Essay on Dietary Supplements
Dietary Supplements
Some manufacturers are marketing supplements that have substances and effects similar to drugs. The FDA is attempting to impose drug status on these supplements and is being challenged in the courts by supplement manufacturers. In this article, I examine the legal debate surrounding the definition and regulation of substances - whether as a drug or a dietary supplement. First, I outline some key differences in the regulation of drugs and supplements and examine the two provisions of DSHEA that blur the distinction. Second, I describe recent attempts by the FDA to clarify the guidelines for defining supplements and their associated health claims, as well as court actions challenging these attempts. Third, I discuss future litigation and other regulatory actions regarding the drug or dietary supplement debate and its implications for marketers, consumers, and policy makers.
Supplements are not required by the FDA to have premarket approval or safety testing, as are necessary for new drugs and food additives. For example, prior to release, a new drug must obtain FDA drug approval through an extensive process that involves preclinical testing on animals, three phases of investigational new drug testing, a new drug application review, and postmarketing surveillance research. Conversely, product testing is not required for any supplement with ingredients that have been present in the food supply prior to October 15, 1994, or that have a history of use or other safety evidence in labeled conditions.
Many supplements were not required to submit evidence because the ingredients were found in food or had been used safely prior to the passage of DSHEA. For those supplements that do not meet these requirements, evidence of safety must be submitted to the FDA 75 days prior to market release. However, this safety information, which could include any citation to a published article may be of questionable quality potentially biased study conducted by the manufacturer, an in vitro rather than human. As a result, the FDA has been put in a policing. Furthermore, DSHEA has made market removal of unsafe supplements more difficult for the FDA.
To be a dietary supplement adulterated and attempt to remove it from the market, the FDA must prove that the product’s ingredient poses a significant or unreasonable risk of illness or injury, whereas previously, it simply had to show that the ingredient was not generally recognized as safe. In all cases, the FDA now bears the burden of proof on each element to demonstrate that a supplement is adulterated. Furthermore, the safety of a supplement can be judged only against its labeled conditions of use and not unintended or actual consumer uses. If no suggested uses are printed on the supplement label, the FDA must try to prove actual conditions of usage in its enforcement actions.
Dr. M. Cooper provides research and term paper assistance at http://www.TermPaperAdvisor and http://www.TermPapersMadeEasy.com on the world-wide web. Dr. Copper has a M.S. degree in data communications and a Ph.D in Computer Information Systems. He is a retired Army officer and a Vietnam veteran.
[tags]supplements, dietary supplements, health supplements, vitamin supplements[/tags]
Definitve Proof - Supplements Heal
No Money in Prevention
I have been recommending a wide variety of dietary supplements to my patients for the past 18 years. Needless to say, this is not the norm for physicians. The medical establishment as a whole is treatment driven rather the prevention driven. There is much more profit in treating illness and disease rather than preventing it. As a matter of fact, the healthcare industry, including the American Medical Association (AMA), medical schools, hospitals, research institutions and drug manufacturers, have made a concerted effort to obfuscate the truth about health supplements and their intrinsic value. What little legitimate research and data, detailing the benefits of supplementation, that actually reaches the general public is quickly dismissed by the medical community as being “unsubstantiated” or “preliminary.” Whenever I relate to a colleague a patient’s recovery from a chronic condition by simply adjusting their diet and prescribing the appropriate health supplements, I often become the recipient of an incredulous laugh or sarcastic comment. At best, I am summarily dismissed with any one of a number of explanations to contradict what I know to be empirical evidence of successful treatment. Supplements can neither treat nor prevent any serious illness or disease according to the vast majority of healthcare providers.
“Only highly trained medical professionals are able to successfully treat chronic illnesses.” This is the mantra of the traditional medical community. The most disturbing aspect of this attitude is that medical students receive little or no education regarding nutrition, dietary supplements or any alternative treatments. There is no curriculum that includes preventative medicine. Similarly, physicians do not augment their education with post-doctoral fellowships in nutrition or alternative treatment research. Additional education or training in this area is non-existent. Again, the primary motivating factor is not the patient’s health and well being, it is treatment. The healthcare system is reactive, not proactive, to such an extent that physicians do not recognize they are, in part, responsible for their patients’ poor health. Physicians wait for symptoms, diagnose the symptoms and then attempt to treat the condition. A more pragmatic and cost-effective approach would be to administer healthcare systemically and organically. Ignoring the importance of preventative medicine contributes to the astronomical cost of healthcare in this country, along with Medicaid/Medicare, frivolous lawsuits and unlimited tort awards. For all these reasons, the average person is woefully misinformed about the benefits that proper nutrition and quality health supplements offer.
Quantifiable Results
Proper nutrition and regular exercise is the cornerstone of any effective health maintenance program. Again, most people do not appreciate the tremendous impact their diet has on their overall health and longevity. There are countless illnesses and diseases that are directly attributable to vitamin and/or mineral deficiencies. It is crucial for you to learn about the nutrients contained in the foods you eat (vitamins, minerals, amino acids, antioxidants, etc.). The only way to accomplish this is to read. There is far too much data to impart to be sufficiently addressed in this article. The Internet is probably the best and easiest venue for obtaining this type of material.
For a nutritionally sound-eating plan, refer to my “Eating for Health, Happiness and Successful Weight Control” (http://www.healthproductsusa.net/free_diet_health.htm) or, for a more structured diet, consider WebMD’s weight loss program (”https://diet.webmd.com/webmddiet/default_main.aspx?referrer=1111_006_0000_0013&secure=1″), which I highly recommend.
Unfortunately, even the healthiest of diets will be somewhat nutritionally deficient due to processing, cooking, and mineral deficient soil. Many food-processing methods, such as pasteurization, destroy essential nutrients necessary for good health. Cooking food also removes many nutritional elements. For decades, our farming soil has been virtually devoid of the 74 minerals necessary to sustain life (see http://www.healthproductsusa.net/govreports_health.htm). Consequently, no matter how much healthful food we eat, without supplementation we are still “starving” for nutrients. Therefore, as part of a comprehensive health maintenance regimen, I recommend that all my patients take a high-quality multivitamin (ingredients will differ for men and women), an absorbable mineral complex (either colloidal or an above-sea coral mineral), CoEnzyme Q10, an omega EFA group, methyl sulfonyl methane (MSM), chondroitin, colostrum and an immune system support supplement (as such beta-1,3D glucan). It is important to note, however, supplements do not replace healthful food. Their function is exactly as their name, “dietary supplements.” Patients that have incorporated a varied, healthful diet coupled with a consistent supplementation program report notably fewer ailments, with the exception of pre-existing conditions.
For patients with pre-existing conditions or new patients with previously undiagnosed conditions, I will, in many cases, prescribe additional supplements based on:
dietary deficiency that may be causing the condition, case history, medical profile, symptomology and test results.
I consider pharmaceuticals a second tier modality and surgery and/or hospitalization a final option unless otherwise indicated. Connective tissue and bone ailments are most easily treated with supplements and have the most dramatic results. Vitamin K1, silica, chrondoitin, MSM, minerals, collagen and elastin are all elements that will facilitate connective tissue and bone (joint) ailment recovery. I could cite a litany of conditions that were markedly improved. Suffice to say, there have been very few patients, whether their condition(s) were minor or chronic, who did not realize at least some relief after taking the recommended supplements for an appropriate period of time. To their pleasant surprise, many patients also experience unexpected ancillary health improvements beyond that of the targeted condition.
Although I have not methodically tracked the recovery success rate, I feel confident in reporting that a significant percentage of my patients have responded well to a nutrition modality. To the extent that the use of more traditional modalities were not required.
For the defintive proof that supplements can heal, read the remainder of Dr. Parsons’ article which can be found at Health Products USA (http://healthproductsusa.net).
Dr. William Parsons is the author of “Eating for Health, Happiness and Weight Control” and “Physicians’ Anti-Supplement Attitude - Conspiracy or Ignorance?” A free condensed versions have been made available to Health Products USA (http://www.healthproductsusa.net).
[tags]health, health supplements, supplements, dietary supplements, health products, alternative treatment[/tags]
Nutritional Supplements The Amazing Vitamin C
The real facts about Vitamin C may surprise you. First of all what is Vitamin C? Vitamin C is a water soluble vitamin. Unlike the oil soluble vitamins such as A and E, Vitamin C cannot be stored by your body. Since Vitamin C is not stored by your body, we need to get it from our diet or from supplements.
But Can’t Our Bodies Just Make Vitamin C?
Great question! Most animals have the ability to make their own Vitamin C. And make it they do… lots of it. It is estimated that if we had the ability to make our own Vitamin C we would make between 3000 and 10,000 mg every day… and 3 to 4 times that amount if we were being stressed by infection.
Unfortunately, humans along with guinea pigs, fruit bats and gorillas are the only mammals that need to ingest our daily dose of Vitamin C. The only vitamin we humans have the ability to make is Vitamin D… and we need the sunshine to help us do that.
Some very exciting facts about Vitamin C have sprung up within the last few years. First off, Vitamin C along with Coenzyme Q10 (CoQ10), have been called the most essential of the “essential nutrients.” That is, without an adequate supply of these two, you die. Maybe not today or tomorrow, but certainly years sooner than the folks with optimal levels of both in their bodies.
Arrrrr!!! Shiver Me Timbers!
Remember the stories about the sailors of old and the disease they contracted during long voyages called scurvy? Scurvy was nothing more than not having enough Vitamin C in their bodies. Without an adequate supply of Vitamin C, the blood vessels did not have enough collagen to repair themselves. Some of these sailors literally bled to death through cracks in their blood vessel walls.
Fortunately, in 1747 a Scottish doctor got a clue about Vitamin c and linked citrus fruits with a decreased incidence of Scurvy. Towards the end of that century, the Brits began sending along lime juice with their sailors on long voyages. Now you know why British sailors are called “limeys.”
Facts About Vitamin C and its Antioxidant Properties
If you’ve read the section of my site on the facts about Vitamin E, you’ve no doubt read about what an antioxidant does. If not we can review quickly.
The cells of your body are under a lot of stress… oxidative stress. Oxidative stress occurs when highly unstable molecules called free radicals roam freely throughout your body.
Free radicals are a by-product of not only the normal metabolic processes of your cells but also your environment… things such as air pollution, sun exposure, industrial chemical exposure, ozone, nitrous oxide (from auto exhaust), cigarette smoke, alcohol consumption and so on.
Free radicals damage cell membranes and DNA and can result in changes to your cells that cause life threatening chronic diseases down the road. When your cells are being damaged by these free radicals, we say your cells are experiencing oxidative stress… and one of the facts about Vitamin C is that it is an antioxidant and can significantly neutralize the free radicals and the damage to your cells that cause oxidative stress.
Facts about Vitamin C and Heart Disease
One of the facts about Vitamin C that we feel is most significant is the role Vitamin C plays in the production of collagen.
Collagen is a protein. It is the connective tissue that holds our bodies together and keeps us from falling apart. Collagen is found in your skin, bones, ligaments, tendons, liver, cartilage, bone marrow and blood vessels.
Collagen is essential for the repair of our bodies. Without collagen our bodies don’t heal. And without Vitamin C we don’t make collagen.
What Does Collagen Production Have to Do With Heart Disease?
Remember the facts about Vitamin C above and the sailors with scurvy? They weren’t getting any Vitamin C. So when their blood vessels cracked, no collagen was being produced to repair the cracks.
Why do your blood vessels crack in the first place? Well consider this. Your heart beats about 4000 times every hour. That’s 96,000 times a day and 35,040,000 times every year (yes that’s million)! The blood vessels of your heart are being squeezed and released that many times as well.
Imagine you were to run over a garden hose laying in your driveway that many times. Do you think it might soon develop some cracks?
Although your body has a difficult time repairing those cracks in the complete absence of Vitamin C (and hence scurvy), most folks in the developed world get just enough Vitamin C to keep scurvy at bay… but not much more.
Problem is, as this sub-optimal amount of Vitamin C in their body is repairing with collagen, it’s not quite enough. Your liver then determines that the repairs are not being made quick enough and sets about to produce a special form of LDL called lipoprotein-a.
Lipoprotein-a is very sticky and acts as a putty to fill in the cracks that the lack of collagen left behind. Great right? Leak stopped.
Well the leak is stopped yes, but being as sticky as it is, lipoprotein-a catches and glues down all the other LDL (bad cholesterol) that floats by. This action results in plaque build-up inside the vessel walls and can eventually close off these blood vessels… and we all know what that means!
Facts about Vitamin C and Cholesterol
Can Vitamin C lower cholesterol? A relationship has been shown experimentally between high levels of Vitamin C and low levels of cholesterol. An article appearing in the National Library of Medicine shows that Vitamin C provides the same mechanism for inhibiting the production of cholesterol as do cholesterol lowering statin drugs.
The American Heart Association also reported that Vitamin C lowered LDL cholesterol in children who were predisposed to high cholesterol.
The facts about Vitamin C also show that Vitamin C lowers cholesterol without the dangerous side effects of these statin drugs. Statin drugs have been shown to inhibit the production of another essential nutrient called Coenzyme Q10 (CoQ10). Decreased levels of CoQ10 result in significant muscle myopathy (wasting away). And since the heart is a muscle, statin drugs have been linked to Congestive Heart Failure (CHF).
More Facts about Vitamin C
Vitamin C has been shown to lower blood pressure, reduce the risk of Alzheimer’s when taken with Vitamin E and cut your chances of having a stroke.
Why is that? Remember the facts about Vitamin C above as an antioxidant? Well, most researchers agree that Vitamin C’s powerful antioxidant properties are responsible. By neutralizing the cell damaging effects of those free radicals running around in your body, Vitamin C works to keep your cells healthy and free of damage. And if your cells are healthy, you are healthy!
Vitamin C is also known to protect the immune system. Vitamin C aids in the manufacture of white blood cells. White blood cells destroy viruses and bacteria.
Also remember the facts about Vitamin C as aiding in the manufacture of collagen? Well collagen being the connective tissue that holds our skin together, our skin is what keeps pathogens out in the first place.
Yeah, But I Drink My Glass of Orange Juice Everyday… Well Almost
What are the facts about Vitamin C concerning the amount you should take? Well who do you want to believe? The official U.S. Government RDA for Vitamin C is 60 to 90 mg. Some would argue that this level does nothing more than ward off scurvy. They would also argue that these levels do nothing to prevent chronic, long term, debilitating diseases.
An article in the American Journal for Clinical Nutrition reports on a study done on antioxidant vitamins and coronary heart disease risk. The study looked at 9 other studies which included participation by Harvard School of Public Health and Tel Aviv University, Tel Aviv, Israel.
Conclusions: “The results suggest a reduced incidence of major CHD (coronary heart disease) events at high supplemental vitamin C intakes.”
How high was the daily Vitamin C intake of the 293,172 patients during this ten year study? Above 700 mg!
Ok, But Is Vitamin C Safe?
In an article titled “Vitamins E and C Are Safe Across a Broad Range of Intakes” published in THE AMERICAN JOURNAL of CLINICAL NUTRITION, a large study concluded that Vitamin C supplements of up to 2000 mg per day were safe for most adults. Exceeding that limit could result in gastrointestinal upset or mild diarrhea.
You can learn much more than just the facts on Vitamin C at our content rich site called Health Supplements Advisor.
[tags]nutritional supplement, dietary supplements, vitamins, health supplements, vitamin c[/tags]
Three Problems of Supplements Today
1.Most of the supplements available on the market today are found to have poor bioavailability. To ensure that the body benefits from the supplement, the active ingredients of the supplements need to be absorbed into the blood stream and reach the organs so that they can do their job.
There are few
ways nutrients can get into the blood stream: injection, via the lining of the walls of upper
intestine and colon. When you consume a supplement, it reaches the stomach and active ingredients are
released. The environment of the stomach is very acidic (ph1.0-3.5). At this stage, majority of the
active ingredients are destroyed by the stomach acids. Some may not be damaged but most are almost
severely affected. As a result, only about 10% of active ingredients manage the absorption process and
enter the blood stream. Some poor quality supplements may even pass through the body with no
absorption at all!
Poor bioavailability of supplements is very common issue in supplements industry today. Unfortunately
very few companies have the know-how knowledge and technology to incorporate the delivery technology
into the supplements.
2.Many supplements are contaminated with metals, unlabeled prescription drugs, microorganisms,
or other substances. In U.S., dietary supplements are regulated by FDA (Food and Drugs Administration)
as foods. The government is not responsible for the safety and effectiveness of the supplements. It’s
the supplements manufacturers’ responsibility to ensure the effectiveness, safety, potency and
efficacy of the products. Many manufacturers took for granted. Most supplements today are produced in
less than optimal environment. As a result, the products are contaminated with leads, metals,
chemicals, bugs, and other substances.
Following are just few reported cases:
- FDA warns consumers that Actra-Rx(dietary supplements for sexual enhancement) undeclared
prescription drug ingredient. - 2 out of 21 magnesium products are found to have lead in a study conducted by independent body,
Consumerlab.com. - Several popular nutritional supplements are found to be contaminated with steroid.
3.Many supplements have false claims and inaccurate labels. Because dietary supplements are loosely regulated, there is no pressure to ensure the accuracy of the labels of the products. This means that you may be taking less, or more of the ingredients stated on the labels. In addition, there are products that promise to cure diseases and wide spectrum of health problems. Most of these claims are rather questionable, for example:
- A product called “Sea Silver” said their product have 98% bioavailability because liquid can
bypass the digestive system. As mentioned earlier, the only way for liquid to bypass the digestive
system is through injection, not drinking - Barefoot coral calcium supplements is said to be able to ‘neutralize’ the toxic acidity of
blood. The truth is, calcium supplements can only change the acidity of body fluids
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Yi Lai is editor of http://www.health-supplements101.com: How to choose the most potent supplements for your health. Contact her at http://www.health-supplements101.com/archive.htm
[tags]Supplements,Supplements caution,dietary supplements,nutritional supplements, health supplements[/tags]
Nutritional Supplements The Amazing Benefits of Vitamin E
The real benefits of Vitamin E may surprise you. First of all, what is Vitamin E? Vitamin E is not one nutrient but actually a group of eight nutrients known as tocopherols and tocotrienols. Each one of these groups is further broken down into alpha, beta, gamma and delta.
Alpha-tocopherol is the most active and common form. This is the form most often found in vitamin supplements. This is also the only form of Vitamin E given an RDA (Recommended Daily Allowance). Folks who eat lots of fruits and vegetables and not much fat in their diet, probably don’t get their RDA of alpha-tocopherol. Although alpha-tocopherol is the only Vitamin E component given an RDA, Gamma tocopherol is an important component as well.
Vitamin E is an oil soluble vitamin and is stored by your body.
Benefits of Vitamin E and What It Does For You
What does Vitamin E do? Vitamin E acts as what’s called an antioxidant. If you’ve read the section of my site on Health Supplements, you’ve no doubt read about what an antioxidant does. If not we can review quickly.
The cells of your body are under a lot of stress… oxidative stress. Oxidative stress occurs when highly unstable molecules called free radicals roam freely throughout your body. Free radicals are a by-product of not only the normal metabolic processes of your cells but also your environment. Things such as air pollution, sun exposure, ozone, nitrous oxide (from auto exhaust), cigarette smoke, alcohol consumption and so on.
Free radicals damage cell membranes and can result in changes to your cells that cause chronic diseases down the road. When your cells are being damaged by these free radicals, we say your cells are experiencing oxidative stress… and one of the benefits of Vitamin E is that it is an antioxidant and can significantly neutralize the free radicals that cause oxidative stress.
Benefits of Vitamin E and Heart Disease
Does Vitamin E aid in the prevention of heart disease? Well, the jury’s still out on this one. Theoretically, the benefits of Vitamin E and its ability to significantly reduce the progression of atherosclerotic plaque (buildup on the inside of your artery walls), says yes, without a doubt.
An article in the Journal of the American Medical Association says so also. Using angiography, a correlation was found between taking Vitamin E supplements and a reduction in coronary artery atherosclerosis. Remember the above benefits of Vitamin E and how Vitamin E acts as an antioxidant? Well this is the same mechanism.
As Jeffrey Blumberg, Ph.D., F.A.C.N. of Tufts University, Boston, Massachusetts states “… surveys of over 200,000 people in different communities around the world have provided compelling evidence that diets high in vitamin E and/or use of vitamin E supplements reduce the risk of heart disease.”
Dr. Blumberg stresses the importance of making the distinction between what he calls primary and secondary prevention. Primary prevention focuses on groups of healthy people and testing for new heart disease against different levels of Vitamin E intake over many years. Secondary prevention is taking groups of folks with existing heart disease and testing for a short duration using Vitamin E supplements along with placebos.
It is felt that the results of some secondary trials (the ones that claim no beneficial relationship between Vitamin E and heart disease) may be skewed by other factors in these heart patients such as smoking and diabetes. Also the drugs that these folks are taking along with the Vitamin E supplements could also affect the outcome of the research.
Concerning the benefits of Vitamin E, Dr. Blumberg goes on to state, “In thinking about the value of vitamin E supplementation, particularly in primary prevention, it is important to appreciate not only its potential benefit in heart disease but also in a variety of other chronic diseases associated with oxidative stress, including age-related macular degeneration, Alzheimer’s disease, cancer, cataract, diabetes, Parkinson’s disease, and rheumatoid arthritis.”
Two other studies were reported on in the New England Journal of Medicine, the Nurses’ Health Study and the Health Professionals Follow-up Study. These two studies followed thousands of women and men. The researchers found a significant reduction in heart disease of the folks taking Vitamin E supplements.
Benefits of Vitamin E and Alzheimer’s
Can Vitamin E help cut your risk of developing Alzheimer’s and other forms of dementia? New studies seem to suggest so. A recent report found in the Archives of Neurology showed that vitamin E taken together with Vitamin C had significant benefits.
The study’s author, Peter Zandi PhD with Johns Hopkins Bloomberg School of Public Health stated, “These results are extremely exciting. Our findings suggest that vitamins E and C may offer protection against Alzheimer’s disease when taken together in the higher doses available from individual supplements.”
Another study also in the Archives of Neurology found that Vitamin E intake may slow the progression of cognitive decline as we grow older.
How does Vitamin E do this? Well, remember some of the benefits of Vitamin E cited above and how Vitamin E acts as an antioxidant? It is widely accepted that oxidative stress plays a role in the bringing about Alzheimer’s. And by its antioxidant properties, Vitamin E is able to reduce this oxidative stress to the cells of your brain.
More Benefits of Vitamin E
Because of Vitamin E’s antioxidant properties, it has been shown effective in helping treat osteoarthritis. Vitamin E has also shown to be helpful in preventing the formation of cataracts in your eyes. And it might also help in protecting your eyes against ARMD (age related macular degeneration) as you get older. ARMD is the major cause of blindness in the U.S.
In folks with diabetes, Vitamin E and other antioxidants have been effective in controlling blood sugar levels. There has also been found to be a relationship between low levels of Vitamin E and an increased risk of getting diabetes.
Vitamin E has also been found to reduce hot flashes for women going through menopause. And for male smokers, it has been shown to reduce the risk of prostate cancer.
Is Vitamin E Safe
A recent article appearing in the Council for Responsible Nutrition stated that Vitamin E is safe for folks in the general population at doses up to 1600 IU daily. With most of the daily doses you’ll find out there being in the 200 - 400 IU range there should be no concern.
You can learn much more than just the facts about Vitamin E at our content rich site called Health Supplements Advisor.
[tags]nutritional supplements, dietary supplements, vitamins, health supplements, vitamin e[/tags]
