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This cereal is a drug: FDA

Thursday, October 1st, 2009

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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Diet supplements caution

Tuesday, September 29th, 2009

Here’s another alert from the FDA on manufacturers Dietary supplements….

FDA Takes Enforcement Action Against Three New Jersey Dietary Supplement and Protein Powder Manufacturers
Companies failed to declare allergens in products and correct filthy conditions

The U.S. Department of Justice, on behalf of the U.S. Food and Drug Administration, has filed a complaint for permanent injunction against Quality Formulation Laboratories, Inc., American Sports Nutrition Inc., Sports Nutrition International LLC and Mohamed S. Desoky, who oversees operations at all three companies.

The companies, located in Paterson, N.J., manufacture dietary supplements and protein powders and distribute them throughout the United States. The companies also export powder mixes and dietary supplements for sale by private label customers.

The government’s complaint, filed July 1, 2009 in the U.S. District Court of New Jersey, alleges that the companies have failed to follow current Good Manufacturing Practice (GMP) by manufacturing and storing food under filthy conditions and in conditions that may cause major food allergens to enter into products not intended to contain them.

The complaint also alleges that the companies failed to disclose major food allergens on the product labels and have other labeling problems.

During a recent inspection, FDA investigators found that several of the companies’ products contained milk ingredients that were not declared on the product labels. In addition, the company failed to clean processing equipment between batches and control allergens in the facility.

FDA investigators also discovered live and dead rodents and rodent urine, feces and gnaw holes on bags of product.

In three inspections, FDA investigators noted deviations from GMP standards. The companies promised to make corrections, but they failed to do so. The complaint requests a court order to stop the companies and its officer from manufacturing and distributing the products until needed corrections are made.

“This company has consistently failed to correct filthy conditions in their plants and to make sure that allergens are appropriately declared on the labels, despite frequent warnings to do so,” said Michael Chappell, the FDA’s acting associate commissioner for regulatory affairs. “The FDA will not tolerate companies that fail to provide adequate safeguards.”

Consumers with allergies to milk ingredients who have used these products and are experiencing any symptoms should contact their health care professional.

Consumers can report problems with FDA-regulated products to their district office consumer complaint coordinator.

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FDA Issues Pharmaceutical Industry Guidance on Preventing Melamine Contamination

Friday, August 14th, 2009

I was shocked to hear that melamine was found in infant’s milk powder manufactured in China. How can these manufacturers not consider the harm to innocent babies who rely on milk as their only source of nutrition? Not only is this happening in China, the very fact that unscrupulous activities can deceive the public is frightening. Hence, the FDA has taken the right approach not to assume anything. Here’s the latest excerpt from FDA on this matter…..


In a guidance issued 6 Aug 2009, the U.S. Food and Drug Administration says that certain pharmaceutical ingredients used in the manufacture or preparation of drug products should be tested for melamine.

Melamine is a synthetic chemical with a variety of industrial uses including the production of resins and foams, cleaning products, fertilizers and pesticides. If ingested in sufficient amounts, melamine can result in kidney failure and death.

Although the FDA has no reason to believe that the U.S. pharmaceutical supply is contaminated with melamine, recent events involving pet and livestock food products in the United States, and milk products for infants in China, underscore the potential problem.

The guidance is an initial measure by the agency in working with pharmaceutical manufacturers, repackers, other suppliers and pharmacists to conduct melamine testing. The agency invites comments on the guidance, available online and titled “Guidance for Industry: Pharmaceutical Components At Risk for Melamine Contamination“.

“The FDA urges implementation of appropriate controls to assure consumers that melamine contamination will not happen in the pharmaceutical supply chain,” said Commissioner of Food and Drugs Margaret A. Hamburg, M.D. “We look forward to working with industry on this serious public health concern.”

The FDA identifies specific pharmaceutical ingredients in the guidance that are recommended to be screened for the presence of melamine. The guidance also recommends the use of FDA-published methods for this testing that are used to detect the presence of melamine in food proteins. These tests rely on equipment that is generally available to pharmaceutical manufacturers or contract testing labs. The agency also is developing a sampling and testing program for pharmaceutical ingredients at risk for melamine contamination.

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FDA: Tuna Salad Sandwiches, Other Products Seized at Louisiana Company

Sunday, August 9th, 2009

Here’s some shocking news about unsanitary conditions which I would like to share….. here’s what the FDA article on 7 August 2009 states:

At the request of the U.S. Food and Drug Administration, U.S. Marshals today seized tuna salad sandwiches and other food products from Bearden Sandwich Company Inc., doing business as Southern Belle Sandwich Company, in Baton Rouge, La.

The seized products, totaling more than $72,000, violate the Federal Food, Drug, and Cosmetic Act because the products have been prepared, packed, and held under unsanitary conditions whereby they may have become contaminated with filth or rendered injurious to the public’s health (the Act uses the term “insanitary” to describe such conditions). In addition, the tuna fish salad sandwiches were processed under conditions that violate Seafood Hazard Analysis Critical Control Point (HACCP) regulations.

“When FDA investigators find violations inside a company’s facility, we will do what is necessary to keep insanitary and potentially harmful products out of consumers’ hands,” said Michael Chappell, the FDA’s acting associate commissioner for regulatory affairs. “Companies that are not complying with our laws will be subject to enforcement actions.”

Recent FDA inspections found evidence of widespread and active rodent and insect infestation, filthy conditions, and poor employee practices, such as allowing food-processing utensils to lie on the floor near live insects.

The company distributes products to convenience and retail stores in southern Louisiana; Mobile, Ala.; Montgomery, Ala.; and Crestview, Fla.

The FDA has not received reports of illnesses associated with consumption of the products. The FDA urges consumers who may have purchased the products to dispose of them in a safe manner and wash their hands thoroughly after handling the products. “Safe disposal” means avoiding bare-hand contact with the recalled products, discarding them in a way that will not allow people and pets to retrieve them, and washing items that came in contact with the products, including hands, with warm, soapy water.
Consumers can also report problems, including adverse reactions, to the FDA district office consumer complaint coordinator.

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Eat What You Love: Mix It Up and Lose Weight

Thursday, March 26th, 2009

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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