United States under the commercial name Belviq. The medication won marketing approval as a drug for "chronic weight management in adult patients" with a body mass index greater than 30, or for those with a BMI of 27 or above with a weight-related condition such as high blood pressure, elevated cholesterol or Type 2 diabetes.

As if studying product labels to keep tabs on calories, carbs and fat grams wasn't painful enough, now dieters have this to worry about: one bakery's "goodies that taste good without being bad" are actually quite naughty, after all. Clifton, N.J.-based Butterfly Bakery promises careful eaters that its sugar-free, no-sugar-added and gluten-free baked goods "will turn your dietary restriction into a dietary indulgence. "  An indulgence, indeed: on Wednesday, the Food and Drug Administration said that tests on samples of Butterfly Bakery products showed that foods labeled as "sugar free" had sugar and that claims about sugar and fat content were false and misleading -- and that the agency obtained a consent decree that effectively shut down operations at the company "for unlawfully distributing mislabeled food products, such as muffins and snack cakes.

1879 ? Johns Hopkins University chemists Ira Remsen and Constantin Fahlberg publish their first paper describing benzoic sulfimide, which became known as saccharin. 1901 ? Monsanto is founded to produce saccharin in the U.S. 1907 ? An official of the U.S. Department of Agriculture investigates whether using saccharin in place of sugar violates the 1906 Pure Food and Drug Act. President Theodore Roosevelt, a saccharin consumer, opposes the investigation. 1909 ? A panel from the USDA's Office of Consulting Scientific Experts reports that saccharin is safe in small doses (less than 1/2 gram per day)

The U.S. Food and Drug Administrationapproved Stendra, a new drug to treat erectile dysfunction in men, on Friday. Like Viagra, Cialis and Levitra, Stendra (generic name avanafil) is a pill, and is in a class of drugs called PDE5 inhibitors. These work by increasing blood flow to the penis. Patients can take Stendra as needed 30 minutes before sexual activity, the FDA said in a statement released Friday. One possible advantage of the new drug?  Vivus Inc., the company that markets Stendra, has claimed that it will provide erections in 15 minutes or less - in about half as much time as Viagra can.  Like other PDE5 inhibitors, Stendra is not recommended for men who take nitrates for chest pain, because taking both drugs can cause a rapid drop in blood pressure, the FDA said. Side effects reported during clinical trials of Stendra included headache and cold-like symptoms.  The National Kidney and Urologic Diseases Information Clearinghouse provides information about erectile dysfunction and its treatment at this website .

WASHINGTON - The Food and Drug Administration on Friday warned physicians to consider alternatives to the popular arthritis drug Celebrex because of new evidence that, like the similar drug Vioxx, removed from the market in September, it doubles the chances of heart attacks and strokes. The federal agency said it may soon take other actions, including requiring stronger warnings, or even blocking the drug from sale. The statements call into question the future of the widely used class of painkilling drug called Cox-2 inhibitors.