How can I reach the FDA or another government agency about my concerns?

Various state and federal agencies employ personnel who can help respond to concerns or questions about adverse reactions. Following is contact information for some of the agencies:

How can I report an adverse event?

FDA’s Center for Food Safety and Applied Nutrition (CFSAN) has an Adverse Event Reporting System (CAERS) that can be contacted in any of the following ways:

You can contact FDA’s MedWatch Program in any of the following ways:

For Non-emergencies related to products purchased via internet, fill out an online form on FDA’s website at vm.cfsan.fda.gov/~dms/qa-top.html (see link to “form to report unlawful Sales”)

You may also contact any local poison control center, local or state health agencies, the department of Health and Human Services, the Federal Trake Commision, the Consumer Products safety Commission, or the Centers for Disease Control and Prevention, and t hey will forward your report to the FDA.

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Vitanet ®

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Date: June 25, 2005 09:56 AM
Author: Darrell Miller (dm@vitanetonline.com)
Subject: HERBAL FORMS

HERBAL FORMS

Fresh Rub: A fresh clove of garlic can be used directly on warts and verrucae. When added to the diet, it works as a prophylactic against infection, helps to reduce high blood cholesterol and improves the cardiovascular system. Eating garlic regularly can also help to lower blood sugar levels.

Juice: Garlic juice can be taken for digestive disorders, infectious diseases and for atherosclerosis (hardening of the arteries). Capsules: Powdered garlic can be taken in capsules and can be purchased in deodorized form. Garlic capsules are a convenient way to supplement the diet with garlic and are good for heart disease, high blood pressure and to fight infections of any kind. Pearls: Pearls are capsulized garlic oil which have been deodorized and are sometimes used as an alternative to the capsules.

(Note: Garlic pearls which have been deodorized are sometimes less potent in their biochemical action. Garlic’s strong, pungent odor compounds are excreted through the lungs and the skin. Eating fresh parsley and lemon juice can help to neutralize garlic odor on the breath.)

Maceration: Garlic cloves can be steeped in water overnight and taken as a treatment for intestinal parasites. Aged Oil: Considered by some to be a superior form of garlic. Storage: Fresh garlic can be stored in a cool, dry, dark place. Garlic extracts and oils should be kept in dark bottles and can be refrigerated.

Regulatory Status
US: generally recognized as sage
UK: general Sales list
Canada: over-the-counter drug status
France: traditional medicinal use
Germany: commission E approved as over-thecounter drug

Recommended Usage: Garlic pills and extracts should be taken as recommend on their labels. If using garlic in cooked form, it can be eaten abundantly. Raw garlic is stronger and should not be eaten indiscriminately as gastric upset might occur. Capsules and pills are best taken with meals.

Safety: Garlic is considered safe when taken in reasonable amounts however it is very heating and when ingested in excess can irritate the stomach. Taken in therapeutic doses during pregnancy or while nursing may cause some gastric upset. Placing fresh, raw garlic or garlic oil directly on the skin may also cause irritation or contact dermatitis. When using garlic externally, apply a layer of olive oil to the skin first.

Very high dosages of garlic tincture have been known to cause leukocytosis. Garlic does not have to be consumed raw to be effective. Moreover, the typical odor of garlic does not always have to be present in order for it to still posses health benefits. If you experience side effects such as a burning sensation when urinating, heartburn, flatulence or belching, you may want to use a processed garlic extract. To avoid garlic breath, deodorized forms of garlic are available. If taken properly, the safety and efficacy of garlic has been well established.

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Date: June 24, 2005 01:07 PM
Author: Darrell Miller (dm@vitanetonline.com)
Subject: Echinacea

ECHINACEA (Echinacea angustifolia)

Common Names: Black Sampson, Purple Coneflower, Rud beckia , Missouri Snakeroot, Red Sunflower

Plant Parts: roots, rhizome

Active Compounds: echinacoside, polysaccharides (echinacin), antibiotic polyacetylenes, betaine, caffeic acid glycosides, inulin, isobutyl amides, ess ential oil (humulene, caryophylene), isobutyl-alkylamines, resin, flavonoids (in leaves and stems), sesquiterpene esters (echinadiole, epoxy - echinadiole, echinax-anthole, and dihydor-xynardole). Pharmacology: Echinacea contains a variety of chemical compounds which have significant pharmacological functions. It has been the subject of hundreds of clinical and scientific studies which have primarily used an extract of the plant portion of the botanical. The rich content of polysaccharides and phytosterols in echinacea are what make it a strong immune system stimulant. The sesquiterpene esters also have immunostimulatory effects. Glycoside echinacoside is found in the roots of the plant. Echinacin has also been found to possess anti-fungal and antibiotic properties. This component of echinacea also has cortisone-like actions which can help promote the healing of wounds and helps to control the inflammatory reactions of allergies.

Vitamin and Mineral Content: vitamins A, E, C, iron, iodine, copper, sulphur and potassium

Regulatory Status

US: None
UK: General Sales List
CANADA: Over-the-Counter drug status
FRANCE: None
GERMANY: Commission E approved as drug

Recommended Usage: Echinacea works best if it is taken right at the onset of an infection in substantial doses and then tapere d off. It can be used in higher quantities as a preventative during winter months when colds and flu are prevalent. If using it to maintain the immune system, periodic use is believed to be more effective than continual usage. Typically, one should use echinacea for seven to eight weeks on followed by one week off. Guaranteed potency echinacea is currently available in capsule form only. Safety: High doses can occasionally cause nausea and dizziness. Echinacea has not exhibited any observed toxicity even in high dosages. Anyone who is suffering from any type of kidney disorder should restrict taking echinacea to one week maximum. Very heavy use of echinacea may temporarily cause male infertility.

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Vitanet ®

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Date: June 14, 2005 11:05 AM
Author: Darrell Miller (dm@vitanetonline.com)
Subject: Your Healthy Harvest

Your Healthy Harvest by Marjorie Flakowitz Energy Times, August 15, 2004

Once frowned on by conventional farmers, organic food has won respect from everyone concerned about the health of both the earth and the people who inhabit it.

Today, organic farming is considered one of the most rapidly growing areas of American agriculture. Organic foods Sales topped $9 billion in 2002 and grew about 20%, up to almost $11 billion in 2003 (Organic Trade Association).

So when you buy organic, you join an expanding market that takes advantage of great-tasting, good-for-you food. Long ago, when the practice of farming was first devised, all farming was organic farming. So today's organic movement is bringing farming back to its roots.

But, safe to say, that is not what's motivating most consumers. A main reason for the popularity of organic food derives from the reassurance that organic foods, raised without artificial chemicals and pesticides, cut your exposure to toxic residues. A growing body of research shows organic food is richer in beneficial natural substances, too.

" Organic food and organic farming represent a philosophy that goes beyond just the quality of the food," says Steve Meyerowitz in The Organic Food Guide (Globe Pequot). "It strives to maintain the integrity of the entire food chain-plants, soil, air, water, animals and people. We are all part of the same ecosystem."

By eating organic, you eliminate pollution both from your body and the earth. Because our bodies are made of the animal and plant products we consume, our internal, physiological ecosystem and the earth's environment are inexorably entwined.

Chilling Arctic Evidence

As evidence of this connection, consider what's happened in the Arctic. Researchers who have analyzed Arctic water, ice, snow, soil and plants have found that chemicals used in farming and industry in other parts of the world have traveled north and accumulated in alarming quantity. How and if these chemicals break down depends on sunlight and the amount of organic matter contained in Arctic waters (American Chemical Society, 9/11/03).

" Once pollutants enter the water column, their behavior is poorly understood-particularly the processes that govern their lifetime and concentrations," says Amanda Grannas, PhD, a researcher at Ohio State University. "Such pollutants are now being found in wildlife, from fish to seals to whales, and even in people living in the Arctic."

Dr. Grannas and others looked at the pesticides lindane and hexachlorobenzene (HCB), two chemicals that have migrated to Arctic waters. Lindane is used by American farmers to treat seeds before they are planted. HCB, banned in the US in 1984, is still used in other countries to protect wheat from fungus.

The scientists found that sunlight at the top of Arctic waterways can help break down some pesticides. At lower depths, however, cut off from the sun's rays, pesticides can remain largely intact. In this research, lindane proved to persist much more readily than HCB.

" Lindane is one of the most persistent of pollutants," warns Dr. Grannas. "This could be because it's photochemically inert, whereas pollutants like HCB degrade relatively quickly. The main message is that pollutants can behave quite differently. These pollutants already affect local ecosystems, and could have repercussions for human health."

Organics Means More Benefits

Researchers are also finding that organic produce contains larger quantities of beneficial natural chemicals. For instance, one study (Journal of Agriculture and Food Chemistry 2/26/03) showed that berries and corn grown organically can have almost 60% more polyphenolics. Polyphenolics are antioxidants plants use for protection against disease and which are good for humans. Researchers believe that when crops are grown conventionally, protected by pesticides and herbicides, they produce fewer of these substances. " This really opens the door to more research in this area," says Alyson Mitchell, PhD, assistant professor of food science at University of California at Davis, who led the research.

These scientists compared levels of total polyphenolics and vitamin C content in marionberries (a type of blackberry) and corn grown organically, sustainably or conventionally, and also looked at chemicals in strawberries grown either sustainably or conventionally. (Sustainable farming falls between the organic and conventional methods, and concentrates on farming that's self-sufficient-for example, feeding cows hay you've grown yourself, and then using the cows' manure to fertilize another crop.) They found that organic marionberries and corn had 50% to 58% more polyphenolics. The sustainably grown strawberries had 19% more polyphenolics. And all the organic produce contained more vitamin C.

Self-Defense for Plants

According to Dr. Mitchell, the organic crops contained the high levels of polyphenolics you'd expect to find in wild plants, suggesting that, on conventional farms, pesticides reduce the necessity for plants to make these protective, natural chemicals. " If an aphid is nibbling on a leaf, the plant produces phenolics to defend itself," she says. "[P]henolics guard the plant against these pests."

Pesticides kill insects like aphids and thereby reduce the antioxidants produced by the plant. " This helps explain why the level of antioxidants is so much higher in organically grown food," Mitchell says. "By synthetically protecting the produce from these pests, we decrease their need to produce antioxidants. It suggests that maybe we are doing something to our food inadvertently.

" We know [polyphenolics] are beneficial [to human health], but we don't know what types of polyphenolics are beneficial, or in what quantities," Dr. Mitchell notes. " Originally, the question was just really intriguing to me. I found that the higher level of antioxidants is enough to have a significant impact on health and nutrition, and it's definitely changed the way I think about my food."

Vitamin C in Oranges

Meanwhile, nutritional research on the vitamin C in oranges turns up similar results: organic oranges are richer in this antioxidant nutrient than conventionally grown oranges (Great Lakes Regional Meeting, American Chemical Society, 6/2/02).

The more common supermarket oranges are significantly larger than organically grown oranges, and they have a deeper orange color. Because of their larger size, "we were expecting twice as much vitamin C in the conventional oranges," says Theo Clark, PhD, chemistry professor at Truman State University in Kirksville, Missouri.

But when he isolated the chemicals in the oranges and further refined his search with nuclear magnetic resonance (NMR), spectroscopy demonstrated that organically grown oranges possess 30% more vitamin C than the conventionally grown fruits-even though they are only about half as large.

Dr. Clark isn't sure why organic oranges are richer in vitamin C, but he says, "...[W]e speculate that with conventional oranges, [farmers] use nitrogen fertilizers that cause an uptake of more water, so it sort of dilutes the orange. You get a great big orange but it is full of water and does not have as much nutritional value.

" However, we can only speculate. Other factors such as maturity, climate, processing factors, packaging and storage conditions require consideration." Along with analyzing oranges, Dr. Clark and his research team questioned about 70 people to measure their concept of the nutritional value of organic oranges. In this survey, 85% of the respondents thought that organic oranges have a higher nutritional content than conventionally grown fruit.

Dr. Clark's laboratory work shows that "they were right on." In Dr. Clark's view, these issues are important because consumers have a right to know the real nutritional content of organic produce, and the fact that analyses show that organic fruit has much more vitamin C validates the benefits of eating organic.

Defense Mechanism

Both plants and animals protect themselves from disease with many of the same chemicals. The natural substances that, in a farmer's field, defend vegetables from insects and microbes before they are harvested for your dinner go to work defending your body after you eat and digest them.

When you eat organic you bolster your health with more of these natural wonders. No wonder organic is becoming so popular!

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Vitanet ®

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Date: June 13, 2005 03:52 PM
Author: Darrell Miller (dm@vitanetonline.com)
Subject: Home on the Range

Home on the Range

by Janis Jibrin, RD Energy Times, September 5, 1999

Got chicken? Americans can't seem to get enough of this bird. Last year each of us ate, on average, just about 80 pounds of chicken, a whopping increase over the 49 pounds we each devoured in 1980 and an eight-pound increase from 1995. Part of this food's popularity comes from its lean image as a healthier, less fatty alternative to red meat (don't forget to take the fatty skin off). Chicken's also a cheap protein source: At many popular supermarkets you'll find weekly specials at about a dollar a pound.

But at health food markets, chicken can cost upwards of $1.69 a pound. These birds may be touted as raised in an organic, stress-free environment and on a vegetarian diet, free of antibiotics. For many people, this poultry is a better buy.

The Alternative Chicken

Most of the supermarket chicken you pick up in grocery refrigerated cases are broilers, birds bred to mature in about eight weeks. In comparison, in the '60s, chickens needed 14 weeks to become adult poultry. Conventionally-raised broilers eat grain mixed with whatever's cheapest on the market, such as recycled cooking oil that's been used to fry fast foods and animal parts.

These birds reside in chicken coops the size of football fields and don't see the light of day until transported to the slaughterhouse. On the other roost, alternatively raised chickens are brought up in a variety of ways (see box), but usually enjoy a more relaxed life and diet.

Chickens on the farm receive antibiotics for two reasons: To fight off the diseases that can run rampant through a crowded chicken coop and to encourage faster growth.

Antibiotics Stimulate Growth

Mark Cook, PhD, professor of animal science at the University of Wisconsin at Madison, explains, "Gut bacteria trigger an immune system assault, which makes chickens a little feverish, suppresses appetite and slows growth. Antibiotics stimulate growth indirectly, by keeping bacteria levels down, and preventing the immune reaction." When birds get sick, they often get dosed with even more antibiotics.

This widespread antibiotic use has come home to roost and may contribute to the growth of bacteria that, frequently exposed to chemicals, have evolved ways to keep from being killed by pharmaceuticals.

This development threatens human health. Bacterial infections that people contract, once easily cured by penicillin or other drugs, are now tougher to eradicate. For instance, campylobactor, a common bacteria found in chicken, and responsible for some food poisonings, now demonstrates signs of resistance to drugs like floroquinolones. A powerful class of antibiotics, floroquinolones used to dependably conquer this infection.

"Floroquinolones are an extremely important class of antibiotics, used to treat many types of infections such as urinary tract infection, a wide variety of gastrointestinal illnesses, pneumonia, almost everything," says Kirt Smith, DVM, PhD, epidemiologist, acute disease epidemiology section, Minnesota Department of Health.

A study by Dr. Smith, published in the New England Journal of Medicine (340, 1999: 1525-32), showed that the percent of floroquinolone-resistant campylobactor appearing in infected people in his state-Minnesota-climbed from a little over 1% in infected people during 1992 to 10.2% in 1998. He and other scientists strongly suspect that the rise is a direct consequence of the Food and Drug Administration's (FDA) decision to allow floroquinolones in poultry feed beginning in 1995.

Although it was nearly impossible for Dr. Smith to trace the precise origin of campylobactor poisoning, he believes chicken was usually the source-and not just U.S. chicken. Many of the infected people had returned from Mexico and other countries.

"Sales of floroquinolones for poultry use in Mexico has increased dramatically," notes Dr. Smith.

Many alternative chicken producers do not use any antibiotic-laced feed at all. Other farmers adjust the feed to lower gut pH, making it more acidic and lowering chances of bacteria. At the U. of Wisconsin, Dr. Cook is developing antibodies to suppress the immune response to bacteria so chickens won't need antibiotics to spur growth. Buying and dining on chicken raised with little or no antibiotics could beneficially lower your risk of contracting a hardy bacterial infection. Better to catch campylobactor from an antibiotic-free chicken than a conventional chicken, speculates Dr. Cook. "There's less likelihood the bug will be resistant, and a better chance your problem can be cured with antibiotics," he explains.

And, looking beyond your own immediate health risk, buying antibiotic-free chicken makes a small contribution to stopping the spread of antibiotic resistant bugs. A Matter of Taste Conventionally raised chickens get little exercise and live only eight weeks, so they're tender but bland.

"There's not much taste in a modern chicken. Free range or organically grown, older birds usually have more taste," notes Dr. Cook.

The days of barnyard chickens happily clucking and strutting around in picturesque nature have disappeared with the family farm. Today, chickens lead a meager existence. After hatching, baby chicks are tossed into a gigantic hen house that is home to up to 30,000 birds. Their short lives are lived within the United States Department of Agriculture (USDA) mandated 3/4 square foot per chicken. In that squeeze, birds can catch "chicken influenza," especially in winter when it's too cold to let in much fresh air.

Laying hens don't experience much more of a peaceful existence. These birds live their years with about five other hens, so crowded they can't flap their wings. Cages, suspended in the air, let eggs roll into a holding area. So they don't peck each other, hens are often debeaked, a painful process that can cause infection.

Hens go through natural laying and "dry" cycles. Growers manipulate this cycle by "forced molting," depriving hens of food for four to 14 days to keep them constantly laying. By the end of two years, hens are worn out. Their inactivity weakens their bones enough that electrical stunning, the usual method for knocking chickens out before slaughter, shatters their bones. So some wind up being plucked and boiled alive, according to Mary Finelli, program director for farm animals and public health at the Humane Society of the United States. The meat from these hens, tougher than other birds, was probably in your deli lunch sandwich. It's also used in the school lunch program or may end up in dog food.

"Generally, organically-grown broilers and hens have it better because room to move is part of the organic certification process," says Finelli. Finelli suggests visiting chicken suppliers to find out how chickens are treated. Or, she advocates a Humane Society book listing reliable firms. For a local producer call the society: 202-452-1100. According to a Consumer Report report, some growers force chickens out the last week of their lives to brand them "free range." So free range isn't a prime standard for choosing a decently raised chicken. However, turkeys thrive outdoors, so choosing free-range turkey is often a good idea for better tasting poultry.

In any case, organic is your best bet for chicken without pesticides. Make it your main choice for your 80 pound yearly consumption!

To fight cruel treatment of poultry:

• Forced Molting Ban. Forced molting is shocking hens for more eggs. To support petitions banning forced molting write: Docket Manage-ment Branch, FDA, Dept. Health & Human Serv-ices, 12420 Parklawn Drive, Room 1-23, Rock-ville, MD 20857. Include docket # 98P-0203/CP

• Downed Animal Protection Bill (House Bill 443, Senate Bill S515) spares some animals from the tortuous journey from chicken house to slaughterhouse. Mandates humane euthanization.

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Vitanet ®

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Date: June 13, 2005 10:19 AM
Author: Darrell Miller (dm@vitanetonline.com)
Subject: Hearty Soy - Soy will cater to your cardiovascular well-being...

Hearty Soy by Joyce Dewon Energy Times, January 5, 2004

It's a diet food, it's a health food. Any way you look at it or eat it, soy's combination of benefits and its versatility as a component of a heart-healthy diet have led to a widespread popularity that continues to grow.

No matter what your taste preference, a soy food is available to satisfy your picky palate and cater to your cardiovascular well-being.

Annual Sales of soy in the US continue to grow more than 10% a year, edging toward the $4 billion mark. Today, the average American consumes about 10 mg of soy protein a day, even though the American Heart Association (AHA) recommends taking in at least 25 mg of soy to benefit your heart. Even the Food and Drug Administration (FDA) has signaled its approval of the soy bandwagon, allowing claims that daily soy can help lower the risk of cardiovascular complications.

As Good as a Drug

Researchers who have investigated how soy can help lower cholesterol and shrink the risk of heart disease have concluded that soy, in a diet with fruits and vegetables, can be as effective as cholesterol-reducing drugs (JAMA 7/22/03).

Researchers at the University of Toronto and St. Michael's Hospital compared the cholesterol-lowering power of soy and other vegetarian foods with that of lovastatin, a standard pharmaceutical used to reduce cholesterol.

In the study, scientists fed people a diet that, along with soy, had large amounts of nuts, such as almonds and walnuts, and high-fiber foods like oats and barley plus margarine made with plant sterols (natural substances derived from leafy greens and vegetable oils). Researcher David Jenkins, PhD, a nutrition science professor, thinks these foods may be good at dropping cholesterol because human evolution makes us well-adapted for an "ape diet," one high in fiber, vegetable protein, nuts and plant sterols.

According to Dr. Jenkins, "As we age, we tend to get raised cholesterol, which in turn increases our risk of heart disease. This study shows that people now have a dietary alternative to drugs to control their cholesterol, at least initially." Dr. Jenkins also thinks that soy and a vegetarian diet can be used to maintain normal cholesterol levels.

Soy Meals

Dr. Jenkins' heart-healthy diet, designed to be easily prepared and consumed, includes oat bran bread and cereal, soy drinks, fruit and soy deli slices. For instance, in his study, a typical dinner consisted of tofu baked with eggplant, onions and sweet peppers, pearled barley and vegetables.

Dr. Jenkins adds, "The Food and Drug Administration has approved these cholesterol-lowering foods as having legitimate health claims for heart disease risk reduction. They're also being recommended by the American Heart Association and the National Cholesterol Education Program as foods that should be incorporated into the diet. And we have now proven that these foods have an almost identical effect on lowering cholesterol as the original cholesterol-reducing drugs."

Dr. Jenkins regrets that health practitioners often give drugs to people with high cholesterol instead of trying to control the problem with soy and other vegetarian foods.

Soy Safety Affirmed

Recently, some doctors have spread the story that soy may increase the risk of cancer because natural chemicals in soy act like estrogens, hormones that may contribute to breast and other cancers. However, research has failed to support this supposition.

As Dr. Jenkins points out, "the concerns have been whether soy estrogen might lead to hormone-dependent breast cancer or abnormal sexual development in children, yet we found no evidence to support this."

In another of Dr. Jenkins' studies, people were put on diets high in soy to see how their estrogen levels were affected. Then, the researchers measured estrogen byproducts in their urine. Since estrogen stimulates breast cancer cells to produce a special protein, the researchers measured the amount of this protein produced by each urine sample to calculate how much estrogen was present.

The total estrogenic activity in the urine of women on soy dropped to lower levels than it had been before they ate soy. "This finding suggests that soy may not have the estrogenic effects that were thought to alleviate menopausal symptoms but it refutes claims about its purported hormone risks," Dr. Jenkins says.

The study also demonstrated that soy can reduce the risk of heart disease by lowering levels of oxidized cholesterol, which is thought to stick to coronary artery walls and form dangerous plaques. Dr. Jenkins' other research demonstrates that soy consumption reduces cholesterol in general while also decreasing the amount of LDL (bad) cholesterol in the body and maintaining the HDL (good) cholesterol. According to Dr. Jenkins, this confirms that soy should be promoted for its important role in preventing heart disease without fear that it will promote cancer.

In another study in China, researchers compared the dietary habits of more than 350 women with breast cancer to the foods eaten by more than 1,000 women who did not have cancer (Amer Assoc Canc Res Second Annual Intl Conf Fron Can Prev Res 10/27/03, Abst 1274). They found that eating large amounts of soy did not raise the risk of breast cancer.

Of course, anyone can develop allergies to almost any food, soy included. If eating soy causes you discomfort, find another source of healthy protein (see box on whey protein above).

Isoflavone Benefit

Isoflavones, soy's plant estrogens, are believed to create some of the most significant heart-healthy soy benefits. Consequently, researchers urge those concerned about their cardiovascular health to combine a diet high in soy, fruits and vegetables with exercise for the highest level of heart protection. Cheaper than cholesterol drugs, tastier than many other healthy foods and available in so many forms, soy's popularity will certainly continue to explode. Soy burgers, soy drinks and soy just-about-everything will continue to be a big part of our lives.

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Vitanet ®

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Date: June 13, 2005 09:45 AM
Author: Darrell Miller (dm@vitanetonline.com)
Subject: Vitali-Tea - Tea fits a healthy lifestyle to a T...

Vitali-Tea by Leah Brinks Energy Times, October 9, 2003

If the research is even only half right, tea fits a healthy lifestyle to a T. Whenever scientists look at a teapot's contents, they find striking health benefits: Heart protection. Reduced cancer risk. Better skin.

All of these are apparently in the bag when you choose to drink tea. Tea green, tea black: Which to choose? Actually, both types come from the same plant, Camellia sinensis. Green tea is steamed and dried; black tea is fermented, which allows its darker color to develop. Some lesser-known types include white tea, which is actually green tea that undergoes the most minimal of handling. (Another rare white tea, white cantaloupe, is rich in antioxidants.) Oolong is a tea that falls between green and black in processing and flavor.

One increasingly popular tea color, red, is not tea at all, but an herbal brew called rooibos (technically, herbal teas are known as tisanes). This South African plant yields a citrus-flavored beverage high in vitamin C. Other herbs known for yielding flavorful infusions include chamomile, used to promote sound sleep; peppermint, a digestion easer; and rose hips, which, like rooibos, combines healthy vitamin C levels with a delightfully zesty taste.

Toxin Blocker

The evidence for tea's health benefits has practically boiled over. For instance, researchers at the University of Rochester have found that green tea substances inhibit the action of a molecule irritated by tobacco smoke, a toxin central to tobacco's cancer-causing danger. This action, say the scientists, may be the reasons that smokers who drink tea suffer less cancer (Chem Res Tox 7/21/03).

The Rochester researchers found that tea helps protect a cellular molecule called the aryl hydrocarbon (AH) receptor. Ordinarily, AH is frequently disturbed by toxic substances that cause cancer and other illnesses. Tobacco smoke (as well as the pollutant dioxin) interacts with AH to initiate cancer and other problems.

But at least two chemicals in green tea-epigallocatechingallate (EGCG) and epigallocatechin (EGC)-interfere with AH's harmful activity. These substances, flavonoids similar to healthful chemicals found in grapes, wine and cruciferous vegetables like broccoli, have been shown to lower cancer risk.

"It's likely that the compounds in green tea act through many different pathways," says Thomas Gasiewicz, professor and chair of Environmental Medicine and director of Rochester's Environmental Health Science Center.

In the Rochester study, Dr. Gasiewicz and his colleagues found that EGCG and EGC close down the AH receptor in cancerous animal cells and most likely produce the same benefit in human cells.

Still to be made clear is how tea is metabolized when the body digests tea, but the Rochester scientists are still peering through their microscopes and teapots to find out.

Tea Protection

Scientists at the Linus Pauling Institute at Oregon State University have found that drinking green or white tea can significantly lower your risk of colon cancer as well the prescription drug sulindac, which has been shown effective for people at high tumor risk (Carcinogenesis 3/03).

"Tea is one of the most widely consumed beverages in the world, and recent upswings in the Sales of green tea in the United States can be attributed to reports of potential health benefits against cancer and other chronic diseases," says Gayle Orner, an OSU research associate. "Teas exert significant protective effects in experimental animal models of skin, lung, esophageal, gastric, hepatic, small intestinal, pancreatic, colon, bladder and mammary cancer."

While many people today take aspirin and similar drugs that have been shown to lower cancer risk, this study shows that drinking tea and taking low doses of these drugs, called NSAIDs, can reduce the risk even further. (High doses of NSAIDs, while protective against colon cancer, can cause internal bleeding.)

"These are pretty exciting results," Orner says. "What's especially significant is that as far as we can tell consumption of tea has none of the side effects of NSAIDs, which can be severe, including bleeding, ulcers and even death."

In this research on animals, use of tea dropped the risk of cancer by about two-thirds. According to the lab results, drinking about three large cups of tea a day should provide significant cancer protection. Based on research in Japan that looked at how green tea lowers the risk of stomach cancer, the Linus Pauling scientists urge plenty of tea drinking: "The more the better."

Tea Surprise

Studies show that nations of tea drinkers have less trouble with their hearts than residents of places where tea is hardly ever brewed. And now research is starting to zero in on the substances in tea that benefit heart health.

A study of 240 Chinese men and women who have high cholesterol has found that chemicals in tea can significantly drop harmful cholesterol (Arch Int Med 6/23/03).

"Personally, I was very surprised," says David J. Maron, MD, professor at the Vanderbilt University Medical Center, lead author of the study. "I expected, if anything, a very slight cholesterol-lowering effect. But what we saw was a 16% reduction in low density lipoprotein (LDL) cholesterol."

LDL cholesterol is known as "bad" cholesterol because it can increase your risk of heart disease.

The researchers in this study gave people extracts of green and black tea enhanced with theaflavin, an antioxidant also found in green tea.

In the future, if past results are any indication, tea's rich supply of beneficial chemicals will continue to pleasantly surprise researchers with even more benefits.

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Vitanet ®

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Date: June 12, 2005 01:59 PM
Author: Darrell Miller (dm@vitanetonline.com)
Subject: Certified Foods

Certified Foods by Glenda Olsen Energy Times, July 13, 2003

What's in your food, and where does it come from? To most American consumers, that question may seem unimportant. But the answers might surprise you. Your food's origin and processing can make a big difference in its nutritional value, for better and for worse. Increasingly, concern over the quality of food and its influence on health are persuading shoppers to take a greater interest in their food. The result: More visits to natural food stores and more Sales of organic food.

Once upon a time, food used to be just food. Crops were grown on family farms, and animals were raised in barnyards. But today, corporations have conquered food production in a big way. Agribusiness is just that-a big business in which animals and plants are treated like assembly-line items and raised on factory farms.

Organic Regulation

While the term "organic" gets tossed around endlessly in the media, the term is often misconstrued. According to the United States Department of Agriculture (USDA), "Organic food is produced by farmers who emphasize the use of renewable resources and the conservation of soil and water to enhance environmental quality for future generations. Organic meat, poultry, eggs and dairy products come from animals that are given no antibiotics or growth hormones."

In addition, organic farmers generally do not use pesticides, sewage sludge or synthetic fertilizers. This type of food is also produced without genetically modified organisms and is not subject to radiation used to zap the bugs on food. Today, USDA-approved certifying agents inspect the farms where organic food is raised to ensure organic standards are followed. In addition, the companies that process food and handle organic food have to be USDA-certified. Meeting these standards allows companies to use the USDA's organic label on foods that are at least 95% organic in origin. Labels for foods that contain between 70% and 95% organic content can use the words "Made With Organic Ingredients," but cannot use the seal.

Solid Nutrition

While the debate over the nutritional benefits of organic food has raged for decades, recent research is beginning to turn up evidence that organically grown fruits and vegetables may contain extra helpings of vitamins and other nutrients. A study at Truman State University in Kirksville, Missouri, found that organically grown oranges contain more vitamin C than conventional supermarket oranges (Great Lakes Regional Meeting, Amer Chem Soc, 6/02).

Theo Clark, PhD, the Truman State professor who investigated the organic oranges, says that when he and his students began their research, "We were expecting twice as much vitamin C in the conventional oranges" because they are larger than organic oranges. To his surprise, chemical isolation combined with nuclear magnetic resonance (NMR) spectroscopy revealed that the organically grown oranges contained up to 30% more vitamin C than the conventionally grown fruits-even though they were only about half the size. "We speculate that with conventional oranges, (farmers) use nitrogen fertilizers that cause an uptake of more water, so it sort of dilutes the orange. You get a great big orange but it is full of water and doesn't have as much nutritional value," Dr. Clark says. "However, we can only speculate. Other factors such as maturity, climate, processing factors, packaging and storage conditions require consideration."

Dodging Pesticides

If you want to avoid pesticide residues in your food, research shows that going organic can make it much less likely that you or your family consumes these unwanted chemicals. Research, for instance, into the diets of children (Enviro Hlth Persp 3/03) shows that dining on organic fruits and vegetables, and organic juice, can lower kids' intake of pesticides.

These scientists took a look at the organophosphorus (OP) pesticide breakdown products in the blood of kids ages two to five who ate conventional supermarket produce and compared it with the OP found in organic kids.

The children on the organic diet had less OP in their blood than the other kids. As a matter of fact, the children on the conventional diet had six times the dimethyl metabolites, dimethyl being a pesticide suspected of affecting nerve function and growth. "Consumption of organic produce appears to provide a relatively simple way for parents to reduce their children's exposure to OP pesticides," note the researchers. "Organic foods have been growing in popularity over the last several years," says Jim Burkhart, PhD, science editor for the journal that published the study. "These scientists studied one potential area of difference from the use of organic foods, and the findings are compelling."

GMO Development

On the way to tonight's dinner, researchers have created genetically modified organisms (GMO), plants and animals that have been transgenically engineered. In the food world, that means organisms containing genes inserted from another species. Chances are if you eat food purchased at the typical supermarket, those comestibles contain GMO ingredients. In the United States, food companies are not required to label for GMO content.

A growing number of American consumers are upset about not being told about the GMO products in their food. But industry scientists, worried that informed consumers may someday turn their back on GMO foods, consider consumer ignorance to be an acceptable state of affairs.

For instance, the American Society of Plant Biologists (ASPB) is fighting regulations that would require GMO labeling. According to ASPB President Daniel Bush, PhD, of the University of Illinois at Urbana, "The language...(in these types of regulations) is based on a system of beliefs of what is 'natural,' rather than a scientifically defined set of criteria focused on content and nutritional value. This is a radical departure from food labeling up to now, which is designed to maximize useful information for consumers concerning what is in the food they are buying."

Dr. Bush continues, "There are, of course, examples of voluntary labeling standards in the food industry that reflect how foods are processed, such as organic foods. The voluntary organic labeling standards were sought by the organic food industry. Kosher foods are also labeled as having been produced in accordance with specific beliefs. However, mandatory labeling of targeted production methods has never before been required and we believe would obscure rather than clarify important issues of food safety."

In other words, Dr. Bush opposes GMO labeling because he feels it would unnecessarily stigmatize GMO food items. Others are not so sanguine about the safety of GMO foods.

GMO Objections

The arguments against GMO foods include:

These types of risks have motivated industry groups to urge more regulation of GMO crops. The Food Marketing Institute, the Grocery Manufacturers of America (GMA) and the National Restaurant Association, plus seven other food groups, are worried that GMO plants grown to produce pharmaceutical drugs could contaminate the food supply and destroy consumer trust in food.

Mary Sophos, a vice president of GMA, warns, "To minimize the possible risks, a clear system of regulatory enforcement and liability needs to be in place. Until then, no permits for new field trials or for commercialization should be issued because there is no room for trial and error."

These food industry groups have voiced their concerns to the Food and Drug Administration (FDA) and the USDA. Last year, the USDA forced ProdiGene Inc., a biotech firm, to dispose of 500,000 bushels of soybeans contaminated with a drug meant to treat diabetes. What are the chances of more GMO accidents? No one knows. But if you buy and eat organic, you minimize your risk and maximize your chances of dining on safer food.

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Vitanet ®

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Date: June 11, 2005 05:04 PM
Author: Darrell Miller (dm@vitanetonline.com)
Subject: Power Protein

Power Protein by Joanne Gallo Energy Times, August 4, 1999

Chances are, if you've been trying to lose weight, build muscle, or increase your energy levels, then you've been hearing about protein. This essential nutrient has stolen the spotlight of the health industry as the alleged key to vitality and a solid physique.

With books like Protein Power (Bantam) and Dr. Atkins' New Diet Revolution (Avon) firmly implanted on The New York Times bestseller list, and protein bars and shakes growing in popularity, more people than ever are seeking to tap into the power of protein.

But before you go on an all-out protein-blitz, how can you decide what's best for you?

The Purpose of Protein

No doubt about it, protein performs a variety of roles. First and foremost, it is used to manufacture and repair all of the body's cells and tissues, and forms muscles, skin, bones and hair. Protein makes up the connective tissue that forms the matrix of bones; keratin is a type of protein used to make hair and nails.

It is essential to all metabolic processes; digestive enzymes and metabolism-regulating hormones (such as insulin, which influences blood sugar levels) are all made of protein. This nutrient also intricately takes part in transport functions: Without sufficient protein the body cannot produce adequate hemoglobin, which carries nutrients through the blood. Lipo-proteins are fat-carrying proteins which transport cholesterol through the bloodstream.

Protein helps regulate fluid and electrolyte balance, maintaining proper blood volume. Immunoglobulins and antibodies that ward off diseases are also comprised of protein.

Any protein that you eat that is not utilized for these purposes is stored as fat, although some may be broken down, converted to glucose and burned for energy. This can occur during intensive workouts, or when the body runs out of carbohydrates from the diet or glycogen from its muscle and liver stores.

"Even though the body can depend on the fat it has stored, it still uses muscle protein, unless it is fed protein as food," explain Daniel Gastelu, MS, MFS, and Fred Hatfield, PhD, in their book Dynamic Nutrition for Maximum Performance (Avery). "When dietary circumstances cause the body to use amino acids as a source of energy, it cannot also use these amino acids for building muscle tissue or for performing their other metabolic functions."

One can see why it is so important to eat a sufficient amount of protein daily in food, shakes or bars. Without it, bone tends to break down, the immune system can become impaired, and muscle strength drops as the body uses up muscle protein for energy.

Acid Trip

Proteins are built of chains of amino acids, and 20 different kinds of these building blocks are necessary for protein synthesis within the body. Eleven of them can be manufactured by the body through a process called de novo synthesis; these are referred to as non-essential amino acids. The other nine, which must be obtained from the diet, are known as essential amino acids. (Although some amino acids are called "non-essential," in actuality they are vital: The body needs all 20 amino acids to function properly.)

Some of the more familiar non-essential amino acids include: n Carnitine helps remove fat from the bloodstream n Arginine helps burn sugar Essential amino acids include: n L-tryptophan, a precursor of the neurotransmitter serotonin, helps create calm moods and sleep patterns n L-lysine, required for the metabolism of fats n L-methionine a component of SAM-e (a supplement intended to relieve depression and arthritis, see p. 45)

The body forms and destroys protein from amino acids in a constant cycle of synthesis and degradation. You must consume protein regularly to replace the lost amino acids that are oxidized when protein is broken down and used for fuel. The amount of amino acids lost each day depends on what you eat and how much exercise you do.

Athletes vs. Weekend Warriors

Protein intake in the general population is still adequate, notes Gail Butterfield, PhD, RD, director of Sports Nutrition at Stanford University Medical School. "But we're learning that what is true for the general population may not be true for the athletic population," she says. "With heavy training there is greater protein degradation and you need to increase your intake. Thus, protein requirements are higher for athletes than regular people."

Also, if you diet or restrict your eating in any way, you may also not be getting enough protein.

Certainly, if you work out, eating protein is important. Providing four calories of energy per gram, protein keeps blood sugar steady during exercise. After exercise, it helps replenish and maintain stores of glycogen (stored muscle fuel) and decreases the loss of amino acids, as recent research has shown (J Appl Physiol 81 (5), Nov. 1996: 2095-2104). Lab studies in animals show that protein consumed after you run, lift weights, bike, etc..., helps stimulate muscle growth (Jrnl of Nut 127 [6], June 1997: 1156-1159)

High-protein diets are frequently touted to promote weight loss and increased energy. One of the most influential: the so-called 40-30-30 formula, developed by Barry Sears in his book The Zone: A Dietary Roadmap (HarperCollins), which describes a diet whose calories are 40% carbohydrates, 30% protein and 30% fat. The rationale: when you eat too many carbohydrates, your body uses these starches for energy instead of burning body fat. A high protein diet is supposed to keep your blood sugar balanced and stimulate hormones that burn body fat instead of carbohydrates for energy.

Other fitness experts such as Sherri Kwasnicki, IDEA International Personal Trainer of the Year of 1998, say that while protein is a necessary component of any diet, extreme high-protein plans aren't necessary for recreational fitness buffs. However, she notes that maintaining muscle mass is the key to aging gracefully, and getting enough protein is critical for that.

Protein Sources

Many people today won't eat meat and dairy for ethical reasons, or to avoid the antibiotics and other chemicals in the raising of poultry and cattle. But that doesn't have to prohibit adequate protein intake. All soybean products, including tofu and soymilk, provide complete proteins, which supply ample quantities of all the essential amino acids.

Vegan Power

In the past vegetarians were told to combine particular foods to make sure they consumed all the essential amino acids at each meal. (For example, beans with either brown rice, corn, nuts, seeds or wheat forms "complete" protein.) Today, diet experts aren't so picky. Eating a variety of plant-based foods throughout the day is just as effective as combining them at one meal.

Vegans who avoid all animal products should eat two servings at sometime during the day of plant-based protein sources, such as tofu, soy products, legumes, seeds and nuts.

Protein On-The-Go

The newest sources of protein are bars and shakes, which are growing steadily in popularity. Protein bars now constitute about 12% of the so-called energy bar market, with Sales increasing about 38% per year. These bars generally provide at least 20 grams of protein, including soy and whey protein and calcium caseinate (milk protein). The benefits: bars supply protein along with carbohydrates for energy; protein powders, on the other hand, provide quickly digested, easily absorbed amino acids.

Edmund Burke, PhD, author of Optimal Muscle Recovery (Avery), suggests "If you need extra protein, you may benefit from the convenience of a mixed carbohydrate-protein supplement... choose a supplement that's healthy and low in fat."

Amino acid supplements are also growing in popularity, reported to build muscle and burn fat, or improve mood by boosting brain neurotransmitters. The amino acids glutamine, phenylalanine, tyrosine and 5-HTP (a form of tryptophan) are all used to boost spirits and enhance brain function.

And if you still ponder the merits of those high protein diets, do keep in mind that protein may be better at controlling hunger than carbohydrates or fat since it steadies blood sugar, so it may help you stick to a reduced-calorie plan. But excess protein can't be stored as protein in the body: It is either burned for energy or converted to fat. And carbs are still the body's top energy source, so forgoing too many can leave you tired and sluggish.

Still, with so many vital functions-and a variety of sources to choose from-you can't afford to not explore the benefits of protein.

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Vitanet ®

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Date: June 10, 2005 04:05 PM
Author: Darrell Miller (dm@vitanetonline.com)
Subject: Drinks Everywhere

Drinks Everywhere

by John Olan Energy Times, January 7, 2002

Water keeps you alive. About 50% to 70% of your cells are made of water. So when you talk about drinks, you're talking about water plus... But, oh, what a plus!

While water is crucial for survival, those pluses can add a waterfall of desirable ingredients to your diet, health and beverage indulgence. Even though water is the basic ingredient when you need a drink, healthy drinking has come to mean much more than H2O. The drink scene has bubbled up to include a new universe of usual and unusual liquids. When your thirst bursts upon the scene, you now have a tremendous choice of ways to quench.

Soy Drinks

The soy revolution in American nutrition has convincingly attacked the drink world. No matter what your age, nutritional requirements or taste preferences, it seems as though someone, somewhere, has designed a soy drink with you in mind. The most convincing health benefit of soy and soy drinks is its boost to heart health. Since 1999, the Food and Drug Administration has allowed soy drinks (and other soy products) to list soy's heart benefits. In so doing, the FDA reviewed 27 studies that demonstrated soy protein could help lower total cholesterol and LDL, the so-called bad cholesterol that can significantly raise heart disease risk. To be allowed the heart disease benefit on their labels, drinks, or other foods, must contain at least 6.25 grams of soy protein per serving, contain less than 3 grams of fat, less than a gram of saturated fat, less than 20 mg of cholesterol and not much salt. According to the FDA, if you consume four daily servings of soy, you can drop your LDL by up to 10%. That's great for heart health: each 1% reduction in total cholesterol can mean about a 2% drop in your risk of heart disease. The key research the FDA looked at included a two month study at Wake Forest University Baptist Medical Center that showed soy can help reduce your total cholesterol and LDL cholesterol without lowering your HDL. HDL, the so-called "good" cholesterol, protects heart health and keeps your heart disease risk down (Arch Int Med, 9/27/99). Meanwhile, another study published in the New England Journal of Medicine (8/3/95) found that soy produces "significant reductions" in cholesterol, LDL and triglycerides, blood fats that can otherwise put your cardiovascular sysem at risk. Isoflavones, natural chemicals found in soy, are phytoestrogens, a weak form of estrogen that is believed by many researchers to produce health benefits. Some studies show that by producing what's called a "weak estrogenic effect," these chemicals may prevent the body's own estrogen from initiating cancer. While studies exist supporting these effects, this claim for cancer prevention is still controversial. A study of Asian women who moved to the United States found that the more soy they ate, the less their risk of breast cancer (Second Intl Symp on Soy and Tr Chron Dis 9/15/96). In any case, soy protein provides complete protein: all the amino acids, or protein building blocks, that the body needs to form its own proteins are found in soy. All of this good soy news has sent Sales of soy drinks and other soy foods soaring. While Sales of soy foods reached a little more $850 million in 1992, by next year they are expected to climb to well over $3.7 billion. Multivitamin Water For vitamin takers on the run, water is now available fortified with a wide collection of micronutrients. The key benefit: possible health enhancement by supplying vitamins your diet may omit. As Walter Willet, MD, points out in Eat, Drink and Be Healthy (Simon & Schuster), "research is pointing ever more strongly to the fact that several ingredients in a standard multivitamin.... are essential players in preventing heart disease, cancer, osteoporosis and other chronic disease... It's the best nutritional bang for your buck." In a Russian study, a group of children, aged four to 14, with gastrointestinal diseases were fed multivitamin-infused drinks and beta carotene. The children experienced vast improvements, leading researchers to suggest fortifying the diets of folks suffering from gastrointestinal diseases with vitamin-containing drinks.

Green with Health

Everyone from mom to the US surgeon general tells you to eat dark green vegetables every day. The truth is, many of us just don't do it. Spirulina, wheat grass, barley grass and chlorella are often referred to as "green foods." Spirulina, a popular food supplement in Japan, is a vitamin and mineral powerhouse available in the US in powder and ready-to-drink shakes. Rich in protein, spirulina contains chlorophyll, carotenoids, minerals, gamma-linolenic acid (GLA) and unique pigments called phycobilins (PDR For Nutritional Supplements, Medical Economics). It's these same healthful pigments that give spirulina its blue/green color. In studies, spirulina has been shown to possess antiviral, antioxidant, anti-allergic and immune-boosting properties (Free Rad Biol Med. 2000; 28:1051-1055; Biochem Pharmacol 1998; 55:1071-1076; Inflamm Res 1998; 47:36-41; Spirulina platensis 1996; 59:83-87). Evidence exists that spirulina may favorably affect immune functions, inhibit some allergic reactions and lower cholesterol. Blended into shakes and drinks, spirulina can add a healthful boost to your day. Now, when Aunt May asks if you've had your green vegetables, just lift your glass, look her in the eye, tell her yes and mean it.

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Vitanet ®

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Date: June 09, 2005 08:41 AM
Author: Darrell Miller (dm@vitanetonline.com)
Subject: Federal Court Overturns FDA Ban on Ephedra at Low Doses

Federal Court Overturns FDA Ban on Ephedra at Low Doses

by Rakesh M. Amin and Mark Blumenthal

A Utah Federal District Court recently limited the scope of a year old Food and Drug Administration’s (FDA) Final Rule1 banning the sale of all ephedrine-alkaloid dietary supplements.2 The Court’s ruling has a limited affect on the ability of companies to sell ephedrine nationally, but is important regarding FDA procedure for creating rules and enforcement powers. Ephedrine alkaloids are found primarily in the controversial herb ephedra (Ephedra sincica Stapf., Ephedraceae).

The District Court determined that the FDA’s use of a risk-benefit analysis was against the intent of Congress in passing the Food, Drug and Cosmetic Act,3 which presumes all foods are safe and requires the FDA to prove the existence of a significant or unreasonable risk. The court held that to require food producers to establish a benefit before selling their product places an improper burden on them and was inconsistent with Congress’s intent when it passed the Dietary Supplement Health and Education Act of 1994 (DSHEA) to clearly place the burden of proof of safety of a dietary ingredient on the FDA.4

Secondly, the court determined the FDA had to show by a preponderance of the evidence “a significant or unreasonable risk of illness or injury.”5 Therefore, in order to ban all Sales of a given product, the FDA must first prove that the dosage amount in the product presents an unreasonable risk.6 Prior to this ruling, the FDA was not required to consider dosage size before banning a substance.

This ruling has limited effects at the moment since the FDA may appeal this decision. Additionally, the ruling has no effect on the laws of several states (including California, Illinois and New York) which have banned all Sales of ephedrine alkaloids in dietary supplements. The ruling also only applies to products containing 10 mg or less of ephedrine alkaloids per daily dosage. Any product exceeding that amount is still banned and will continue to be enforced under the FDA rule.7

The court, in its ruling, specifically precluded the FDA from taking any enforcement action against Nutraceutical Corporation, the company that filed the lawsuit, for its sale of products containing 10mg or less of ephedra and for the FDA to consider further rulemaking “consistent with this Order”.8 However, the court did not specifically instruct the FDA to refrain from taking enforcement action against other brands containing less than 10mg of ephedrine.9 As such, companies considering launching new products containing ephedrine alkaloids are advised to do so carefully.

Nutraceutical Corporation president Bruce Hough was cited in The New York Times as saying that the company’s reason for filing the suit was not based on ephedra and that his company had no plans to begin marketing ephedra supplements in the near future.10 Hough was quoted as saying, “We filed it [the lawsuit] because the FDA established rules that could cause problems to the rest of our business.” Hough was referring to the legal basis upon which the FDA banned the sale ephedra. He told the American Botanical Council that the FDA was applying a drug standard of risk vs. benefit to herbs and dietary supplements – technically foods under the law. [Hough B. Personal communication to M. Blumenthal, Apr. 27, 2005.] His company filed the lawsuit in an attempt to deter FDA’s new procedure for creating what he considered arbitrary rules which contradict the plain meaning of existing federal law (DSHEA).

The American Herbal Products Association (AHPA) issued a statement on April 26 clarifying its policy on the sale of ephedra in dietary supplements.11 AHPA has notified all its members that at this time it is the organization’s policy that none of its members should be selling low doses (10 mg or less) of ephedra in dietary supplements until the FDA has clarified its position on the Court decision. At this time it is not clear whether FDA plans on appealing the decision or will implement the new policy set by the Court.

The court decision does not affect the sale of the herb ephedra in traditional formulations intended for use that is consistent with traditional uses, e.g., pulmonary complaints, and are dispensed by licensed healthcare practitioners.

As might be expected, court’s decision has stimulated a new round of media and congressional criticism of the relative safety of herbs and dietary supplements as well as DSHEA. For example, a highly critical article by Chris Mooney was posted on the website of the American Prospect on April 25.12 The Prospect is relatively influential in Democratic and progressive political circles in Washington. The article uses language such as the court decision is a “scandal” and a “disturbing ruling”, refers to DSHEA as “a terrible law” and a “peculiar and misguided law” and the “wrongheaded standards encoded in the DSHEA”, and repeats the often-cited media mantra about “unregulated herbal supplements” and that the “FDA has been hamstrung and effectively rendered impotent.”

More information regarding the sale of ephedrine products or FDA regulations in general is available from the law offices of Rakesh M. Amin at (312) 327-3382 or rakesh@amin-law.com.

References

1 21 C.F.R. Pt. 119, Final Rule Declaring Dietary Supplements Containing Ephedrine Alkaloids Adulterated Because They Present an Unreasonable Risk (Published February 11, 2004) (Effective April 12, 2004) available at /dockets/98fr/1995n-0304-nfr0001.pdf

2 Nutraceutical Corporation and Solaray, Inc. v. Lester Crawford, D.V.M., Acting Commissioner, U.S. Food and Drug Administration, et al., Case No. 2:04CV409TC, U.S. District Court for the Central District of Utah; available at gov/reports/204cv409-28.pdf

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Date: May 31, 2005 04:27 PM
Author: Darrell Miller (dm@vitanetonline.com)

AHCC

The human immune system is the extraordinary biochemical network responsible for keeping us well. As our molecular interface with the environment, it has evolved complex interactions with the plant world. Mushrooms, which form one of the most primitive plant groups, have been valued for decades by progressive medical practitioners as immunopotentiators. Only recently, however, has science identified and tested the specific mushroom nutrients that augment natural defenses. AHCC® (active hexose correlated compound) is a proprietary mushroom compound. It is wellresearched in Japan for its immune-supportive properties, in particular the ability to increase natural killer cell and macrophage activity. Hundreds of Japanese hospitals and clinics recommend AHCC as part of an immune maintenance regimen, and its potent effects are so highly regarded that Sales exceed $200 million dollars per year.

AHCC ®: A Unique Compound

AHCC, or “active hexose correlated compound,” is a rich source of polysaccharides (beta glucan 1,3 and activated hemicellulose) and glycoproteins, plus amino acids and minerals. It is produced by enzymatic modification of several types of medicinal mushrooms, including shiitake. AHCC is derived from organically cultivated mushroom mycelia (the rich pre-mushroom stage, a network of fibrous filaments plus the medium it lives on and uses for fuel). The low molecular weight of AHCC makes it easier to absorb.

Natural Killer Cell and Macrophage Activity

Your trillions of cells are susceptible to damage by free radicals and toxins, so a healthy immune system uses its first line of defense—natural killer (NK) cells—to quickly identify and destroy threatening particles. The effectiveness of NK cells depends on their activity level, so boosting NK activity is a smart strategy for those committed to maintaining vibrant health and longevity. AHCC is a potent biological response modifier that may significantly increase activity of NK cells and macrophages, according to human and animal studies. Literally “large things that devour,” macrophages are white blood cells that engulf and aid in the removal of foreign particles.

Cytokine Production

Studies show AHCC also enhances production of cytokines, including interferons and interleukins. These intercellular chemical messengers trigger white blood cell production and activity. In one recent study, AHCC was shown to support normal basal levels of two cytokines, as well as NK activity. It is rare for a natural compound to have such a profound impact on strengthening the immune system.

Liver Support

Your liver is your body’s chemical manufacturing and detoxification factory. It must handle the full brunt of assault from environmental contaminants and pharmaceuticals. Stress further burdens this overworked organ. Human studies suggest AHCC supports healthy liver function.

Your Source for Scientifically Advanced Nutrition

Source Naturals AHCC is the original proprietary compound that is attracting worldwide attention. And with no adverse side effects reported in dozens of studies and abstracts, it is certainly a nutritional approach worth considering. At a time when our systems are challenged by an unprecedented array of toxins, research into the remarkable immune-supportive properties of the plant world is critical. Source Naturals is your connection to this research, dedicated to quickly bringing you the benefts of the latest emerging wellness strategies.
© 2003 Source Naturals, Inc., P.O. Box 2118, Santa Cruz, CA 95063 Strategies for Wellnesss

References Uno, K. et al. Biother 2000 14(3) 303-309. Matsiu, Y. et al. J Hepatol 37 (2002) 78-86.

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Date: May 09, 2005 06:10 PM
Author: Darrell Miller (dm@vitanetonline.com)

It's in the Blood

The National Cholesterol Education Program (NCEP) last July lowered the threshold for considering the use of statin drugs—a move which some say was motivated more by profits than scientific evidence. For example, the Center for Science in the Public Interest pointed out that eight of the nine authors behind the new recommendations had financial ties to statin manufacturers, which stand to reap billions of dollars more from a category that grossed $14 billion in the U.S. last year. And though the Food and Drug Administration (FDA) in January decided against authorizing over-the-counter (OTC) Sales of statin drugs, drug companies would still like to see this happen.

“The medical establishment’s pushing of these drugs to becoming the number one category of prescribed drugs in the world has led them to keep lowering the total cholesterol number that triggers the drug recommendation,” said Neil E. Levin, C.C.N., D.A.N.L.A., nutrition educator, product formulator, and “Truth Advocate” for NOW Foods (Bloomingdale, IL), which produces a number of supplements for addressing cholesterol. “This is despite the lack of evidence that total cholesterol means much as regards cardiovascular risks.

“Other tests are much more important in terms of predicting risks, including CRP (C-reactive protein), the balance of different cholesterol fractions, and homocysteine,” he continued. “Add adult-onset diabetes to the risk factors for cardiovascular disease (CVD).”

At the same time, the allegation that enormous Sales potential lay behind the lower threshold for prescribing statin drugs illustrates how widespread the problem of hypercholesterolemia (elevated total cholesterol) is. More than 100 million Americans have elevated cholesterol (total cholesterol values of 200 mg/dl and higher), and of these, more than a third have high cholesterol (levels of 240 mg/dl and higher), according to the American Heart Association. Those numbers have unfavorable implications for the incidence of CVD, as high cholesterol is considered a risk factor for coronary heart disease and stroke.

While statin drugs haven’t garnered the same degree of negative publicity that COX-2 inhibitors have suffered lately, safety concerns have arisen nonetheless. For one thing, these drugs lower the liver’s production of coenzyme Q10 (coQ10) along with its production of cholesterol. “CoQ10 is related to energy production and immune functions, is an antioxidant, and [is] an important cardiovascular nutrient,” Levin said. “It is not good to lower one’s coQ10 levels by half!”

Moreover, said Levin, statins increase the tendency of muscle tissues to break down. “Combined with inactivity or certain drugs, this can stimulate muscle wasting,” he said. “Muscle is where a good deal of calories are burned, so a loss of muscle could affect mobility and energy production, potentially adding to obesity problems. These muscle changes occurred in patients and persisted for years after treatment was discontinued, as shown by muscle biopsies, even if no obvious muscle problems were observed by the patients.”

And the last word on the subject may not have been spoken. Predicted Dr. Frank King, Jr. president of King Bio Natural Medicine (Asheville, NC), “Once the appropriate studies are finished, these drugs, along with hypertensives, will hit the fan bigger than the COX-2 inhibitors.”

Also looking toward the future, Levin said that of the 20 million Americans who will be “targeted” for statin drug prescriptions under the new NCEP guidelines, “Some of these will want to try natural methods first. Others will rebel at the side effects of the drugs and experiment with alternative products.”

King and Levin both saw opportunity for natural products in the fallout from drug safety concerns, with King projecting that Sales of his company’s cholesterol-related homeopathic remedies will double in 2005. “The reports of deaths from drugs will always overshadow the trumped-up studies and news reports blasting dietary supplements,” said Levin. “Vioxx knocked vitamin E off the media’s radar screens pretty rapidly, though we still see ignorant reporters citing that [Johns Hopkins] vitamin E analysis as if it were true. But the comparable safety of supplements means that open-minded people will want to at least try natural therapies before signing in to a lifetime of drug therapies. Meanwhile, the studies on natural products will continue to build our credibility.”

Those studies keep coming in, with at least four major findings published in the past few months, plus a heart-health claim on walnuts authorized by FDA. They join a raft of earlier findings that link natural products—branded and otherwise—to healthy cholesterol levels.

"Blur of Products"

With so many natural alternatives to cholesterol drugs available, it can be hard to keep track. “As with any other category, the blur of products as they cascade over several shelves means that the retailer needs to have a good sense of what works and what they want to recommend to their customers,” Levin said. “Really, each person needs a protocol that would include antioxidants, fiber, vitamins, herbs, and oils. The pre-mixed cholesterol support formulas are a good starting place.”

To help retailers get a sense of “what works,” here is an alphabetical discussion of several nutrients that have demonstrated benefits in serum cholesterol levels. They include the following:

Barley may help lower cholesterol, according to a report in the American Journal of Clinical Nutrition (2004, vol.80, no.5: 1185-1193). Twenty-five adults with mild hypercholesterolemia consumed a controlled diet low in total fat, saturated fat, and cholesterol for 19 weeks. They then added whole-grain products containing barley to their diets that contained low (0 g), medium (3 g), or high (6 g) amount of beta-glucan per day for five weeks. Total cholesterol was reduced by 4 percent 9 percent, and 10 percent, respectively. The diet with the highest amount of beta-glucan led to a decrease in LDL cholesterol of 17 percent.

Chromium. There’s evidence, Levin said, that chromium in doses of 500 mg a day may decrease levels of low-density lipoprotein (LDL, the so-called “bad” cholesterol) and total cholesterol while raising levels of high-density lipoprotein (HDL, or “good” cholesterol). At the annual meeting of the American College of Nutrition last October, a poster presentation on the safety of Benicia, CA-based InterHealth Nutraceuticals’ ChromeMate niacin-bound chromium won first prize; among other things, the presentation cited chromium’s role in maintaining healthy blood lipid levels.

Fatty Acids. The latest in a long line of studies demonstrating the benefits of fatty acids in heart health is a study published in The International Journal of Clinical Pharmacology and Therapeutics in December 2004. It showed that docosahexaenoic acid (DHA), an omega-3 fatty acid, can restore normal blood vessel function in children with inherited high cholesterol. The study, which used Martek DHA produced from microalgae, concluded that restoration of normal blood vessel function has the “potential for preventing the progression of early coronary heart disease in high-risk children.”

“The evidence continues to accumulate on the cardiovascular benefits of DHA for people of all ages,” said Henry “Pete” Linsert, Jr., chairman and CEO of Martek Biosciences, an ingredient supplier based in Columbia, MD. “This study clearly indicates that DHA played an important role in healthy blood vessel function in the children in this study.”

On the Omega-Research.com Website maintained by fish oil manufacturer Nordic Naturals (Watsonville, CA) can be found summaries of several earlier studies linking omega-3 fatty acids to maintaining healthy blood lipid levels, as well as related benefits such as elasticity of the arteries. In a 2003 study published in the American Journal of Clinical Nutrition, it was found that women receiving a mixture of 4 g eicosapentaenoic acid (EPA) and DHA along with 2 g of gamma-linolenic acid (GLA) had lower levels of LDL cholesterol after 28 days compared to those who received either the EPA/DHA supplements without DHA, EPA/DHA with a smaller dose of GLA, or GLA alone.

Flax is another source of omega-3s, and Arkopharma/Health From The Sun (Bedford, MA) offers FiProFLAX in a variety of forms. Marketing director Hugues P. Mas said the flax is “QAI [Quality Assurance International] certified organic and guaranteed GMO [genetically modified organism]-free.” On its Website, the company offers a cholesterol quiz geared to consumers, discussing the importance of omega-3s as well as other nutrients.

Garlic. Adding to an already considerable body of research demonstrating that garlic can lower total cholesterol, LDL cholesterol, and triglycerides while increasing HDL cholesterol, researchers at UCLA in 2003 reported that Kyolic aged garlic extract reduced or inhibited plaque formation in the arteries of 19 cardiac patients taking statin drugs.

Lead researcher Matthew Budoff, Ph.D. commented at the time that the study “suggests that aged garlic extract may be a useful and beneficial dietary addition for the people who have high cardiovascular risk or who have undergone heart surgery.” Budoff has since presented several trade show seminars sponsored by Los Angeles-based Wakunaga of America, the makers of Kyolic.

Guggul. In use for centuries as a component of Ayurvedic medicine, guggul—a gummy resin tapped from the Commiphora mukul tree, which is native to India—has been studied since the early 1960s for its hypolidemic (blood-lipid lowering) properties. Sabinsa Corp. (Piscataway, NJ), an ingredient supplier which produces a standardized extract under the brand name Gugulipid, says the studies on guggul indicate that its hypolipidemic activity can be attributed to more than one mechanism of action.

Among the possible mechanisms are: inhibition of cholesterol biosynthesis, enhancing the rate of excretion of cholesterol, promoting rapid degradation of cholesterol, thyroid stimulation, alteration of biogenic amines, and “high affinity binding and anion exchange.”

Homeopathy. “Homeopathy activates the body’s own control system to work properly,” said King. “This is the safest and most curative approach to take.

“Forcing the body into biochemical change even naturally doesn’t actually have the curative action of homeopathy,” King continued. “Homeopathy can even correct the genetic predispositions to disease we may have inherited from as deep as a thousand years into our family chain.” King Bio makes Artery/Cholesterol/BP, a homeopathic formula intended to help tone heart muscles and blood vessels.

Low glycemic index foods. In a study published in the February issue of the American Journal of Clinical Nutrition, researchers found that high glycemic load is negatively correlated to serum levels of HDL cholesterol. Assessing the relationship between blood levels of lipids and diet in a test population of 32 healthy males and females ages 11 to 25, the researchers found that glycemic load accounted for 21.1 percent of the variation in HDL cholesterol. They concluded that glycemic load appears to be an important independent predictor of HDL cholesterol in youth and noted that dietary restrictions without attention to glycemic load could unfavorably influence blood lipids.

Medicinal Mushrooms. Although its product SX-Fraction is intended primarily to address high blood sugar, Maitake Products, Inc. (MPI, Ridgefield Park, NJ) found in a clinical study that LDL cholesterol in diabetic patients declined modestly (from 142 mg/dl to 133 mg/dl) over a two-month period. Those taking SX-Fraction also lost about 7 lbs. in the same time period.

“The more impressive lowering of cholesterol, however, comes from the dietary fiber that is found in all medicinal mushrooms,” said Ellen Shnidman, manager of scientific affairs at MPI. She cited animal studies which documented the cholesterol-lowering properties of four different mushrooms: maitake, shiitake, agaricus, and enokitake.

For example, a study reported in the September 1996 issue of Alternative Therapies showed “a 44 percent reduction in total cholesterol in rats consuming maitake mushroom in their diet,” said Shnidman. “This cholesterol reduction is accompanied by weight loss, relative to rats eating a similar high-choelsterol diet without mushrooms. Apparently, cholesterol is excreted by the rats in sufficient quantity to aid in weight loss.”

Oat bran. A 2004 consumer study conducted by the Natural Marketing Institute (NMI, Harleysville, PA) for Nurture, Inc. (Devon, PA), which produces the ingredient OatVantage, found that 63 percent of consumers managing their cholesterol levels prefer oat-based ingredients.

Oat bran is the subject of a health claim authorized by FDA in 1999, and NMI research found that 69 percent of respondents preferred the FDA-permitted health claim, “Helps Lower Cholesterol,” over the model structure-function claim, “Helps Maintain Healthy Cholesterol Levels.” “This is significant for food, beverage, and dietary supplement manufacturers who want to increase Sales by using a more consumer-desired claim on the product label,” said Griff Parker, Nurture CEO.

Plant sterols. Also the subject of an FDA-approved claim for heart health, plant sterols (structurally similar to cholesterol in humans) can block the absorption of cholesterol, according to a number of studies. In an “Ask the Doctor” publication (available online at www.atdonline.org), Decker Weiss, N.M.D. noted that sterols enter the same receptor sites that cholesterol enters on its way to the bloodstream. “The cholesterol, being blocked from absorption, remains in our intestines where it is eventually excreted,” Weiss wrote. General Mills has just introduced Yoplait Healthy Heart, a yogurt high in plant sterols.

Policosanol. A mixture of fatty alcohols derived from sugar cane or beeswax, policosanol has been favorably compared in clinical studies to several types of prescription drugs for managing cholesterol. On its own, policosanol was found in a 1999 study to reduce LDL cholesterol while raising levels of HDL cholesterol.

Probiotics. “Several studies have indicated that consumption of certain cultured dairy products resulted in reduction of serum cholesterol, as well as triglycerides,” wrote Dr. S.K. Dash, president of probiotic manufacturer UAS Laboratories (Eden Prairie, MN), in his Consumer Guide to Probiotics. Among other studies, Dash cited two controlled clinical studies from the VA Medical Center at the University of Kentucky.

“In the first study, fermented milk containing [Lactobacillus] acidophilus was accompanied by a 2.4 percent reduction of serum cholesterol concentration,” he wrote. “In the second study, a different L. acidophilus strain reduced serum cholesterol concentration by 3.2 percent. Since every 1 percent reduction in serum cholesterol concentration is associated with an estimated 2 to 3 percent reduction in risk for coronary heart disease [CHD], regular intake of fermented milk containing an appropriate strain of L. acidophilus has the potential of reducing risk for [CHD] by 6 to 10 percent.”

Dash said his company’s DDS Probiotics contain DDS-1 L. acidophilus, “which has been researched and demonstrated to show cholesterol-lowering effect.”

Psyllium. “Internal cleansing is very important” in maintaining healthy cholesterol levels, “especially if you do it with a lot of fiber,” said Sunil Kohli, vice president of Chino, CA-based Health Plus, Inc. The cholesterol-managing ability of fiber in general and psyllium in particular is “very well-established,” he said.

However, Kohli said, “It will probably do you no good if it’s random. It should be done on a regular basis, and it should be supervised. Consulting the doctor or pharmacist is important.”

Soy. The protein in soy “has evidence of lowering total cholesterol and LDL cholesterol, based on reviews of studies using over 20 g of soy protein per day,” said Levin. “Soy isoflavones are considered only partly responsible for this effect.”

Sytrinol. A patented proprietary formula derived from natural citrus and palm fruit extracts and containing citrus polymethoxylated flavones and palm tocotrienols, Sytrinol has been shown in clinical trials to improve total cholesterol, LDL cholesterol, and triglycerides by up to 30 percent, 27 percent, and 33 percent, respectively. Having just wrapped up Phase III of a long-term trial of Sytrinol, Chicago-based SourceOne Global Partners, which owns the exclusive worldwide license for intellectual property associated with the ingredient, is commencing a study that combines Sytrinol with plant sterols.

Tocotrienols. On its Website discussing the science and benefits of tocotrienols (www.tocotrienol.org), ingredient supplier Carotech Inc. (Edison, NJ) identifies several benefits for blood lipid levels. Tocotrienols, according to the Website, have been shown to “inhibit cholesterol production in the liver, thereby lowering total blood cholesterol;” “[suppress] hepatic HMG-CoA reductase activity [and result in] the lowering of LDL cholesterol levels;” and “inhibit cholesterogenesis by suppressing HMG-CoA reductase.”

New Weapons

There are also nutrients that are emerging as potential weapons in the fight against cholesterol. Levin cited rice bran oil, resveratrol, pantethine, l-carnitine, and niacin as showing promise.

With all of this, Levin said, it’s important for retailers to remember that “they are not allowed to discuss diseases and remedies unless there is an approved FDA health claim allowed on the label, as with soy protein and plant sterols. What is allowed are structure-function claims such as ‘cholesterol support,’ ‘promoting normal, healthy circulation,’ ‘homocysteine regulators,’ etc.”

Supplementation is only one tool for managing cholesterol levels, manufacturers pointed out. “Besides nutrition, lifestyle is a key to controlling cholesterol,” Levin said. “Eating a variety of antioxidant-rich foods will prevent the liver from churning out cholesterol as a ‘cheap’ antioxidant. The body uses oxidized cholesterol to patch leaky and damaged blood vessels, so the ability to build healthy collagen is a must, using nutrients like vitamin C, Pycnogenol, rutin, hyaluronic acid, and MSM.

“Don’t forget exercise and stress reduction,” he added. “Stress results in high cortisol levels—usually accompanied by poor blood lipid levels—and a lack of good sleep to produce unhealthy people.” VR

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