Guest guest Posted October 16, 2009 Report Share Posted October 16, 2009 ....By the FTC... http://www.npr.org/blogs/health/2009/10/fda_and_ftc_slam_swine_flu_cla.html Astragalus is a problem??? I think suggesting efficacy for preventing/managing flu viral infection without evidence needs to be at least clarified. Comments? ann Quote Link to comment Share on other sites More sharing options...
Guest guest Posted October 17, 2009 Report Share Posted October 17, 2009 He may have gotten away with it except for the other stuff about cure. Probably, legally, " help support immune function " would have worked better than " immune boosting " . Dr. Stone? Doug , " A. Brameier " <snakeoil.works wrote: > > ...By the FTC... > http://www.npr.org/blogs/health/2009/10/fda_and_ftc_slam_swine_flu_cla.html > > Astragalus is a problem??? > I think suggesting efficacy for preventing/managing flu viral > infection without evidence needs to be at least clarified. > > Comments? > > ann > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted October 17, 2009 Report Share Posted October 17, 2009 Astragalus is not the problem; the arrogance of Dr. W. is. This kind of press does no favors for us either. Frances Gander Quote Link to comment Share on other sites More sharing options...
Guest guest Posted October 17, 2009 Report Share Posted October 17, 2009 Well said on both counts... ann Astragalus is not the problem; the arrogance of Dr. W. is. This kind of press does no favors for us either. Frances Gander and > He may have gotten away with it except for the other stuff about > cure. Probably, legally, " help support immune function " would have > worked better than " immune boosting " . > Dr. Stone? > Doug > > , " A. Brameier " > <snakeoil.works wrote: > > > > ...By the FTC... > > http://www.npr.org/blogs/health/2009/10/fda_and_ftc_slam_swine_flu_cla.html > > > > Astragalus is a problem??? > > I think suggesting efficacy for preventing/managing flu viral > > infection without evidence needs to be at least clarified. > > > > Comments? > > > > ann > > > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted October 17, 2009 Report Share Posted October 17, 2009 On Sat, Oct 17, 2009 at 7:38 AM, wrote: > > > He may have gotten away with it except for the other stuff about cure. > Probably, legally, " help support immune function " would have worked better > than " immune boosting " . > Dr. Stone? > Doug > Doug, I really don't see any DSHEA violation on Dr. Weil's page. This whole " immune boost " and the other words he used " immune modulator " are both okay from the DSHEA standpoint. It is strange that they're complaining about the less than stellar (by their standards) studies to support Dr. Weil's health claims. I find that strange because that isn't even the DSHEA violoation. The violation comes from the implication that astragalus can prevent H1N1. Even if astragalus had enough studies that the FDA couldn't have a problem with it, we could not say it if there is a purchase opportunity on the same web page. So, I don't know where they're coming from there. DSHEA doesn't say you can make health claims only if they're true. DSHEA says you can't make health claims. That's it. DSHEA says you can make " structure/function " claims which are all those iterations of " immune boost " and " immune modulator " . I don't like to read intent into government action, there's a lot of room for projection in such things. But my impression was that the FDA doesn't want to see people selling dietary supplements in such a way that there is the suggestion that it would be applicable to H1N1. For the FDA to go after a big fish such as Dr. Weil, I take that as a warning to the industry, personally. -al. -- , DAOM Pain is inevitable, suffering is optional. http://twitter.com/algancao Quote Link to comment Share on other sites More sharing options...
Guest guest Posted October 17, 2009 Report Share Posted October 17, 2009 I agree. The immune claims were not the problem; they are standard structure function claims. His swine flu article recommended his own product as a defense against swine flu, and he provided a link to the product. That made his web article the equivalent of a product label. Any mention of a disease on a product label automatically turns it into an illegal disease claim. - Bill Schoenbart > Doug, I really don't see any DSHEA violation on Dr. Weil's page. This whole > " immune boost " and the other words he used " immune modulator " are both okay > from the DSHEA standpoint. > > It is strange that they're complaining about the less than stellar (by their > standards) studies to support Dr. Weil's health claims. I find that strange > because that isn't even the DSHEA violoation. The violation comes from the > implication that astragalus can prevent H1N1. Even if astragalus had enough > studies that the FDA couldn't have a problem with it, we could not say it if > there is a purchase opportunity on the same web page. So, I don't know where > they're coming from there. > > DSHEA doesn't say you can make health claims only if they're true. DSHEA > says you can't make health claims. That's it. DSHEA says you can make > " structure/function " claims which are all those iterations of " immune boost " > and " immune modulator " . > > I don't like to read intent into government action, there's a lot of room > for projection in such things. But my impression was that the FDA doesn't > want to see people selling dietary supplements in such a way that there is > the suggestion that it would be applicable to H1N1. > > For the FDA to go after a big fish such as Dr. Weil, I take that as a > warning to the industry, personally. > > -al. > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted October 18, 2009 Report Share Posted October 18, 2009 I am just curious if we can say general things such as " Chinese medicine can prevent colds and flu's " ? -Jason On Behalf Of Al Stone Saturday, October 17, 2009 9:50 AM Re: Re: Weil whacked On Sat, Oct 17, 2009 at 7:38 AM, < <taiqi%40taiqi.com> > wrote: > > > He may have gotten away with it except for the other stuff about cure. > Probably, legally, " help support immune function " would have worked better > than " immune boosting " . > Dr. Stone? > Doug > Doug, I really don't see any DSHEA violation on Dr. Weil's page. This whole " immune boost " and the other words he used " immune modulator " are both okay from the DSHEA standpoint. It is strange that they're complaining about the less than stellar (by their standards) studies to support Dr. Weil's health claims. I find that strange because that isn't even the DSHEA violoation. The violation comes from the implication that astragalus can prevent H1N1. Even if astragalus had enough studies that the FDA couldn't have a problem with it, we could not say it if there is a purchase opportunity on the same web page. So, I don't know where they're coming from there. DSHEA doesn't say you can make health claims only if they're true. DSHEA says you can't make health claims. That's it. DSHEA says you can make " structure/function " claims which are all those iterations of " immune boost " and " immune modulator " . I don't like to read intent into government action, there's a lot of room for projection in such things. But my impression was that the FDA doesn't want to see people selling dietary supplements in such a way that there is the suggestion that it would be applicable to H1N1. For the FDA to go after a big fish such as Dr. Weil, I take that as a warning to the industry, personally. -al. -- Quote Link to comment Share on other sites More sharing options...
Guest guest Posted October 18, 2009 Report Share Posted October 18, 2009 Dear Jason, Your question reminds me of a story that I heard many years ago, but whose authenticity I am not certain of: A delegation of scientists and physicians from China were guests of their American counterparts. They toured all over and beheld all of the crown jewels: all of the great scientific and medical research facilities that the Americans had to offer, JPL, The super accelerator, etc. The culmination of their trip was a great banquet made in their honor. At the banquet, the head of the American delegation asked his Chinese counterpart--What most impressed you about American medicine and science? The Chinese delegation head answered, " Most honorable delegates, what most impresses me, is that you Americans still believe that there is no cure for the common cold, whereas we have been successfully treating it for hundreds of years. " ________________________________ Sun, October 18, 2009 2:41:44 PM RE: Re: Weil whacked I am just curious if we can say general things such as " Chinese medicine can prevent colds and flu's " ? -Jason [] On Behalf Of Al Stone Saturday, October 17, 2009 9:50 AM Re: Re: Weil whacked On Sat, Oct 17, 2009 at 7:38 AM, <taiqi (AT) taiqi (DOT) com <taiqi% 40taiqi.com> > wrote: > > > He may have gotten away with it except for the other stuff about cure. > Probably, legally, " help support immune function " would have worked better > than " immune boosting " . > Dr. Stone? > Doug > Doug, I really don't see any DSHEA violation on Dr. Weil's page. This whole " immune boost " and the other words he used " immune modulator " are both okay from the DSHEA standpoint. It is strange that they're complaining about the less than stellar (by their standards) studies to support Dr. Weil's health claims. I find that strange because that isn't even the DSHEA violoation. The violation comes from the implication that astragalus can prevent H1N1. Even if astragalus had enough studies that the FDA couldn't have a problem with it, we could not say it if there is a purchase opportunity on the same web page. So, I don't know where they're coming from there. DSHEA doesn't say you can make health claims only if they're true. DSHEA says you can't make health claims. That's it. DSHEA says you can make " structure/function " claims which are all those iterations of " immune boost " and " immune modulator " . I don't like to read intent into government action, there's a lot of room for projection in such things. But my impression was that the FDA doesn't want to see people selling dietary supplements in such a way that there is the suggestion that it would be applicable to H1N1. For the FDA to go after a big fish such as Dr. Weil, I take that as a warning to the industry, personally. -al. -- Quote Link to comment Share on other sites More sharing options...
Guest guest Posted October 18, 2009 Report Share Posted October 18, 2009 Sure, you can say that Chinese medicine can prevent colds and flus. Not a problem. Freedom of speech and all of that. Teaching also falls under this right. However if you are also SELLING a Chinese medicine product that treats colds and flus, from let's say the same web page, then you're making a claim which the FDA doesn't like to see. On Sun, Oct 18, 2009 at 2:41 PM, < > wrote: > > > I am just curious if we can say general things such as " Chinese medicine > can prevent colds and flu's " ? > > -Jason > -- , DAOM Pain is inevitable, suffering is optional. http://twitter.com/algancao Quote Link to comment Share on other sites More sharing options...
Guest guest Posted October 19, 2009 Report Share Posted October 19, 2009 Correct. As soon as you are selling a dietary supplement, you can no longer mention colds and flu on the label, literature, or on the web site for that product. Airborne received a 30 million dollar fine for that very reason: http://www2.ftc.gov/opa/2008/08/airborne.shtm - Bill , Al Stone <al wrote: > > Sure, you can say that Chinese medicine can prevent colds and flus. Not a > problem. Freedom of speech and all of that. Teaching also falls under this > right. > > However if you are also SELLING a Chinese medicine product that treats colds > and flus, from let's say the same web page, then you're making a claim which > the FDA doesn't like to see. > > On Sun, Oct 18, 2009 at 2:41 PM, < > > wrote: > > > > > > > I am just curious if we can say general things such as " Chinese medicine > > can prevent colds and flu's " ? > > > > -Jason > > > -- > , DAOM > Pain is inevitable, suffering is optional. > http://twitter.com/algancao > > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted October 19, 2009 Report Share Posted October 19, 2009 But this is an FTC issue not FDA/DSHEA. The FTC (Federal Trade Commission) is more concerned with honest and not misleading statements. They say of Airborne: There is no credible evidence that Airborne products, taken as directed, > will reduce the severity or duration of colds, or provide any tangible > benefit for people who are exposed to germs in crowded places > On Mon, Oct 19, 2009 at 5:51 PM, bill_schoenbart <plantmed2wrote: > > > Correct. As soon as you are selling a dietary supplement, you can no longer > mention colds and flu on the label, literature, or on the web site for that > product. Airborne received a 30 million dollar fine for that very reason: > > http://www2.ftc.gov/opa/2008/08/airborne.shtm > > - Bill > -- , DAOM Pain is inevitable, suffering is optional. http://twitter.com/algancao Quote Link to comment Share on other sites More sharing options...
Guest guest Posted October 19, 2009 Report Share Posted October 19, 2009 They are still working from the same laws as the FDA. The FTC gets involved because they can levy serious fines. , Al Stone <al wrote: > > But this is an FTC issue not FDA/DSHEA. The FTC (Federal Trade Commission) > is more concerned with honest and not misleading statements. They say of > Airborne: > > There is no credible evidence that Airborne products, taken as directed, > > will reduce the severity or duration of colds, or provide any tangible > > benefit for people who are exposed to germs in crowded places > > > > On Mon, Oct 19, 2009 at 5:51 PM, bill_schoenbart <plantmed2wrote: > > > > > > > Correct. As soon as you are selling a dietary supplement, you can no longer > > mention colds and flu on the label, literature, or on the web site for that > > product. Airborne received a 30 million dollar fine for that very reason: > > > > http://www2.ftc.gov/opa/2008/08/airborne.shtm > > > > - Bill > > > -- > , DAOM > Pain is inevitable, suffering is optional. > http://twitter.com/algancao > > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted October 19, 2009 Report Share Posted October 19, 2009 Here is an example of the FDA version of enforcing a cold claim. In this case, the letter was sent to a company marketing a lozenge called " cold-free " : " Section 403®(6) of the act makes clear that a statement included in labeling under the authority of that section may not claim to diagnose, mitigate, treat, cure, or prevent a specific disease or class of diseases. The statements that you are making for these products and the inclusion of the term " cold-free " in the product name suggest that they are intended to treat, mitigate, or prevent a,disease, namely the common cold. These claims do not meet the requirements of section 403®(6) of the act. These claims suggest that these products are intended for use as drugs within the meaning of section 201 (g)(l)(B) of the act, and that they are subject to regulation under the drug provisions of the act. " Same principal: you can't make a " drug or disease " claim for a dietary supplement. In FDA's case, they will force the company to delete the claim. In FTC's case, they will fine the company for violating advertising laws. But it is the disease name that triggers the response in both cases. - Bill , Al Stone <al wrote: > > But this is an FTC issue not FDA/DSHEA. The FTC (Federal Trade Commission) > is more concerned with honest and not misleading statements. They say of > Airborne: > > There is no credible evidence that Airborne products, taken as directed, > > will reduce the severity or duration of colds, or provide any tangible > > benefit for people who are exposed to germs in crowded places > > > > On Mon, Oct 19, 2009 at 5:51 PM, bill_schoenbart <plantmed2wrote: > > > > > > > Correct. As soon as you are selling a dietary supplement, you can no longer > > mention colds and flu on the label, literature, or on the web site for that > > product. Airborne received a 30 million dollar fine for that very reason: > > > > http://www2.ftc.gov/opa/2008/08/airborne.shtm > > > > - Bill > > > -- > , DAOM > Pain is inevitable, suffering is optional. > http://twitter.com/algancao > > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted October 20, 2009 Report Share Posted October 20, 2009 gan mao is ok though? The dz name is often included in the name. Walk down the aisle of any health food store. ann On Oct 20, 2009, at 1:31 AM, bill_schoenbart wrote: > Here is an example of the FDA version of enforcing a cold claim. In > this case, the letter was sent to a company marketing a lozenge > called " cold-free " : > > " Section 403®(6) of the act makes clear that a statement included > in labeling under the authority of that section may not claim to > diagnose, mitigate, treat, cure, or prevent a specific disease or > class of diseases. The statements that you are making for these > products and the inclusion of the term " cold-free " in the product > name suggest that they are intended to treat, mitigate, or prevent > a,disease, namely the common cold. These claims do not meet the > requirements of section 403®(6) of the act. These claims suggest > that these products are intended for use as drugs within the meaning > of section 201 (g)(l)(B) of the act, and that they are subject to > regulation under the drug provisions of the act. " > > Same principal: you can't make a " drug or disease " claim for a > dietary supplement. In FDA's case, they will force the company to > delete the claim. In FTC's case, they will fine the company for > violating advertising laws. But it is the disease name that triggers > the response in both cases. > > - Bill > > , Al Stone <al wrote: > > > > But this is an FTC issue not FDA/DSHEA. The FTC (Federal Trade > Commission) > > is more concerned with honest and not misleading statements. They > say of > > Airborne: > > > > There is no credible evidence that Airborne products, taken as > directed, > > > will reduce the severity or duration of colds, or provide any > tangible > > > benefit for people who are exposed to germs in crowded places > > > > > > > On Mon, Oct 19, 2009 at 5:51 PM, bill_schoenbart > <plantmed2wrote: > > > > > > > > > > > Correct. As soon as you are selling a dietary supplement, you > can no longer > > > mention colds and flu on the label, literature, or on the web > site for that > > > product. Airborne received a 30 million dollar fine for that > very reason: > > > > > > http://www2.ftc.gov/opa/2008/08/airborne.shtm > > > > > > - Bill > > > > > -- > > , DAOM > > Pain is inevitable, suffering is optional. > > http://twitter.com/algancao > > > > > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted October 20, 2009 Report Share Posted October 20, 2009 Hmmmm, I wonder about " cold-quell " ? -Jason On Behalf Of bill_schoenbart Here is an example of the FDA version of enforcing a cold claim. In this case, the letter was sent to a company marketing a lozenge called " cold-free " : " Section 403®(6) of the act makes clear that a statement included in labeling under the authority of that section may not claim to diagnose, mitigate, treat, cure, or prevent a specific disease or class of diseases. The statements that you are making for these products and the inclusion of the term " cold-free " in the product name suggest that they are intended to treat, mitigate, or prevent a,disease, namely the common cold. These claims do not meet the requirements of section 403®(6) of the act. These claims suggest that these products are intended for use as drugs within the meaning of section 201 (g)(l)(B) of the act, and that they are subject to regulation under the drug provisions of the act. " Quote Link to comment Share on other sites More sharing options...
Guest guest Posted October 20, 2009 Report Share Posted October 20, 2009 Jason, Don't know whether it would pass FDA scrutiny. Good question. Hope we never find out. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted October 20, 2009 Report Share Posted October 20, 2009 A Chinese disease name won't attract attention. By the way, you will see dozens of illegal label claims in the stores. That doesn't mean that it is OK. FDA enforcement is sporadic, and they tend to go after the big problems first. , " A. Brameier " <snakeoil.works wrote: > > gan mao is ok though? > > The dz name is often included in the name. Walk down the aisle of any > health food store. > ann > > On Oct 20, 2009, at 1:31 AM, bill_schoenbart wrote: > > > Here is an example of the FDA version of enforcing a cold claim. In > > this case, the letter was sent to a company marketing a lozenge > > called " cold-free " : > > > > " Section 403®(6) of the act makes clear that a statement included > > in labeling under the authority of that section may not claim to > > diagnose, mitigate, treat, cure, or prevent a specific disease or > > class of diseases. The statements that you are making for these > > products and the inclusion of the term " cold-free " in the product > > name suggest that they are intended to treat, mitigate, or prevent > > a,disease, namely the common cold. These claims do not meet the > > requirements of section 403®(6) of the act. These claims suggest > > that these products are intended for use as drugs within the meaning > > of section 201 (g)(l)(B) of the act, and that they are subject to > > regulation under the drug provisions of the act. " > > > > Same principal: you can't make a " drug or disease " claim for a > > dietary supplement. In FDA's case, they will force the company to > > delete the claim. In FTC's case, they will fine the company for > > violating advertising laws. But it is the disease name that triggers > > the response in both cases. > > > > - Bill > > > > , Al Stone <al@> wrote: > > > > > > But this is an FTC issue not FDA/DSHEA. The FTC (Federal Trade > > Commission) > > > is more concerned with honest and not misleading statements. They > > say of > > > Airborne: > > > > > > There is no credible evidence that Airborne products, taken as > > directed, > > > > will reduce the severity or duration of colds, or provide any > > tangible > > > > benefit for people who are exposed to germs in crowded places > > > > > > > > > > On Mon, Oct 19, 2009 at 5:51 PM, bill_schoenbart > > <plantmed2@>wrote: > > > > > > > > > > > > > > > Correct. As soon as you are selling a dietary supplement, you > > can no longer > > > > mention colds and flu on the label, literature, or on the web > > site for that > > > > product. Airborne received a 30 million dollar fine for that > > very reason: > > > > > > > > http://www2.ftc.gov/opa/2008/08/airborne.shtm > > > > > > > > - Bill > > > > > > > -- > > > , DAOM > > > Pain is inevitable, suffering is optional. > > > http://twitter.com/algancao > > > > > > > > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted October 20, 2009 Report Share Posted October 20, 2009 That would be an illegal disease claim. , " " wrote: > > Hmmmm, I wonder about " cold-quell " ? > > > > -Jason > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted October 20, 2009 Report Share Posted October 20, 2009 Oh, that's an actual product? If it's a practitioner-only line, FDA is much less likely to cause a problem. , " pemachophel2001 " <bob wrote: > > Jason, > > Don't know whether it would pass FDA scrutiny. Good question. Hope we never find out. > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted October 20, 2009 Report Share Posted October 20, 2009 Bill, " Oh, that's an actual product? If it's a practitioner-only line, FDA is much less likely to cause a problem. " Agreed, but ColdQuell is sold OTC in some Wholefoods around the country. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted October 20, 2009 Report Share Posted October 20, 2009 This all brings up an interesting point. Isn't 'quells cold' different from 'quells colds'? In Chinese medicine, what constitutes a disease name? In this context are Wind, Cold, Damp, Heat, etc. symptoms or diseases? An MD might 'dummy down' to patients and say 'you caught a cold', but he wouldn't write that formally as it doesn't really contain any substantial or specific meaning to the western doc. The same probably could be said about many symptoms which have become common parlance in both Chinese and 'western' medical circles--such as lumbago. In the realm of commonspeak (ie., excluding obvious technical or specific 'names' such as either Swine flu or H1N1), who decides what is a legal disease name and what is isn't. If we cannot claim to cure Gonnorhea then what about " the clap " (Clap Queller) if not that, then what about a claim to clear damp heat in the lower burner? Some random morning thoughts... Daniel Altschuler That would be an illegal disease claim. , " " wrote: > > Hmmmm, I wonder about " cold-quell " ? > > > > -Jason > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted October 20, 2009 Report Share Posted October 20, 2009 Since it is just the common cold and you are not making related cure claims, the worst that you can likely expect is a courtesy letter from FDA instructing you to remove that name from labels and advertising. Even that is unlikely, since it isn't being promoted in a national advertising claim that would draw their attention. , " pemachophel2001 " <bob wrote: > > Bill, > > " Oh, that's an actual product? If it's a practitioner-only line, FDA is much less likely to cause a problem. " > > Agreed, but ColdQuell is sold OTC in some Wholefoods around the country. > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted October 21, 2009 Report Share Posted October 21, 2009 Daniel, You might be able to get an attorney to argue this point that " quell-cold " means " warm up " rather than " fix rhino-virus " but the FDA guildelines are pretty well hip to this sort of issue. They state: [if a supplement claims that it] Has an effect, using scientific or lay > terminology, on one or more signs or symptoms that are recognizable to > health care professionals or consumers as being characteristic of a specific > disease or of a number of different specific diseases [then it is making a > disease claim]. (source<http://gancao.net/dshea/claims-supplements/tcm-disease-terms-replacing-w\ m-terms-119> > ) > Even if we were to say that Shen Ling Bai Zhu San is good for Spleen qi deficiency, we're still making a disease claim because Spleen qi deficiency is defined as bloating, gas, loose stools, easy bruising, prolapsed organs etc. It wouldn't take the FDA long to track down that information. Personally, I think that your example of claiming to treat damp heat in the lower burner rather than gonorrhea or The Clap would be okay, not from a regulatory standpoint, but from a much lower likelihood of triggering any red flags on the part of regulators. However, there are some symptoms that the FDA does not consider diseases. For instance, things that happen due to the normal aging process are not considered diseases such as menopause, adolescent acne and even senile memory loss. However cystic acne and Alzheimer's disease are considered diseases. (more<http://gancao.net/dshea/claims-supplements/disease-definition-exceptions-1\ 08> ) One area where I think we have some wiggle room is in the treatment of temporary things that don't require any particular medical attention such as " temporary heartburn due to overeating " . We see this sort of thing on the label of many over the counter medications too. So, Bao He Wan could be said to treat " occasional heartburn " . -al. On Tue, Oct 20, 2009 at 11:08 AM, Daniel Altschuler <daltschwrote: > > > > This all brings up an interesting point. Isn't 'quells cold' different from > 'quells colds'? In Chinese medicine, what constitutes a disease name? In > this context are Wind, Cold, Damp, Heat, etc. symptoms or diseases? An MD > might 'dummy down' to patients and say 'you caught a cold', but he wouldn't > write that formally as it doesn't really contain any substantial or specific > meaning to the western doc. The same probably could be said about many > symptoms which have become common parlance in both Chinese and 'western' > medical circles--such as lumbago. In the realm of commonspeak (ie., > excluding obvious technical or specific 'names' such as either Swine flu or > H1N1), who decides what is a legal disease name and what is isn't. If we > cannot claim to cure Gonnorhea then what about " the clap " (Clap Queller) if > not that, then what about a claim to clear damp heat in the lower burner? > > Some random morning thoughts... > > Daniel Altschuler > -- , DAOM Pain is inevitable, suffering is optional. http://twitter.com/algancao Quote Link to comment Share on other sites More sharing options...
Guest guest Posted October 21, 2009 Report Share Posted October 21, 2009 Al, There is no way that an attorney would convince the FDA that " quell-cold " means to warm up. It would be a waste of money. As you mentioned, they are hip to this sort of strategy. Also, it is not always OK to claim that a product treats heartburn. The rules are different for OTC drugs and supplements. In one case, the FDA ruled against a company because they made a heartburn claim along with a description of acid reflux. That made it a disease claim. If they just mentioned occasional heartburn without describing acid reflux, it would have been an acceptable structure function claim. - Bill , Al Stone <al wrote: > > Daniel, > > You might be able to get an attorney to argue this point that " quell-cold " > means " warm up " rather than " fix rhino-virus " but the FDA guildelines are > pretty well hip to this sort of issue. They state: > > [if a supplement claims that it] Has an effect, using scientific or lay > > terminology, on one or more signs or symptoms that are recognizable to > > health care professionals or consumers as being characteristic of a specific > > disease or of a number of different specific diseases [then it is making a > > disease claim]. (source<http://gancao.net/dshea/claims-supplements/tcm-disease-terms-replacing-w\ m-terms-119> > > ) > > > > Even if we were to say that Shen Ling Bai Zhu San is good for Spleen qi > deficiency, we're still making a disease claim because Spleen qi deficiency > is defined as bloating, gas, loose stools, easy bruising, prolapsed organs > etc. It wouldn't take the FDA long to track down that information. > Personally, I think that your example of claiming to treat damp heat in the > lower burner rather than gonorrhea or The Clap would be okay, not from a > regulatory standpoint, but from a much lower likelihood of triggering any > red flags on the part of regulators. > > However, there are some symptoms that the FDA does not consider diseases. > For instance, things that happen due to the normal aging process are not > considered diseases such as menopause, adolescent acne and even senile > memory loss. However cystic acne and Alzheimer's disease are considered > diseases. (more<http://gancao.net/dshea/claims-supplements/disease-definition-exceptions-1\ 08> > ) > > One area where I think we have some wiggle room is in the treatment of > temporary things that don't require any particular medical attention such as > " temporary heartburn due to overeating " . We see this sort of thing on the > label of many over the counter medications too. So, Bao He Wan could be said > to treat " occasional heartburn " . > > -al. > > On Tue, Oct 20, 2009 at 11:08 AM, Daniel Altschuler <daltschwrote: > > > > > > > > > This all brings up an interesting point. Isn't 'quells cold' different from > > 'quells colds'? In Chinese medicine, what constitutes a disease name? In > > this context are Wind, Cold, Damp, Heat, etc. symptoms or diseases? An MD > > might 'dummy down' to patients and say 'you caught a cold', but he wouldn't > > write that formally as it doesn't really contain any substantial or specific > > meaning to the western doc. The same probably could be said about many > > symptoms which have become common parlance in both Chinese and 'western' > > medical circles--such as lumbago. In the realm of commonspeak (ie., > > excluding obvious technical or specific 'names' such as either Swine flu or > > H1N1), who decides what is a legal disease name and what is isn't. If we > > cannot claim to cure Gonnorhea then what about " the clap " (Clap Queller) if > > not that, then what about a claim to clear damp heat in the lower burner? > > > > Some random morning thoughts... > > > > Daniel Altschuler > > > > -- > , DAOM > Pain is inevitable, suffering is optional. > http://twitter.com/algancao > > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted October 22, 2009 Report Share Posted October 22, 2009 Just wanted to add my 2 cents to this. I had some problems myself with the FDA a few years ago and I wanted to fight them so bad Grrrr. But my wife said (in short) go with the flow. Do what they asked and yes it all went away really quite painless for me business wise. The other side of me said hey .bring it on . and wanted to fight on the grounds that California took my money and issued me a license. Now if I do what I am qualified to do under California law; that is use the terms exactly as on the State Exam, referenced from the material indicated for that examination, then the Fed's have a problem with the Sate of California not with me! So I do cheer on all those who choose to fight. said quietly from the safety of keeping my head low, my family well fed, and a decent bank account. Ed Kasper LAc Quote Link to comment Share on other sites More sharing options...
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