FDA Falls Short in Regulating Dietary Supplements

Add dietary supplements to the growing list of products the beleaguered Food and Drug Administration (FDA) is failing to regulate. According to a Government Accountability Office (GAO) report to Congress, the FDA does not have even the most basic information to protect the public from hazardous supplements.

It doesn't have an accurate inventory of the supplement ingredients on store shelves. It doesn't have a firm handle on the number and nature of serious adverse reactions to dietary supplements.

In fact, the GAO found, the agency doesn't even have a list of the names and locations of herbal supplement manufacturers. And several substances banned overseas are readily available on the Internet and in retail stores all over the U.S. even though they are variously linked to kidney damage, liver damage, seizures, and death.

"When it comes to dietary supplements, it's like the Wild West, and the bad guys know they don't have to take the sheriff seriously," said Center for Science in the Public Interest (CSPI) legal affairs director Bruce Silverglade. "Even when confronted with people dying from a dangerous substance like ephedra, the FDA has limited authority to get the product off the market."

It took the FDA nearly 10 years to ban ephedra, also known as ma huang. Ephedra-containing dietary supplements, often marketed as weight-loss aids and performance enhancers, were linked to numerous deaths and thousands of adverse reactions, including irregular heartbeat and stroke.

The herbal ingredients kava, lobelia, and supplements containing aristolochic acid are all banned in some countries, but FDA has taken no action short of issuing public warnings.

Meanwhile, such products are available to consumers.

St. John's wort, often marketed as an herbal anti-depressant, may interfere with birth control pills, a medicine used to treat HIV, and other prescription medications. While the FDA has issued alerts to that effect, it hasn't required warning labels on the products. As a result, some brands bear warnings while others do not.

Similarly, GAO pointed out that although such popular supplements as garlic, ginkgo biloba, ginseng, and Vitamin E may cause blood thinning and result in life-threatening complications during surgery, consumers are not warned of such risks.

A CSPI market survey of warning labels on Vitamin E and other popular supplements found that such leading supplement manufacturers as GNC, Nature's Plus, and Rite Aid do not warn of the risks associated with Vitamin E.

"The supplement industry operates in a gray area where the loopholes loom larger than the law," Silverglade said. "Congress should close those loopholes by requiring that ingredients be reviewed for safety and effectiveness and that cautionary information appear on product labels."

Under current law, dietary supplements sold before 1994 are presumed safe, and manufacturers of new dietary ingredients only need to notify the FDA 75 days before marketing new products. The vast majority of the claims on the labels, like the substances themselves, do not require any FDA approval.

The GAO also found that the boundaries between dietary supplements and foods that contain herbal ingredients are not clear. The food industry often markets teas and other energy drinks as supplements to take advantage of weaker safety laws.

"This report highlights significant gaps in FDA's ability to ensure the safety of dietary supplements," said Rep. Henry A. Waxman (D-CA), chairman of the Energy and Commerce Committee. "Because of limitations on FDA’s authority and its lack of resources, consumers don't have the assurance they should that all supplements are safe."

CSPI has repeatedly urged the FDA to take enforcement action against supplements that contain ingredients the agency has told the industry are not recognized as safe for use in foods, including echinacea, ginkgo biloba, ginseng, chromium picolinate, guarana and gotu kola. Foods containing such ingredients include Arizona Rx Iced Teas, Snapple Awaken, and SoBe Lifewater Zingseng.

In addition, Mars continues to sell its Cocoa Via candy bars despite the fact FDA told the company that folate is not recognized as safe for use in candy. Fuze Black and Green Tea with Acai Berry also contains added folate in violation of FDA rules. Excess consumption of folate masks the presence of anemia in persons with a vitamin B12 deficiency.

The GAO pointed out the FDA lacks statutory authority to keep potentially hazardous supplement ingredients off the market and the resources to study adverse reaction reports or inspect manufacturing facilities. As with contaminated foods, the agency lacks mandatory recall authority.

In comments supplied to GAO, the FDA stated it generally agreed with the report's recommendations for improving regulation of the industry, which in 2007 had more than $23 billion in sales.

www.consumeraffairs.com

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Weight loss pill - Alli

For the first time, the U.S. Food and Drug Administration has approved an over-the-counter drug that's designed to block fat absorption in the body.

When combined with a healthy lifestyle, research shows Alli (orlistat) weight loss pill will boost weight loss by 50 percent.

"In real terms, that means if you would have lost 10 pounds with diet and physical activity, with diet, physical activity and Alli, you'll lose 15 pounds," says Gary Foster, Ph.D., an obesity researcher from Temple University in Philadelphia.

Alli works by blocking lipases, the enzymes that break down fat. The body excretes about 25 percent of the fat instead of absorbing it as calories. Users take the pills with meals.

The downside? About half the patients in clinical trials had loose stools or an oily discharge. Also, a month's supply could run as high as $60.

Wanda Hill is working on losing weight. She says she will not take weight loss pills to help her reach her goal. "When people begin to rely on a drug, what happens when you can no longer get that drug, or you can no longer afford that drug?"

Wanda is determined to shed 70 pounds the old fashioned way. She's counting calories and controlling her portions.

"To me it's a temporary thing -- a quick fix," she says of Alli.

But some disagree, saying Alli weight loss pill could live up to its name as a friend for those fighting fat. There are also many evidences that Alli really makes what it promises, and people even are ready to live along those side effects but have their body shedding extra pounds away effectively.

Alli is a reduced-strength version of the prescription drug orlistat. You're at highest risk for the side effects if you eat more than 15-grams of fat with your meals. Experts recommend taking a daily multivitamin like A, D, E and K to offset the loss of fat-soluble nutrients.

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Question: I have heard a lot about a new over-the-counter weight loss pill. Is it safe and how do I know if I am a good candidate?

Answer: The new drug on the market is Alli. It is the first over-the-counter weight-loss drug that has been approved by the Food and Drug Administration.

Other weight loss drugs or supplements fall into a category that is not tested by the FDA. Such supplements are not allowed to claim that they cure or prevent disease and if the claims made do seem promising then the FDA does not back it up.

However, this new drug has been tested. I still warn you to be cautious since many drugs have side effects and interactions that are not found until the drug has been used for some time. The fact that the FDA has approved its proper use is helpful in determining a level of safety and efficacy.

The drug, Alli, claims to help you lose 50 percent more weight than what you would lose on just exercise and diet alone. It is not suggested for use by those who need to lose only a few pounds. Alli is a drug that blocks the absorption of fat by the body. This can lessen the amount of calories that your body absorbs and thus, helps you lose weight.

It works as an enzyme that attaches to the fat molecules that enter your body. It blocks about a quarter of the amount of fat absorbed as calories.

What isn't absorbed is carried out of the body. Therefore, if you eat too much fat in your diet, the excess fat can leave your body in a not-too-pleasant way.

Alli side effects

There are side effects to this weight loss plan. These are some of the side effects: Gas with oily spotting, loose stools and more frequent stools that may be hard to control.

Those effects may not be worth the added weight loss. So I highly recommend that you try a reduced-calorie diet and a healthy dose of exercise first. The Alli weight loss plan includes daily pills as well as tailored eating plan found on the Web site.
Once you purchase the package, you will be able to register for myalliplan for free. You can also take a quick quiz on the Web site to see if you are a good candidate.

General questions are if you are: willing to try to lose weight gradually, committed to eating a low-calorie, low-fat diet (15 grams or less a day), committed to eating smaller portions, understand the possible side effects, make more time to be physically active and if you will read the label and follow directions properly. It is also recommended that you only do this program if you have significant weight to lose.

As with any weight loss program, you should consult with your physician before starting.

There are other fat blocking supplements and pills, including Orlistat, that you have to get through a prescription, and chitosan, which is derived from shellfish. Do your research and remember that many weight loss supplements are not tested by the FDA and have a greater risk for side effects and improper ingredients.

Another thing to consider is the cost. You can take up to three capsules a day and the starter pack contains 90 capsules. The starter pack costs roughly $60 and the refill container contains 60 capsules at about $50. That between $2 and $2.50 a day.

If you decide to try this plan, then make sure you change your lifestyle habits so that when you quit the program, you can maintain your weight loss and control the things that got you where you are.

Natural and safe alternative – Proactol fat binder

Important to notice that among natural weight loss pills Proactol fat binder is alternative fat blocker that blocks 27% of your fat effectively. Being weight loss supplement, Proactol is not FDA approved but it is clinically tested (including double-blind placebo studies) and approved by MHRA as medical device for weight management.




Proactol is the only credible natural alternative to Alli that is available now without side effects. You can get all the necessary information on Proactol site. Generally Proactol offered along with special weight loss program, including healthy low fat recipes, exercising demonstration videos and toning belt as free bonus.

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It is imperative that you find ways to change lifestyle habits and if a program like this can help you lower your calories and fat intake, then it is helping you gain some control and balance. Make sure that the program leads you be to a healthier person inside and out.

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Alli - arguable weight loss effects

For the first time, the Food and Drug Administration approved selling a prescription-only diet aid over the counter. Although Alli has been selling quickly, its "treatment effects" are controversial.

Alli, which went on sale June 15, is half as strong as its prescribed version, Xenical, said Brian Jones, the vice president of communications for GlaxoSmithKline, the manufacturer of Alli, in an e-mail interview.

According to an Alli brochure, the active ingredient, orlistat, prevents digestion of approximately 25 percent of fat consumed. Instead, it is released as "treatment effects," including gas, frequent bowel movements and oily discharge.

Effects are reduced if the fat intake for each meal is around 15 grams and calories remain low.

If Alli is used with diet and exercise, a person can "lose about 50 percent more weight than dieting alone," the brochure says.

Sheida Guilak, Cal State Fullerton graduate and pharmacy manager of Target in Fullerton, said Alli just "might give some people a jump start [in their diet]."

Jones defended Alli when asked about its possible abuse and said GlaxoSmithKline has been candid about treatment effects.

"Post-marketing surveillance recorded shows no signal of people with eating disorders finding any appeal in Alli. If you are not eating, there is no benefit; if you are binge eating, the treatment effects would be undesirable," Jones said.

But what about nasty treatment effects?

Senior Dustin Martinez, a kinesiology major at CSUF said peers in one of his classes take diet pills similar to Alli with warnings about "anal leakage," but they say these side effects do not happen to them.

When asked if he would recommend Alli to someone trying to lose weight Martinez said he would.

"Yeah, because if they're serious about a diet and they eat a lot of fast food, they'll learn the hard way. I think it will help them regulate their diet."

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