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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The U.S. Food and Drug Administration today approved the 4 milligram maximum dose of Livalo (pitavastatin), a drug intended to improve blood cholesterol levels in persons with elevated or abnormal blood cholesterol levels.

Like other statins, Livalo is intended for patients when diet and exercise fail to lower their cholesterol levels. Statins improve elevated blood cholesterol levels primarily by inhibiting a liver enzyme called HMG Co-A reductase, thus reducing the liver’s ability to make cholesterol.

“Elevated or abnormal cholesterol levels are associated with an increased risk for heart disease and stroke,” said Eric C. Colman, M.D., deputy director, Division of Metabolism and Endocrinology Products, in the FDA’s Center for Drug Evaluation and Research. “Today’s approval offers patients and their health care professionals another alternative way to treat high cholesterol.”

Livalo was approved on the basis of five clinical trials comparing its efficacy and safety to that of three currently marketed statins.

The most frequently reported adverse reactions from taking Livalo were muscle pain, back pain, joint pain and constipation.

Livalo is manufactured by Kowa Pharmaceuticals America Inc. of Montgomery, Ala.

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I found this article amusing enough to post……

WASHINGTON - POPULAR US breakfast cereal Cheerios is a drug, at least if the claims made on the label by its manufacturer General Mills are anything to go by, the US Food and Drug Administration (FDA) has said.

‘Based on claims made on your product’s label, we have determined that your Cheerios Toasted Whole Grain Oat Cereal is promoted for conditions that cause it to be a drug,’ the FDA said in a letter to General Mills which was posted on the federal agency’s website on Tuesday.

Cheerios labels claim that eating the cereal can help lower bad cholesterol, a risk factor for coronary heart disease, by four per cent in six weeks.

Citing a clinical study, the product labels also claim that eating two servings a day of Cheerios helps to reduce bad cholesterol when eaten as part of a diet low in saturated fat and cholesterol, the FDA letter says.

Those claims indicate that Cheerios - said by General Mills to be the best-selling cereal in the United States - is intended to be used to lower cholesterol and prevent, lessen or treat the disease hypercholesterolemia, and to treat and prevent coronary heart disease.

‘Because of these intended uses, the product is a drug,’ the FDA concluded in its letter. Not only that, but Cheerios is a new drug because it has not been ‘recognized as safe and effective for use in preventing or treating hypercholesterolemia or coronary heart disease,’ the FDA said.

That means General Mills may not legally market Cheerios unless it applies for approval as a new drug or changes the way it labels the small, doughnut-shaped cereal, the FDA said.

General Mills defended the claims on Cheerios packaging, saying in a statement that Cheerios’ soluble fiber heart health claim has been FDA-approved for 12 years, and that its ‘lower your cholesterol four percent in six weeks’ message has been featured on the box for more than two years. The FDA’s quibble is not about whether Cheerios cereal is good for you but over ‘how the Cheerios cholesterol-lowering information is presented on the Cheerios package and website,’ said General Mills.

‘We look forward to discussing this with FDA and to reaching a resolution.’ Meanwhile, the FDA warned in its letter that if General Mills fails to ‘correct the violations’ on its labels, boxes of Cheerios could disappear from supermarket and wholesaler shelves around the United States and the company could face legal action.

According to General Mills, one in eight boxes of cereal sold in the United States is a box of Cheerios. The cereal debuted on the US market in 1941. — AFP

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It is a well known fact that people use supplements in their quest for the perfect body….but the article below from the FDA  serves as a reminder that some supplements can cause more harm than good. Feel free to send it to anyone whom you think will benefit from this information…

Agency issues Warning Letter to American Cellular Laboratories for marketing and distributing potentially harmful steroid-containing products

The U.S. Food and Drug Administration today issued a Public Health Advisory (PHA) warning consumers to stop using body building products that are represented as containing steroids or steroid-like substances. Many of these products are marketed as dietary supplements.

The agency also issued a Warning Letter to American Cellular Laboratories Inc. for marketing and distributing body building products containing synthetic steroid substances. Although these products are marketed as dietary supplements, they are not dietary supplements, but instead are unapproved and misbranded drugs.

The PHA notifies consumers and health care professionals that the FDA has received reports of serious adverse events associated with the use of body building products that claim to contain steroids or steroid-like substances. Those adverse events include cases of serious liver injury, stroke, kidney failure and pulmonary embolism (artery blockage in the lung). The PHA also advises consumers to stop taking body building products from any manufacturer that claim to contain steroid-like substances or to enhance or diminish androgen-, estrogen-, or progestin-like effects in the body.

The FDA has received five adverse event reports, including serious liver injury, in men taking products marketed as dietary supplements by American Cellular Laboratories including TREN-Xtreme and MASS Xtreme. Acute liver injury is generally known to be a possible side effect of using products that contain anabolic steroids. Some of the cases resulted in hospitalization, but there were no reports of death or acute liver failure.

“Products marketed for body building and claiming to contain steroids or steroid-like substances are illegal and potentially quite dangerous,” said Commissioner of Food and Drugs Margaret A. Hamburg, M.D. “The FDA is taking enforcement action today to protect the public.”

The products listed in the Warning Letter to American Cellular Laboratories Inc.,  include “TREN-Xtreme,” “MASS Xtreme,” “ESTRO Xtreme,” “AH-89-Xtreme,” “HMG Xtreme,” “MMA-3 Xtreme,” “VNS-9 Xtreme,” and “TT-40-Xtreme,” and are sold on the Internet and in some stores. These products, which claim to contain steroid-like ingredients but in fact contain synthetic steroid substances, are unapproved new drugs because they are not generally recognized as safe and effective.  In addition, the products are misbranded because the label is misleading and does not provide adequate directions for use.

Consumers taking body building supplements that claim to contain steroids or steroid-like substances should stop taking them immediately. Consumers should also consult a health care professional if they suspect they are experiencing problems associated with the products. Health care professionals and consumers are encouraged to report adverse events that may be related to the use of these types of products to the FDA’s MedWatch Program by phone at 1-800-FDA-1088 or by fax at 1-800-FDA-0178 or by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787.

To view the Public Health Advisory:
http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm173935.htm

To view the July 27, 2009 Warning Letter to American Cellular Laboratories Inc., and the FDA consumer article on body building products marketed as containing steroids or steroid-like substances:
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm173965.htm

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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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