THE PERILS AND PITFALLS OF HARMONIZED FOOD SUPPLEMENTS

[Guest guest]

Sardi asks a very good question at the end of his article: he wants to know

why there has been NO EFFORT on the part of CRN, NNFA, so called " Citizens

for Health " or other supposed " Health Freedom Organizations " world wide to

bring the information contained within his article (below) to light? Could

it be that many such groups are actually controlled opposition groups being

paid off by pharmaceutical interests to do NOTHING to stop this attempted

genocide? All evidence indicates that this is the case. A quick perusal of

the CRN website's membership section at http://www.crnusa.org/2members.html

indicates MASSIVE conflict of interest within that body as Bayer, BASF,

Monsanto, Cargill, Archers s Midland, Hoffman La Roche, Kline

Beecham, and numerous other pharmaceutical companies belong to this

supposed " vitamin " trade association. NNFA is caught in a very similar

conflict of interest as is supposed " Citizens for Health " . Is our health

freedom being hijacked? In another 5 months, unless massive grass roots

opposition can be mustered within the EU, all 15 EU countries will soon

walk in lockstep with Germany and France, and the USA could be set up like

a bowling pin at Codex in 2002.

You think your access to dietary supplements is secure here in the USA or

anywhere else in the world? Better think again! Jeanne Grimmett of the

Congressional Research Service published an article titled " Dispute

Settlement " which documents the fact that NONE of our (US) domestic laws is

safe from harmonization to rapidly emerging international standards, most

of which go diametrically against the environment and against the public

health.

THE PERILS AND PITFALLS OF

HARMONIZED FOOD SUPPLEMENTS

STATEMENT REGARDING THE ESTABLISHMENT OF

TOLERABLE UPPER LIMITS AND DOSAGE HARMONIZATION

OF FOOD SUPPLEMENTS

By Bill Sardi

Copyright 2000

Knowledge of Health, Inc.

You may circulate this document on the Internet.

But it is not to be re-produced or distributed for commercial purposes or

posted on the Internet without permission.

The dietary supplements sector-working group of the Trans Atlantic Business

Dialogue (TABD), composed of manufacturers of nutritional supplements, has

agreed to " harmonize the regulatory framework for vitamin and mineral food

supplements on both sides of the Atlantic. " (Statement from the

www.crnusa.org website) The fact that the food-supplement industry has

embraced the idea of " maximum levels " for food supplements is of serious

concern to every health-conscious consumer.

There are a number of concerns regarding the establishment of " maximum

levels " for nutritional supplements. These are:

1. The establishment of " tolerable upper limits " may assume there are no

health benefits, and only undesirable side effects, beyond a certain point of

consumption. No mention is made of a therapeutic range. For example, some

heart disease patients take 3200 units of vitamin E, which exceeds current

maximum recommendations.

2. The establishment of " tolerable upper limits " for developed Atlantic

nations is likely to be adopted as a world standard, since consumers in many

undeveloped countries consider western-made products to be superior.

However, the nutritional needs of human populations vary. Factors such as

age, sex, geography, skin pigmentation, season, health habits (tobacco and

alcohol consumption), nutrient soil levels, cultural dietary practices,

dependence upon processed foods, prescription drug usage, individual health

status and other factors may not be encompassed by a one-size fits all " upper

limits " standard. For example, the safe range for vitamin D consumption is

not likely to be sufficient to prevent immune system dysfunction among Blacks

living in northern climates in winter months (dark skin pigmentation reduces

natural vitamin D production). Likewise, the safe upper limit may not

accommodate the! need for folic acid by fertile Caucasian females living in

equatorial climates (solar ultraviolet radiation significantly reduces folic

acid levels among light-skinned individuals).

3. There is concern that " tolerable upper limits " will be intentionally set

at levels that will be below therapeutic dosages. Consumers are fully aware

that pervasive pharmaceutical interests, which exert influence through

corporate ownership or material supply, may sway " upper tolerable limits " in

food supplements so as not to compete with prescription drugs. The public is

aware that the biological action of virtually every prescription drug can be

duplicated with nutritional supplements and that the therapeutic effect of

many nutrients depends upon dosage.

4. The fact that a profit-minded group of manufacturers is entrusted with the

establishment of such an important standard is questionable on its face.

Manufacturers may not represent the interests of consumers who desire to use

food supplements as part of a health maintenance regimen. The validity of an

" upper limits " standard may later be called into question should the public

not have a voice in their formation. For example, a court recently threw out

the well-publicized food pyramid when its authors were found to have

conflicts of interest with food suppliers. Without notice or ample

opportunity for public comment, the National Academy of Sciences recently

introduced tolerable upper limits for antioxidant vitamins. These maximal

limits were apparently established without scientific consensus (see the

report below on vitamin C).

5. The establishment of " tolerable upper limits " is likely to be based upon

outdated or inaccurate information. Recently published scientific studies

indicate the daily dosage levels for vitamin B12, vitamin D, iron, calcium,

folic acid, and other nutrients may need to be re-evaluated. There is

concern that the latest science may not be included in the development of the

maximum nutrient levels.

For example, much of the information provided in nutritional textbooks,

regarding vitamins A and D is outdated.

Consumers are mistakenly warned by the US Food and Drug Administration that

excessive vitamin A supplementation can produce a toxic liver buildup.

However, an estimated 30-60 cases of vitamin A overdose are reported

annually, while over a million older Americans report symptoms of night

vision problems due to a lack of vitamin A. Cases of liver/vitamin A

toxicity often involve alcoholics and others who have liver disease. Vitamin

A toxicity is completely reversible. The US FDA has only chosen to warn

doctors and consumers of the potential for vitamin A overdose without a

balanced reporting on vitamin A deficiencies. The only reported case of

mortality from vitamin A toxicity involved a hunter in Canada who consumed

bear liver, which provided over 1 million units of vitamin A. There is

concern over birth defects with high-dose vitamin A supplementation, but

conflicting studies are still a pu! zzlement.

Due to the potential risk of liver buildup, the US FDA restricts vitamin

supplements to no more than 1000 international units of vitamin D per pill.

However, blood levels of vitamin D do not even rise till 5000 units is

consumed, and the full-body skin exposure to midday sunlight in a

mid-equatorial zone in the summer would produce 10,000 units of vitamin D,

which completely confounds any notion that vitamin D is toxic. Toxicity from

vitamin D does not begin till 40,000 units of vitamin D are consumed daily

for an extended period of time. [American Journal Clinical Nutrition 69:

842-56, 1999] Doctors used to inject 50,000 units of vitamin D for

therapeutic purposes. Vitamin D3 is the proper form of vitamin D for human

nutrition. The inferior form of vitamin D, vitamin D2, is provided in milk.

[Am Journal Clinical Nutrition 68: 854-88, 1998]

6. The exclusion of certain nutrients from the " maximum level " list may

unfairly infer that they are not necessary for human nutrition. There is

evidence that certain nutrients should be added to the list of essential life

factors. This list may include nutrients such as lutein, sulfur, phytic

acid/inositol hexaphosphate (IP6), essential fatty acids, and others.

There is no daily requirement established for essential omega-3 fatty acids,

even though 8 in 10 Americans do not consume adequate amounts of these fats.

Omega-3s are required for maintenance of the nervous system (myelin sheath),

production of hormones, reduction of inflammation, lining of the retinal

photoreceptors, control of triglycerides and regulation of immune system. An

estimated 20 percent of Americans do not exhibit detectable levels of omega-3

fatty acids in their tissues. Essential omega-3 fats have been removed from

eggs, meat, grain and even fish. This is largely a result of the use of

feeding pens for domesticated animals. Chickens, turkeys, hogs and steers

are all fed corn meal rather than foraging in the wild for foods that are a

source of omega-3 fatty acids. Grass-fed animal meat will provide a

sign! ificant amount of omega-3 fatty acids, whereas animals sent to the

feeding pen two weeks prior to slaughter will provide little or no omega-3

fatty acids and plentiful amounts of saturated fat. [www.eatwild.com]

The widespread use of processed grains also eliminates omega-3s from the

human food chain. Cereals and grains are engineered for storage, not human

nutrition.

Finally, the practice of fish farming prevents fish from acquiring the

phytoplanktons that are the source of omega-3s for waterborne animals. The

result is an omega-3 nutritional deficiency that is of epidemic proportion.

Nearly every human being now must supplement their diet to acquire

maintenance levels of omega-3 fatty acids. For health officials to ignore

this nutritional deficiency is akin to ignoring outbreaks of pellagra and

beri beri over a century ago.

The need for omega-3 fats is particularly critical among newborns, even more

so among premies. Currently, infant formulas do not provide these essential

fats, though the Food & Drug Administration is soon due to make a statement

regarding the provision of omega-3 fats in infant formulas.

There is also no daily requirement for sulfur, a mineral required for the

production of glutathione, the major antioxidant produced within all living

cells (plants, insects, animals, humans). Glutathione consumption from foods

ranges from 25-125 milligrams per day. With the provision of sufficient

amounts of sulfur, the liver will produce far more glutathione (up to 14,000

milligrams per day) than what the diet provides. Sulfur-rich foods (garlic,

eggs, asparagus, onions) may be lacking in various diets and the provision of

sulfur in food supplements (sulfur-bearing amino acids like N-acetyl

cysteine, taurine, and lipoic acid) or glutathione itself, may be

advantageous.

There is now ample evidence that lutein, a cousin of beta carotene, is

essential for maintenance of the human visual system. Lutein requirements

increase dramatically among blue-eyed individuals who have far less of this

antioxidant pigment at the back of their eyes than brown-eyed individuals and

are at a 2000% increased risk of developing loss of central vision (macular

degeneration) in their lifetime. Lutein is not currently considered an

essential nutrient. It is unlikely that the at-risk population will consume

the 3-5 weekly servings of spinach or kale (equivalent to 6 milligrams of

daily lutein), required to prevent ocular disease. [Journal Am Medical Assn

272: 1413-20, 1994] Lutein food supplements appear to be practical and

economical.

When husks (bran) were separated from rice, the B vitamins were removed,

which led to deficiency diseases of pellagra and beri beri. However, in

addition to B vitamins, these rice polishings (bran) provided phytic acid

(IP6), also called inositol hexaphosphate, an important mineral binder and

antioxidant. [Free Radical Biology Medicine 8: 61-69, 1990; J Biological

Chemistry 262: 11647-50, 1987] IP6 is found in every living cell in the body

and is also an important second messenger for the nervous system. The low

consumption of whole grains has led to reduced consumption of IP6 and the

development of iron, copper and calcium overload diseases (hemochromatosis,

's disease, kidney stones, mitral valve, calcium cataracts) and other

iron-overload sequelae such as hypertension, atherosclerosis, brain

disorders, liver disease, colon cancer and other maladies. IP6-phytic acid

has been mistakenly br! anded as an anti-nutrient because it interferes with

mineral absorption among growing children. Nutritionists fail to recognize

that most of the anemia in developing countries is caused by intestinal

parasites, not the lack of iron, and that nature favors iron anemia over iron

overload, since iron is a major growth factor for bacteria, viruses, fungi

and tumor cells. Bran has never been fully restored to the food supply, and

the world is still suffering from deficiency diseases.

7. There is concern that the establishment of " tolerable upper limits " would

cause some consumers to needlessly seek the counsel of a physician or other

health professional when high-dose vitamin usage is in question. Doctors are

solely oriented to prescribe prescription drugs and are notoriously known to

harbor prejudices against food supplements. Despite their theoretical

widespread application in disease prevention and treatment, less than 1

percent of all doctors' prescriptions are for nutritional supplements.

8. There is concern that high-dose pills would only be available via a

doctor's prescription, which would raise costs to consumers. Nutritional

supplements that are sold without prescription in the USA are only available

through a doctor's prescription in many other countries. If employed in the

USA, this practice would serve to drive up consumer costs and stunt the

practice of self care and preventive care.

9. There is concern that the establishment of a " tolerable upper limit, "

without accompanying information regarding the type, severity and

reversibility of any side effects, would induce undue alarm among consumers.

For example, if a consumer is only informed of a maximum level of consumption

and no further information is provided, then the consumer may be misled into

thinking potential side effects are of a serious, or even lethal, nature.

Specifically, if an upper limit of consumption is established for magnesium,

and excessive dosage may produce known symptoms of " loose stool, " then this

fact should be provided to consumers with the notation that the remedy is to

reduce the dosage and that this symptom is completely reversible. Similarly,

excessive consumption of vitamin C may produce temporary symptoms of

diarrhea, a symptom that is completely reversible with discontinuance or

reduced dosage. & nbs! p;Other examples of reversible side effects are

neuropathy

from high-dose vitamin B6 (pyridoxine), nausea from high-dose iron, facial

flushing from high-dose niacin, and headaches and breast tenderness from

high-dose vitamin E.

10. There is concern that once maximal limits are established, and the

concept has been adopted, it will be easy to arbitrarily change the numbers.

11. There is concern that health care consumers have no unbiased governing

bodies to turn to in regards to accessibility to food supplements. As stated

above, physicians have inherent conflicts of interest since nutritional

supplements currently do not require their prescription. There has been

continued reluctance by the National Academy of Sciences, the National

Institutes of Health, the Food & Drug Administration, and other governmental

health offices, to endorse habitual use of food supplements. Dietary

practices (fruits and vegetables) and food fortification are favored over

supplementation. The new standard is likely to stop short of supplementation

in favor of dietary consumption at the low end, and will stop short of

therapeutic action at the top range.

The cost of non-supplementation

Only recently did the US Food & Drug Administration concede to demands for

more folic acid via food fortification. Foot dragging on folic acid led to

many more babies being born with birth defects.

After spending millions of dollars, the Five-A-Day program, promoted by the

National Institutes of Health, is a failure. Repeated studies indicate only

a minority of the population consumes the recommended five servings of fresh

fruits and vegetables on a daily basis. After repeated public information

campaigns aimed at increasing the consumption of fruits and vegetables, the

proportion of adults who actually say they consume 5 servings of plant foods

a day only increased from 19 to 23 percent from 1990 to 1996. [Am Journal

Public Health 90: 777-81, 2000] Nutritional supplementation may be a

practical and economic way of filling nutritional gaps in the population at

large.

The reluctance of the US health authorities to endorse food supplements in

favor of plant-food diets and food fortification is costing the US health

care system dearly.

The Western Journal of Medicine reports that the provision of folic acid and

zinc containing multivitamins by all women of childbearing age, and daily

supplementation of vitamin E for adults over age 50, would reduce hospital

charges by $20 billion annually. [Western Journal Medicine 166: 306-12,

1997] If all at-risk Americans took the recommended amounts of vitamin

supplements, the managed care industry would save approximately $5.5 billion.

[Managed Care Interface 11: 95-99, 1998] The National Defense Council

Foundation indicates the provision of food supplements to active and retired

military personnel would reduce health care costs by $6.3 billion annually.

[Press Release May 22, 1997]

While pharmaceutical companies lure retirees into lobbying for a national

prescription drug program, they are never told that nutritional supplements

will do far more to promote health, without the side effects and costs of

prescription drugs.

12. There is concern that maximal upper limits may not accommodate the

nutritional needs of specific organs in the body. Nutritional authorities

have given too much attention to achieving minimal and maximal blood levels

of nutrients, which may not be an adequate measure of nutrients in specific

tissues. For example, it has been stated that the blood circulation becomes

saturated with vitamin C at about 240 milligrams. Even when saturation has

been achieved in the blood plasma, the provision of 2000 milligrams of

vitamin C further increases the levels of vitamin C in the aqueous fluid of

the human eye by 35 percent. Higher levels of vitamin C are required in the

aqueous fluid of the eye than in the blood circulation because the human eye

is transparent and is prone to harm by products of oxidation (hydrogen

peroxide) emanating from exposure to solar ultraviolet radiation. Much

higher levels of v! itamin C are required to prevent cataracts than to prevent

scurvy. The daily amount of vitamin C required to prevent cataracts is in

the range of 300-2000 milligrams (the equivalent of 6-30 oranges), which

exceeds the best dietary consumption (about 200-250 milligrams from

consumption of five servings of fruits and vegetables). The National Academy

of Sciences (NAS) now considers 2000 milligrams of vitamin C as " toxic. "

[see my addendum regarding the issuance of new recommendations for

antioxidants by the NAS below.] The human eye has greater need for vitamin C,

lutein, vitamin E, glutathione and vitamin A, than most other tissues in the

body.

13. There is concern that food fortification may be offered as an option to

the establishment of higher therapeutic doses of supplemental vitamins and

minerals. However, food fortification may not be adequate in all instances.

The National Academy of Sciences recently reported that Americans fall short

of magnesium requirements by about 200 milligrams per day. It is difficult

to fortify food with this bulky mineral, and it is not easily incorporated

into flour and bread. Only bottled water provides a medium for the delivery

of magnesium in the diet. Thus supplementation rather than food

fortification may be required to meet human needs. Furthermore, where foods

are heated prior to consumption, nutrient values may be diminished. Consider

that flour and cereals are now being fortified with higher levels of folic

acid, a B vitamin known to prevent birth defects among newborns (spina

bifida). But folic acid, as well as all B vitamins, is easily destroyed by

heat from baking or toasting. Food fortification is a success, but it may

not prevent all nutritional shortages.

Why no opposition to harmonization?

Why has there been no opposition to the harmonization of dietary supplements?

The dietary supplements sector working group of the Trans Atlantic Business

Dialogue, Citizens for Health, the Council for Responsible Nutrition, the

National Nutritional Foods Association, and other organizations, have not

voiced serious objection to the establishment of tolerable upper limits of

nutritional supplements. This goes unexplained. Either ignorance or

conflicts of interest within these organizations, has resulted in inaction

and a lock-step movement towards the establishment of " tolerable upper

limits. " Vital health freedoms are about to be swept under the bus in the

name of harmonization.

Summary

Centuries ago mankind could only dream of finding remedies that would prevent

infections, eradicate blinding cataracts, avert heart stoppage, hinder

tumors, and forestall aging. Now that mankind has discovered that these

health benefits are achieved through the provision of concentrated

nutritional factors, the idea to establish harmonized dosages runs contrary

to the progress of western civilization. Consumer access to high-dose vitamin

and mineral supplements may save the economies of western civilizations.

Addendum

Previously published in Whole Foods Magazine

Recently the National Academy of Sciences (NAS) issued dietary antioxidant

recommendations. The new recommendations call for 90 mg. for vitamin C for

healthy adults, up from 60 mg per day under the previous standard. Yet the

government keeps preaching five servings of fresh fruits and vegetables,

which supplies more than 200 mg. of vitamin C. [Am J Clin Nut 62: 1347-56S,

1995] These two figures don't correlate. Just months before the 90 mg

vitamin C recommendation was issued, various government scientists were

calling for 120-200 mg per day in published reports. [Proc Natl Acad Sci 93:

3704-09, 1996; Nutrition Reviews 57: 222-24, 1999; Am J Clin Nut 69:

1086-1107, 1999] One researcher at the Massachusetts Institute of

Technology, Laboratory of Human Nutrition, using a technique called

saturation kinetics, suggested that even the 200-mg level was not adequate to

meet individual vitamin! C needs by as much as 2-3 fold. [Proc Natl Acad Sci

93: 14344,48, 1996]

While the Food & Nutrition Board suggested adding another 35 mg of vitamin C

for smokers (125 mg total), researchers at the Medical College of Wisconsin

found that it takes 200 mg of vitamin C before smokers achieve the same serum

levels of ascorbic acid as non-smokers. [Am J Clin Nut 53: 1466-70, 1991]

Other investigators have called for 200-mg daily consumption of vitamin C for

smokers. [Ann NY Acad Sci 686: 335-46, 1993] Swedish investigators

demonstrated that a single 2000 mg dose of vitamin C can completely abolish

the typical reduction in blood circulation that occurs while smoking a

cigarette. A 1000 mg dose had no effect. [Microvascular Res 58: 305-11,

1999]

What happened to these recommendations? The NAS recommendations conveniently

stopped short of recommending levels of vitamin C that would require

supplementation. The Academy of Sciences set the tolerable upper limit at

2000 mg, but a recent review indicated doses of vitamin C up to 4000 mg. are

well tolerated. [Nut Rev 57: 71-77, 1999] Eight placebo-controlled,

double-blind studies and six non-placebo clinical trials in which up to

10,000 mg of vitamin C was consumed daily for up to 3 years confirm the

safety of vitamin C in high doses. [J Am Coll Nut 14: 124-36, 1995] Yet the

headline in the press release from the National Academy of Sciences

concerning antioxidants read " huge doses considered risky. "

Furthermore, Maret Traber PhD, a member of the NAS panel, says there is " no

evidence that proves antioxidant supplements will help people live better

longer. " [Whole Foods Magazine, August 2000] Really? There was a UCLA

study, which showed that greater than 300 mg of daily vitamin C increases the

male life span by six years, a report that was widely reported in Newsweek

and other periodicals. [Epidemiology 3: 194-202, 1992] A recent study

confirms that finding. [Epidemiology 11: 440-45, 2000]

Furthermore, one study shows that about 294 mg of vitamin C significantly

decreases the risk of cataracts compared to 77 mg. per day (about the level

set by the Academy of Sciences). [Clin Chem 39: 1305, 1993] To get that

much vitamin C a person would have to consume 5 oranges per day. Daily

consumption of vitamin C supplements for 10 years or more results in a 77-83

percent reduction in the prevalence of cataracts. [Am J Clin Nut 66: 911-16,

1997]

One of the fallacies of current vitamin C research is the use of blood serum

levels as the gold standard for establishing recommended daily consumption

levels. A 1991 study, conducted at the USDA Human Nutrition Research Center

on Aging at Tufts University, found that there were " striking differences " in

ocular levels of vitamin C among older adults who consume 148 mg of vitamin C

from their daily diet (which is 2.5 times the old 60 mg RDA and 1.6 times the

current 90 mg recommendation) compared to adults who took 2000 mg daily from

supplements. The level of vitamin C in the focusing lens and aqueous fluid

of the eye increased by 22-32 percent with consumption of 2000 mg of daily

vitamin C supplementation, which affords protection against cataracts. Thus

the idea that vitamin C levels reach a saturation point at about 240 mg in

the blood serum, and that additional vitamin C is worthless and only washes

out i! n the urine, is dispelled by this research. [Current Eye Research 8:

751-59, 1991] This is the same level of vitamin C that the National Academy

of Sciences now considers " risky. " [NAS press release April 10, 2000]

The message the National Academy of Sciences sends is always the same,

regardless of the evidence, which is that you can get all the nutrients you

need from your diet, not pills. But this recommendation comes with

asterisks. The fine print reads that the NAS recommendation is only for

healthy individuals, and it only spells out " the minimum amount of a nutrient

that has beneficial health effects. " The NAS says the effects of

antioxidants are " promising but unproven. "

How much evidence is enough? The answers provided by the NAS Food and

Nutrition Board members amount to doublespeak. The discussion becomes almost

unintelligible with all the talk about daily value, Recommended Daily

Allowance (RDA), USRDA, daily reference intake (DRI) and tolerable upper

level. Which consumer, let alone rocket scientist, can decipher these

standards so they can make an intelligent health decision?

One assumption is that people don't need antioxidant supplement until they

become unhealthy. But the Journal of the American Medical Association admits

the destructive process of oxidation is involved in virtually every disease.

[J Am Med Assn 271: 1148-49, 1994] Aging, disease and antioxidant status

often parallel each other. Living tissues slowly age or wear out, they don't

become ill overnight. For example, the focusing lens of the human eye loses

about 1 percent of its clarity for every year of life. Cataract formation is

universal and slowly progressive with advancing age. By age 60 only about 35

percent of light reaches the retina. By age 85 a person needs a 250-watt

light bulb to see what they saw with a 60-watt light bulb when they were 20

years old. The level of vitamin C in the lens of the eye has been correlated

with severity of cataract. [internatl J Vitamin ! Nutr Res 68: 309-15, 1998]

If an individual consumes the minimum amount of vitamin C that produces

healthful benefits (90 mg. per day by the NAS standards), and waits till they

develop a cataract to take more vitamin C, it will probably be too late to

reverse a cataract. About 300-2000 mg per day of vitamin C would be required

to prevent cataracts, according to the data at hand.

NAS panel member Maret Traber, Ph.D., says " it was disappointing that the

news media focused on the 'new' upper limits for vitamin C, vitamin E and

selenium, rather than the 'new requirements'. " But it was the NAS themselves

who chose to issue a press release that carried the headline " Antioxidants'

role in chronic disease prevention still uncertain; huge doses considered

risky. " Their own press release didn't emphasize the fact that their report

called for an increase in the daily intake of vitamins C and E. The NAS can't

entirely shift the blame onto the news media. While these experts admit that

the news media mistakenly emphasized the tolerable-upper limits issued by the

NAS panel of experts, the panel members apparently did nothing to correct the

problem either. They could have written to the news media. Apparently none

did. ####

Copyright 2000 Bill Sardi

Knowledge of Health, Inc.