Agency alerts consumers to the finding of new undeclared drug ingredients

The U.S. Food and Drug Administration is expanding, for the second time, its nationwide alert to consumers about tainted weight loss products containing undeclared, active pharmaceutical ingredients.

The FDA has identified additional weight loss products (Herbal Xenicol, Slimbionic, and Xsvelten) and new undeclared active pharmaceutical ingredients (fenproporex, fluoxetine, furosemide, and cetilistat). The current list now includes the following 72 products:

* This product should not be confused with the line of meal replacement and related products that are marketed as conventional foods under the brand name “Slim-Fast®”.  The manufacturer of Slim-Fast®, Unilever United States, Inc., maintains that the Slim Fast product which appears on this list is not in any way associated with, sponsored or approved by, or otherwise related in any way to the Slim-Fast® brand of meal replacement and related products.

“These tainted weight loss products pose a great risk to public health because they contain undeclared ingredients and, in some cases, contain prescription drugs in amounts that greatly exceed maximum recommended dosages,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “Consumers have no way of knowing that these products contain dangerous drugs that could cause serious consequences to their health.”

On Dec. 22, 2008, the FDA warned consumers not to purchase or consume 28 different products marketed for weight loss. On Jan. 8, 2009, the FDA expanded the list of tainted weight loss products to include 41 additional tainted products. The FDA will continue to update this list as warranted.

The products listed above, some of which are marketed as dietary supplements, are promoted and sold on various Web sites and in some retail stores and beauty salons. Some of the products claim to be “natural” or to contain only “herbal” ingredients, but actually contain potentially harmful ingredients not listed on the products’ labels or in promotional advertisements. These products have not been approved by the FDA, are illegal, and include the following undeclared active pharmaceutical ingredients:

• sibutramine (an appetite suppressant available by prescription only and a controlled substance)
• fenproporex – a controlled substance not approved for marketing in the United States;
• fluoxetine – an antidepressant available by prescription only;
• bumetanide – a potent diuretic available by prescription only;
• furosemide – a potent diuretic available by prescription only;
• rimonabant – a drug not approved for marketing in the United States;
• cetilistat – an experimental obesity drug not approved for marketing in the United States;
• phenytoin – an anti-seizure medication available by prescription only; and
• phenolphthalein – a solution used in chemical experiments and a suspected cancer-causing agent that is not approved for marketing in the United States.

The FDA has inspected a number of companies associated with the sale of these illegal products and is currently seeking product recalls. Based on the FDA’s inspections and the companies’ inadequate responses to recall requests, the FDA may take additional enforcement steps, such as issuing warning letters or initiating seizures, injunctions, or criminal charges.

The FDA advises consumers who have used any products containing these ingredients to stop taking them and consult their health care professional immediately. The FDA also encourages consumers to seek guidance from a health care professional before purchasing weight loss products.

The health risks posed by these products can be very serious and include high blood pressure, seizures, tachycardia (rapid heartbeat), palpitations, heart attack, and stroke. Sibutramine, a controlled substance, was found in many of these products at levels much higher than the maximum daily dosage for Meridia, the only FDA-approved drug product containing sibutramine. These higher levels of sibutramine can increase the incidence and severity of these health risks. Fenproporex, another controlled substance, can cause arrhythmia and possible sudden death.

Health care professionals and consumers should report serious adverse events (side effects) or product quality problems to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone.

• Online
• Regular Mail: use postage-paid FDA form 3500 and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
• Fax: 800-FDA-0178
• Phone: 800-FDA-1088

For more information:

Information on FDA’s Initiative Against Contaminated Weight Loss Products

To learn more about the FDA’s initiative against unapproved drugs see the FDA’s Compliance Policy Guide at: http://www.fda.gov/cder/Guidance/6911fnl.htm.

For drug safety information, see: FDA’s Drug Safety Initiative.

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FDA alleged ‘Body-building’ products contained unapproved food additive, new dietary ingredient and these products will now be destroyed

The U.S. District Court for the Eastern District of Michigan, Southern Division, today entered a consent decree that condemns and forfeits to the United States for destruction about $1.3 million worth of dietary supplements.

“The court order is the result of efforts by the federal government to protect consumers from products for which there is inadequate information to assure that they do not present a significant or unreasonable risk of illness or injury,” said Michael Chappell, FDA’s acting associate commissioner for regulatory affairs. “It shows that the agency is prepared to use the necessary legal means to keep such products out of the marketplace.”

At the request of the FDA, U.S. Marshals seized more than 23,300 bottles of three dietary supplement products distributed by LG Sciences LLC, of Brighton, Mich. The seized products were marketed for use by body builders and distributed on the Internet and in retail stores under the names “Methyl 1-D,” “Methyl 1-D XL,” and “Formadrol Extreme XL.”

Based on laboratory tests, the FDA determined that the products contain one or more unapproved food additives and/or new dietary ingredients for which there is inadequate information to assure that the ingredients do not present a significant or unreasonable risk of illness or injury. Specifically, the condemned Methyl 1-D and Methyl 1-D XL contained 1,4,6-androstatriene-3,17-dione, also known as “ATD” or 1,4,6-etioallocholan-dione. The condemned Formadrol Extreme XL contained ATD and 3,6,17-androstenetrione (also known as “6-OXO”). Both of these substances are steroids that inhibit the activity of the enzyme aromatase and may be found in dietary supplements promoted to boost testosterone levels.

The FDA has no scientific information concerning the safety of the condemned products or their ingredients and, thus, cannot determine whether they represent a hazard to consumers. Under the circumstances, consumers who use or have used the products should discuss their use with their health care professionals.
The FDA also recommends that consumers consult their health care professionals if they have experienced any adverse events that they suspect are related to the products’ use.
Health care professionals and consumers may report serious adverse events (side effects) or product quality problems with the use of this product to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone.

• Online
• Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
• Fax: (800) FDA-0178
• Phone: (800) FDA-1088

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When did eating become such an all-or-nothing proposition? It seems that Americans are either gorging on gigantic portions of unhealthy, highly processed foods and getting fatter all the time, or they’re starving themselves on the latest hyper-restrictive diet that no one could stay on for more than a few weeks without feeling miserable and deprived.

Whatever happened to just enjoying good food, in moderation, without guilt?

If we buy into the common-sense wisdom found in books like the bestseller French Women Don’t Get Fat by Mireille Guiliano, it’s clear that the way to be thin and still have some joy with our meals is to adopt a more traditional, and worldly, way of dining. Moderate portions, fresh whole foods, relaxing and lingering with family and friends at the table — it’s what they do not just in France, but throughout the Mediterranean, Latin America and Asia. These are places where obesity rates have historically been low (at least until the global spread of fast food and sedentary lifestyles boosted obesity everywhere). It’s where the “gym workout” was a bicycle ride to work or school, or where eating a low-fat diet meant Mom stretching the meat by stuffing cabbage or grape leaves.

This reminds us that it is possible to eat what you love without feeling guilty, deprived or going on any restrictive regimen. Here’s how:

1. Start with soup.

This Japanese tradition is one of the best weight-loss strategies. That’s because eating soup, particularly the broth-based vegetable kind, before your entrée fills you up so you eat less during the meal, explains Barbara Rolls, Guthrie professor of nutrition at Penn State University in University Park, and author of The Volumetrics Eating Plan (HarperCollins, 2005). A two-year French study of 2,188 men and 2,849 women found that those who ate soup five to six times a week were more likely to have BMIs below 23 (considered lean), compared with infrequent- or non-eaters whose BMIs tended to be in the 27 range.

2. Make lunch your main meal.

Although they do this throughout Europe, a good explanation for eating your big meal at midday comes from ayurveda, India’s 5,000-year-old approach to wellness. “According to ayurveda, we’re actually designed to eat the larger meal at lunch because our digestive ‘fire,’ called agni, is strongest between 10 a.m. and 2 p.m., so we digest more efficiently,” explains Jennifer Workman, a Boulder, Colorado-based ayurveda specialist, registered dietitian and author of Stop Your Cravings (Free Press, 2001). “I’ve seen people in my practice lose 5 to 10 pounds just by doing this.”

3. Think quality, not quantity.

The French snub processed “diet foods” not found in nature, opting instead for high-quality meats, fish, produce, dairy, even desserts. When food is fresh and flavorful, you can be satisfied with smaller portions. This is the opposite of the American approach, which is to fill up on bland diet foods, then gorge on sweets later. “The French set the standard for small portions with their haute cuisine,” says David Katz, MD, author of The Way to Eat (Source Books, 2002). “If we consider that part of eating is to induce pleasure, if you can get there with quality of choice, you get there in fewer calories.”

4. Mix up the flavors.

In ayurveda, including the six basic tastes — sweet, sour, salty, bitter, pungent and astringent — is the key to a satisfying meal that won’t leave you craving junk food later.

Not sure where to start? This will cover all the flavor bases: Try salmon with yogurt dill sauce along with some sautéed kale topped with mango chutney, a sweet potato sprinkled with sea salt and a little clarified butter, and finish with a cup of chai and a small piece of dark chocolate.

5. Go for color.

The Japanese have a saying: “Not dressing up the meal with color is like going out without clothes.” Not only does color make food more attractive, but consciously seeking out colorful foods is a great way to bulk up your meals without a lot of calories. A Cornell University study of 6,500 adults in rural China found that while the Chinese ate about 30 percent more than the average American male, they weighed about 25 percent less, largely because they ate a lot of plant-based foods. The Japanese aim for five colors at each meal: red, blue-green, yellow, white and black, including things like red peppers, squash, broccoli, onions, black beans or black olives. “We’re variety seekers, so instead of seeking a variety of, say, cookies, get the variety from these low-energy-dense foods,” Rolls says.

Enjoy Yourself
Drizzle on the healthy oils. Healthy fats like olive oil, a staple of the Mediterranean diet, and canola oil, a staple of Okinawans, make vegetables tastier, so you’re likely to eat more of them. According to data from the Catalan Nutrition Survey done in Spain, people who ate the most olive oil also consumed more vegetables than those who consumed the least olive oil. And, as we know, eating a diet rich in produce is key to maintaining a healthy weight. In a study of more than 74,000 female nurses conducted over 12 years, Northwestern and Harvard University researchers discovered that those who added the most fruits and vegetables to their diets lowered their risk for major weight gain by 28 percent.

When you’re eating, just eat.

No other culture multitasks meals the way Americans do with our TV dinners, fast-food drive-throughs and grab-’n-go food that’s designed to fit into a car cup holder and be eaten with one hand. In Japan, it’s considered rude to eat while walking. And you’ll never catch the French gulping coffee in the car. “In France, there are no car cup holders because you don’t drink coffee while driving,” explains Will Clower, PhD, author of The Fat Fallacy: The French Diet Secrets to Permanent Weight Loss (Three Rivers Press, 2003). “Eating and drinking aren’t errands. It’s not what you do on the way to something else.” Good advice. When you’re distracted by work, traffic or the TV, you’re apt to overeat without even realizing it, notes Dean Ornish, MD, author of Eat More, Weigh Less (Perennial Books, 2001). “If you really pay attention to what you’re eating, you enjoy it more fully and don’t need as much food.”

Enjoy regular meals.

One reason French women don’t get fat is because French women eat three meals a day. You may think skipping meals cuts calories, but all it does is evoke a primal “fear of hunger response” that causes overeating later, explains Dr. Katz. “Throughout most of our history, we had too little to eat. So when you go for long periods without eating, you stir up all that native programming, which says eat like crazy when you can, because all too often you can’t.” Start with breakfast. Studies show that breakfast-eaters are slimmer than skippers.

Stop eating before you’re full.

The Okinawans, whose average BMI is 21.5 for those who eat a traditional diet, call this hara hachi bu, or eating till you’re 80 percent full. Of course, we’re not suggesting that you leave the table hungry. But eating until the buttons pop stretches the stomach by about 20 percent each time you do it, so you inevitably need more food to feel satisfied, explains Bradley Willcox, MD, co-author of The Okinawa Diet Plan (Random House, 2004). He says that putting your fork down “when you feel that first twinge of fullness” gives your brain a chance to realize that you are full before you overdo it.

Chow down only when you’re hungry.

Americans eat for all sorts of reasons besides hunger, especially from boredom, loneliness, stress or fear, a foreign concept in other cultures. “You can’t make food the solution to every issue in your life and expect to be thin,” says Dr. Katz. “If you eat from boredom, find a hobby. If you eat to relieve stress, learn meditation or yoga.”

Dine with others.

Eating with family or friends vs. alone in your car, at your desk or on the couch is part and parcel of traditional cultures. Not only does camaraderie make the meal more enjoyable, it’s slimming. “Eating with others restrains your own behavior,” notes Dr. Katz. “You eat more slowly, which increases the likelihood that you’ll register when you’re full before you’ve eaten more than you should.”

Have a glass of wine.

A staple of French and Mediterranean tables, wine adds joie to the meal, and because it contains potent antioxidants, is at least partly responsible for why these cultures traditionally have lower rates of cardiovascular disease and mortality despite their higher-fat diets. And while some studies show that we tend to eat more when we imbibe, a Finnish study actually found that male drinkers were leaner than abstainers.

Get moving.

People in Asian countries, France and the Mediterranean tend to be slim because they’re more active. Not that they spend hours at the gym; they simply walk a lot. It can work for Americans too. A study of 200,000 Americans at Rutgers University in New Brunswick, New Jersey, found that city dwellers were six pounds lighter than their suburban counterparts, largely because, instead of driving, they walked more. “You’re not working out,” says Dr. Clower. “You’re just moving.”

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The U.S. FDA has issued an alert on 19 Marc 09 o remind the public that Insulin Pens and Insulin Cartridges Must Not Be Shared.

Originally, this alert was sent to health care professionals reminding them that single-patient insulin pens and insulin cartridges should not be used to administer medication to multiple patients due to the potential risk of transmitting blood-borne pathogens such as HIV and the hepatitis viruses. However, I felt that this is something all diabetic patients should be aware of, so that if it happend to them, they are also well aware of the risks.

What’s the rationale for this alert?
Well, insulin pens are pen-shaped injector devices that contain a disposable needle and either an insulin reservoir or an insulin cartridge. The devices typically contain enough insulin for a patient to self-administer several doses of insulin before the reservoir or cartridge is empty. All insulin pens are approved only for single-patient use (one device for only one patient).

Apparently, the FDA was aware of incidents at two undisclosed hospitals involving more than 2,000 people in which the cartridge component of the insulin pens were used to administer insulin to multiple patients, although the disposable needles were reportedly changed among patients.

“Insulin pens are designed to be safe for one patient to use one pen multiple times with a new, fresh needle for each injection,” said Amy Egan, M.D., deputy director of safety at the FDA’s Division of Metabolism and Endocrinology Products in the Center for Drug Evaluation and Research. “Insulin pens are not designed, and are not safe, for one pen to be used by more than one patient, even if needles are changed between patients due to the risk of transmitting blood-borne pathogens.”

Patients exposed to shared insulin pens are being contacted by the two hospitals and are being offered testing for hepatitis and HIV. Some of the potentially exposed patients have reportedly tested positive for the hepatitis C virus, although it is not known if the virus was spread as a result of insulin pen sharing.

The FDA is working with the Centers for Disease Control and Prevention and professional organizations to address infection control issues related to insulin pens.

For us, as Diabetes patients, please be aware of the risks of sharing insulin catridges. If you see it being done at health care centres, stop the staff immediately and report the incident to the FDA. Also, don’t share the catridges amongst family members. Better safe than sorry!

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Professor Herbert Herzog, Director of the Neuroscience Research Program at

Australia-based Garvan Institute of Medical Research, together with scientists

from the US and Slovakia, have done obesity research which have shown that

neuropeptide Y (NPY), a molecule the body releases when stressed, can

‘unlock’ Y2 receptors in the body’s fat cells, stimulating the cells to grow in

size and number. By blocking those receptors, it may be possible to prevent

fat growth, or make fat cells die.

“We have known for over a decade that there is a connection between chronic

stress and obesity,” said Professor Herzog. “We also know that NPY plays a

major role in other chronic stress-induced conditions, such as susceptibility

to infection. Now we have identified the exact pathway, or chain of molecular

events, that links chronic stress with obesity.”
“There is not much we can do about the increased levels of NPY caused by

stress, but we can do something about the damage it causes. If we can

interfere before it causes fat to amass, it could have a major impact on

cardiovascular disease, diabetes, and cancer (which all have links with

obesity). When we have a stress reaction, NPY levels rise in our bodies,

causing our heart rate and blood pressure to go up, among other things.

Stress reactions are normal, unavoidable, and generally serve a useful

purpose in life. It’s when stress is chronic that its effects become damaging,”

he said.
Scientists at Georgetown University (Washington DC), part of this

collaborative study, have found a direct connection between stress, a high

calorie diet and unexpectedly high weight gain. Stressed and unstressed

mice were fed normal diets and high calorie (high fat and high sugar, or so

called comfort food) diets. The mice on normal diets did not become obese.

However, stressed mice on high calorie diets gained twice as much fat as

unstressed mice on the same diet. The novel and unexpected finding was

that when stressed and non-stressed animals ate the same high calorie

foods, the stressed animals utilized and stored fat differently.
“Our findings suggest that we may be able to reverse or fidn treatments for

obesity caused by stress and diet, including the worst kind of obesity; the

apple-shaped type, which makes people more susceptible to heart disease

and diabetes,” said Professor Zofia Zukowska, the senior author of paper

published in Nature Medicine. “Using animal models, in which we have either

blocked the Y2 receptor, or selectively removed the gene from the abdominal

fat cells, we have shown that stressed mice on high calorie diets do not

become obese. Even more surprisingly, in addition to having flatter bellies,

adverse metabolic changes linked to stress and diet, which include glucose

intolerance and fatty liver, became markedly reduced. We do not know yet

exactly how that happens, but the effect was remarkable,” said Professor

Zukowska.
Professor Herzog believes that these research findings will have a profound

effect on the way society will deal with the obesity epidemic. “There are

millions of people around the world who have lived with high levels of stress for

so long their bodies think it’s ‘normal’. If these people also eat a high fat and

high sugar diet, which is what many do as a way to reduce their stress, they

will become obese. Until now, the pharmaceutical industry has focused on

appetite suppressants with only moderate success. Our hope is that in the

near future pharmaceutical companies, using the results of our research, will

develop antagonists against the Y2 receptor that will bring about a reduction

in fat cells.” . This could be a good approach in finding a treatment for obesity

and the key to obesity prevention.

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