I have thought this to be an issue for years
Showing posts with label supplements. Show all posts
Showing posts with label supplements. Show all posts
Anticaking ingredients may help to degrade, not stabilise, powdered nutrients, suggests research
Discussing FDA Current Attack on Supplements
This is from a colleague of mine who is known as the "Vitamin Lawyer".
LEF, Citizen's for Health and other groups already have action established to contact CONgress to make sure this latest round of insanity and Big PhRMA's attack on your supplemnts is stopped.
Remember that currently the FDA is telling you that wlanuts are 'drugs'.
The amount of documentation and safety information that the Food and Drug administration (FDA) now says it requires to prove new ingredients in supplements are safe goes well beyond what Congress envisaged when it ratified the Dietary Supplements Health and Education Act (DSHEA) in 1994 and now establishes a process “ominously like the one for new food additives,” according to the Council for Responsible Nutrition (CRN).CRN chief executive Steve Mister, in commenting on the Food and Drug Administration's (FDA's) long-awaited draft guidance on New Dietary Ingredient (NDI) notifications, said that the new NDI process now ‘sounds an awful lot like the food additive petition process.’The Dietary Supplements Health and Education Act was enacted in overwhelmingly negative consumer and industry response to 1993 Congressional efforts to medicalize the supplements industry. It requires firms filing NDI notifications to establish a ‘reasonable expectation’ of safety, whereas those filing petitions for new food additives were required to demonstrate ‘reasonable certainty’ that no harm will result from use of the new food additive.But if you look at the section on safety requirements in the new NDI guidelines and all of the studies that are now required, it now sounds an awful lot like the food additives petition process, which is exactly what Congress was trying to avoid.“It is terribly disheartening to see the FDA going in this direction. They had a chance to create a workable system that would incentivize more companies to follow the law, use the NDI notification process and draw a line between responsible companies and those ignoring the whole process completely. “But instead they have come up with a document that stifles innovation and will deny consumers access to new products. We are terribly disappointed,” Mister added.As to what now constitutes an NDI, the fact that changes to the manufacturing process, new solvents or new extraction methods could turn scores of old dietary ingredients, which were assumed to have been ‘grandfathered in’ under DSHEA into new NDIs was alarming enough. Ironically, the new requirements could force the industry to revert to extraction processes used nearly 20 years ago.However, the fact that separate NDI notifications for supplements containing the same NDI are required if the supplement is reformulated in any way, and that notifications are required for finished products, not just ingredients, means that the FDA would be “flooded” with NDI submissions if the guidance were not revised.‘Absolute nonsense with no basis in science’
A section in the new FDA guidelines claims that a synthetic copy of a constituent or extract of a herb or botanical is not a dietary ingredient at all – even if it is chemically identical to its ‘natural’ counterpart – as in the case of a number of higher dose vitamins, is particularly troubling, although not wholly unexpected.
The FDA recently argued that the synthetic organic compound, homotaurine, which was being investigated as a potential treatment for Alzheimer's disease, was not a dietary ingredient even though it is chemically identical to homotaurine from red algae extract. “Again, the FDA is defining incredibly narrowly what constitutes a dietary ingredient, but very broadly what is a ‘new’ dietary ingredient.”
Marc Ullman, with the New York law firm, Ullman, Shapiro & Ullman, which represents companies in the supplements industry, said he was particularly frustrated by this aspect of the guidance: “It really is preposterous, absolute nonsense, with no basis in science. If we’re talking about something that is chemically identical to a botanical extract, but is synthesized, there really is no rational basis for taking the position that it is not a dietary ingredient.”
from Natural Health News
http://naturalhealthnews.blogspot.com/2011/07/save-your-supplements.htmlSAVE YOUR SUPPLEMENTS
NEWS RELEASE
SAVE YOUR SUPPLEMENTS
Write the FDA Now - Here's Why & How
By Scott Tips
July 19, 2011
Everyone with even an ounce of common sense has grave concerns about the U.S. Food and Drug Administration’s recently released Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues. This Agency sprang this trap on both industry and consumers without seeking any prior input from us at all. It had almost 17 years to seek our opinion before coming out with this document, and now they are giving us a miserly 90 days to respond with our comments. Why is this issue so important?
The Erosion of Our Health Rights
When the Dietary Supplement Health and Education Act of 1994 (DSHEA) was passed, contrary to what the mainstream media falsely reports, the law did not remove dietary supplements from the regulatory oversight of the FDA. What it did do is to remove the FDA’s arbitrary powers of life and death over supplements so that they could be treated more like foods rather than as drugs. The innovative tidal wave that was unleashed as a result of this breakout from regulatory prison resulted in some 1,000 new products a year in this market. What an incredible difference DSHEA made, and we all benefitted from the prison break. Oh, wait, the FDA’s drug-industry bosom-buddies did not benefit. And that is something they have never forgotten and have been fuming over ever since.
Not without their cohorts in U.S. Congress, the drug industry’s lobbyists have been pushing for years to hamstring DSHEA and its freedoms. For more than a decade, they have failed. But for the last several years, they have succeeded with sausage-slicing tactics that have gradually eroded DSHEA. First, there was the Adverse Event Reporting law, then the law mandating “Good Manufacturing Practices,” and after that came the so-called FDA “Modernization” Act – each one designed to ratchet up the pressure on supplements, to drive out the smaller supplement manufacturers who could not keep up with the increasing regulatory costs demanded of them by these laws that were touted as making already-safe supplements “safe,” and to gradually eliminate individual supplements. Were these laws ever truly designed to protect consumers? No, these laws had only one purpose in mind: To make supplements more expensive, less available, and to drive the consumer back into the filthy arms of the drug pushers.
This latest nonsense is straight out of the warped minds of the FDA’s Berchtesgaden nest of anti-health thugs. They could care less about good health, certainly care less about you or me. This has been proven so many, countless times over the decades of the Agency’s existence that there can no longer be even a shred of doubt. The revolving door between the drug industry and the FDA is a never-stopping one. Just witness its recent hiring of Johnson & Johnson’s executive Spielberg who was tapped by FDA Commissioner Margaret Hamburg, as the latest deputy commissioner within the Office of the Commissioner to oversee the Agency’s drug and device centers. This is not an exception, this is the rule.
The Compromise
Unfortunately, when DSHEA was passed, a compromise was reached in order to get unanimous passage. The parties agreed that all dietary supplements not marketed as of the date of DSHEA’s passage (October 15, 1994) would be “new dietary ingredients” (NDIs) for which notification would be sent to the FDA. At the time, some did not think much was wrong with this compromise. After all, most supplements had already been discovered. But, now, almost 17 years later, the health-food market is awash with these new dietary ingredients, such as resveratrol, ubiquinol, GABA, curcumin, and bioperine. Notifications to the FDA have been made for many, but what is to happen to them now, with the FDA changing the law, all on its own?
Fantasy Land
This draft Guidance is a step into fantasy land. One night the FDA went to sleep and had a wonderful dream, a dream about a land where bureaucrats reigned supreme and the common citizen answered to every edict that flowed from the lovely bureaucrats’ mouths. If the bureaucrat said jump, then the citizen would jump; if the bureaucrat said roll over, then the citizen would roll over. It was a wonderful place, this bureau-paradise. But then the FDA woke up, and the non-dream reality was not nearly that perfect, yet the urge to make it bureau-perfect remained. Hence, these constant bureaucratic attempts to whittle down our freedoms until we can only jump to the tune of some unknown functionary sitting in some unknown office thinking that he or she knows better for us than we do.
This draft Guidance is just such an attempt. It turns the law on its head by changing a very basic notification system into an approval system subject to the arbitrary whims of the FDA. It requires very safe NDIs to go through unnecessary, expensive tests so that they can meet drug-like safety requirements. In essence, this Guidance ignores the incredible, proven safety record of supplements, both new and old. The FDA can produce no dead bodies whatsoever coming from the use of these new dietary ingredients.
Yet the FDA, ignoring the many tens of thousands of actual dead bodies coming from its expensive drug-approval regulatory regime, wants to imprint that badly flawed drug-approval regime upon the dietary-supplement market. In doing so, it ignores the clear intent of Congress when passing DSHEA that “the Federal Government should not take any actions to impose unreasonable regulatory barriers limiting or slowing the flow of safe products and accurate information to consumers” and that “the right of access of consumers to safe dietary supplements is necessary in order to promote wellness.”
Flood Them with Letters
The Guidance document is not law, but it is a clear expression of how the FDA intends to enforce its interpretation of the law. This interpretation is badly flawed. And its implementation will result in unnecessary high costs, arbitrary discrimination against small- and medium-sized businesses that will put thousands of people out of work by destroying jobs in a time of economic decline, and the loss of many useful and healthful supplements.
The FDA must withdraw this Guidance document at once, consult with industry and consumers on a longer-term basis than this miserly 90-day period, and come out with a new Guidance that better reflects the realities of the marketplace and the safe track record of supplements, including those with NDIs. The FDA’s proposed document is unauthorized under Law and will guarantee a backlash of legislative action the likes of which have not been seen in this legislative arena since the passage of DSHEA in 1994. The NHF suggests that the cut-off date for NDIs either be eliminated entirely or else pushed forward to a date 15 years after 1994.
Please mail, fax, or e-mail your protest letter ( Click Here for Sample Letter) to the FDA as soon as possible, but in no event later than October 1st of this year. They need to be awakened from dreamland.
********************
Click here for the permanent link to this news release, use this link to inform others.
********************
National Health Federation: Established in 1955, the National Health Federation is a consumer-education, health-freedom organization working to protect individuals' rights to choose to consume healthy food, take supplements and use alternative therapies without unnecessary government restrictions. The NHF is the only such organization with recognized observer-delegate status at Codex meetings.
********************
FIND US ON FACEBOOK!
P.O. Box 688, Monrovia, CA 91017 USA ~ 1 (626) 357-2181 ~ Fax 1 (626) 303-0642
Website: www.thenhf.com E-mail: contact-us@thenhf.com
SAVE YOUR SUPPLEMENTS
Write the FDA Now - Here's Why & How
By Scott Tips
July 19, 2011
Everyone with even an ounce of common sense has grave concerns about the U.S. Food and Drug Administration’s recently released Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues. This Agency sprang this trap on both industry and consumers without seeking any prior input from us at all. It had almost 17 years to seek our opinion before coming out with this document, and now they are giving us a miserly 90 days to respond with our comments. Why is this issue so important?
The Erosion of Our Health Rights
When the Dietary Supplement Health and Education Act of 1994 (DSHEA) was passed, contrary to what the mainstream media falsely reports, the law did not remove dietary supplements from the regulatory oversight of the FDA. What it did do is to remove the FDA’s arbitrary powers of life and death over supplements so that they could be treated more like foods rather than as drugs. The innovative tidal wave that was unleashed as a result of this breakout from regulatory prison resulted in some 1,000 new products a year in this market. What an incredible difference DSHEA made, and we all benefitted from the prison break. Oh, wait, the FDA’s drug-industry bosom-buddies did not benefit. And that is something they have never forgotten and have been fuming over ever since.
Not without their cohorts in U.S. Congress, the drug industry’s lobbyists have been pushing for years to hamstring DSHEA and its freedoms. For more than a decade, they have failed. But for the last several years, they have succeeded with sausage-slicing tactics that have gradually eroded DSHEA. First, there was the Adverse Event Reporting law, then the law mandating “Good Manufacturing Practices,” and after that came the so-called FDA “Modernization” Act – each one designed to ratchet up the pressure on supplements, to drive out the smaller supplement manufacturers who could not keep up with the increasing regulatory costs demanded of them by these laws that were touted as making already-safe supplements “safe,” and to gradually eliminate individual supplements. Were these laws ever truly designed to protect consumers? No, these laws had only one purpose in mind: To make supplements more expensive, less available, and to drive the consumer back into the filthy arms of the drug pushers.
This latest nonsense is straight out of the warped minds of the FDA’s Berchtesgaden nest of anti-health thugs. They could care less about good health, certainly care less about you or me. This has been proven so many, countless times over the decades of the Agency’s existence that there can no longer be even a shred of doubt. The revolving door between the drug industry and the FDA is a never-stopping one. Just witness its recent hiring of Johnson & Johnson’s executive Spielberg who was tapped by FDA Commissioner Margaret Hamburg, as the latest deputy commissioner within the Office of the Commissioner to oversee the Agency’s drug and device centers. This is not an exception, this is the rule.
The Compromise
Unfortunately, when DSHEA was passed, a compromise was reached in order to get unanimous passage. The parties agreed that all dietary supplements not marketed as of the date of DSHEA’s passage (October 15, 1994) would be “new dietary ingredients” (NDIs) for which notification would be sent to the FDA. At the time, some did not think much was wrong with this compromise. After all, most supplements had already been discovered. But, now, almost 17 years later, the health-food market is awash with these new dietary ingredients, such as resveratrol, ubiquinol, GABA, curcumin, and bioperine. Notifications to the FDA have been made for many, but what is to happen to them now, with the FDA changing the law, all on its own?
Fantasy Land
This draft Guidance is a step into fantasy land. One night the FDA went to sleep and had a wonderful dream, a dream about a land where bureaucrats reigned supreme and the common citizen answered to every edict that flowed from the lovely bureaucrats’ mouths. If the bureaucrat said jump, then the citizen would jump; if the bureaucrat said roll over, then the citizen would roll over. It was a wonderful place, this bureau-paradise. But then the FDA woke up, and the non-dream reality was not nearly that perfect, yet the urge to make it bureau-perfect remained. Hence, these constant bureaucratic attempts to whittle down our freedoms until we can only jump to the tune of some unknown functionary sitting in some unknown office thinking that he or she knows better for us than we do.
This draft Guidance is just such an attempt. It turns the law on its head by changing a very basic notification system into an approval system subject to the arbitrary whims of the FDA. It requires very safe NDIs to go through unnecessary, expensive tests so that they can meet drug-like safety requirements. In essence, this Guidance ignores the incredible, proven safety record of supplements, both new and old. The FDA can produce no dead bodies whatsoever coming from the use of these new dietary ingredients.
Yet the FDA, ignoring the many tens of thousands of actual dead bodies coming from its expensive drug-approval regulatory regime, wants to imprint that badly flawed drug-approval regime upon the dietary-supplement market. In doing so, it ignores the clear intent of Congress when passing DSHEA that “the Federal Government should not take any actions to impose unreasonable regulatory barriers limiting or slowing the flow of safe products and accurate information to consumers” and that “the right of access of consumers to safe dietary supplements is necessary in order to promote wellness.”
Flood Them with Letters
The Guidance document is not law, but it is a clear expression of how the FDA intends to enforce its interpretation of the law. This interpretation is badly flawed. And its implementation will result in unnecessary high costs, arbitrary discrimination against small- and medium-sized businesses that will put thousands of people out of work by destroying jobs in a time of economic decline, and the loss of many useful and healthful supplements.
The FDA must withdraw this Guidance document at once, consult with industry and consumers on a longer-term basis than this miserly 90-day period, and come out with a new Guidance that better reflects the realities of the marketplace and the safe track record of supplements, including those with NDIs. The FDA’s proposed document is unauthorized under Law and will guarantee a backlash of legislative action the likes of which have not been seen in this legislative arena since the passage of DSHEA in 1994. The NHF suggests that the cut-off date for NDIs either be eliminated entirely or else pushed forward to a date 15 years after 1994.
Please mail, fax, or e-mail your protest letter ( Click Here for Sample Letter) to the FDA as soon as possible, but in no event later than October 1st of this year. They need to be awakened from dreamland.
********************
Click here for the permanent link to this news release, use this link to inform others.
********************
National Health Federation: Established in 1955, the National Health Federation is a consumer-education, health-freedom organization working to protect individuals' rights to choose to consume healthy food, take supplements and use alternative therapies without unnecessary government restrictions. The NHF is the only such organization with recognized observer-delegate status at Codex meetings.
********************
FIND US ON FACEBOOK!
P.O. Box 688, Monrovia, CA 91017 USA ~ 1 (626) 357-2181 ~ Fax 1 (626) 303-0642
Website: www.thenhf.com E-mail: contact-us@thenhf.com
More Americans Using Supplements
A report published in the February, 2011 issue of the Journal of Nutrition reveals widespread use of dietary supplements among Americans, particularly among older individuals.
Researchers from the National Institutes of Health, Office of Dietary Supplements and the National Center for Health Statistics, Centers for Disease Control and Prevention in Maryland utilized data obtained from 18,758 participants in the National Health and Nutrition Examination Survey (NHANES) 2003-2006. Infants under the age of one were excluded from the current analysis.Forty-four percent of males and 53 percent of females reported using supplements, which is an increase from the percentages reported in earlier NHANES surveys beginning in 1971. For those aged 71 and older, supplement use was reported by 70 percent. Multivitamin/mineral formulas were the most common form of supplementation. Twenty-eight to 30 percent of those surveyed used supplements containing vitamins A, B6, B12, C and E; 18 to 19 percent used chromium, iron and selenium, and 26-27 percent used magnesium and zinc. Herbs were used by 20 percent of adults and were more commonly used by older adults.While 56 percent of those of normal weight were supplement users, this number declined to 48 percent among those who were obese, a finding that is consistent with that of other analyses. Non-Hispanic whites were more likely to use supplements compared to Hispanics and non-whites and higher education was associated with greater use of supplements compared to having a high school diploma or less education."About one-half of the US population and 70% of adults ≥ 71 years use dietary supplements; one-third use multivitamin-multimineral dietary supplements," the authors conclude. "Given the widespread use of supplements, data should be included with nutrient intakes from foods to correctly determine total nutrient exposure."
More About Natural Cancer Treatments
from Krista Peterson in response to our post about supplements
More on immune system health
More on immune system health
Natural Cancer TreatmentsTraditional cancer treatments work by targeting the tumor with toxic chemicals or radiation, killing off the malignant cells – but also damaging healthy cells in the process. For this reason, chemotherapy and radiation are extremely difficult on the body, causing side effects ranging from hair loss to nausea and vomiting to anemia. Some of the most lethal cancers, such as mesothelioma, are not diagnosed until the late stages. Mesothelioma treatment generally includes traditional therapies like radiation, chemotherapy, and – more rarely – surgery, but these treatments are often of limited effectiveness by the time the cancer is diagnosed.As a result, many cancer patients turn to alternative treatment as a method of alleviating symptoms or fighting the cancer itself. There are many natural alternative remedies available, though most are used in conjunction with traditional therapies rather than replacements for them. The reason these treatments are not part of standard medical care is that most have not been proven to show significant positive effects in clinical trials. However, when even conventional medical treatment offers little chance of recovery, it is only natural to search for natural alternatives with fewer harsh side effects.Vitamin C – an important nutrient found in citrus and other fruits and vegetables, given intravenously in large doses. This therapy is based on a 1976 study that suggested the vitamin may increase survival time for terminal cancer patients. However, other scientists have not been able to reproduce the results of this study.Mushroom extract – the use of mushrooms for medicinal purposes. Compounds called beta-glucans found in some mushrooms are thought to boost the body’s immune responses, allowing it to better fight the cancer.Cat’s claw – the common name for Uncaria tormentosa, a vine found in the tropics of Central and South America. The inner bark and root are used by indigenous cultures to treat intestinal ailments, and there has been some indication that it may also have a stimulating effect on the immune system in cancer patients.Iscador – an extract of the mistletoe plant, especially popular as a cancer therapy in Europe. Though the National Cancer Institute does not list it as an approved treatment, some tests have been promising and the extract is currently undergoing clinical trials.Quercetin – an anti-oxidant flavonoid found in some fruits and vegetables. Some in vitro studies have shown quercetin to suppress malignant cancer cells, and the National Cancer Institute highly recommends a diet rich in fruits and vegetables for cancer prevention as well as during treatment.Macrobiotic diet – a diet that consists primarily of whole grains, vegetables, and beans while avoiding refined or processed foods. Practitioners claim this diet is linked to the traditions of Chinese, Japanese, or Incan cultures and is based on the principle of balance in food and in life.An Important NoteIf you are receiving medical treatment for cancer or other serious illness, it is imperative that you speak to your doctor before beginning any alternative therapies to prevent possibly dangerous interactions or side effects. Any changes in diet should also be discussed with a medical professional, since chemotherapy or radiation may change the way your body takes in nutrients and malnutrition can be a serious risk.Referenceshttp://www.mesotheliomatreatment.net/http://www.mesotheliomatreatment.net/alternative-therapieshttp://www.ncbi.nlm.nih.gov/pmc/articles/PMC431183/?tool=pmcentrezhttp://naturalhealthnews.blogspot.com/2011/01/supplements-and-cancer-what-works.html
Supplements and Cancer: What Works
| What Really Works? Part One |
| Sunday, 09 January 2011, from Ralph Moss, PhD | |||
One of the hardest questions to answer is which, out of the many supplements really benefits cancer patients? There are many self-interested statements of benefit, but an inadequate amount of objective research on what is effective and what is not. I therefore want to call your attention to an interesting article from Memorial Sloan-Kettering Cancer Center (MSKCC). It compared the following seven botanical extracts and fractions: (1) H-48 (a Chinese mixture of herbs) (2) Coriolus vesicolor, or its derivatives: purified polysaccharide-K (PSK) or purified polysaccharide-peptide (PSP) (3) Maitake mushroom extract (4) Echinacea (5) Astragalus root (6) The yellow spice turmeric; and (7) β-glucan derived from yeast. All of these are popular supplements used by cancer patients. The MSKCC authors looked at the ability of these substances to induce immune reactions in laboratory mice. Specifics on these products, and how they were tested, are given in the reference below. (The full paper is available for free, and readers should consult that text for details). The bottom line of the study was this: Consistently significant activity was seen with four of the preparations: (1) Coriolus mushroom extracts (especially PSK); (2) Alcohol extract of astragalus ; (3) yeast β-glucan; and (to a lesser extent) (4) Maitake mushrooms. Little or no adjuvant activity was demonstrated with H48, Echinacea extracts or a water-based extract of astragalus. The results with turmeric were mixed (but the New Chapter brand of turmeric was active.) Coriolus versicolor (also called Trametes versicolor or Turkey tail mushroom) is available from a number of sources. I will have more to say about Astragalus in a future blog entry. | |||
To Those Who Are On The Attack Against Supplements
I was looking for an image to use in an article I am working on earlier today and literally stumbled upon an article against supplements with a very trendy, techy type chart.
At the same time I literally stumbled upon a good article from an MDs magazine about using homeopathy for trigeminal neuralgia.
Hardly accurate, and hardly fair, at least in my book. What a way to dis-inform people while using something beguiling to lure them in to a limited way of thinking about their health and what can improve it!
You have to be the judge, but my money will always be on the side of supplements for promoting and maintaining good health...
Many of the supplements at the lower part of the chart have been used effectively over decades for positive health results. It is difficult to overlay the biased type of studies relied on in mainstream medicine to show less than the already known benefits of vitamins, minerals, and herbs for health.
If all these things were of no use or no benefit how is it that other than US cultures have relied on them for thousands of years, and even the medical system of pharmaceuticals in the US is based on these very things.
Take this as a jumping off point to learn about what you can do to protect and maintain your health.
And that's a fact, or my name isn't Edith Ann...
At the same time I literally stumbled upon a good article from an MDs magazine about using homeopathy for trigeminal neuralgia.
Resource 1After perusing the homeopathic articles I went back to the chart and played around with it a little and discovered something quite interesting: The links go to articles that are limited in information toward supplements.
Resource 2
Hardly accurate, and hardly fair, at least in my book. What a way to dis-inform people while using something beguiling to lure them in to a limited way of thinking about their health and what can improve it!
You have to be the judge, but my money will always be on the side of supplements for promoting and maintaining good health...
Many of the supplements at the lower part of the chart have been used effectively over decades for positive health results. It is difficult to overlay the biased type of studies relied on in mainstream medicine to show less than the already known benefits of vitamins, minerals, and herbs for health.
If all these things were of no use or no benefit how is it that other than US cultures have relied on them for thousands of years, and even the medical system of pharmaceuticals in the US is based on these very things.
Take this as a jumping off point to learn about what you can do to protect and maintain your health.
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