Guest guest Posted April 12, 2007 Report Share Posted April 12, 2007 When it comes to health freedom, this is the FDA's end game. A new FDA " guidance " document, published on the FDA's website, reveals plans to reclassify virtually all vitamins, supplements, herbs and even vegetable juices as FDA-regulated drugs. Massage oils and massage rocks will be classified as " medical devices " and require FDA approval. 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 Draft Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration.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. They tried to sneak this under the radar, but word got out and now the natural health community is up in arms over this rule. If you wish to protect your access to nutritional supplements, herbs, essential oils, homeopathic medicine or any other " complementary " or " alternative " modality, it is crucial that you take action to post your comments with the FDA right now and write your representatives in Washington to put a stop to this outrageous effort to destroy natural medicine. (And be sure to really write them. Just sending an email has virtually no impact compared to writing a physical letter in your own words.) Click here for the direct link to the FDA's comment posting page for this docket. This move by the FDA is designed to once and for all destroy the 1994 DSHEA law that has made supplements " legal " while eliminating nutritional supplements and natural medicine from the United States, ensuring monopoly profits and control by drug companies and the FDA. It is the latest action item by the FDA / Big Pharma conspiracy that will not stop until health freedom has been abolished, drug companies rule the nation, and every citizen is diagnosied with a fictitious disease and drugged up on monopoly-priced pharmaceuticals. FDA " experts " will decide what's a drug or medical deviceUnder these proposed guidelines, FDA " experts " (the same corrupt officials who reapproved Vioxx after it killed over 50,000 Americans) will decide whether herbs, supplements, vitamins or simple devices like massage stones are to be regulated as drugs and medical devices. If the FDA experts, in their infinite wisdom, decide that these things are to be reclassified, they will essentially be outlawed, stripped from the shelves, and regulated out of existence. Anyone who dares to manufacture, promote or sell such products may be branded a criminal and rounded up by armed FDA agents who have a well established history of suppressing natural medicine. I've documented much of the criminal history of the FDA in my recent book, Natural Health Solutions and the Conspiracy to Keep You From Knowing About Them, which suddenly seems even more relevant today than when I wrote it. In that book, I documented the FDA ordered book burnings, the raids on vitamin shops, the kidnapping of natural health practitioners, the threats, intimidation and oppression tactics that have been used to suppress natural medicine for nearly a hundred years now. And now, with this CAM Products Regulation effort, the FDA is about to deal a final, fatal blow to the alternative medicine industry, outlawing nutritional supplements, functional foods, homeopathy and natural therapies all at once. This is not a drill. It really is time to be alarmed. Nothing else I've written about this year is as important as this sinister plot to destroy natural medicine and force the American population to resort to dangerous prescription medications sold at monopoly prices under a system of medical tyranny. Your access to vitamins, supplements, herbs, and even energy medicine modalities is now directly threatened, and you have until April 30 to make your voice heard. Action itemsFirst, read the document yourself. Click here for the PDF version. 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 existenceIt 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. Does anyone honestly believe that this criminal organization has any capacity whatsoever to act in the public interest? Even many Senators are fed up with the FDA's unprecedented level of corruption and criminal behavior. Action items, continued...Read Jon Barron's comments on this rule at the JonBarron.org website Next, lodge your complaint against the FDA by commenting on this docket through the FDA's docket comment form. And finally, write your Senator or Congressperson about this issue and let them know, in blatant language, that you will not stand by and allow the criminals running medicine today to take away your access to vitamins, supplements, herbs and homeopathic medicine. Write the letter in your own words, even if it's just two sentences. Individual letters have a hundred times the impact of form letters. Medical wasteland USAEverything is at stake here. If the FDA gets its way, the United States will become a medical wasteland, dominated by corporate drug company interests, where the naturopaths are imprisoned and their products destroyed. Supplements and herbs will become contraband, and gardeners who grow their own medicinal herbs may be raided and arrested by DEA agents wielding assault rifles. Simply selling dried broccoli sprouts as being " good anti-cancer foods " may land you in prison, and running a vitamin shop could result in you being arrested for " practicing medicine. " Imagine a nation where Whole Foods stores are stripped of all herbs and supplements, where vitamin shops are emptied and abandoned, where books that promote herbs are bulldozed into large piles and burned, where natural healers are rounded up and " disappeared " into incarceration centers. This is the future that will become reality if the FDA has its way. The plan has been explained to us in plain language. Any agency that openly states " vegetable juice will be regulated as a drug " has quite simply lost its marbles. We're are now clearly being regulated by clinically insane bureaucrats. With this desperate proposal by the FDA -- clearly designed as a last-ditch effort to save the failing conventional medical industry from a massive public shift towards natural medicine -- the war against health freedom has reached our shores, and the FDA is plotting a 9/11-style attack to bring down the towers of health freedom in one swift motion. This is the same agency that currently represents the greatest threat to the health and safety of the American people, far outweighing the threat of real terrorism. This agency, we have seen, will do ANYTHING to protect the profits and power of drug companies. It will lie, steal, accept bribes, hide scientific evidence, distort statistics, commit scientific fraud, break federal laws, threaten its own drug safety scientists, conspire with drug company executives, intimidate American citizens and use terror-style tactics to achieve its goals of complete domination over foods, drugs and health. Why do Americans tolerate terrorism in their own government? It is time we put a stop to this home-grown tyranny. We have fought too hard for freedom in the United States to allow us all to be steamrolled by a criminal front group covertly working for Big Pharma. The FDA has declared war on natural medicine and the American people, and we will lose our family members, children, brothers and sisters as casualties of this war if we don't stand up now and demand radical changes. It's time to stop this terrorist organization from destroying the lives of yet more U.S. citizens. Make your voice heard now, or forever surrender your access to supplements, herbs, superfoods and functional foods. By the time the FDA is done with this country, we'll all be eating medication for breakfast, lunch and dinner. Action reminders:1. Lodge a complaint with the FDA by clicking here. MAKE SURE you include the docket number 2006D-0480. But don't trust this to be enough. The FDA will probably simply delete half the complaints it receives, so don't trust your complaint to actually count. It's important to continue... 2. Send a strongly-worded letter to your representatives in Washington. Be sure to cite Docket No. 2006D-0480. Draft Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration. Tell them you support open access to vitamins, herbs, and supplements, and you do not want CAM to be regulated by the FDA. 3. Send this story to everyone you know. Spread the word. Raise the alarm. With enough public support, the FDA will be forced to back off this insane proposal. And stay tuned to NewsTarget for more news, analysis and action alerts on health freedom. Even though we're under constant attack by criminal organizations trying to disrupt our servers and take us off line, we're still here, beating the drum for health freedom, and hoping that we have enough sane-minded Americans remaining to save this country from its government. Actual FDA quote is gobbledygookHere's an actual FDA statement from the CAM Guidance report: For example, naturopathic cranberry tablets might be labeled for use to maintain the health of the urinary tract. In this example, the cranberry tablets generally would be regulated as " dietary supplements " ...if they were labeled for use to " maintain the health of the urinary tract " rather than " prevent urinary tract infections. " The cranberry tablets would be regulated as " drugs " ....if they were labeled for use to " treat urinary tract infections " even if they were labeled as dietary supplements. Additional phone numbers as listed in the FDA documentSheryl Lard-Whiteford at 301-827-0379 Daniel Nguyen at 301-827-8971 Ted Stevens at 301-594-1184 Wayne Amchin at 301-827-6739 Don't be flakey. Get Mail for Mobile and always stay connected to friends. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted April 12, 2007 Report Share Posted April 12, 2007 Thanks for posting this. The pharmaceutical industry won't rest until it's legislated the competition out of business. No matter how many people this hurts and even kills. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted April 12, 2007 Report Share Posted April 12, 2007 Thank you Twyla, for the heads up on this. I want to include the full links for everyone on this list, that they may access source material and submit comments to be included in public record. Here is the FDA Docket being referred to: http://www.fda.gov/ohrms/dockets/dockets/06d0480/06d0480.htm On the surface it seems relatively benign, perhaps even beneficial. Beware! How else do you take candy from a baby? Their strategy as mentioned in Twyla's post seems to be to reclassify dietary supplements out from under the protection of DSHEA 1994, if not just outright ignore it. (There is no mention of DSHEA at all in the online docket.) Please consider following this link (or pasting it into your browser) to include your comments as a part of public record. http://www.accessdata.fda.gov/scripts/oc/dockets/comments/COMMENTSMain.CFM?EC_DO\ CUMENT_ID=1451 & SUBTYP=CONTINUE & CID= & AGENCY=FDA Also, please consider writing your elected official and expressing your concern that non-elected FDA appointees are in effect usurping their legislative authority. That might help get their attention! In health, Matthew Polly, L.Ac. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted April 14, 2007 Report Share Posted April 14, 2007 I read the PDF in this link, and I don't really see any real info as to what they are trying to restrict and why. I feel that at the moment we are a country of regulation. I mean if you look at the western medical community, you will see an environment full of regulations. They have to get mal-practice insurance because of all the lawsuits, and the fact that the public demands everything nearly perfect all the time (ie no deaths or permanent effects for any procedure, surgery, medicine, or advice that has been successful for someone else). The fact is that " CAM " like it says in the article is becoming a very big deal. To quote the article, more visits were made to CAM providers than to all medical Dr's combined. Since everything else that is main stream in this society is heavily regulated... if CAM is being looked at to be regulated, this might be a good sign that it is coming out into the mainstream, which for the most part is what CAM providers are wanting to happen. I am not saying that I agree with what they are doing or not (I did not see any of that kind of info in the link that I followed, like what they are regulating and why). I also do believe that certain regulations in place will help the TCM community gain more creditability, because of the higher regulations, allowing less people to slip by that haven't learned quite enough to treat the general masses (ie, they can treat a few types of people well, or people that do not have complications). I have seen studies done on acupuncture, and I don't have the link, but if anyone does or has read any of them, please post them =). Basically what it showed is that full OMD's and MSOM's (with so many clinical hours, forget how many but probably something between 2,000 and 4,000 hours) had a very very low incidence of problems associated with acupuncture (something like 10 in 50,000). MD's and chiropractors were slightly less but still had a really good track record (maybe 1/2 of what the trained TCM's had), which is surprisingly good considering their short training as far as acupuncture (this study did not rate effectiveness, just severe problems), and then the lower trained individuals (probably something like less than 1000 hours and not in the previous two groups) had something like 10 to 20 times the amount of problems. If these regulations made it so these people who did not have enough training had to have more training before they could work on their own, I think it would make TCM more trustable, and more likely for people to use it of they know that there isn't a substantial risk involved (no matter how rare). Again, I am not saying they are doing this or not, but rather that I think it would be a good idea. Another thing to think about is that if vitamins are said to have the power to heal, then they have the power to harm as well. There is no such thing as something that can heal that cannot harm equally as much as it has the ability to heal. It is my opinion and my experience that the general public does not know enough to really be prescribing their own vitamins. Many people do not even know what the vitamins do or how they work in the body. I have not seen too many healing processes through vitamins, although I think in certain instances they can be very helpful, and in some of those they can even be required in order to heal. I am not saying stop taking vitamins, but what I am saying is that my opinion and observation of vitamins is that they can do a pretty good job of maintaining health, but in restoring health. They generally are not strong enough, or don't hit the nail right on the head a fair amount of the cases. It might be good to have people go to someone like a dietician, an MD or a CAM provider to be able to explain to them what types of vitamins would be good for them, and why. How much to take, and when, and what it can interfere with. I think that if this is what they are looking to do that they need to make it fair so that someone in a CAM field can get the certification through the same process as anyone else, and not just grant the certification to Dr's because they are Dr's (like they basically do with acupuncture). I think there will be a big public resistance to removing the OTC status of even some of the vitamins and minerals, and it will likely not happen. I think we do need to fight for our rights as proficient, competent, and professional health care providers and I don't think the FDA should at anytime now or in the future be able to limit CAM providers from their supplies, but limiting the general public from them might, in some cases, be useful. One note about that: when the FDA was limiting the use and sale of ephedra (not sure if it was ephedra or ephedrine, but something along those lines), and the country was in a huge weight loss craze with it, and it was causing a lot of problems. The recognized that applications with this herb specific to TCM did not have the same effect, consequently TCM practitioners were still allowed to use it. I think what it amounts to is that our governing agencies want to make sure that providers are capable and proficient to reduce risk to the uneducated public (You'll see this all over our society as a whole. There are protections everywhere for the uninformed, even the people that are uninformed because they choose not to find out), and it does this through regulations, and certifications. They just need to remember to allow a reasonable way for CAM providers to obtain the same sorts of status and position. What are they regulating? And who are they regulating (professionals and what type, or general public)? Are they making it so that the CAM sector does not have the power to do what they need to do to help people out? Or are they raising the bar and requiring providers are tested to assess their abilities? A good practitioner should be able to walk in and take some sort of skill or written or whatever other test on their subject any hour and any day of the week IMPO. This should be the kind of knowledge that they should carry with them, and if it is, taking the test or whatever it is shouldn't be but an inconvenience. As far as outlawing v8 and bottled water and being prosecuted as a drug dealer by the FDA, this is quite an extreme view. I don't feel this is a view with just the facts on the table, but rather a use of words to explain something in a very passionate dramatic way to get people up and doing something about the world they live in. This is exactly what makes you a good author. I feel that this info is quite extreme though, and it would serve the community better having the hard facts laid out so that we can see exactly what we are up against and the best method to approach it. " ...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. " I do not believe this is the case. I believe what they are trying to do is say if you are a provider and telling someone to follow this regimen (ie how much to take and when and of what type), then you are responsible for it as if you were prescribing them a drug. I read this as being the FDA's way of regulating accountability to the practitioner to protect the public. Just telling your friend that you heard this was good for that is not prescribing for someone and you are not in the position of a health provider, and would not fall under what they are outlining, and you would not be arrested. If you were a health professional and you recommended something, it would likely fall under a different category. Again this rule I feel is to protect the uninformed public rather than take away our healing methods and supplies. I feel that if a practitioner is prescribing something for a certain disease or condition, they should be held responsible for it. Also if a practitioner already knows what they are doing and how to apply things to certain conditions, they will not have a problem with being accountable for their treatment. If there is something that is truly at risk here, I think we could band together as a group and accomplish some really good things. We would need to know what they are and how they will affect us, and who we need to contact about it. I noticed that you already provided at least one good contact =) Chinese Traditional Medicine , " skyheights " <mattpolly wrote: > > Thank you Twyla, for the heads up on this. I want to include the full > links for everyone on this list, that they may access source material > and submit comments to be included in public record. > > Here is the FDA Docket being referred to: > http://www.fda.gov/ohrms/dockets/dockets/06d0480/06d0480.htm > > On the surface it seems relatively benign, perhaps even beneficial. > Beware! How else do you take candy from a baby? Their strategy as > mentioned in Twyla's post seems to be to reclassify dietary > supplements out from under the protection of DSHEA 1994, if not just > outright ignore it. (There is no mention of DSHEA at all in the online > docket.) > > Please consider following this link (or pasting it into your browser) > to include your comments as a part of public record. > http://www.accessdata.fda.gov/scripts/oc/dockets/comments/COMMENTSMain.CFM?EC_DO\ CUMENT_ID=1451 & SUBTYP=CONTINUE & CID= & AGENCY=FDA > > Also, please consider writing your elected official and expressing > your concern that non-elected FDA appointees are in effect usurping > their legislative authority. That might help get their attention! > > In health, > > Matthew Polly, L.Ac. > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted April 14, 2007 Report Share Posted April 14, 2007 I don't agree with your assertions! The FDA is not this benevolent agency that is out to protect the public! Sorry, but they are just as subject to corruption as most other governmental agency and I don't trust them to be in control of deciding what I can consume or not. The FDA, the AMA. big Pharma and the Industrialized Food Production & Processing business are one big business conglomerate! The FDA plays the role of independent overseer, but this is all a farce to make the consumers feel safe so that they can be used as guinea pigs! Case in point Vioxx! The only reason why they are now trying to muscle in on the alternative medicine business is because they don't like competition and they are losing market shares. Their aim is no different than any other powerful industry in the USA these days: They want to eliminate the little guy. Accidental injuries caused by supplements or alternative medicine procedures are practically ZERO when compared to those of conventional medicine with their FDA approved pharmaceutical drugs. Let's be clear about this their aim is not to legitimize Alternative Health Care by bringing in its practitioners into their mafia like circle, but rather to drive you out through regulation intended to make it impossible for you to stay in business so that only the AMA certified MDs and big pharma can be licensed to provide medical services(you can forget about the word alternative). What will be the result of this? Well you can see what their aim is today... not cure, not root cause, but maintenance... symptom management! Domingo mrasmm wrote: > > I read the PDF in this link, and I don't really see any real info as > to what they are trying to restrict and why. > > I feel that at the moment we are a country of regulation. I mean if > you look at the western medical community, you will see an environment > full of regulations. They have to get mal-practice insurance because > of all the lawsuits, and the fact that the public demands everything > nearly perfect all the time (ie no deaths or permanent effects for any > procedure, surgery, medicine, or advice that has been successful for > someone else). The fact is that " CAM " like it says in the article is > becoming a very big deal. To quote the article, more visits were made > to CAM providers than to all medical Dr's combined. Since everything > else that is main stream in this society is heavily regulated... if > CAM is being looked at to be regulated, this might be a good sign that > it is coming out into the mainstream, which for the most part is what > CAM providers are wanting to happen. > > I am not saying that I agree with what they are doing or not (I did > not see any of that kind of info in the link that I followed, like > what they are regulating and why). I also do believe that certain > regulations in place will help the TCM community gain more > creditability, because of the higher regulations, allowing less people > to slip by that haven't learned quite enough to treat the general > masses (ie, they can treat a few types of people well, or people that > do not have complications). > > I have seen studies done on acupuncture, and I don't have the link, > but if anyone does or has read any of them, please post them =). > Basically what it showed is that full OMD's and MSOM's (with so many > clinical hours, forget how many but probably something between 2,000 > and 4,000 hours) had a very very low incidence of problems associated > with acupuncture (something like 10 in 50,000). MD's and > chiropractors were slightly less but still had a really good track > record (maybe 1/2 of what the trained TCM's had), which is > surprisingly good considering their short training as far as > acupuncture (this study did not rate effectiveness, just severe > problems), and then the lower trained individuals (probably something > like less than 1000 hours and not in the previous two groups) had > something like 10 to 20 times the amount of problems. If these > regulations made it so these people who did not have enough training > had to have more training before they could work on their own, I think > it would make TCM more trustable, and more likely for people to use it > of they know that there isn't a substantial risk involved (no matter > how rare). Again, I am not saying they are doing this or not, but > rather that I think it would be a good idea. > > Another thing to think about is that if vitamins are said to have the > power to heal, then they have the power to harm as well. There is no > such thing as something that can heal that cannot harm equally as much > as it has the ability to heal. It is my opinion and my experience > that the general public does not know enough to really be prescribing > their own vitamins. Many people do not even know what the vitamins do > or how they work in the body. > > I have not seen too many healing processes through vitamins, although > I think in certain instances they can be very helpful, and in some of > those they can even be required in order to heal. I am not saying > stop taking vitamins, but what I am saying is that my opinion and > observation of vitamins is that they can do a pretty good job of > maintaining health, but in restoring health. They generally are not > strong enough, or don't hit the nail right on the head a fair amount > of the cases. > > It might be good to have people go to someone like a dietician, an MD > or a CAM provider to be able to explain to them what types of vitamins > would be good for them, and why. How much to take, and when, and what > it can interfere with. I think that if this is what they are looking > to do that they need to make it fair so that someone in a CAM field > can get the certification through the same process as anyone else, and > not just grant the certification to Dr's because they are Dr's (like > they basically do with acupuncture). I think there will be a big > public resistance to removing the OTC status of even some of the > vitamins and minerals, and it will likely not happen. > > I think we do need to fight for our rights as proficient, competent, > and professional health care providers and I don't think the FDA > should at anytime now or in the future be able to limit CAM providers > from their supplies, but limiting the general public from them might, > in some cases, be useful. > > One note about that: when the FDA was limiting the use and sale of > ephedra (not sure if it was ephedra or ephedrine, but something along > those lines), and the country was in a huge weight loss craze with it, > and it was causing a lot of problems. The recognized that > applications with this herb specific to TCM did not have the same > effect, consequently TCM practitioners were still allowed to use it. > > I think what it amounts to is that our governing agencies want to make > sure that providers are capable and proficient to reduce risk to the > uneducated public (You'll see this all over our society as a whole. > There are protections everywhere for the uninformed, even the people > that are uninformed because they choose not to find out), and it does > this through regulations, and certifications. They just need to > remember to allow a reasonable way for CAM providers to obtain the > same sorts of status and position. > > What are they regulating? And who are they regulating (professionals > and what type, or general public)? Are they making it so that the CAM > sector does not have the power to do what they need to do to help > people out? Or are they raising the bar and requiring providers are > tested to assess their abilities? A good practitioner should be able > to walk in and take some sort of skill or written or whatever other > test on their subject any hour and any day of the week IMPO. This > should be the kind of knowledge that they should carry with them, and > if it is, taking the test or whatever it is shouldn't be but an > inconvenience. > > As far as outlawing v8 and bottled water and being prosecuted as a > drug dealer by the FDA, this is quite an extreme view. I don't feel > this is a view with just the facts on the table, but rather a use of > words to explain something in a very passionate dramatic way to get > people up and doing something about the world they live in. This is > exactly what makes you a good author. I feel that this info is quite > extreme though, and it would serve the community better having the > hard facts laid out so that we can see exactly what we are up against > and the best method to approach it. > > " ...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. " > > I do not believe this is the case. I believe what they are trying to > do is say if you are a provider and telling someone to follow this > regimen (ie how much to take and when and of what type), then you are > responsible for it as if you were prescribing them a drug. I read > this as being the FDA's way of regulating accountability to the > practitioner to protect the public. Just telling your friend that you > heard this was good for that is not prescribing for someone and you > are not in the position of a health provider, and would not fall under > what they are outlining, and you would not be arrested. If you were a > health professional and you recommended something, it would likely > fall under a different category. Again this rule I feel is to protect > the uninformed public rather than take away our healing methods and > supplies. > > I feel that if a practitioner is prescribing something for a certain > disease or condition, they should be held responsible for it. Also if > a practitioner already knows what they are doing and how to apply > things to certain conditions, they will not have a problem with being > accountable for their treatment. > > If there is something that is truly at risk here, I think we could > band together as a group and accomplish some really good things. We > would need to know what they are and how they will affect us, and who > we need to contact about it. I noticed that you already provided at > least one good contact =) > > Chinese Traditional Medicine > <Chinese Traditional Medicine%40>, " skyheights " > <mattpolly wrote: > > > > Thank you Twyla, for the heads up on this. I want to include the full > > links for everyone on this list, that they may access source material > > and submit comments to be included in public record. > > > > Here is the FDA Docket being referred to: > > http://www.fda.gov/ohrms/dockets/dockets/06d0480/06d0480.htm > <http://www.fda.gov/ohrms/dockets/dockets/06d0480/06d0480.htm> > > > > On the surface it seems relatively benign, perhaps even beneficial. > > Beware! How else do you take candy from a baby? Their strategy as > > mentioned in Twyla's post seems to be to reclassify dietary > > supplements out from under the protection of DSHEA 1994, if not just > > outright ignore it. (There is no mention of DSHEA at all in the online > > docket.) > > > > Please consider following this link (or pasting it into your browser) > > to include your comments as a part of public record. > > > http://www.accessdata.fda.gov/scripts/oc/dockets/comments/COMMENTSMain.CFM?EC_DO\ CUMENT_ID=1451 & SUBTYP=CONTINUE & CID= & AGENCY=FDA > <http://www.accessdata.fda.gov/scripts/oc/dockets/comments/COMMENTSMain.CFM?EC_D\ OCUMENT_ID=1451 & SUBTYP=CONTINUE & CID= & AGENCY=FDA> > > > > Also, please consider writing your elected official and expressing > > your concern that non-elected FDA appointees are in effect usurping > > their legislative authority. That might help get their attention! > > > > In health, > > > > Matthew Polly, L.Ac. > > > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted April 14, 2007 Report Share Posted April 14, 2007 As a former news and public affairs journalist, I know from witnessing firsthand money, corruption and collusion drive legislation in this country as evidence shows each day - even the corporate controlled media is forced to out the truth from time to time, in spite of itself - the first rule of journalism was and still is: 'follow the money'. The FDA has its lobbyists on that greased beltway to Congress and regulation of everything governing our lives, lets make no mistake about that. My personal feeling is as practitioners many of us fail to lobby aggressively enough on behalf of our own interests or that of our patients. I also acknowledge how hard it is to try to make a living in the treatment room and stay abreast of the legislative and political issues. The sad fact is we simply aren't organized enough and need to pay more attention to state, national, local organizations working on our behalf. Twyla Domingo Pichardo <dpichardo3 wrote: I don't agree with your assertions! The FDA is not this benevolent agency that is out to protect the public! Sorry, but they are just as subject to corruption as most other governmental agency and I don't trust them to be in control of deciding what I can consume or not. The FDA, the AMA. big Pharma and the Industrialized Food Production & Processing business are one big business conglomerate! The FDA plays the role of independent overseer, but this is all a farce to make the consumers feel safe so that they can be used as guinea pigs! Case in point Vioxx! The only reason why they are now trying to muscle in on the alternative medicine business is because they don't like competition and they are losing market shares. Their aim is no different than any other powerful industry in the USA these days: They want to eliminate the little guy. Accidental injuries caused by supplements or alternative medicine procedures are practically ZERO when compared to those of conventional medicine with their FDA approved pharmaceutical drugs. Let's be clear about this their aim is not to legitimize Alternative Health Care by bringing in its practitioners into their mafia like circle, but rather to drive you out through regulation intended to make it impossible for you to stay in business so that only the AMA certified MDs and big pharma can be licensed to provide medical services(you can forget about the word alternative). What will be the result of this? Well you can see what their aim is today... not cure, not root cause, but maintenance... symptom management! Domingo mrasmm wrote: > > I read the PDF in this link, and I don't really see any real info as > to what they are trying to restrict and why. > > I feel that at the moment we are a country of regulation. I mean if > you look at the western medical community, you will see an environment > full of regulations. They have to get mal-practice insurance because > of all the lawsuits, and the fact that the public demands everything > nearly perfect all the time (ie no deaths or permanent effects for any > procedure, surgery, medicine, or advice that has been successful for > someone else). The fact is that " CAM " like it says in the article is > becoming a very big deal. To quote the article, more visits were made > to CAM providers than to all medical Dr's combined. Since everything > else that is main stream in this society is heavily regulated... if > CAM is being looked at to be regulated, this might be a good sign that > it is coming out into the mainstream, which for the most part is what > CAM providers are wanting to happen. > > I am not saying that I agree with what they are doing or not (I did > not see any of that kind of info in the link that I followed, like > what they are regulating and why). I also do believe that certain > regulations in place will help the TCM community gain more > creditability, because of the higher regulations, allowing less people > to slip by that haven't learned quite enough to treat the general > masses (ie, they can treat a few types of people well, or people that > do not have complications). > > I have seen studies done on acupuncture, and I don't have the link, > but if anyone does or has read any of them, please post them =). > Basically what it showed is that full OMD's and MSOM's (with so many > clinical hours, forget how many but probably something between 2,000 > and 4,000 hours) had a very very low incidence of problems associated > with acupuncture (something like 10 in 50,000). MD's and > chiropractors were slightly less but still had a really good track > record (maybe 1/2 of what the trained TCM's had), which is > surprisingly good considering their short training as far as > acupuncture (this study did not rate effectiveness, just severe > problems), and then the lower trained individuals (probably something > like less than 1000 hours and not in the previous two groups) had > something like 10 to 20 times the amount of problems. If these > regulations made it so these people who did not have enough training > had to have more training before they could work on their own, I think > it would make TCM more trustable, and more likely for people to use it > of they know that there isn't a substantial risk involved (no matter > how rare). Again, I am not saying they are doing this or not, but > rather that I think it would be a good idea. > > Another thing to think about is that if vitamins are said to have the > power to heal, then they have the power to harm as well. There is no > such thing as something that can heal that cannot harm equally as much > as it has the ability to heal. It is my opinion and my experience > that the general public does not know enough to really be prescribing > their own vitamins. Many people do not even know what the vitamins do > or how they work in the body. > > I have not seen too many healing processes through vitamins, although > I think in certain instances they can be very helpful, and in some of > those they can even be required in order to heal. I am not saying > stop taking vitamins, but what I am saying is that my opinion and > observation of vitamins is that they can do a pretty good job of > maintaining health, but in restoring health. They generally are not > strong enough, or don't hit the nail right on the head a fair amount > of the cases. > > It might be good to have people go to someone like a dietician, an MD > or a CAM provider to be able to explain to them what types of vitamins > would be good for them, and why. How much to take, and when, and what > it can interfere with. I think that if this is what they are looking > to do that they need to make it fair so that someone in a CAM field > can get the certification through the same process as anyone else, and > not just grant the certification to Dr's because they are Dr's (like > they basically do with acupuncture). I think there will be a big > public resistance to removing the OTC status of even some of the > vitamins and minerals, and it will likely not happen. > > I think we do need to fight for our rights as proficient, competent, > and professional health care providers and I don't think the FDA > should at anytime now or in the future be able to limit CAM providers > from their supplies, but limiting the general public from them might, > in some cases, be useful. > > One note about that: when the FDA was limiting the use and sale of > ephedra (not sure if it was ephedra or ephedrine, but something along > those lines), and the country was in a huge weight loss craze with it, > and it was causing a lot of problems. The recognized that > applications with this herb specific to TCM did not have the same > effect, consequently TCM practitioners were still allowed to use it. > > I think what it amounts to is that our governing agencies want to make > sure that providers are capable and proficient to reduce risk to the > uneducated public (You'll see this all over our society as a whole. > There are protections everywhere for the uninformed, even the people > that are uninformed because they choose not to find out), and it does > this through regulations, and certifications. They just need to > remember to allow a reasonable way for CAM providers to obtain the > same sorts of status and position. > > What are they regulating? And who are they regulating (professionals > and what type, or general public)? Are they making it so that the CAM > sector does not have the power to do what they need to do to help > people out? Or are they raising the bar and requiring providers are > tested to assess their abilities? A good practitioner should be able > to walk in and take some sort of skill or written or whatever other > test on their subject any hour and any day of the week IMPO. This > should be the kind of knowledge that they should carry with them, and > if it is, taking the test or whatever it is shouldn't be but an > inconvenience. > > As far as outlawing v8 and bottled water and being prosecuted as a > drug dealer by the FDA, this is quite an extreme view. I don't feel > this is a view with just the facts on the table, but rather a use of > words to explain something in a very passionate dramatic way to get > people up and doing something about the world they live in. This is > exactly what makes you a good author. I feel that this info is quite > extreme though, and it would serve the community better having the > hard facts laid out so that we can see exactly what we are up against > and the best method to approach it. > > " ...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. " > > I do not believe this is the case. I believe what they are trying to > do is say if you are a provider and telling someone to follow this > regimen (ie how much to take and when and of what type), then you are > responsible for it as if you were prescribing them a drug. I read > this as being the FDA's way of regulating accountability to the > practitioner to protect the public. Just telling your friend that you > heard this was good for that is not prescribing for someone and you > are not in the position of a health provider, and would not fall under > what they are outlining, and you would not be arrested. If you were a > health professional and you recommended something, it would likely > fall under a different category. Again this rule I feel is to protect > the uninformed public rather than take away our healing methods and > supplies. > > I feel that if a practitioner is prescribing something for a certain > disease or condition, they should be held responsible for it. Also if > a practitioner already knows what they are doing and how to apply > things to certain conditions, they will not have a problem with being > accountable for their treatment. > > If there is something that is truly at risk here, I think we could > band together as a group and accomplish some really good things. We > would need to know what they are and how they will affect us, and who > we need to contact about it. I noticed that you already provided at > least one good contact =) > > Chinese Traditional Medicine > <Chinese Traditional Medicine%40>, " skyheights " > <mattpolly wrote: > > > > Thank you Twyla, for the heads up on this. I want to include the full > > links for everyone on this list, that they may access source material > > and submit comments to be included in public record. > > > > Here is the FDA Docket being referred to: > > http://www.fda.gov/ohrms/dockets/dockets/06d0480/06d0480.htm > <http://www.fda.gov/ohrms/dockets/dockets/06d0480/06d0480.htm> > > > > On the surface it seems relatively benign, perhaps even beneficial. > > Beware! How else do you take candy from a baby? Their strategy as > > mentioned in Twyla's post seems to be to reclassify dietary > > supplements out from under the protection of DSHEA 1994, if not just > > outright ignore it. (There is no mention of DSHEA at all in the online > > docket.) > > > > Please consider following this link (or pasting it into your browser) > > to include your comments as a part of public record. > > > http://www.accessdata.fda.gov/scripts/oc/dockets/comments/COMMENTSMain.CFM?EC_DO\ CUMENT_ID=1451 & SUBTYP=CONTINUE & CID= & AGENCY=FDA > <http://www.accessdata.fda.gov/scripts/oc/dockets/comments/COMMENTSMain.CFM?EC_D\ OCUMENT_ID=1451 & SUBTYP=CONTINUE & CID= & AGENCY=FDA> > > > > Also, please consider writing your elected official and expressing > > your concern that non-elected FDA appointees are in effect usurping > > their legislative authority. That might help get their attention! > > > > In health, > > > > Matthew Polly, L.Ac. > > > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted April 14, 2007 Report Share Posted April 14, 2007 Chinese Traditional Medicine , " mrasmm " <mrasmm wrote: > > I read the PDF in this link, and I don't really see any real info as > to what they are trying to restrict and why. I disagree because of long experience and observation. I will make just a few points. > to CAM providers than to all medical Dr's combined. Since everything > else that is main stream in this society is heavily regulated... This simply is not true. The US actually is underregulated, and what little regulation there is is not enforced all too often. This bill is not about regulating things for the public's safety but regulating the business rivals of big campaign donors out of business. This is the function that " regulation " serves in the US today. Don't believe me? Consider this: The recent poisonings of so many pets and the massive recalls of pet food. Before that the recalls of Peter Pan and Walmart brand peanut butter. Before that people sickened because of contaminated spinach. Etc. Etc. Etc. Also consider that the Bush administration keeps slashing funding for food inspection. There are all these failures in regulation in the US. Given how iffy the food supply has become for humans and pets, there is no way this is about protecting the public. > like less than 1000 hours and not in the previous two groups) had > something like 10 to 20 times the amount of problems. If these > regulations made it so these people who did not have enough training > had to have more training before they could work on their own, I think > it would make TCM more trustable, and more likely for people to use it It's not working this way. Legislation which controls acupuncture should be putting doctors who practice acupuncture under the control of acupuncturists but instead put acupuncturists who know far more about acupuncture than MDs and DOs do under the control of doctors. Again, this is not about protecting the public but about protecting the income of the members of some very powerful and very rich lobbying groups. > as it has the ability to heal. It is my opinion and my experience > that the general public does not know enough to really be prescribing > their own vitamins. Based on my experiences and observations of others' experiences, the vast majority of MDs and DOs don't know enough about vitamins and minerals to know when to prescribe them. Far too many of them are tied into drug company propaganda into being knowledgeable about cheaper, safer, and often more efffective than drugs vitamins and minerals. I know that if I had had to rely on MDs and DOs for treatment, this list wouldn't exist because I'd probably be dead years ago. > maintaining health, but in restoring health. They generally are not > strong enough, or don't hit the nail right on the head a fair amount > of the cases. Believe me, they can do a lot to help. Voice of experience here. > to do that they need to make it fair so that someone in a CAM field > can get the certification through the same process as anyone else, It's a myth that doctors in the US are being adequately regulated. See the book put out by I believe Common Cause called 6,000 Problem Doctors. The former head of Arizona BOMEX (Board of Medical EXaminers) stated in public that BOMEX's primary job was not to protect the public but protect the income of doctors. If they're disciplined in AZ, they have trouble getting hired by HMOs. BTW, AZ BOMEX has been one of the worst BOMEXes in the US when it comes to reigning in problem doctors. No, this legislation is not about protecting the public or improving the quality of medical care in the US. It's strictly about regulating the competition out of business. If politicians cared about the quality of medicine in the US and about protecting the public, they'd be forcing enforcement of the few regulations there already are. But since this is about keeping their big campaign donors happy, they aren't doing that. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted April 15, 2007 Report Share Posted April 15, 2007 I would just like to reply and say that from what I am hearing back what I had to say appears to be largly misunderstood. I was not, and am not saying the FDA is some great benevolent organization that has no coruption in it and always looks out for the publics best interest. I also never said that Dr's are great and powerful and should be governming alternative medicine, or have the right to really recommend alot of the things they do including vitamins. The fact is, in alot of cases they don't know that much more about vitamins than your every day average joe, and that is sometimes pretty scary. Basically the just of what I was saying is that if you actually step in the shoes on the other side for a bit, it may not be quite as ideal, and maybe not quite what you thought it was. Sometimes it's this that has us stuck and fighting rather than the real issues and the solutions for them. I feel a doomsday type atmosphere here as far as this topic, and what I was going for is bringing about some different ideas of different ways to maybe see more of what is going on so it doesn't feel quite so impending. I just don't like to see what happens when people start believing that something is taking over their lives and they have little to no control over it and feel helpless. I am talking about this regardless of if there is some truth to it or not. I guess that's what you get though anytime you talk about politics Anyways, whatever works. Hopefully we can as a TCM community in the world figure out how to work it out so we as humans can get the most benifit from it as we can. Quote Link to comment Share on other sites More sharing options...
Recommended Posts
Join the conversation
You are posting as a guest. If you have an account, sign in now to post with your account.
Note: Your post will require moderator approval before it will be visible.