This is where the medicinal world divides into two: nutraceuticals and pharmaceuticals. They are both regulated and watched over by the Food and Drug Administration, the FDA.
The FDA came into being due to the necessity of regulating pharmaceutical drugs. This was especially important because of the nature of the product. One can easily understand the FDA's responsibility for these products, "pharma" is a Greek word that means "poison" and "ceutical" means "medicine". These are chemically altered ingredients from natural products or even a newly inspired arrangement of molecules into something not seen in Nature.
The pharma products require strict guidelines for testing and reporting. That is because they represent something new in the world of medicine. Even so, many products gain approval only to be forbidden for sale after actual use and performance proves them to be dangerous or life threatening to the public.
In most cases pharmaceuticals have added bad effects that are listed as "side effects" with warnings stating to immediately stop the drug and seek medical advice. The FDA monitors this activity and determines the availability and safety of the drug. It's major goal is to protect people from these dangers and also, to protect the pharmaceutical industries' role in providing new medicines.
Into this world is cast the natural remedies that have been used for centuries by medical practitioners, along with the nutritional derivatives of the natural diet that have been found to be necessary for life called vitamins and other nutritional medicines, along with minerals, amino acids, and enzymes.
These substances from food have been discovered because without them a deficiency disease occurs. Their discoveries result in great advances in medicine and health and their researchers receive Nobel prizes for their discoveries.
Can you imagine the difficulty of having two distinct worlds of medicinal aids regulated by the same regulatory agency?
Pharmaceutical is a patent oriented, high profit producing enormously wealthy segment that also maintains deep ties to the government regulators of the industry. (For example, one product alone for lowering cholesterol produces more incomes than the entire nutraceutical industry)
Whereas, the nutraceuticals are usually in competition without patent protection, easily available on the open market, does not require a doctor's prescription, extremely safe, low priced and growing rapidly.
Here is an agency, the FDA, whose goal is to protect pharmaceuticals and looks at everything from the viewpoint that there must be something wrong with the drug since all have "side effects". And I'm not joking here. The number of deaths annually reported by medical records due to pharmaceuticals makes it the fourth major cause of death in the USA. The number of hospitalized severe reactions to pharmaceutical drugs is in the low millions. This makes pharmaceuticals one of the major causes of seeing a doctor, buying a prescription, and being hospitalized which in turn produces the most expensive cause of high medical costs and funeral expenses.
The FDA is protecting this system and even goes to court to stop anything else that competes with a pharmaceutical.
There was a simple eye drop formula with Vitamin A that produces excellent, inexpensive medicinal relief to eye problems which was attacked by the FDA which prefers to protect a new pharmaceutical eye drop appearing in the marketplace. The attack results in high legal costs causing the business to fail. Meanwhile, the pharmaceutical derivative that is more expensive, requires a prescription and doctor's visit, and is less effective remains.
The eye product was taken off the market the first time because it used Vita A in its name, which is a description of its contents. However, the FDA said it was prescriptive because vitamin A is good for the eyes and as an eye drop could not be called Vita A eye drops. When the company struggled onward and changed their name they were then hit with other regulatory issues that could have been resolved with the FDA's help but were not.
So you can easily see the difficulty of having a government agency meant for drug control overseeing the Nutraceutical world. For your information the safety differences are so great that one need only read this quote:
The FDA came into being due to the necessity of regulating pharmaceutical drugs. This was especially important because of the nature of the product. One can easily understand the FDA's responsibility for these products, "pharma" is a Greek word that means "poison" and "ceutical" means "medicine". These are chemically altered ingredients from natural products or even a newly inspired arrangement of molecules into something not seen in Nature.
The pharma products require strict guidelines for testing and reporting. That is because they represent something new in the world of medicine. Even so, many products gain approval only to be forbidden for sale after actual use and performance proves them to be dangerous or life threatening to the public.
In most cases pharmaceuticals have added bad effects that are listed as "side effects" with warnings stating to immediately stop the drug and seek medical advice. The FDA monitors this activity and determines the availability and safety of the drug. It's major goal is to protect people from these dangers and also, to protect the pharmaceutical industries' role in providing new medicines.
Into this world is cast the natural remedies that have been used for centuries by medical practitioners, along with the nutritional derivatives of the natural diet that have been found to be necessary for life called vitamins and other nutritional medicines, along with minerals, amino acids, and enzymes.
These substances from food have been discovered because without them a deficiency disease occurs. Their discoveries result in great advances in medicine and health and their researchers receive Nobel prizes for their discoveries.
Can you imagine the difficulty of having two distinct worlds of medicinal aids regulated by the same regulatory agency?
Pharmaceutical is a patent oriented, high profit producing enormously wealthy segment that also maintains deep ties to the government regulators of the industry. (For example, one product alone for lowering cholesterol produces more incomes than the entire nutraceutical industry)
Whereas, the nutraceuticals are usually in competition without patent protection, easily available on the open market, does not require a doctor's prescription, extremely safe, low priced and growing rapidly.
Here is an agency, the FDA, whose goal is to protect pharmaceuticals and looks at everything from the viewpoint that there must be something wrong with the drug since all have "side effects". And I'm not joking here. The number of deaths annually reported by medical records due to pharmaceuticals makes it the fourth major cause of death in the USA. The number of hospitalized severe reactions to pharmaceutical drugs is in the low millions. This makes pharmaceuticals one of the major causes of seeing a doctor, buying a prescription, and being hospitalized which in turn produces the most expensive cause of high medical costs and funeral expenses.
The FDA is protecting this system and even goes to court to stop anything else that competes with a pharmaceutical.
There was a simple eye drop formula with Vitamin A that produces excellent, inexpensive medicinal relief to eye problems which was attacked by the FDA which prefers to protect a new pharmaceutical eye drop appearing in the marketplace. The attack results in high legal costs causing the business to fail. Meanwhile, the pharmaceutical derivative that is more expensive, requires a prescription and doctor's visit, and is less effective remains.
The eye product was taken off the market the first time because it used Vita A in its name, which is a description of its contents. However, the FDA said it was prescriptive because vitamin A is good for the eyes and as an eye drop could not be called Vita A eye drops. When the company struggled onward and changed their name they were then hit with other regulatory issues that could have been resolved with the FDA's help but were not.
So you can easily see the difficulty of having a government agency meant for drug control overseeing the Nutraceutical world. For your information the safety differences are so great that one need only read this quote:
(OMNS Jan 16, 2015) There was not one death caused by any dietary supplement in 2013, according to the most recent information collected by the U.S. National Poison Data System. The new 251-page annual report of the American Association of Poison Control Centers, published in the journal Clinical Toxicology (1), shows no deaths whatsoever from any dietary supplement. ( Mowry JB, Spyker DA, Cantilena LR Jr, McMillan N, Ford M. 2013 Annual Report of the American Association of Poison Control Centers' National Poison Data System (NPDS): 31st Annual Report. Clinical Toxicology (2014), 52, p 1032-1283. ISSN: 1556-3650 print / 1556-9519 online. DOI: 10.3109/15563650.2014.987397)This is part one of several articles to come that look at the differences of pharmaceuticals vs. nutraceuticals.
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