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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Pros & Cons Of Weight Loss Pills

A reader recently e-mailed me about the weight loss pill Phentermine, which she's been taking from a weight loss clinic. "Is this the same as the Phen-Fen weight loss pill that was taken off the market a few years ago?" she asked.

The answer is yes and no.

Phentermine was one half of the weight loss pill combination called Phen-Fen. Several years ago the Fen part (Fenfluramine) was pulled from the market due to adverse health risks. Phentermine is a very effective weight loss medication, however it should not be taken lightly, and certainly is not for everyone.

Our reader isn't alone out there looking for some help in losing weight. Obesity affects more than one-half of our population and is linked to health problems ranging from heart disease to cancer. Unfortunately, with our busy schedules and the easy access to fast food, exercising and eating right is easier said than done.

Phentermine has recently had a resurgence in use with the growing popularity of weight loss clinics that combine high doses of the drug with vitamin injections and very restrictive diets (as low as 500 calories a day).
So what is it? How does it work? Is it safe?

Most of the supplements and medications on the market that have any effect on weight loss typically contain caffeine or another type of stimulant.

Phentermine falls into that category as well. It has a stimulant effect similar to an amphetamine and works in the brain to increase your metabolism and reduce appetite.

It is given in doses of 15 to 37.5 mg daily, usually in the morning or during the day so it doesn't interfere with sleep.

Since it acts as a stimulant, phentermine can have wide-ranging effects including elevated blood pressure, heart palpitations, rapid heart rate, dizziness, headache, insomnia, restlessness, stomach upset and nervous tremors. There is also an association with the development of heart valve disease.

Even more worrisome is that Phentermine can be habit-forming with long-term use. That means it can be addictive. Bottom line, while Phentermine would likely be OK for most people without chronic medical problems (such as diabetes, high blood pressure, heart disease), it should be used only after a thorough discussion with your doctor of the risks and benefits.

Most of you are likely still wondering, "but does it work?" The answer is yes, at least short term. Patients have lost 30 to 40 pounds in some studies, however no long-term studies have been conducted. Another similar-sounding drug, Phendimetrazine, is similar to Phentermine in effectiveness and side effects. Other prescription medications such as Meridia or Xenical have shown a weight loss of 10 percent over a year when combined with diet and exercise.

And that is the take-home lesson. As much as we all would love a simple pill to resolve a weight problem, anything that does not include diet and exercise has little chance of long-term success. Be wary of quick fixes, and make sure to talk with your doctor. Even over-the-counter remedies can be dangerous for some patients.

Do you have a health question relating to adult, pediatric, or women's health issues? E-mail Dr. Andy.

Editor's note: The information in this column is meant to discuss medical issues in general. Any individual decisions should be made by the reader only after consultation with his or her physician.

- Andrew Oakes-Lottridge, M.D., is the only concierge physician in Southwest Florida exclusively making house-calls in Lee, Collier and Charlotte counties. He has pediatric and adult privileges at HealthPark Hospital. E-mail Andy@DrAndy.US or call 239-694-6246.

www.news-press.com

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Health Canada Warns of Weight Loss Pills Use

Health Canada is advising consumers not to use Natural (Xin Yi Dai) and Lasmi weight loss pills due to concerns about possible side-effects.

Natural (Xin Yi Dai) and Lasmi are both promoted for weight loss.

Reason for Warning

The Hong Kong Department of Health warned against the use of Natural (Xin Yi Dai) and Lasmi because they were both found to contain undeclared pharmaceutical ingredients.

Natural (Xin Yi Dai) was found to contain sibutramine and phenolphthalein, and Lasmi was found to contain sibutramine and spironolactone.

Sibutramine is used in the treatment of obesity and spironolactone is used in the treatment of fluid retention. Both are prescription drugs that should only be used under the supervision of a health care professional.

Phenolphthalein was previously used in over-the-counter laxative preparations but is currently prohibited in Canada as it may cause cancer. Individuals who may have been exposed to phenolphthalein should consult with their health care professional.

Possible Side-Effects

Use of sibutramine may cause headaches, increased heart rate and blood pressure, chest pain and stroke.

Abuse of phenolphthalein-containing laxatives has been associated with stomach and intestinal bleeding, anemia, acute pancreatitis and, in cases of massive overdose, multiple organ damage (including liver failure).

Side-effects associated with spironolactone include electrolyte imbalance, breast enlargement in males, gastrointestinal irritation, fatigue, dizziness and reproductive disorders.

www.emaxhealth.com

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Is it possible to eat much and stay fit? Scientists have the answer

Australian scientists say they may have found a way to help people lose weight without cutting back on food.

A breakthrough that could pave the way for fat-burning drugs has been found which, by manipulating fat cells in mice, is able to speed up their metabolism.

Researchers found that when they took out an enzyme - angiogenesis converting enzyme (ACE) - the mice could eat the same amount as other mice but burn more calories and therefore gain less weight.

Animals without the enzyme were, on average, 20% lighter than normal mice and had between 50% and 60% less body fat, said senior researcher Michael Matthai.
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"It is very clear that they do have less body fat," he said.

The slimmer mice also appeared to have less chance of developing diabetes because they processed sugar faster than normal mice, Mr Matthai said.

The research could be used to develop drugs to help weight loss, he added.

Drugs which impair the action of ACE already exist and are mostly used to control high blood pressure.

"The drugs are out there because they are used for hypertension," he said.

"So we know their safety and their tolerability. What we don't know is whether or not they will work in humans.

"And we don't know whether it will work in all obese humans."

Mr Matthai said it could be a question of finding the right dosage of hypertension medication, or developing a new type of drug of the same class, to be used as weight-loss pills.

"This might be one way in which you can increase metabolic rate in combination with managing nutrition to limit the intake of calories," he said.

The research has yet to pinpoint why the genetic manipulation led to weight loss.

http://news.sky.com

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FTC Sues Sellers of Weight-Loss Pills for False Advertising

The Federal Trade Commission has charged a business operation with violating federal law by falsely claiming that its weight-loss pills cause users to lose weight without dieting or exercise.

According to the FTC’s complaint, since 2005 the defendants have marketed their product throughout the nation under the names Zyladex Plus, Questral AC, Questral AC Fat Killer Plus, Rapid Loss 245, and Rapid Loss Rx. Their advertising, which has included statements such as “Lose up to 15 pounds a week,” “Not Even Total Starvation Can Slim You Down and Firm You Up This Fast - This Safe!,” and “No Dieting, No Exercise,” has appeared in Sunday newspaper supplements, including SmartSource by News America Marketing FSI, Inc.

The defendants, Medlab, Inc., Pinnacle Holdings, Inc., Metabolic Research Associates, Inc., U.S.A. Health, Inc., and their principal, L. Scott Holmes, located in California, are charged with violating Sections 5 and 12 of the FTC Act by making false and unsubstantiated claims that their product causes users to lose substantial amounts of weight rapidly, including as much as 15 to 18 pounds per week and as much as 50 percent of all excess weight in just 14 days, without dieting or exercise; that clinical studies prove those claims; and that their product causes permanent or long-term weight loss.

The FTC ultimately seeks to permanently bar the defendants from further violations and to obtain redress for affected consumers.

Through its “Red Flag” education campaign, announced in December 2003, the Commission encourages media outlets not to run ads for weight-loss products that contain false claims. As part of this effort, the FTC may notify media outlets when ads making bogus weight-loss claims appear in their publications. More information about the “Red Flag” campaign is available at http://www.ftc.gov/redflag/

The Commission vote to authorize the staff to file the complaint was 5-0. The complaint was filed in the U.S. District Court for the Northern District of California, San Francisco Division.

NOTE: The Commission files a complaint when it has “reason to believe” that the law has been or is being violated, and it appears to the Commission that a proceeding is in the public interest. The complaint is not a finding or ruling that the defendant has actually violated the law. The case will be decided by the court.

Copies of the complaint are available from the FTC’s Web site at http://www.ftc.gov and
the FTC’s Consumer Response Center, Room 130, 600 Pennsylvania Avenue, N.W.,
Washington, D.C. 20580. The FTC works for the consumer to prevent fraudulent, deceptive, and unfair business practices and to provide information to help spot, stop, and avoid them. To file a complaint in English or Spanish, click http://www.ftc.gov/ftc/complaint.shtm or call 1-877-382-4357. The FTC enters Internet, telemarketing, identity theft, and other fraud-related complaints into Consumer Sentinel, a secure, online database available to more than 1,600 civil and criminal law enforcement agencies in the U.S. and abroad. For free information on a variety of consumer topics, click http://ftc.gov/bcp/consumer.shtm.

www.npicenter.com

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Tighter regulation by the FDA of misleading health ads is definitely needed.
At least the FDA does have oversight over print and television ads by the pharmaceutical industry. I am far more troubled by the ads for over-the-counter "food supplement" products, which the FDA has no power to regulate. For example, the pandemic of obesity has led to an ever-increasing spate of ads for useless weight loss pills on which consumers waste billions of dollars.
Federal Trade Commission recently levied fines of more than $25 million for false advertising of four weight loss products - Xenadrine EFX, Cortislim, TrimSpa and One-A-Day Weight Smart (a green tea extract added to a standard multivitamin preparation).

Particularly troublesome is the fact that the latter product is advertised under the widely respected Bayer name. The Bayer ad did recommend a lift-twist-and-bend exercise (which apparently consists of lifting the bottle, twisting off the cap, and bending a wrist to take the pill). Although the advertisements are judged misleading, the products are not harmful and can still be purchased.

As often is the case, the marketing campaign for one of these products relied on a testimonial and endorsement by a celebrity. Of course, such celebrities are paid by the supplement maker and may be aided by diet coaches and personal trainers who help the weight loss pill achieve its goal. It's hard to believe, but people apparently accept as gospel the statements made in these promotions and the benefits claimed in testimonials.

It's time that newspapers and magazines stop accepting ads from weight loss pill manufacturers. Some time ago, after seeing an ad with too many errors to list here, I wrote a letter urging the Baltimore Sun newspaper not to print ads for such questionable over-the-counter weight loss pills. Although the newspaper never responded, and it may be wishful thinking, I have the impression that they have recently printed fewer ads for such weight loss pills.

Via www.health.yahoo.com

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'Skinny gene' could lead to weight loss pill

A skinny gene that may pave the way for a fat burning pill has been pinpointed by scientists.

The gene governs whether the body piles on pounds or burns them off, researchers found.

Further study could lead to drugs that trick the body into shedding fat.
Ultimately, such pills could give men and women a trim body without any visits to the gym.

The finding follows the discovery of an obesity gene … and could help explain why some seem to eat what they like without putting on weight, while others constantly fight the flab.

Researcher Dr Jonathan Graff, of the University of Texas, said: "From worms to mammals, this gene controls fat formation."

"It could explain why so many people struggle to lose weight and suggests an entirely new direction for developing medical treatments that address the current epidemic of obesity."

"People who want to fit in their jeans might some day be able to overcome their genes."

Dr Graff focused on a gene that was named adipose when it was discovered in rotund fruit flies almost 50 years ago.

He turned the gene on and off at different stages in the lives of a range of animals and in various parts of their bodies.

Mice with highly active genes ate as much, or more, than normal mice, yet remained leaner.

They also appeared to be at lower risk of diabetes.

But rodents with lower adipose activity were fatter, less healthy and developed diabetes.

Tests on flies suggested that the gene acts as a dimmer switch, with different combinations leading to different levels of fat accumulation.

We all carry two copies of every gene. Flies with two inactive genes were fat and struggled to get about.

Those with just one inactive gene were slightly plump, while those with two fat-burning genes were a normal weight.

The results suggest that the gene is a master-switch which tells the body whether to burn fat or pile it on.

A similar gene is known to exist in humans … and if it has the same effect on the human body, could pave the way for anti-obesity drugs.

Treatments could include drugs that produce the same effect on the body as the gene or pills that boost its activity.

Dr Graff, whose findings are published in the journal Cell Metabolism, said: "This is good news for potential obesity treatments. It is like a volume control instead of a light switch.

"It can be turned up or down, not just on or off. Maybe if you could affect this gene, even just a little bit, you might have a beneficial effect on fat."

Via www.dailymail.co.uk.

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