Guest guest Posted July 10, 2006 Report Share Posted July 10, 2006 Hi All- I was wondering if anyone has information about FDA rulings that might affect how granulated herbs are compounded by practitioners. What exactly are we responsible for in our own clinics in terms of labeling, clean rooms, etc? I know the big distributors are bound by FDA rulings on GMP, but was wondering if there was an exception for local practitioners and clinics where patients receive compounded granulated formulas. Any help is appreciated. Thanks -Steve Stephen Bonzak, M.S., L.Ac., Dipl. Ac. & C.H. Assistant Professor, Department of Herbal Medicine Pacific College of Oriental Medicine - Chicago sbonzak 773-470-6994 Quote Link to comment Share on other sites More sharing options...
Guest guest Posted July 10, 2006 Report Share Posted July 10, 2006 Hi Steve, As extrapolated from various Federal government organizations by AHPA, the new CGMPs will not (supposedly) be mandated until after the November elections; therefore, Dec. 2006 is the expected date. Of course, the cGMPs were due out 2 years ago. As Chair of the Chinese Heb Product Committee of AHPA, most of the herb companies that sell into the professional healthcare market are looking forward to the new cGMPs being implemented. There will be some major positive aspects to being able to prove to the consumer the quality of herbs and herb products being manufactured. For example, the first major hurdle will be the Species ID issue with TLC (Thin Layer Chromatography). Re : practitioners : there has been no indication from the Working Group on cGMPs that compounding regulations will be lessened. But given the financial impact of the new cGMPs on everybody, including regulators, the smaller enterprises will have longer to implement changes and will be the last to be inspected, supposedly. AHPA is conducting TeleSeminars in the near future for cGMP implementation. So I believe the writing is on the wall that the cGMP implementation is coming soon, if not in December. Stay tuned, Bill Egloff Crane Herb Company On 7/10/06 3:17 PM, " Stephen Bonzak " <smb021169 wrote: > Hi All- > > I was wondering if anyone has information about FDA rulings that might > affect how granulated herbs are compounded by practitioners. What > exactly are we responsible for in our own clinics in terms of labeling, > clean rooms, etc? I know the big distributors are bound by FDA rulings > on GMP, but was wondering if there was an exception for local > practitioners and clinics where patients receive compounded granulated > formulas. Any help is appreciated. Thanks > > -Steve > > Stephen Bonzak, M.S., L.Ac., Dipl. Ac. & C.H. > Assistant Professor, Department of Herbal Medicine > Pacific College of Oriental Medicine - Chicago > sbonzak <sbonzak%40pacificcollege.edu> > 773-470-6994 Quote Link to comment Share on other sites More sharing options...
Guest guest Posted July 10, 2006 Report Share Posted July 10, 2006 Hi Stephen, I've been swimming through these issues for about a month now and have come up with at least enough information for me, a private practitioner, to get my labeling " up to code " . FYI: For those of you outside the USA, this doesn't effect you, unless of course you're selling herbs in the USA, in which case you probably already have a cue... Firstly, when it comes to labeling of your supplements' bottles here's the most current thinking from the FDA on this topic. This is a " guideline " document for " small entities " which are small businesses. Here's the URL: *http://tinyurl.com/m6a7c* Please note that if you're grossing less than $500,000/year in sales, you're exempt from the " supplement facts " table on the side of the bottle, or box, or whatever. Now, here's the rub for many of us. DSHEA (Dietary Supplement and Health Education Act of 1994) says that any publication, information, books, websites, etc. that promote one particular manufacturer, distributor, or practitioner selling a dietary supplement (aka Chinese herbs) is ALSO labeling, and so any words you have to promote your products that aren't necessarily found on the product label itself is still considered " labeling " and is scrutinized by the FDA. So, what's okay to say and what isn't? This is quite interesting. You can talk about any herb or formula as treating anything you want including cancer, etc. Presumably, it will be a well-reference article or at least favor traditional uses of the formula/herb that is backed up by text books, peer-reviewed journals, etc. This is not a problem, however the moment you include a " buy now " button on a webpage or some other means by which a purchase can be made that favors one brand, manufacturer, distributor, then you've got labeling. Now I know why Marny Naesser's article on laser acupuncture at gancao.netwent to such lengths to list ALL of the outlets where the discussed laser devices could be purchased. If you list them all (or none, or a link to a google search that is random) you're not favoring any outlet and thus avoiding a claim that would be considered labeling. So, this topic of website labeling now becomes one of " claims " . There are a few different types of " claims " that can be found on labels and/or supporting documents: 1) health claim (aka disease claim): this is a statement that a particular supplement will have a direct effect on a disease. What's a disease? Diarrhea is a disease, anything that needs to be fixed is a disease. One page at the FDA site says that if it appears in a medical text, its a disease. Does that means that Spleen Qi deficiency is a disease? It certainly doesn't appear in too many Western medicine texts. I believe that the answer will end up being " yes " . The litmus test of " health claim " is if there's a problem that is being fixed. So, if your materials say that Shen Ling Bai Zhu San treats, cures, mitigates, or otherwise improves a Spleen Qi deficiency, that is a health or disease claim and guess what? Only drugs can do that! Drugs, and a few vitamins and minerals that have gone through rigorous scientific examination. Examples of dietary supplement health claims that can be made include " calcium for osteoporosis " and such. Since this law was passed in 1994, there have only been 12 approved health claims! Now these health claims do not require explicit claims to be made. There are plenty of opportunities for implied claims such as the name of the product. If I wanted to make the formula name " Shen Ling Bai Zhu San " easier for a consumer to remember, I might chose a name like " diarrhea begone " in which case I am making an implied health claim. No good. There are a few other classes of claims, but the one that we have to pay attention to under DSHEA is the so-called " structure-function " claim. This is where we get in to those " promotes healthy bowel movements " type statements. We can't fix a problem, but we can promote health,whatever that means. :/ There are a few exceptions, specifically stuff that we go through as a matter of passage through life such as menopause would not be considered a disease, nor would hot flashes, night sweats, or any of the other symptoms of a normal change of life. Funny thing is, they way that the FDA limits this is by stating that if the symptom that arises occurs in a minority of the population, then it isn't considered part of a life change, but rather a disease. So, if 49% of the (menopausal) population get headaches, that is a disease that we cannot claim to treat. However if 51% of the population gets menopausal headaches, it is no longer a minority and thus no longer a disease claim! I'd reference that, but I can't find it in front of me right now, I believe its in the claims guidelines. This document is called " Structure/Function Claims, Small Entity Compliance Guide " : *http://tinyurl.com/kk3zs *These two labeling issues (the bottle and supporting documentation claims) are the key questions to answer. There is one area in which I'm somewhat unclear, though. If you make a structure/function claim, you're supposed to notify the FDA, even though you don't have to turn in any substantiation of your claim. However elsewhere in the guidelines that I've come across, they say that no notification is needed, so I'm a little bit confounded by that. Also, with that structure/function claim you have to add that disclaimer that says " these statements have not been evaluated by the FDA, this product is not intended to diagnose,cure or prevent any disease. " As for GMP, to my knowledge, they're still working on this, however I've seen a few FDA warming letters that dealt with manufacturing facilities that weren't up to snuff. I *believe* that these regulations are defaulting back to food manufacturing regulations. -al. On 7/10/06, Stephen Bonzak <smb021169 wrote: > > Hi All- > > I was wondering if anyone has information about FDA rulings that might > affect how granulated herbs are compounded by practitioners. What > exactly are we responsible for in our own clinics in terms of labeling, > clean rooms, etc? I know the big distributors are bound by FDA rulings > on GMP, but was wondering if there was an exception for local > practitioners and clinics where patients receive compounded granulated > formulas. Any help is appreciated. Thanks > > -Steve > > Stephen Bonzak, M.S., L.Ac., Dipl. Ac. & C.H. > Assistant Professor, Department of Herbal Medicine > Pacific College of Oriental Medicine - Chicago > sbonzak <sbonzak%40pacificcollege.edu> > 773-470-6994 > -- Pain is inevitable, suffering is optional. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted July 10, 2006 Report Share Posted July 10, 2006 Bill- I tried wading through the documents you pointed me toward on your site, but a 137 page government document is not the easiest thing to read and get anything useful. Do you, or the AHPA, have a short list of the requirements for practitioners in their pharmacies? I saw the tele-courses on the AHPA'a website, but those look like they were geared toward large distributors like yourself. Thanks. -Steve On Jul 10, 2006, at 2:55 PM, William Egloff wrote: > Hi Steve, > > As extrapolated from various Federal government organizations by AHPA, > the > new CGMPs will not (supposedly) be mandated until after the November > elections; therefore, Dec. 2006 is the expected date. Of course, the > cGMPs > were due out 2 years ago. > > As Chair of the Chinese Heb Product Committee of AHPA, most of the herb > companies that sell into the professional healthcare market are looking > forward to the new cGMPs being implemented. > There will be some major positive aspects to being able to prove to the > consumer the quality of herbs and herb products being manufactured. > > For example, the first major hurdle will be the Species ID issue with > TLC > (Thin Layer Chromatography). > > Re : practitioners : there has been no indication from the Working > Group on > cGMPs that compounding regulations will be lessened. But given the > financial > impact of the new cGMPs on everybody, including regulators, the smaller > enterprises will have longer to implement changes and will be the last > to be > inspected, supposedly. > > AHPA is conducting TeleSeminars in the near future for cGMP > implementation. > So I believe the writing is on the wall that the cGMP implementation is > coming soon, if not in December. > > Stay tuned, > Bill Egloff > Crane Herb Company > > > > > > On 7/10/06 3:17 PM, " Stephen Bonzak " <smb021169 wrote: >> Hi All- >> >> I was wondering if anyone has information about FDA rulings that might >> affect how granulated herbs are compounded by practitioners. What >> exactly are we responsible for in our own clinics in terms of >> labeling, >> clean rooms, etc? I know the big distributors are bound by FDA >> rulings >> on GMP, but was wondering if there was an exception for local >> practitioners and clinics where patients receive compounded granulated >> formulas. Any help is appreciated. Thanks >> >> -Steve >> >> Stephen Bonzak, M.S., L.Ac., Dipl. Ac. & C.H. >> Assistant Professor, Department of Herbal Medicine >> Pacific College of Oriental Medicine - Chicago >> sbonzak <sbonzak%40pacificcollege.edu> >> 773-470-6994 > > > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted July 11, 2006 Report Share Posted July 11, 2006 About 2 years ago the FDA warned me that my web page was in violation. I offered for sale Ginseng. I made no personal claims on that page but did have links to numerous research articles on Ginseng. (thousands of reputable links are available to choose from). They listed violations and issued specific warnings to me. 1. that those (books publications and by extension web links) are, in their opinion, a extension of my label. Therefore " I " was claiming Ginseng could treat [in this case] diabetes. And the FDA had no proof that Ginseng could treat diabetes therefore I could not make that claim. 2. If ginseng could treat diabetes, than the FDA warned, ginseng would fall into the " new drug " classification and I would need a Federal license to dispense ginseng. IMO, Xiao Chai Hu Tang will be classified a " new drug " within a few years. And will be available - not over the counter - but by prescription. BTW, a " new drug " does not need to go through any thought process it is a simple declaration by someone in the FDA and possibly when they are standing right in front of you. As of today, if you happen to display some herbs on your clinical shelf , say ginseng and XCHT, and you happen to have a trade journal like Acupuncture Today, laying somewhere near by, and there happens to be an article on some Chinese herbs treating some western disease, you stand in violation of federal law. Ah, you say will never happen in America ....its already the law. I say forget diabetes. Claim that Ginseng CURES " Thirst and Wasting Disease " forget cancer and say " Use Xiao Chai Hu Tang for Shao Yang Disorders " or " Phlegm " or Qi Stasis " or ... Speak Traditional . Reference only products and disorders/diseases that are _primarily_ a TCM Differential Diagnosis. State your qualifications to diagnosis/dispense Chinese herbs and claims how the herbal formula is expected to function within TCM. State that cancer/diabetes/... are trademarked A.M.A. disease's and only their duly ordained members can use those terms. Reassure your patients that you are not a member of the A.M.A Make at least one patient well Ed Kasper LAc. Licensed Acupuncturist & Herbalist in weird Santa Cruz, CA. (we like it that way) ............................................................. ....................... 2c. Re: FDA rulings on cGMP Posted by: " Al Stone " al alllstone Mon Jul 10, 2006 1:43 pm (PDT) Hi Stephen, I've been swimming through these issues for about a month now and have come up with at least enough information for me, a private practitioner, to get my labeling " up to code " . FYI: For those of you outside the USA, this doesn't effect you, unless of course you're selling herbs in the USA, in which case you probably already have a cue... Firstly, when it comes to labeling of your supplements' bottles here's the most current thinking from the FDA on this topic. This is a " guideline " document for " small entities " which are small businesses. Here's the URL: *http://tinyurl.com/m6a7c* Please note that if you're grossing less than $500,000/year in sales, you're exempt from the " supplement facts " table on the side of the bottle, or box, or whatever. Now, here's the rub for many of us. DSHEA (Dietary Supplement and Health Education Act of 1994) says that any publication, information, books, websites, etc. that promote one particular manufacturer, distributor, or practitioner selling a dietary supplement (aka Chinese herbs) is ALSO labeling, and so any words you have to promote your products that aren't necessarily found on the product label itself is still considered " labeling " and is scrutinized by the FDA. So, what's okay to say and what isn't? This is quite interesting. You can talk about any herb or formula as treating anything you want including cancer, etc. Presumably, it will be a well-reference article or at least favor traditional uses of the formula/herb that is backed up by text books, peer-reviewed journals, etc. This is not a problem, however the moment you include a " buy now " button on a webpage or some other means by which a purchase can be made that favors one brand, manufacturer, distributor, then you've got labeling. Now I know why Marny Naesser's article on laser acupuncture at gancao.netwent to such lengths to list ALL of the outlets where the discussed laser devices could be purchased. If you list them all (or none, or a link to a google search that is random) you're not favoring any outlet and thus avoiding a claim that would be considered labeling. So, this topic of website labeling now becomes one of " claims " . There are a few different types of " claims " that can be found on labels and/or supporting documents: 1) health claim (aka disease claim): this is a statement that a particular supplement will have a direct effect on a disease. What's a disease? Diarrhea is a disease, anything that needs to be fixed is a disease. One page at the FDA site says that if it appears in a medical text, its a disease. Does that means that Spleen Qi deficiency is a disease? It certainly doesn't appear in too many Western medicine texts. I believe that the answer will end up being " yes " . The litmus test of " health claim " is if there's a problem that is being fixed. So, if your materials say that Shen Ling Bai Zhu San treats, cures, mitigates, or otherwise improves a Spleen Qi deficiency, that is a health or disease claim and guess what? Only drugs can do that! Drugs, and a few vitamins and minerals that have gone through rigorous scientific examination. Examples of dietary supplement health claims that can be made include " calcium for osteoporosis " and such. Since this law was passed in 1994, there have only been 12 approved health claims! Now these health claims do not require explicit claims to be made. There are plenty of opportunities for implied claims such as the name of the product. If I wanted to make the formula name " Shen Ling Bai Zhu San " easier for a consumer to remember, I might chose a name like " diarrhea begone " in which case I am making an implied health claim. No good. There are a few other classes of claims, but the one that we have to pay attention to under DSHEA is the so-called " structure-function " claim. This is where we get in to those " promotes healthy bowel movements " type statements. We can't fix a problem, but we can promote health,whatever that means. :/ There are a few exceptions, specifically stuff that we go through as a matter of passage through life such as menopause would not be considered a disease, nor would hot flashes, night sweats, or any of the other symptoms of a normal change of life. Funny thing is, they way that the FDA limits this is by stating that if the symptom that arises occurs in a minority of the population, then it isn't considered part of a life change, but rather a disease. So, if 49% of the (menopausal) population get headaches, that is a disease that we cannot claim to treat. However if 51% of the population gets menopausal headaches, it is no longer a minority and thus no longer a disease claim! I'd reference that, but I can't find it in front of me right now, I believe its in the claims guidelines. This document is called " Structure/Function Claims, Small Entity Compliance Guide " : *http://tinyurl.com/kk3zs *These two labeling issues (the bottle and supporting documentation claims) are the key questions to answer. There is one area in which I'm somewhat unclear, though. If you make a structure/function claim, you're supposed to notify the FDA, even though you don't have to turn in any substantiation of your claim. However elsewhere in the guidelines that I've come across, they say that no notification is needed, so I'm a little bit confounded by that. Also, with that structure/function claim you have to add that disclaimer that says " these statements have not been evaluated by the FDA, this product is not intended to diagnose,cure or prevent any disease. " As for GMP, to my knowledge, they're still working on this, however I've seen a few FDA warming letters that dealt with manufacturing facilities that weren't up to snuff. I *believe* that these regulations are defaulting back to food manufacturing regulations. -al. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted July 11, 2006 Report Share Posted July 11, 2006 On 7/11/06, Ed Kasper LAc <eddy wrote: > > I say forget diabetes. Claim that Ginseng CURES " Thirst and > Wasting Disease " > forget cancer and say " Use Xiao Chai Hu Tang for Shao Yang > Disorders " or " Phlegm " or Qi Stasis " or ... > I agree, though in another way, the FDA's guidelines may be interpreted to see through that. They don't want to see any *problems* fixed with dietary supplements. You can call it the common cold, tai yang bing, or la gripa. Its still a problem that the herbs are expected to fix, and hence you're making a drug claim. In the state of California it's no better. To put it into our local dialect, " this is totally bogus. " Our acupuncture license allows us to diagnosis, treat, cure, make better, etc... but only with the act of acupuncture (and presumably allied physical therapies). When it comes to our herbs, we're still not able to give something to a patient and say " here, take this, it'll help you. " The only reason the FDA isn't preventing us from saying that is because they don't regulate speech, only labeling, devices, etc. It is for this reason that I'm confounded by the FDA's insistence that TCM practitioners retain access to ma huang. They say that our use of it is different than the dietary supplement industry. There are two interpretations of this statement. 1) We can use raw (bulk) ma huang, not a supplement in a capsule for instance. 2) We can use any form of ma huang we choose in the treatment of external wind-cold, wind cold bi syndrome, or other traditionally indicated syndromes. We don't provide ma huang for weight loss or athletic performance. If that second interpretation is correct, your idea to advertise our formulas as good for a TCM diagnosis may fly. However the state of California certainly does believe that our use of herbs is only in our scope of practice as far as the FDA will allow, basically with the same terms and conditions as they have regarding claims. The Acupuncture Committee of California states this here: http://www.acupuncture.ca.gov/scope_practice.htm It says that we can prescribe drugless substances. " Drug " is defined later on this page as: " the intended use of the substance in the diagnosis, cure, treatment, mitigation or prevention of disease. Thus, any herb or substance which is put to a prophylactic, therapeutic, or medicinal purpose in the diagnosis, cure, treatment, mitigation or prevention of disease is a drug. " This means that we can't, with our thousands of years of experience, thousands of dollars spent on education and licensure, and thousands of healed patients (and even a few adverse events) we still can't cure, treat, mitigate or prevent a disease, even tai yang disease. -al. -- Pain is inevitable, suffering is optional. Quote Link to comment Share on other sites More sharing options...
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