Results tagged “FDA” from Weight Loss & Nutrition News

By Sally Squires, Washington Post Staff Writer

The Food and Drug Administration recently approved the first nonprescription drug for weight loss. Alli (pronounced AL-eye) is slated to hit shelves this year, according to its maker, GlaxoSmithKline (GSK). That move has been denounced by some who say it should not be made so readily available because of limited efficacy and safety concerns.

Before you even consider this drug, there are some facts you need to know and some questions to ponder:

Gosh, how much weight can I lose with this new drug? First, the drug isn't new. It contains orlistat, a weight-loss medication that has been sold by prescription as Xenical for nine years worldwide and since 1999 in the United States. There have been about 100 studies of the drug involving some 30,000 people. The results suggest that users can shed as much as 50 percent more weight than they would by diet alone.

WASHINGTON - As more Americans struggle with growing waistlines, U.S. health officials Wednesday set out their own tips for drugmakers seeking to develop products for people trying to shed pounds.

The Food and Drug Administration’s draft guidelines — more than 10 years in the making — aim to help companies develop and test new drugs and devices for treating obesity.

About a third of U.S. adults, or more than 60 million people, are obese and another third are overweight, government statistics show. Nearly a fifth of U.S. children weigh too much.

The first non-prescription drug to treat obesity in American adults was approved Wednesday by the U.S. Food and Drug Administration.

The drug, called alli (orlistat), is designed to be used only in tandem with a reduced-calorie, low-fat diet by overweight adults 18 and older. According to manufacturer GlaxoSmithKline, the drug helps people lose 50 percent more weight than dieting alone, should cost consumers $12 to $25 a week and is expected to be available by this summer.

"This is the only FDA-approved, over-the-counter weight loss drug product," Dr. Charles J. Ganley, the FDA's director of the Division of Over-The-Counter Drug Products, said during a teleconference. "There are some products, primarily dietary supplements, that make weight-loss claims and those are not FDA-approved, although they are permitted to make these claims."

Food safety scares could result in a long lasting impact on purchasing decisions, with new research revealing that 15 percent of consumers stop eating a product entirely after a food safety incident.

The findings come as the industry is already battling to recover from several cases of food poisoning in recent months, which resulted in serious illness and severe market consequences.

According to a new survey conducted last month, over one in ten adults say they or someone in their household have been affected by food poisoning, although only a third of these incidents were reported.

WASHINGTON, Dec. 23 (UPI) -- Meat and milk from cloned animals and their offspring are safe to eat and should be allowed into the U.S. food supply without special labeling, a report says.

"All of the studies indicate that the composition of meat and milk from clones is within the compositional ranges of meat and milk consumed in the U.S.," two Food and Drug Administration scientists wrote in a report published in the Jan. 1 issue of the journal Theriogenology, which focuses on animal reproduction.

The finding is a strong signal the FDA will endorse the use of cloning technology for cattle, goats and pigs when it publishes a key safety assessment next week, The Los Angeles Times reported Saturday.

The Center for Science in the Public Interest is asking the Food and Drug Administration to develop one national set of easy-to-use symbols as a value of supplement to the current nutrition facts label. Simply stated, the Center wants to bring uniformity to what the consumer organization calls a hodgepodge of commercially-driven labeling by a variety of food companies.

The group sites the United Kingdom system that uses green, yellow and red dots to rank fats, sugar and salt as low, medium or high.

The Center's proposal has already drawn the endorsement of incoming Senate Ag Committee Chairman Tom Harkin of Iowa. The Senator says a uniform system of nutrition symbols can help consumers make sense of diverse and often conflicting nutrition information and advice.

Consumer and industry groups are clashing over how -- and if -- the government should regulate foods sold in the U.S. that tout an array of health claims.

Regulators are watching as companies market an ever wider list of energy drinks, teas, and even candy bars with added dietary supplement ingredients purported to improve health. Watchdog groups want authorities to crack down, accusing companies of making unfounded and sometimes bogus claims about the benefits of the products.

The FDA takes action against unsafe dietary supplements after they are on the market. Manufacturers are responsible for making sure their products are safe before they are marketed.

For many, grocery shopping today is more about hunting for bargains; it's about finding the healthiest offerings on the shelves.

Labels play a big part in helping shoppers separate the healthy choices from the junk. But with dozens of apparent ratings systems out there -- from Kraft's "Sensible Solution" accolade to the American Heart Association's "Heart-Check" endorsement, consumers may be left wondering how much weight these approvals carry.

Now, the nonprofit Center for Science in the Public Interest (CSPI) is petitioning the Food and Drug Administration (FDA) to design a national set of symbols to help consumers quickly identify healthier foods.

NEW YORK (Reuters Health) - The U.S. Department of Health and Human Services and the Food and Drug Administration have announced the availability of two new tools designed to help consumers use the Nutrition Facts label on foods to make healthy and nutritious food choices.

The tools are "Make Your Calories Count," an interactive online learning program, and a new Nutrition Facts Label brochure. Both are available and downloadable at www.fda.gov.

"These tools will empower consumers to be better informed to make better and wiser food choices," Dr. Andrew C. von Eschenbach, Acting FDA Commissioner, said at a news briefing announcing the self-help aids.

Labelman has joined the pantheon of cartoon characters the government is using to promote healthier eating habits.

The red cartoon figure with a nutrition label body was unveiled Tuesday by health officials as part of their latest effort at solving obesity in the United States.

Labelman guides consumers through a new Web-based program, “Make Your Calories Count,” which the Department of Health and Human Services and the Food and Drug Administration announced along with a brochure on how to use nutrition labels.

U.S. firm Scientific Intake said it has finished enrolling patients in a study of its non-invasive weight-loss device.

The company said it has recruited 190 patients in a multi-center study and would seek approval of the device for use in people with a body mass index from 27 to 35.

The device simulates a physical condition linked with thinness called Torus Palatinus. The device contains a wireless microsensor linking patients and providers for remote monitoring of compliance, behavior change and progress.

Scientific Intake said the device increases savoring, reduces bolus size, slows intake and allows the body's built in defense mechanism, the satiety response, to trigger.