FDA Attempting to Regulate Supplements, Herbs and Juices as "Drugs"

MHz

Time Out
Mar 16, 2007
41,030
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Red Deer AB
This is a great remedy for swimmers ear, but your ear canal and ear drum have nothing to do with your sense of balance. The semicircular canals of your cochlea, your inner ear, are responsible for balance, and they are a closed system. If there is an infection of the inner ear, time and/or antibiotics are the only things that will help.
http://www.earthclinic.com/CURES/earache.html

I like the one about the cigarette, LOL

You clearly do not understand anything about the ways the FDA regulations work. They are not targeted at people who make use of regulated medications, they are targetted at people who sell regulated products. And they only apply in that someone selling baking soda could only label it 'baking soda', rather than 'baking soda... will cure cancer'.

The proposed document is about a lot more than a 'labeling issue'.

"The document is called Docket No. 2006D-0480. Draft Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration.

The FDA is accepting public comments on the docket until April 30th."

Are you saying the FDA wouldn't then do just what an article proposes they will do?

"Take special care to notice the following text, taken directly from the FDA's own document: (italicized text is from the FDA, with my own translation following)

"...a product used in a CAM therapy or practice may be subject to regulation as a biological product, cosmetic, drug, device, or food (including food additives and dietary supplements) under the act or the PHS Act. Second, neither the act nor the PHS Act exempts CAM products from regulation."

Translation: Anything used in any system of medicine may now be regulated as a drug or medical device by the FDA. This includes a biofeedback machine, acupuncture needles, a cup of herbal tea, massage oil, a glass of vegetable juice or even a bottle of water.

"...if a person decides to produce and sell raw vegetable juice for use in juice therapy to promote optimal health... [and] if the juice therapy is intended for use as part of a disease treatment regimen instead of for the general wellness, the vegetable juice would also be subject to regulation as a drug under the Act."

Translation: Raw vegetable juice will be regulated as a drug and must be FDA approved as a drug if it has any health effect whatsoever. Handing a cup of raw vegetable juice to someone and telling them it's good for the detoxification of their liver will get you arrested for practicing medicine without a license and promoting an "unapproved drug."

..."biologically based practices" includes, but is not limited to, botanicals, animal-derived extracts, vitamins, minerals, fatty acids, amino acids, proteins, prebiotics and probiotics: whole diets, and "functional foods". ...a botanical product intended for use in treating a disease would generally be regulated as a drug." ..."functional foods" may be subject to FDA regulation as foods, dietary supplements, or drugs under the Act.

Translation: All foods, supplements, superfoods and functional foods may be reclassified as drugs by the FDA, then regulated off the market.

If... the manipulative and body-based practices involve the use of equipment (such as massage devices) or the application of a product (such as a lotion, cream, or oil) to the skin or other parts of the body, those products may be subject to regulation under the Act."

Translation: Massage oils and creams will be regulated as "drugs" and acupuncture needles as "medical devices." Taking this absurdity one step further, massage therapists who use their fingers to touch patients may have their fingers regulated as "medical devices" and be accused of practicing medicine for merely touching patients.

Things that will be regulated out of existence It is very clear that the FDA is intending to regulate and ultimately destroy the entire CAM industry (Complementary and Alternative Medicine). Based on the explanations in the FDA's own document, the following things are likely to occur:

* All vitamins, nutritional supplements and functional foods will be stripped of their structure & function claims, reducing them to empty labels where virtually nothing at all is allowed to be stated.

* Vegetable juice will be regulated as a drug. Raw juice retreats will be raided or shut down.

* Growing and selling common garden herbs will get you arrested as a drug dealer.

* Massage oils and handheld massagers will be regulated as "medical devices."

* Yoga props, pilates machines and weight machines will be regulated as "medical devices" and require FDA approval before being sold or used.

* Raw sprouts and other anti-cancer foods will be regulated as drugs.

* Bottled water that "treats" dehydration will be regulated as a drug.

* Massage therapists who use hot rocks as part of their therapy will have the ROCKS regulated as medical devices! (It's true. The FDA will actually look at a pile of rocks and declare, "Those are medical devices!")

* Functional foods, supplements, vitamins and homeopathic remedies will disappear from store shelves, pending FDA "review." (The only things remaining will be processed junk foods and pharmaceuticals, which is exactly what Big Business wants.)

* Therapeutic tea products, such as green tea, will be outlawed and confiscated.

* Vitamin store owners will be arrested and prosecuted for "practicing medicine without a license."

* Citizens owning personal inventories of "unapproved drugs" (vitamins and herbs) may have their homes raided at gunpoint and their inventories confiscated by armed law enforcement agents.

* The importation of herbs and functional foods from all countries may be banned.

Keep in mind that the FDA is the same agency that:

* Wants to label irradiated foods as "pasteurized."

* Voted to put the deadly drug Vioxx back on the market after tens of thousands of deaths, even after its own manufacurer pulled it from pharmacies.

* Raided a church at gunpoint, confiscating biofeedback machines and charging that they were "practicing medicine" by counseling church members on issues like depression.

* Openly allows corrupt, "on the take" experts to vote on new drug approvals, even when those experts are taking money from the same companies impacted by their votes.

* Refuses to legalize stevia, the safe, natural herbal sweetener that's used virtually everywhere else in the world. The agenda? Protect the profits of aspartame and other chemical sweeteners.

* Openly allows the mass poisoning of the public with cancer-causing food additives such as sodium nitrite.

* Refuses to enforce its own laws regarding unsafe chemical toxins in personal care products, allowing perfume and lotion companies to continue poisoning the public with cancer-causing chemicals that don't even have to be listed on the label, nor proven safe.

* Ordered the destruction of recipe books that mentioned stevia. (A campaign to keep the public ignorant of the herb.)

* Does everything in its power to protect drug company profits, including discrediting herbs, supplements and alternative medicine."
 

gc

Electoral Member
May 9, 2006
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No. I can take you to the first article I read about it though.

If this were true, it would be published in a peer-reviewed journal. I have never seen an article on it and I doubt it is true.

I could also give you links to papers that indicate cancer cells do not like oxygen.
I could also give you links to papers that indicate cancer cells do not like oxygen.

If it is credible (ie peer reviewed journal), please do.
 

gc

Electoral Member
May 9, 2006
931
20
18
cancer cells CONTAIN less oxygen. Don't know if that means they dont like it or they just dont have it.

I believe that is correct. I know that tumours will actively seek blood vessels in order to obtain oxygen (but it could be for other nutrients as well). They also stimulate blood vessels to grow towards themselves. I know this because it is somewhat related to the research I do.

I'm still interested in seeing what MHz is talking about....if nothing else, it's fun to call his bluff :lol:
 

MHz

Time Out
Mar 16, 2007
41,030
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Red Deer AB
If this were true, it would be published in a peer-reviewed journal. I have never seen an article on it and I doubt it is true.
Well lets start our journey with one article that says this is a 'fake'.
http://www.cancer.org/docroot/ETO/content/ETO_5_3x_Hyperbaric_oxygen_therapy.asp
"
Overview
Research has shown HBOT is effective when used in addition to conventional treatment for the prevention and treatment of osteoradionecrosis (delayed bone damage caused by radiation therapy). There is also some evidence suggesting HBOT may be helpful as an additional treatment for soft tissue injury caused by radiation. There is no evidence that HBOT cures cancer. The US Food and Drug Administration (FDA) has approved HBOT to treat decompression sickness, gangrene, brain abscess, air bubbles in the blood, and injuries in which tissues are not getting enough oxygen."

Notice the 'effects of radiation', oxygen is used to combat those things. Just what is cancer if not an " injuries in which tissues are not getting enough oxygen." ??

"
The lack of randomized clinical studies makes it hard to judge the value of HBOT for many of its claims. There is no scientific evidence that HBOT stops the growth of cancer cells, destroys germs, improves allergy symptoms, or helps patients who have chronic fatigue syndrome, arthritis, multiple sclerosis, autism, stroke, cerebral palsy, senility, cirrhosis, or gastrointestinal ulcers.
Carefully controlled scientific studies are going on to find out whether HBOT may be helpful for lymphedema (swelling in arms or legs after surgery, which can happen after mastectomy), diabetic ulcers, cluster headaches, heart attacks, and other conditions."


Notice it say there has been a 'lack of' research, not that there has been extensive research and it has then been determined it doesn't work.


http://www.cancer.org/docroot/ETO/content/ETO_5_3X_Oxygen_Therapy.asp?sitearea=ETO

"
Description
Oxygen therapy uses one or more chemicals that are supposed to release oxygen after they are put into the body. The extra oxygen is believed to increase the body's ability to destroy disease-causing cells. Two of the most common compounds used in oxygen therapy are ozone (a chemically active form of oxygen) and hydrogen peroxide. Oxygen therapy, as described here, is different from hyperbaric oxygen, which involves the use of pressurized oxygen (see Hyperbaric Oxygen Therapy).
Overview
There is no evidence that oxygen therapy is effective in treating cancer. It may even be dangerous. There have been reports of patient deaths from this method."

So in one article getting oxygen into the blood is good for treatment of some things, but if you do it for cancer the odds (no data given on who has died) are you will die.

"

What does it involve?
Ozone gas may be mixed with air or liquids and introduced into the body. It may be given under pressure into the rectum, vagina, or other body opening, or injected into a muscle or under the skin. In an approach called autohemotherapy, some practitioners use a special device to force ozone into a pint of blood that has been drawn from the patient. The blood is then returned to the patient's body.
Hydrogen peroxide is used internally or injected into a vein. Some practitioners promote it for use rectally, vaginally, as a nasal spray, and as eardrops. It is often used to soak affected parts of the body. The stronger solutions (about 35%) recommended by alternative medicine practitioners are sold in some health food stores.
Sometimes less frequently used oxygen therapy compounds are injected into muscles.
The frequency of treatments varies widely, from 3 times a day over several weeks, to once a week for several months."
Getting ozone into the body can be done by 'bubbling' ozone through some distilled water and then you drink it. Some city sewage places bow bubble ozone through waste water, Why? To kill a lot of harmful bacteria. While being in a room with too much ozone can harm you a glass of ozonated water will not harm you. Just don't have your face over the glass when you are making your own. (shelf-life 1/2 hour before the water reverts back to original state).
If ozone is so unkind to the body why are some countries using it in dentistry?
http://www.craigentinny.co.uk/ozone.htm
"Ozone Dentistry

What do you dislike most about having a filling? Is it the numb feeling, the noise, the vibration or just keeping your mouth open for a long time?
Ozone Treatment is a totally new hi-tech approach to treating tooth decay and might just change the way you feel about dentistry.
It is not a magic cure all but we believe it will change the way that dentistry is delivered over the next few years.
We were among the first dental practices in Scotland to offer this injection free treatment."


Notice the reference to the 35% food grade peroxide (that is the best for internal use) but it fails to mention the 'recommendation' for the amount to be used is "by the drop in a glass, 8oz, of distilled water". Starting a 1 drop in the water 3 times a day, increasing by a drop a day for each glass untill you get to 25 drops/glass 3 times a day (if your stomach doesn't get 'upset', if it does you go back to what is was the day before and stay at that level and then taper off). The way the article is written it gives no warning to dilute the 35% back to 3% before you use it for any purpose, like ear drops.



"During the 1930s, Otto Warburg, MD, a Nobel Prize winner, discovered that cancer cells have a lower-than-normal respiration rate compared to normal cells. He reasoned that cancer cells thrived in a low-oxygen environment and that increased oxygen levels would harm and even kill them. Many of the beliefs held by oxygen therapy practitioners are still based on Dr. Warburg’s theories, even though they have since been discredited."

Yet no links to the 'tests' that have proven it to be false.

"Drinking food grade hydrogen peroxide can cause vomiting, severe burns of the throat and stomach, and even death. If it gets in the eyes, it can damage the corneas and cause blindness. Direct skin contact with food grade hydrogen peroxide can cause blistering or burns, and breathing its vapors can also be harmful."

No **** Sherlock. It fails to touch on what is a safe level and it utterly fails to mention that our body produces hydrogen peroxide on its own and the other ways our body get H2O2, like vitamin C and breast milk.

http://home.bluegrass.net/~jclark/peroxide_therapy.htm

"[FONT=Arial,Helvetica][SIZE=+1] Most of us started on hydrogen peroxide shortly after birth. Not only does mother's milk contain high amounts of H²O², the amount contained in the first milk (colostrum) is even higher. This seems only reasonable now that we know one of its main functions is to activate and stimulate the immune system."

The linked article gives the recommended dosage. 3 drops/day in 24oz of water is not a 'high dosage' Do the math 1 drop of 35% H2O2 / 250ml water = ??% H2O2, now use 25 drops.
I trust this stuff is important enough to read the article in full. I have my doubts that it is very important to you as doing a google search for 'cancer oxygen' seems to require more effort than you are willing expend.

http://www.alkalizeforhealth.net/oxygen.htm
"[/SIZE][/FONT]
Normal Metabolism vs. Cancer Metabolism
"The fuel on which the body's cells run is called adenosine triphosphate (ATP). ATP must be created by all cells, including cancer cells, for energy. The biochemical process in which ATP is created is called oxidation phosphorylation and is oxygen-dependent. Healthy cells require the conditions of alkalinity and high molecular oxygen (O2) to produce ATP and function properly. In contrast, non-oxygen-respiratory organisms - like cancer cells - make ATP by fermentation phosphorylation, which requires the conditions of acidity and low oxygen to function, and actually produces additional acids." - Philpott, page 75.
Cellular Respiration
The human body's main fuel is a simple sugar called glucose. Glucose comes from the plants we eat. Through photosynthesis, plants use light energy to produce glucose and oxygen from carbon dioxide and water.
Carbon dioxide + water + energy --> glucose + oxygen
6CO2 + 6H2O + energy --> C6H12O6 + 6O2
Plants then use the glucose to create cellulose and complex carbohydrates. When we eat the plants, the complex carbohydrates are broken down by our digestive system into glucose. Then this food energy is converted to chemical energy by a series of reactions known as cellular respiration. Aerobic respiration uses oxygen.
Glucose + oxygen --> carbon dioxide + water + energy
This reaction occurs in mitochondria in cells. Aerobic respiration extracts the maximum amount of energy from glucose, because the molecule is completely broken down.
When the supply of oxygen is insufficient, there is a back-up system known as anaerobic respiration, that can release energy without oxygen.
Glucose --> lactic acid + energy
This reaction occurs in the cytoplasm of the cell. It does not put any extra pressure on the respiratory or circulatory systems, because it does not produce carbon dioxide, but it can cause muscle stiffness after exercise. Cancer cells have either wholly or partially switched to anaerobic respiration. Enzymatic decomposition of glucose in the absence of oxygen is also known as "fermentation", though in humans the end result is the production of lactic acid, not alcohol, because we lack the enzymes to produce alcohol.
"The ideal task of cancer therapy is to restore the function of the oxidizing systems in the entire organism." - Dr. Max Gerson, page 7.
Aerobic cellular respiration creates as many as 36 ATP molecules from each glucose molecule, and anaerobic respiration creates only 2 ATP molecules. Anaerobic respiration releases one eighteenth of the available energy. Cancer cells must feel very tired!
For more information regarding cellular respiration, see Hydrazine Sulphate and cancer and oxygen. Also, you can do a search of the Internet for subjects such as cellular respiration, citric acid cycle, cellular biology and ATP, fermentation, lactic acid fermentation, cellular metabolism and fermentation, adenosine triphosphate, healthy mitochondria, Dr. Otto Warburg, etc."
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http://www.mnwelldir.org/docs/nutrition/sugar.htm
"[/SIZE][/FONT]
Every doctor learned back in medical school all about Otto Warburg's discovery; a discovery of humongous proportions, because way back in the thirties Otto discovered the main biochemical cause of cancer, or what differentiates a cancer cell from a normal, healthy cell. So big a discovery was this, that Otto Warburg was awarded the Nobel Prize.
Cancer has only one prime cause. It is the replacement of normal oxygen respiration of the body's cells by an anaerobic [i.e., oxygen-deficient] cell respiration. -Dr. Otto Warburg
But what else does Warburg's discovery tell us. First off, it tells us that cancer metabolizes much differently than normal cells. Normal cells need oxygen. Cancer cells despise oxygen. In fact, oxygen therapy is a favorite among many of the alternative clinics we've researched.
Another thing this tells us is that cancer metabolizes through a process of fermentation.
If you've ever made wine, you'll know that fermentation requires sugar.
The metabolism of cancer is approximately 8 times greater than the metabolism of normal cells.
Okay, so here is what we can put together knowing the above: The body is constantly overworked trying to feed this cancer. The cancer is constantly on the verge starvation and thus constantly asking the body to feed it. When the food supply is cut off, the cancer begins to starve unless it can make the body produce sugar to feed itself.
The wasting syndrome, cachexia, is the body producing sugar from proteins (you heard it right, not from carbohydrates or fats, but from proteins) in a process called glycogenesis. This sugar feeds the cancer. The body finally dies of starvation, trying to feed the cancer."

I believe that is correct. I know that tumours will actively seek blood vessels in order to obtain oxygen (but it could be for other nutrients as well). They also stimulate blood vessels to grow towards themselves. I know this because it is somewhat related to the research I do.

I'm still interested in seeing what MHz is talking about....if nothing else, it's fun to call his bluff :lol:
How do you know it is oxygen, and not sugar, they are after?

http://www.clinicaltrials.gov/ct/gui/show/NCT00160979
(from 2005)
"[SIZE=+1]Purpose [/SIZE] Prostate cancer is now the most commonly diagnosed tumor among men in the United States. Most patients have tumors that are confined to the prostate gland at diagnosis and are suitable for treatment with surgery or radiotherapy (RT) that is aimed at curing the disease. Nevertheless, despite recent improvements in these treatments, a large number of men continue to die of prostate cancer. These patients often have spread of tumor to other areas of the body, and are treated with hormones that produce initial tumor shrinkage. However, over time the tumor learns to grow despite continued hormonal treatment. Effective therapy for patients with hormone-resistant prostate cancer is lacking and patients often deteriorate quickly and die. Thus, there is a need for better treatment that cures prostate cancer at an early stage, and a better understanding of the biology of prostate cancer specifically with respect to factors that determine the effectiveness of RT, the spread of tumor and the development of hormone-resistant disease.
Low levels of oxygen (hypoxia) are known to exist in many human tumors, and studies have shown that hypoxic tumors are less likely to be cured by RT. In addition, hypoxia may lead to lower cure rates following surgery, spread of cancer to other areas of the body, and changes in the genetic characteristics of the cancer cells that cause them to behave more aggressively.
The importance of hypoxia in prostate cancer has not previously been evaluated. The aims of this study are to determine how often hypoxia occurs in early prostate cancer and whether hypoxia influences the success of RT, tumor spread beyond the prostate to bones and other organs and the development of hormone-resistant disease. Patients will have tumor oxygen levels measured using a special fine-needle electrode system prior to beginning treatment with either RT or the combination of hormones plus RT. The measurements will be made through the rectum using ultrasound to position and guide the electrode. A biopsy of the tumor will be obtained at the site of the measurements, and this will be used to determine how oxygen influences changes in the genetic character of prostate cancer cells. A total of 195 patients will be evaluated in this way over 3 years."



From the above they have found low levels of oxygen and when treated with radiation it kills the 'local cells' but then spreads to other parts of the body. The only way to test if oxygen is factor would be to map the whole body at lots of specific points before radiation. When that localized spot is 'killed' you would compare your chart to where the 'spread appears next'. If that point showed a previous low level of oxygen (compared to it popping up where oxygen levels were highest). A more realistic evaluation would be to get some extra oxygen into the blood of some of those 195 before any radiation treatment and keep it high for the duration. (from one of those links above it would seem that taking hydrogen peroxide does not account for the extra oxygen in the blood.



(my theory)The peroxide cause some 'natural cells that carry oxygen' to bloom, it is the increase in those cells that is one factor in how much oxygen rich cells are traveling around in the blood.
This is based on other ways the body 'reacts'. Normally adrenalin is at a lower rate (when you are resting than when your are in the 'fight or flight mode)


"[FONT=Arial,Helvetica][SIZE=+1]Only very diluted amounts of H²O² are ever introduced into the body. The small amount of oxygen present couldn't be solely responsible for the dramatic changes that take place. Dr. Charles Farr, a strong proponent of intravenous use, has discovered another possible answer. [/SIZE][/FONT]
[FONT=Arial,Helvetica][SIZE=+1] Dr. Farr has shown that hydrogen peroxide stimulates enzyme systems throughout the body. This triggers an increase in the metabolic rate, causes small arteries to dilate and increase blood flow, enhances the body's distribution and consumption of oxygen and raises body temperature (Proceedings of the International Conference on Bio-Oxidative Medicine 1989, 1990, 1991)."[/SIZE][/FONT]


[FONT=Arial,Helvetica][SIZE=+1]ACA says this area of treatment says hasn't been researched very much and at the same time says research has shown it doesn't work, come on, it has to be one or the other.
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[FONT=Arial,Helvetica][SIZE=+1]Also notice the article that has the 195 in it, that they are bringing oxygen into the conversation but not trying to diminish the use of radiation, rather use the 'oxygen' to repair the damage the radiation causes. If you attacked this cancer with a local shot of oxygen whild not giving that same protection to all other areas of the body the cancer will die in that one spot but pop up again is some area that is either low in oxygen to begin with of the cancer cells cause when they begin to multiply. Same with the ph level (if that has an effect) you want the whole body at 7.3 to stop cancer from starting to form and up to 8.5 when treating an existing cancer. (no link just save me looking it up again).[/SIZE][/FONT]


[FONT=Arial,Helvetica][SIZE=+1]I doubt any of the makers of the radiation machines (donating the machines 'buys' input into the 'research path')will be promoting turning off any of the machines and just going with the extra oxygen.[/SIZE][/FONT]


[FONT=Arial,Helvetica][SIZE=+1]"[/SIZE][/FONT]Lack of oxygen and high levels of acidity go together. One reason for this: "In the electron transport scheme during oxidative metabolism, electrons are transferred along a set of electron acceptors, ending up, ultimately with the combination of hydrogen and oxygen to form water. However, when there is an oxygen deficiency, the loss of electrons can result in the accumulation of positive hydrogen ions, which lead to blood acidification." - Sandra Goodman, PhD, Germanium - The Health and Life Enhancer, Chapter 4. You can read her book on the Internet here: http://www.positivehealth.com/permit/Articles/Nutrition/Germanium/chapter4.htm"


Here's an article on cancer and acidity
http://www.kabencompany.com/article-RII-sang-understanding-cancer.html