Guest guest Posted January 18, 2004 Report Share Posted January 18, 2004 Has anyone heard anything new on the ma huang scenario? I just read a mayway press release and they said that their products will not be affected? So does this mean any chinese herbal product (whatever that means) is exempt? Comments? - Quote Link to comment Share on other sites More sharing options...
Guest guest Posted January 20, 2004 Report Share Posted January 20, 2004 Not sure about Ma Hunag but I was just informed by the Department of Health & Human Services (FDA) that Ginseng may be considered as a " new drug " The intended use of the product which may be established by ... brochures, audio and videotapes, internet sites or " other circumstances " ---and that is what they argue constitutes a new drug... skip to the last lines below of my comments or go to see http://www.cfsan.fda.gov/~lrd/fr000106.html of interest in this report is a survey conducted. It says a lot to me about where acupuncturists / herbalists are. " 500 to 850 firms manufacture dietary supplements. [ " ...5 percent [of the industry] ... account for 80 percent of industry sales. " ] The recent RTI study, however, has identified 1,050 manufacturers (Ref. 12). This higher number probably overestimates the size of the industry covered by this rule, because it includes homeopathic products, which are drugs by statutory definition, and ``functional foods'' and sports nutrition products, which may be either conventional foods or dietary supplements depending on how they are marketed and used. For this final analysis, FDA has assumed that 1,000 companies manufacture the dietary supplement products covered by this rule " Wonder if this (may latter) include acupuncturists / herbalist and their " dietary supplements " . " ... The dietary supplement industry has grown rapidly, with estimated sales in 1996 of $10.4 billion for all dietary supplements, including $4.9 billion for vitamins and $3.0 billion for nonprescription herbal products (Ref. 8). FDA has limited information on the number of products and quantities sold, or on the age, gender, and disease status of persons currently using dietary supplements. However, a 1997 survey of 43,000 households, conducted by the Hartman and New Hope research organization, indicates that approximately 70 percent of all households reported using vitamins, minerals, or herbal supplements in the past 6 months (Ref. 9). Among survey respondents, those under age 30 accounted for only 8 percent of all households with a member using dietary supplements; ages 30 to 39 accounted for 21 percent, ages 40 to 49 accounted for 22 percent, ages 50 to 59 accounted for 18 percent, and ages 60 or older accounted for 30 percent (Ref. 10). Although the oldest group of survey respondents were, on the whole, less knowledgeable about individual products, they reported more regular product use and more use for specific conditions than younger respondents. ... " just to repeat its " $3.0 billion for nonprescription herbal products (Ref. 8) " wow, meanwhile back at reality, the last lines .... (viii) Has a role in the body's response to a disease or to a vector of disease; (ix) Treats, prevents, or mitigates adverse events associated with a therapy for a disease, if the adverse events constitute diseases; or (x) Otherwise suggests an effect on a disease or diseases. I reckon if you suggest to someone to take something for something you may be prescribing a drug. Methinks, I'll attempt to stick to Traditional , which predates the FDA and to which I am duly licensed and ordained to prescribe, albeit in precise TCM terms - not to be confused with whatever the FDA said above. My advice Speak TCM Ed Kasper gotta keep my head lower, santa cruz, ca. Mon, 19 Jan 2004 04:58:39 -0000 " " < FDA Has anyone heard anything new on the ma huang scenario? I just read a mayway press release and they said that their products will not be affected? So does this mean any chinese herbal product (whatever that means) is exempt? Comments? - -- Outgoing mail is certified Virus Free. Checked by AVG Anti-Virus (http://www.grisoft.com). Version: 7.0.209 / Virus Database: 261.6.1 - Release 1/8/2004 Quote Link to comment Share on other sites More sharing options...
Guest guest Posted January 21, 2004 Report Share Posted January 21, 2004 , " Ed kasper LAc " <eddy@h...> wrote: > > Methinks, I'll attempt to stick to Traditional , which > predates the FDA and to which I am duly licensed and ordained to prescribe, > albeit in precise TCM terms - not to be confused with whatever the FDA said > above. that's admirable, Ed. You can always grow the herbs and give them to your patients for free after the feds take them off the shelves and raid your office. Anyone ever hear of Jonathon Wright, MD. Do a google search. I am still waiting for a rational explanation from ANYONE as to how the FDA plans to exempt us from their rules. They don't regulate practitioners, only substances. And only congress can create a newly defined class of substances such as " traditional chinese herbal remedies " . Congress has not done this. The FDA has yet to issue the rule that defines this term as they promised 3 weeks ago. I believe the FDA has no power to exempt prepared chinese medicines which already fall under the jurisdiction of DSHEA. Their own website still seems to imply that the ONLY exempt products will be teas dispensed in bulk. I know people will think I am getting hysterical here, but where is the evidence to counter. I will say again that we may be putting our heads in the sand here and by the time we pull them out, we may have lost something that we will never get back. If you have not yet badgered the FDA, please do so now. Let them know you are a citizen. Demand they define the term traditional chinese herbal remedies " in their press relases. Tell them their carelessness has impacted your means of earning a living and you are planning a class action suit against the agency for this. All this can be avoided if they withdraw the rule, have congress write the appropriate exemption and then reissue it in a way that clearly protects our field. If they have already done this, then cough up the wording that proves it NOW!!! Each passing day in limbo further injurs us. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted January 21, 2004 Report Share Posted January 21, 2004 Would you be willing to put tougher a form letter that we could circulate through the Acupuncture communities to use as a common mailer to the FDA? If you make it easy for us to look like a unified front, we will be more of a unified front. Just a thought, Chris In a message dated 1/21/2004 5:30:38 PM Eastern Standard Time, writes: Let them know you are a citizen. Demand they define the term traditional chinese herbal remedies " in their press relases. Tell them their carelessness has impacted your means of earning a living and you are planning a class action suit against the agency for this. All this can be avoided if they withdraw the rule, have congress write the appropriate exemption and then reissue it in a way that clearly protects our field. If they have already done this, then cough up the wording that proves it NOW!!! Each passing day in limbo further injurs us. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted January 21, 2004 Report Share Posted January 21, 2004 If it is possible, lets get an email out to as many of our kind so we can hopefully get some people involved and the FDA will know we have numbers behind us. Chris In a message dated 1/21/2004 6:18:11 PM Eastern Standard Time, rory.kerr writes: Have you consulted an attorney about this. Is it possible? If so, why aren't we already having an attorney take some preliminary action that would grab the FDA's attention? Rory Quote Link to comment Share on other sites More sharing options...
Guest guest Posted January 21, 2004 Report Share Posted January 21, 2004 At 6:29 PM +0000 1/21/04, wrote: >Tell them their carelessness has impacted your means of earning a >living and you are planning a class action suit against the agency >for this. -- Have you consulted an attorney about this. Is it possible? If so, why aren't we already having an attorney take some preliminary action that would grab the FDA's attention? Rory -- Quote Link to comment Share on other sites More sharing options...
Guest guest Posted January 21, 2004 Report Share Posted January 21, 2004 just to validate what you say: http://www.usatoday.com/news/health/2004-01-21-dietary- supplements_x.htm I commend your call-to-action, and will contact the FDA in regard to clarifying their position and protection of our field. Here is a link to contact FDA: http://www.fda.gov/comments.html If there are more expedient ways of doing this, please let me know Oren , " " wrote: > , " Ed kasper LAc " <eddy@h...> > wrote: > > > > > Methinks, I'll attempt to stick to Traditional , which > > predates the FDA and to which I am duly licensed and ordained to prescribe, > > albeit in precise TCM terms - not to be confused with whatever the FDA said > > above. > > > that's admirable, Ed. You can always grow the herbs and give them to your > patients for free after the feds take them off the shelves and raid your office. > Anyone ever hear of Jonathon Wright, MD. Do a google search. > > I am still waiting for a rational explanation from ANYONE as to how the FDA > plans to exempt us from their rules. They don't regulate practitioners, only > substances. And only congress can create a newly defined class of substances > such as " traditional chinese herbal remedies " . Congress has not done this. > The FDA has yet to issue the rule that defines this term as they promised 3 > weeks ago. I believe the FDA has no power to exempt prepared chinese > medicines which already fall under the jurisdiction of DSHEA. Their own > website still seems to imply that the ONLY exempt products will be teas > dispensed in bulk. I know people will think I am getting hysterical here, but > where is the evidence to counter. I will say again that we may be putting our > heads in the sand here and by the time we pull them out, we may have lost > something that we will never get back. If you have not yet badgered the FDA, > please do so now. > > Let them know you are a citizen. Demand they define the term traditional > chinese herbal remedies " in their press relases. Tell them their carelessness > has impacted your means of earning a living and you are planning a class > action suit against the agency for this. All this can be avoided if they > withdraw the rule, have congress write the appropriate exemption and then > reissue it in a way that clearly protects our field. If they have already done > this, then cough up the wording that proves it NOW!!! Each passing day in limbo > further injurs us. > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted January 21, 2004 Report Share Posted January 21, 2004 Just add : " supplements_x.htm " to the address where that first link takes you. , " Oren Markowitz " <orenm1@e...> wrote: > just to validate what you say: > > http://www.usatoday.com/news/health/2004-01-21-dietary- > supplements_x.htm > > I commend your call-to-action, and will contact the FDA in regard to > clarifying their position and protection of our field. > Here is a link to contact FDA: > > http://www.fda.gov/comments.html > > If there are more expedient ways of doing this, please let me know > > Oren > > , " " > wrote: > > , " Ed kasper LAc " > <eddy@h...> > > wrote: > > > > > > > > Methinks, I'll attempt to stick to Traditional Chinese Medicine, > which > > > predates the FDA and to which I am duly licensed and ordained to > prescribe, > > > albeit in precise TCM terms - not to be confused with whatever > the FDA said > > > above. > > > > > > that's admirable, Ed. You can always grow the herbs and give them > to your > > patients for free after the feds take them off the shelves and raid > your office. > > Anyone ever hear of Jonathon Wright, MD. Do a google search. > > > > I am still waiting for a rational explanation from ANYONE as to how > the FDA > > plans to exempt us from their rules. They don't regulate > practitioners, only > > substances. And only congress can create a newly defined class of > substances > > such as " traditional chinese herbal remedies " . Congress has not > done this. > > The FDA has yet to issue the rule that defines this term as they > promised 3 > > weeks ago. I believe the FDA has no power to exempt prepared > chinese > > medicines which already fall under the jurisdiction of DSHEA. > Their own > > website still seems to imply that the ONLY exempt products will be > teas > > dispensed in bulk. I know people will think I am getting > hysterical here, but > > where is the evidence to counter. I will say again that we may be > putting our > > heads in the sand here and by the time we pull them out, we may > have lost > > something that we will never get back. If you have not yet > badgered the FDA, > > please do so now. > > > > Let them know you are a citizen. Demand they define the term > traditional > > chinese herbal remedies " in their press relases. Tell them their > carelessness > > has impacted your means of earning a living and you are planning a > class > > action suit against the agency for this. All this can be avoided > if they > > withdraw the rule, have congress write the appropriate exemption > and then > > reissue it in a way that clearly protects our field. If they have > already done > > this, then cough up the wording that proves it NOW!!! Each passing > day in limbo > > further injurs us. > > > > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted January 22, 2004 Report Share Posted January 22, 2004 Todd and Rory, I am already in the eye of the FDA (or rather the department of Health and Human resources). At this time I expect to quickly and humbly comply (you will comply) to their requests. Aww, but this is such a glorious and noble battle ... If only I were young and single - as my wife reminds me that I am the sole support for her, our six year old and 6 month old... I don't believe I have been an obnoxious standout in this feud just caught up in the net. In their letter to me they state " ...claims that dietary supplements are intended to prevent, diagnosis, migrate, treat, or cure disease (disease claims), excepting health claims authorized for use by the FDA, cause the products to be drugs. The Intended use of a product may be established through .... brochures,... So if I have a product simply labeled Ginseng (nothing else) and on the shelf next to it is a published book on Japanese or Chinese research on Ginseng and walla ... its a drug. So you're at a party, she complains about weak eyes ... you say ... eat more carrots, the feralalies haul you away for prescribing drugs and Cali-fornia throws away the keys because you did not do a proper diagnosis. So I say forgot about that guy with the carrots, think Liver Yin Shoe, she squints her eyes and grimaces as she quickly hurries away... Aw to be young again... Eddy http://www.cfsan.fda.gov/~lrd/fr000106.html Wed, 21 Jan 2004 18:29:54 -0000 " " < Re: FDA , " Ed kasper LAc " <eddy@h...> wrote: > > Methinks, I'll attempt to stick to Traditional , which > predates the FDA and to which I am duly licensed and ordained to prescribe, > albeit in precise TCM terms - not to be confused with whatever the FDA said > above. that's admirable, Ed. You can always grow the herbs and give them to your patients for free after the feds take them off the shelves and raid your office. Anyone ever hear of Jonathon Wright, MD. Do a google search. I am still waiting for a rational explanation from ANYONE as to how the FDA plans to exempt us from their rules. They don't regulate practitioners, only substances. And only congress can create a newly defined class of substances such as " traditional chinese herbal remedies " . Congress has not done this. The FDA has yet to issue the rule that defines this term as they promised 3 weeks ago. I believe the FDA has no power to exempt prepared chinese medicines which already fall under the jurisdiction of DSHEA. Their own website still seems to imply that the ONLY exempt products will be teas dispensed in bulk. I know people will think I am getting hysterical here, but where is the evidence to counter. I will say again that we may be putting our heads in the sand here and by the time we pull them out, we may have lost something that we will never get back. If you have not yet badgered the FDA, please do so now. Let them know you are a citizen. Demand they define the term traditional chinese herbal remedies " in their press relases. Tell them their carelessness has impacted your means of earning a living and you are planning a class action suit against the agency for this. All this can be avoided if they withdraw the rule, have congress write the appropriate exemption and then reissue it in a way that clearly protects our field. If they have already done this, then cough up the wording that proves it NOW!!! Each passing day in limbo further injurs us. Message: 22 Wed, 21 Jan 2004 14:52:39 -0500 Rory Kerr <rory.kerr Re: FDA At 6:29 PM +0000 1/21/04, wrote: >Tell them their carelessness has impacted your means of earning a >living and you are planning a class action suit against the agency >for this. -- Have you consulted an attorney about this. Is it possible? If so, why aren't we already having an attorney take some preliminary action that would grab the FDA's attention? Rory -- Outgoing mail is certified Virus Free. Checked by AVG Anti-Virus (http://www.grisoft.com). Version: 7.0.209 / Virus Database: 261.6.1 - Release 1/8/2004 Quote Link to comment Share on other sites More sharing options...
Guest guest Posted January 23, 2004 Report Share Posted January 23, 2004 I wish to address those professionals that seek to integrate WM and CM The letter I received last week from the FDA stated I was in violation of promoting Ginseng as a drug. I had referenced Ginseng in western speak: addressing western defined diseases. I did not make any claims myself. I directly quoted studies/research done in Japan, China, Europe and America. FDA specifically cited these statements; " ome herbal specialists may consider ginseng as part of the treatment for depression " " Severe chronic respiratory diseases (such as emphysema or chronic bronchitis), daily treatment with ginseng improved respiratory function... " " Diabetes: oth Chinese and American ginsengs appear to lower blood sugar (glucose) levels... " continuing the quote ... " Furthermore, FDA has no information that your products are generally recognized as safe and effective for the above referenced conditions and therefore, the products may also be " new drugs " under section 201 (p) of the Act [21 USC 321 (p)]. .. " Now, If I said " Ginseng Tonifies Qi " and " Ginseng helps the Kidneys Grasp the Qi, aids the Lung Qi (Breath) and Builds the Qi (Energy) of the Body " . .... no problems. Another one of my products (Colloidal Silver) which I promote as a dietary supplement, ran afoul of the FDA where I stated " Apply liberally and directly to cuts, scrapes, and open sores. " -- The FDA here states " only products that are intended for ingestion may be lawfully marketed as dietary supplements. Topical products and products ... are not dietary supplements. For these products, both disease and structure/function claims may cause them to be new drugs. " How does this apply to those Chinese herbs that may ONLY be applied topically? According to Cali-fornia acupuncturists/herbalist may only prescribe dietary supplements. Now it appears the FDA is re-defining what is a or may be a dietary supplement. All this is simply politics and has nothing to do with truth. acupuncturists/herbalist do not diagnosis nor treat [cancer] or any western disease. acupuncturists/herbalist do not do diet supplements. We are not nutritionists. we diagnosis and prescribe herbal medicine safely, honestly, and responsibly (with accountability) to restore health and ability. just my remaining 2 cents. Ed Kasper LAc., Santa Cruz, CA -- Outgoing mail is certified Virus Free. Checked by AVG Anti-Virus (http://www.grisoft.com). Version: 7.0.209 / Virus Database: 261.6.1 - Release 1/8/2004 Quote Link to comment Share on other sites More sharing options...
Guest guest Posted January 23, 2004 Report Share Posted January 23, 2004 , " Ed kasper LAc " <eddy@h...> wrote: > > -- The FDA here states " only products that are intended for ingestion may be > lawfully marketed as dietary supplements. Topical products and products ... > are not dietary supplements. For these products, both disease and > structure/function claims may cause them to be new drugs. " > > How does this apply to those Chinese herbs that may ONLY be applied > topically? > > According to Cali-fornia acupuncturists/herbalist may only prescribe dietary > supplements. Now it appears the FDA is re-defining what is a or may be a > dietary supplement. We may need to amend the law to explicitly include topicals. But it does make sense that something you put on the skin is not necessarily a dietary supplement. Some are most definitely being used as medicines. But what about lotions that restore moisture. Isn't that nutritive in a way. Or how about vaginal and rectal insertion of herbal extracts? Can we do that? Quote Link to comment Share on other sites More sharing options...
Guest guest Posted January 23, 2004 Report Share Posted January 23, 2004 Having taking a quick look at his web-site I can see why the FDA took an interest in Ed's work. Having a direct link to an online Western pharmacy, even with a disclaimer, should call attention to it enough. Quite frankly, online diagnosing and prescribing TCM herbs in California with a California license is problematic also. I have a feeling this " correspondence " with the FDA has more to do with the whole of his business than just ginseng or topicals. ____________ Another one of my products (Colloidal Silver) which I promote as a dietary supplement, ran afoul of the FDA where I stated " Apply liberally and directly to cuts, scrapes, and open sores. " -- The FDA here states " only products that are intended for ingestion may be lawfully marketed as dietary supplements. Topical products and products ... are not dietary supplements. For these products, both disease and structure/function claims may cause them to be new drugs. " How does this apply to those Chinese herbs that may ONLY be applied topically? ____________________ If this weren't meant to be put into cuts and open wounds then I doubt there is a problem. As far as I know, none of our patent topicals are meant to be applied in this way... perhaps the burn creme comes close. best of luck, doug http://www.happyherbalist.com/tcm_Herbal_Diagnosis.htm , " " wrote: > , " Ed kasper LAc " <eddy@h...> > wrote: > > > > > -- The FDA here states " only products that are intended for ingestion may be > > lawfully marketed as dietary supplements. Topical products and products ... > > are not dietary supplements. For these products, both disease and > > structure/function claims may cause them to be new drugs. " > > > > How does this apply to those Chinese herbs that may ONLY be applied > > topically? > > > > According to Cali-fornia acupuncturists/herbalist may only prescribe > dietary > > supplements. Now it appears the FDA is re-defining what is a or may be a > > dietary supplement. > > > We may need to amend the law to explicitly include topicals. But it does make > sense that something you put on the skin is not necessarily a dietary > supplement. Some are most definitely being used as medicines. But what > about lotions that restore moisture. Isn't that nutritive in a way. Or how > about vaginal and rectal insertion of herbal extracts? Can we do that? > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted January 24, 2004 Report Share Posted January 24, 2004 Doug, you may have (some) points are problemic with the online diagnosis and the herbal claims. However this is not /nor should be limited solely to me. I am presenting TCM in a new format- the web. I have found completing this questionnaire prior to an office visit is helpful to both the patient and myself. I also state that I may not be able to give a diagnosis without an office visit and cite the California Standard of care that I abide to. Everything that I have done has/is being done everyday somewhere in our profession. I believe in our profession I would be considered a " moderate " . I do link with a western diagnosis/drug pharmacy. Medical doctor online. Since I have only limited knowledge in herbal-drug interactions? Why not ask an MD - there online its free. These doctors will probably tell them not to take any herbal supplements (like most local MD's where one pays for a office visit). Are you suggesting that what I am doing is illegal, un-ethical or immoral? If you have that opinion I will endeavor to re-make my presentation " more honest " . Years ago when the FDA went against those products like Ginseng, that were labeled with health claims, and made those companies remove those statements from the labels. Those companies simply wrote books and placed books, brochures, videos [and now internet links] next to their products. Today the FDA wants that practice of promoting herbs - like Ginseng - as a drug stopped. In my office on land, I have a small Herbal product bookcase. Also available is literature , books, as well as a recent copy (Oct 2003) of Acupuncture Today Newspaper with the headline " Ginseng Shows Promise in Treating Diabetes " . All of these may be considered an violation as cited in the FDA letter to me. My question is also to our professionals. How can you write articles (like in AT), hold seminars and discuss Ginseng treating Diabetes and then go into clinical practice and not say those things to your patient? The FDA letter to me was clear. I can not " link " Ginseng and Diabetes period And I am not the only one caught up in this net. http://www.herbalhealer.com/ " Herbal Healer provides Natural Supplements, Correspondence Courses, Informative Newsletters and information on our ongoing research for our members. " This recent exercise by the FDA is still under way and is a directed intentional campaign. It is not a complaint driven issue as you may have suggested. According to their website they have targeted the 3 Billion dollar herbal business. They have also calculated how much it will cost to bring everyone into compliance as well as the impact. You personally may not be targeted - but your profession will be brought into compliance! (that's the message on their website) http://www.cfsan.fda.gov/~lrd/fr000106.html Regulations on Statements Made for Dietary Supplements Concerning the Effect of the Product on the Structure or Function of the Body; Final Rule Sat, 24 Jan 2004 05:09:48 -0000 " " Re: FDA Having taking a quick look at his web-site I can see why the FDA took an interest in Ed's work. Having a direct link to an online Western pharmacy, even with a disclaimer, should call attention to it enough. Quite frankly, online diagnosing and prescribing TCM herbs in California with a California license is problematic also. I have a feeling this " correspondence " with the FDA has more to do with the whole of his business than just ginseng or topicals. ____________ Another one of my products (Colloidal Silver) which I promote as a dietary supplement, ran afoul of the FDA where I stated " Apply liberally and directly to cuts, scrapes, and open sores. " -- The FDA here states " only products that are intended for ingestion may be lawfully marketed as dietary supplements. Topical products and products ..... are not dietary supplements. For these products, both disease and structure/function claims may cause them to be new drugs. " How does this apply to those Chinese herbs that may ONLY be applied topically? ____________________ If this weren't meant to be put into cuts and open wounds then I doubt there is a problem. As far as I know, none of our patent topicals are meant to be applied in this way... perhaps the burn creme comes close. best of luck, doug http://www.happyherbalist.com/tcm_Herbal_Diagnosis.htm -- Outgoing mail is certified Virus Free. Checked by AVG Anti-Virus (http://www.grisoft.com). Version: 7.0.209 / Virus Database: 261.6.1 - Release 1/8/2004 Quote Link to comment Share on other sites More sharing options...
Guest guest Posted January 24, 2004 Report Share Posted January 24, 2004 Ed, I think you are touching on the dilemna that probably has faced doctors for centuries if not millenia. Those most qualified to prescribe are often limited by the professional standards that they must be held to. You have a number of issues going on here. One is the ginseng claim, which I can't comment on because I couldn't find where the reference might have been on your web-site. I just know that I was involved in writing a web-site for herbal supplements that got hung up for many of these same issues. We could refer to studies but not claim them for the product we would sell. (this site never got off the ground). All you can do is offer selections for the consumer to choose from. The issue then becomes in using your license to suggest products you may be seen as " prescribing them " . Hence you can't do what they can do at the local health food store. This is also the opinion with the California Board which has recently said a diagnosis needs face to face contact. So while you may want to use the web to present TCM in a new format, you may be limited in the business opportunities. I know that, having some knowledge about Hep C I thought about selling formulas over the web. (Dr. Zhang in NYC has a very big clientele over the web doing this. Many of my patients started with his herbs). I concluded I wasn't comfortable with this from a medical point of view. The letter last year from the California State Board confirmed the legal problems. I would like to know more about your letter from the FDA and the context in which it came. It indeed is an important issue. doug , " Ed kasper LAc " <eddy@h...> wrote: > Doug, you may have (some) points are problemic with the online diagnosis and > the herbal claims. > However this is not /nor should be limited solely to me. I am presenting TCM > in a new format- the web. > I have found completing this questionnaire prior to an office visit is > helpful to both the patient and myself. I also state that I may not be able > to give a diagnosis without an office visit and cite the California Standard > of care that I abide to. > > Everything that I have done has/is being done everyday somewhere in our > profession. I believe in our profession I would be considered a " moderate " . > > I do link with a western diagnosis/drug pharmacy. Medical doctor online. > Since I have only limited knowledge in herbal-drug interactions? Why not ask > an MD - there online its free. These doctors will probably tell them not to > take any herbal supplements (like most local MD's where one pays for a > office visit). Are you suggesting that what I am doing is illegal, > un-ethical or immoral? If you have that opinion I will endeavor to re-make > my presentation " more honest " . > > Years ago when the FDA went against those products like Ginseng, that were > labeled with health claims, and made those companies remove those statements > from the labels. Those companies simply wrote books and placed books, > brochures, videos [and now internet links] next to their products. Today the > FDA wants that practice of promoting herbs - like Ginseng - as a drug > stopped. > > In my office on land, I have a small Herbal product bookcase. Also available > is literature , books, as well as a recent copy (Oct 2003) of Acupuncture > Today Newspaper with the headline " Ginseng Shows Promise in Treating > Diabetes " . All of these may be considered an violation as cited in the FDA > letter to me. > > My question is also to our professionals. How can you write articles (like > in AT), hold seminars and discuss Ginseng treating Diabetes and then go into > clinical practice and not say those things to your patient? > > The FDA letter to me was clear. I can not " link " Ginseng and Diabetes period > > And I am not the only one caught up in this net. > http://www.herbalhealer.com/ > " Herbal Healer provides Natural Supplements, Correspondence Courses, > Informative Newsletters and information on our ongoing research for our > members. " Quote Link to comment Share on other sites More sharing options...
Guest guest Posted January 25, 2004 Report Share Posted January 25, 2004 Ed wrote: > > > > My question is also to our professionals. How can you write articles (like > > in AT), hold seminars and discuss Ginseng treating Diabetes and then go into > > clinical practice and not say those things to your patient? > > > > The FDA letter to me was clear. I can not " link " Ginseng and Diabetes period But the FDA cannot micromanage what goes on between the doctor and the patient. They can control what you claim in written literature or public seminars, but do they have any power over the privileged conversation between doctor and patient? MD's prescribe off-label all the time, but drug co's cannot make off-label claims in advertising. Is this similar to making an oral claim to a single patient in your office behind closed doors. Maybe not, but the FDA cannot even look there for evidence unless numerous patients complain. I always give the context of any evidence I provide the patient: the issue of unblinded research, historical uses, etc. If a patient asks if ginseng can lower blood sugar, should one just look away and change the subject? I think there are ways to answer these questions in private that fall short of " claims " for diseases. BTW, in the state of CA, we are legally allowed to claim that we can promote, maintain and RESTORE health using the modalities of CM without making any specific claims for any particular herb. Quote Link to comment Share on other sites More sharing options...
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