Tag: FDA

Erythritol

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Erythritol is a naturally-derived sugar substitute that looks and tastes very much like sugar, yet has almost no calories. It comes in granulated and powdered forms.

Erythritol has been used in Japan since 1990 in candies, chocolate, yogurt, fillings, jellies, jams, beverages, and as a sugar substitute.

Erythritol is classified as a sugar alcohol. Sugar alcohols, also called polyols, are sugar substitutes that are either extracted from plants or manufactured from starches. Some of the more common sugar alcohol sweeteners are sorbitol and xylitol.

Sugar alcohols also occur naturally in plants. Erythritol is found naturally in small amounts in grapes, melons, mushrooms, and fermented foods such as wine, beer, cheese, and soy sauce.

Erythritol is a natural sugar alcohol (a type of sugar substitute) which has been approved for use in the United States and throughout much of the world. It occurs naturally in fruits and fermented foods . At industrial level, it is produced from glucose by fermentation with a yeast, Moniliella pollinis. It is 60-70% as sweet as table sugar yet it is almost non-caloric, does not affect blood sugar, does not cause tooth decay, and is absorbed by the body, therefore unlikely to cause gastric side effects unlike other sugar alcohols. Under U.S. Food and Drug Administration (FDA) labeling requirements, it has a caloric value of 0.2 calories per gram (95% less than sugar and other carbohydrates), but some countries like Japan label it at 0 calories. European legislation actually considers it at 2.4 kcal/g but pending discussion will certainly achieve a 0 kcal/g caloric value by 2009.

Erythritol and human digestion
In the body, erythritol is absorbed into the bloodstream in the small intestine, and then for the most part excreted unchanged in the urine. Because erythritol is normally absorbed before it enters the large intestine, it does not normally cause laxative effects as are often experienced after over-consumption of other sugar alcohols (such as xylitol and maltitol) and most people will consume erythritol with no side effects. This is a unique characteristic, as other sugar alcohols are not absorbed directly by the body in this manner, and consequently are more prone to causing gastric distress .

As a whole, erythritol is generally free of side-effects in regular use, but if consumed in very extreme quantities (sometimes encouraged by its almost non-caloric nature), effectively consuming it faster than one’s body can absorb it, a laxative effect may result. The laxative response does not begin until you cross your body’s natural absorption threshold, which is the point at which you have ingested more erythritol than is found in reasonable servings of food products and is usually a larger amount than most people will eat in a single sitting. Erythritol, when compared with other sugar alcohols, is also much more difficult for intestinal bacteria to digest, so it is unlikely to cause gas or bloating [5], unlike maltitol, sorbitol, or lactitol. Allergic side effects can be itching with hives.

How is Erythritol Made?
Erythritol is usually made from plant sugars. Sugar is mixed with water and then fermented with a natural culture into erythritol. It is then filtered, allowed to crystallize, and then dried. The finished product is white granules or powder that resembles sugar.

How Sweet is Erythritol?
Erythritol is approximately 70 percent as sweet as table sugar (sucrose). Some manufacturers, however, claim that their erythritol products are as sweet as sugar.

Physical properties

Heat of solution
Erythritol has a strong cooling effect (positive heat of solution when it dissolves in water, often combined with the cooling effect of mint flavors, but proves distracting with more subtle flavors and textures. The cooling effect is only present when erythritol is not already dissolved in water, a situation that might be experienced in an erythritol-sweetened frosting, chocolate bar, chewing gum, or hard candy. When combined with solid fats, such as coconut oil, cocoa butter or cow’s butter, the cooling effect tends to accentuate the waxy characteristics of the fat in a generally undesirable manner. This is particularly pronounced in chocolate bars made with erythritol. The cooling effect of erythritol is very similar to that of xylitol and among the strongest cooling effects of all sugar alcohols.

Blending for sugar-like properties:
Beyond high intensity sweeteners, erythritol is often paired with other bulky ingredients that exhibit sugar-like characteristics to better mimic the texture and mouthfeel of sucrose. Often these other ingredients are responsible for the gastric side effects blamed on erythritol. The cooling effect of erythritol is rarely desired, hence other ingredients are chosen to dilute or even negate that effect. Erythritol also has a propensity to crystallize and is not as soluble as sucrose, so ingredients may also be chosen to help negate this disadvantage. Furthermore, erythritol is non-hygroscopic, meaning it does not attract moisture, which can lead to products, particularly baked goods, drying out if another hygroscopic ingredient is not used in the formulation.

Very commonly, inulin is combined with erythritol, due to inulin offering a complementary negative heat of solution (warming effect when dissolved that helps cancel erythritol’s cooling effect) and non-crystallizing properties. Unfortunately, inulin has a propensity to cause gas and bloating when consumed in moderate to large quantities, particularly in individuals unaccustomed to it. Other sugar alcohols are sometimes utilized with erythritol, particularly isomalt due to its minimally positive heat of solution, and glycerin which has a negative heat of solution, moderate hygroscopicity, and non-crystallizing liquid form.

Erythritol and bacteria:
Erythritol has been certified as tooth-friendly[7]. The sugar alcohol cannot be metabolized by oral bacteria, and so does not contribute to tooth decay. Interestingly, erythritol exhibits some, but not all, of the tendencies to “starve” harmful bacteria like xylitol does. Unlike xylitol, erythritol is actually absorbed into the bloodstream after consumption but before excretion. However, it is not clear at present if the effect of starving harmful bacteria occurs systemically.

Resources:
http://en.wikipedia.org/wiki/Erythritol
http://altmedicine.about.com/cs/herbsvitaminsa1/a/Bee_propolis.htm

Tags Business, FDA, Food and Related Products, Sugar, Sugar substitute, Sweeteners, United States, US Food and Drug Administration

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How Safe is Stevia

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The sweetener is banned from food products in the U.S. due to toxicity fears. But the findings of several recent studies suggest otherwise.

Stevia followers are a diverse bunch, including health nuts and food-industry magnates. The draw? The sweetener is all-natural and naturally calorie-free. But “natural” doesn’t necessarily mean safe, and scientists have long struggled to make sense of early evidence hinting that stevia could be toxic. A series of studies published last month in the journal Food and Chemical Toxicology put that question to the test for one type of stevia-based sweeteners.

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Stevia, a South American shrub, has leaves up to 300 times sweeter than table sugar. Extracts have been available as a dietary supplement since 1995. It’s a popular food additive in Japan, Brazil and its native Paraguay, but in the U.S., where the Food and Drug Administration has determined there isn’t sufficient proof it’s nontoxic, stevia is banned from such uses. (Exceptions are made for food and drink items billing themselves as dietary supplements, such as the stevia-sweetened diet drink Zevia.)

FOR THE RECORD:
Stevia sweeteners: An article in Monday’s Health section about no-calorie sweeteners derived from the plant stevia said supermarket sales tests of stevia-derived rebaudioside A (sold as Truvia) were being conducted in New York with the blessing of the Food and Drug Administration. Permission from the FDA was not required for Truvia to be sold. However, Truvia is the subject of an FDA review process that will determine whether the product is safe and allowed to remain on the market. —

The sponsors of the recently published studies — food manufacturer Cargill and the Coca-Cola Co. — hope that in light of recent findings, the agency will reconsider its position on the calorie-free sweetener.

Scientists began studying stevia in the lab roughly 40 years ago, and the first findings gave food safety officials in several countries pause. A 1968 study in female rats showed that drinking a concoction of stevia leaves and stems significantly reduced fertility. A 1985 study, published in the Proceedings of the National Academy of Sciences, showed that steviol, a breakdown product of stevia, might cause genetic mutations. (In Paraguayan traditional medicine, stevia is used to lower blood sugar and as a contraceptive.)

Evidence of genetic and reproductive toxicity was sufficient to inspire a ban on the sweetener in the U.S. since the 1970s. (The 1994 Dietary Supplement Health and Education Act made it legal to sell stevia as a dietary supplement only, as long as it’s not an ingredient in food.) But the research on which the FDA based its long-ago decision may now be out of date. In the last decade, countless studies have revisited stevia, often using purer extracts.

The more-recent research has largely focused on purified forms of the two main chemicals responsible for the stevia plant’s sweetness: stevioside and rebaudioside A. Findings from some studies — still few in number — have resulted in a perhaps overstated claim: that stevia lowers blood pressure.

For example, a 2000 study of 100 adults in Taiwan showed that 250 milligrams of stevioside a day lowered subjects’ blood pressure by 8% to 12% within three months. A 2003 Chinese study in which nearly 170 adults were given 1,500 mg of stevioside daily in three 500 mg doses also reported that subjects’ blood pressure went down. (Both doses are far greater than the amount of stevioside in the few grains of powdered stevia it takes to sweeten a cup of tea.)

Authors of a 2006 report by the World Health Organization acknowledged the promise of the blood pressure studies. The authors also reviewed the dozens of lab and animal studies that had been done on stevioside and rebaudioside A in recent years — and concluded that the compounds appear unlikely to harm DNA or the reproductive system.

The eight studies published in Food and Chemical Toxicology last month went even further. One report showed no reproductive toxicity in rats exposed to the sweetener for two generations, and two human studies showed that 1,000 mg of rebaudioside A per day was safe for healthy adults as well as those with Type 2 diabetes. Rebaudioside A (dubbed Rebiana by Coca-Cola and Cargill) is “safe for human consumption,” three of the study authors wrote. They did not report on stevioside.

These latest findings — should the FDA find them compelling — may be good news for food manufacturers, which have long sought a natural zero-calorie sugar alternative to market to the calorie-conscious public.

But some aren’t convinced it’s good news for consumers just yet. Michael Jacobson, executive director of the Center for Science in the Public Interest Group, a Washington, D.C.-based nutrition advocacy group, said the research still hasn’t quelled concerns about stevia’s genetic toxicity. Although dozens of studies have shown stevia compounds to be harmless, a handful suggest it can damage genetic material. “It’s a warning flag,” he said.

Jacobson added that genetic toxicity may turn out to be attributable to a specific species or component of stevia. Cargill, meanwhile, is certain that at least one stevia component is safe. Rebaudioside A, under the brand name Truvia, is already on store shelves in New York as a test, with the FDA’s blessing. Consumers can expect to see it across the country this fall — if the FDA agrees.

Sources: Los Angles Times

Tags Dietary supplement, FDA, Food and Drug Administration, Stevia, United States, US, US Food and Drug Administration, World Health Organization

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Do Arthritis Drugs Cause Cancer?

Post author By Mukul
Post date June 30, 2008
No Comments on Do Arthritis Drugs Cause Cancer?

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The U.S. Food and Drug Administration (FDA) is investigating whether four drugs used to treat rheumatoid arthritis and other immune system diseases might increase the risk of cancer in children.

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The FDA has received reports of 30 cases of cancer among children and young adults treated with the drugs. The agency did not make clear how many children had taken the drugs.

The drugs involved are:

1. Enbrel, sold by Amgen and Wyeth
2. Remicade, sold by Johnson & Johnson and Schering-Plough
3. Humira, sold by Abbott Laboratories
4. Cimzia, sold by the Belgian company UCB

All of the drugs block a protein called tumor necrosis factor, and are therefore known as TNF-blockers. They are used to treat not only rheumatoid arthritis but also psoriasis, Crohn’s disease and other immune diseases.

Because the drugs block part of the immune system, it’s long been known that they might contribute to a higher risk of cancers and infections. The drugs’ labels contain warnings as such, including warning about a risk of lymphomas, which are cancers of immune system cells.

Among adults, meanwhile, one study found that those given Humira or Remicade to treat rheumatoid arthritis had 2.4 times the cancer rate of those in control groups.

Sources: New York Times June 5, 2008

Tags Abbott Laboratories, Adalimumab, Certolizumab pegol, Crohn, Crohn's disease, FDA, Food and Drug Administration, Humira, Johnson & Johnson, New York Times, Remicade, Schering-Plough, Tumor necrosis factors

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FDA Forced to Admit That Mercury Fillings are Hazardous

Post author By Mukul
Post date June 29, 2008
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If you’re like most people, you probably have cavities that have been filled with metal or a silver-mercury amalgam. While you probably recognize that such fillings are unattractive in your smile, you might not realize that they’re hazardous to your teeth.

Silver-mercury fillings react to temperature changes, expanding and contracting within your delicate tooth. This movement can weaken the tooth, causing it to break. It can also create a space between the tooth surface and filling that allows bacteria to enter, causing decay.

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Old, broken mercury fillings were replaced with beautiful, strong Porcelain onlays.

The U.S. Food and Drug Administration (FDA) has finally admitted that metal dental fillings containing mercury can cause health problems in pregnant women, children and fetuses.
As part of the settlement of a lawsuit filed by several consumer advocacy groups, the FDA agreed to alert consumers about the potential risks on its Web site and to issue a more specific rule next year for fillings that contain mercury.

The FDA’s Web site now states that: “Dental amalgams contain mercury, which may have neurotoxic effects on the nervous systems of developing children and fetuses.”

Charles Brown, a lawyer for advocacy group Consumers for Dental Choice, said the agency’s move represented an about-face. According to Brown, “Gone, gone, gone are all of FDA’s claims that no science exists that amalgam is unsafe … The impact of the re-writing of its position on amalgam can hardly be understated. FDA’s website will no longer be cited by the American Dental Association in public hearings.”

You may click to see:->Mercury in your brain from amalgam fillings in your mouth.

>Amalgam Fillings: They are Hazardous to Your Health

Sources:

* eMax Health

* Reuters June 4, 2008

Tags Amalgam (dentistry), American Dental Association, Consumers for Dental Choice, Dental restoration, FDA, Food and Drug Administration, United States Environmental Protection Agency, US Food and Drug Administration

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Salmonella Scare Over US Tomatoes

Post author By Mukul
Post date June 10, 2008
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Supermarkets and restaurants in the US have stopped selling certain types of tomatoes because of salmonella fears.

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US officials have warned against Roma, round and plum red tomatoes

The US Food and Drug Administration (FDA) is still searching for the source of an outbreak that has affected at least 145 people in some 17 states.

The FDA has warned against eating raw plum, round or Roma red tomatoes unless they are from certain states or abroad.

McDonald’s, Burger King and Taco Bell are among the chains to have stopped serving those types of tomatoes.

Cherry and grape tomatoes and those sold with the vine still attached have not been associated with the outbreak.

Home-grown tomatoes are also safe to eat raw, US officials say.

Symptoms of salmonella, which usually appear within 12 to 72 hours of eating contaminated food, include diarrhoea, nausea and vomiting, headaches, stomach cramps and fever.

Full recovery

The US Centers for Disease Control and Prevention said on Saturday there had been 145 reported cases – all caused by the same unusual type of the bacteria, salmonella saintpaul – since mid-April.

The illness has struck most often in New Mexico and Texas.

At least 23 people have been treated in hospital in the present outbreak but no-one has died as a direct result of infection.

The giant US chain Wal-Mart is among a number of US supermarkets to pull the types of tomato under suspicion from its shelves.

Tomatoes that have not been associated with the outbreak come from US states that include Arkansas, California, Georgia, Hawaii, North and South Carolina, Tennessee and Texas.

The symptoms of salmonella can last for several days, but most people make a full recovery within a week.

Those most at risk of developing severe illness are the elderly, infants and people with weakened immune systems.

Sources: BBC NEWS:June 10. ’08