Guest guest Posted July 12, 2007 Report Share Posted July 12, 2007 Good news. Just got off an AHPA conference call seminar on the new FDA cGMPs for dietary and herbal supplements. The FDA representative said that these GMPs had nothing to do with practitioners treating their patients one to one. So practitioners with clinic dispensaries don't have to worry about complying with these GMPs. The FDA guy said they have no interest in policing the dispensing of appropriately trained and certified professional practitioners. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted July 12, 2007 Report Share Posted July 12, 2007 Great news indeed. . . On Jul 12, 2007, at 12:41 PM, Bob Flaws wrote: > Good news. Just got off an AHPA conference call seminar on the new FDA > cGMPs for dietary and herbal supplements. The FDA representative said > that these GMPs had nothing to do with practitioners treating their > patients one to one. So practitioners with clinic dispensaries don't > have to worry about complying with these GMPs. The FDA guy said they > have no interest in policing the dispensing of appropriately trained > and certified professional practitioners. > > > Chair, Department of Herbal Medicine Pacific College of Oriental Medicine San Diego, Ca. 92122 Quote Link to comment Share on other sites More sharing options...
Guest guest Posted July 12, 2007 Report Share Posted July 12, 2007 Great news, Bob! Thanks for the follow-up. Doug , " Bob Flaws " <pemachophel2001 wrote: > > Good news. Just got off an AHPA conference call seminar on the new FDA > cGMPs for dietary and herbal supplements. The FDA representative said > that these GMPs had nothing to do with practitioners treating their > patients one to one. So practitioners with clinic dispensaries don't > have to worry about complying with these GMPs. The FDA guy said they > have no interest in policing the dispensing of appropriately trained > and certified professional practitioners. > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted July 12, 2007 Report Share Posted July 12, 2007 Dear Bob, I'd like to offer a somewhat different perspective. No matter what the FDA representative said, the fact remains that under the terms of the final rule, individual herbal practitioners are considered to be manufacturers of dietary supplements engaged in interstate commerce, and therefore subject to the rule. Such small entities have three years to come into compliance. The FDA may (or may not) choose not to enforce the rule on individual practitioners. Their policy can change at any time, by processes entirely internal to the FDA, and that policy can change very quickly. The new FDA standards will be relied on by judges and lawyers as the legal standard for herbal practice, if and when things go awry and suits start flying. Thus it is not wise to ignore the rule just because one believes one won't get busted by the FDA. If herbalists spend the next three years ignoring the rule, they will be entirely unprepared for the altered legal liabilities they will then face. They will also be unprepared should the FDA not honor the verbal assurance you heard, or should the FDA rapidly reverse that stance. There are four options for herbalists to consider: 1. Ignore the final rule and do business as usual. 2. Close the in-office herbal pharmacy and fax patient herbal orders to a CGMP-compliant herbal pharmacy that will custom compound. 3. Bring the in-office herbal pharmacy into full CGMP compliance. 4. Bring the in-office herbal pharmacy into modified CGMP compliance by formally requesting some testing exemptions from the FDA. I'd suggest that options 3 and 4 may not be financially viable. I've already pointed out the problems with option 1. Even though it will take several years to fully realize it, the game has just been radically changed. I expect that when FDA considers the time opportune, it will lower the axe on individual herbal practitioners who are not CGMP compliant. Best Regards, David Kailin, Ph.D., M.P.H., L.Ac. Author, Quality In Complementary & Alternative Medicine http://www.convergentmedical.com Quote Link to comment Share on other sites More sharing options...
Guest guest Posted July 12, 2007 Report Share Posted July 12, 2007 David- I understand what you are saying re: the wording of the final rule. But having work in other fields that are inspected by government agencies, I really find it doubtful that the FDA has the personnel, the time, and the money to track down individual herbal practitioners. There is still the loophole that the wording of the FDA rule can actually be used against us, but the reality does not seem to square with the ideal of the ruling. FWIW -Steve On Jul 12, 2007, at 10:18 PM, convergentmedical wrote: > Dear Bob, > I'd like to offer a somewhat different perspective. No matter what the > FDA representative said, the fact remains that under the terms of the > final rule, individual herbal practitioners are considered to be > manufacturers of dietary supplements engaged in interstate commerce, > and therefore subject to the rule. Such small entities have three > years to come into compliance. > > The FDA may (or may not) choose not to enforce the rule on individual > practitioners. Their policy can change at any time, by processes > entirely internal to the FDA, and that policy can change very quickly. > > The new FDA standards will be relied on by judges and lawyers as the > legal standard for herbal practice, if and when things go awry and > suits start flying. Thus it is not wise to ignore the rule just > because one believes one won't get busted by the FDA. If herbalists > spend the next three years ignoring the rule, they will be entirely > unprepared for the altered legal liabilities they will then face. > They will also be unprepared should the FDA not honor the verbal > assurance you heard, or should the FDA rapidly reverse that stance. > > There are four options for herbalists to consider: > 1. Ignore the final rule and do business as usual. > > 2. Close the in-office herbal pharmacy and fax patient herbal orders > to a CGMP-compliant herbal pharmacy that will custom compound. > > 3. Bring the in-office herbal pharmacy into full CGMP compliance. > > 4. Bring the in-office herbal pharmacy into modified CGMP compliance > by formally requesting some testing exemptions from the FDA. > > I'd suggest that options 3 and 4 may not be financially viable. > I've already pointed out the problems with option 1. > > Even though it will take several years to fully realize it, the game > has just been radically changed. I expect that when FDA considers the > time opportune, it will lower the axe on individual herbal > practitioners who are not CGMP compliant. > > Best Regards, > > David Kailin, Ph.D., M.P.H., L.Ac. > Author, Quality In Complementary & Alternative Medicine > http://www.convergentmedical.com > > > Stephen Bonzak, L.Ac., Dipl. C.H. sbonzak 773-470-6994 Quote Link to comment Share on other sites More sharing options...
Guest guest Posted July 12, 2007 Report Share Posted July 12, 2007 Bob, so us small fish are happy about this conversation, do you have any sense of what it means for Blue Poppy, Crane etc... in terms of changes in your operations? Doug > Great news indeed. . . > > > On Jul 12, 2007, at 12:41 PM, Bob Flaws wrote: > > > Good news. Just got off an AHPA conference call seminar on the new FDA > > cGMPs for dietary and herbal supplements. The FDA representative said > > that these GMPs had nothing to do with practitioners treating their > > patients one to one. So practitioners with clinic dispensaries don't > > have to worry about complying with these GMPs. The FDA guy said they > > have no interest in policing the dispensing of appropriately trained > > and certified professional practitioners. > > > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted July 12, 2007 Report Share Posted July 12, 2007 Dear Stephen, My larger point is that FDA regulations are drawn on by the courts to establish standards of practice. Even if the FDA exercises its enforcement discretion, we will encounter the new standards as part of the evolving legal definition of the standard of herbal practice. Is it possible that the FDA would temporarily conduct enforcement actions against individual herbal practitioners, perhaps to wrest the market away from them, for the benefit of some other competing group? Has the FDA ever engaged in such political actions before? Are you well aware of the history and tactics of the FDA's enforcement division with respect to CAM? The FDA certainly does many fine things, and I am more than willing to honor the essential services they provide. Yet there is small comfort in the FDA's unwillingness to exempt herbal practitioners from the final rule, providing instead an assurance to consider the use of discretion in enforcement. That's not even a promise to use such discretion. Best Regards, David Kailin, Ph.D., M.P.H., L.Ac. Author, Quality In Complementary & Alternative Medicine http://www.convergentmedical.com Quote Link to comment Share on other sites More sharing options...
Guest guest Posted July 13, 2007 Report Share Posted July 13, 2007 I agree that the FDA won't spend time pursuing our industry as a whole. However, what they may do is " interact " with a individual here and there and create an environment of fear. Remember how they persecuted MD's not long ago. They invaded only an office or two a year, but created a strong message, " Practice medicine the way we want, or face a challenge to your career " . Of course it is all done under the guise of " safety " for the patients, but that was just a lie to cover their actions. They have more than enough man power to create fear in an industry to keep the majority within " Party " lines. IMHO, it would be foolish not to acknowledge that past and think they will play fair with us. If there is any perception of our industry eating into the profits of the drug companies, they will find ways to protect themselves and the way the new law is written, they can do it easily. Chris In a message dated 7/12/2007 11:44:20 P.M. Eastern Daylight Time, stephenbonzak writes: David- I understand what you are saying re: the wording of the final rule. But having work in other fields that are inspected by government agencies, I really find it doubtful that the FDA has the personnel, the time, and the money to track down individual herbal practitioners. There is still the loophole that the wording of the FDA rule can actually be used against us, but the reality does not seem to square with the ideal of the ruling. FWIW -Steve ************************************** Get a sneak peak of the all-new AOL at http://discover.aol.com/memed/aolcom30tour Quote Link to comment Share on other sites More sharing options...
Guest guest Posted July 13, 2007 Report Share Posted July 13, 2007 Hi Doug, For Crane, we will have 3 years to comply with the new cGMPs as a distributor and as a manufacturer. Every company is still digesting the new regulations and I want to be brief, but I presume you are asking about our compounding pharmacy, individual practitioners and school pharmacies. 1. Certainly ³appropriately trained and certified² has to be defined. When the FDA understands how practitioners currently compound custom prescriptions, any patient complaint (serious Adverse Event Report) could trigger a reevaluation of the practitioners status. For instance, unprocessed Fu Zi has created some real problems (Kidney loss); this was not related to a specific practitioner but the FDA and ³their spokesmen² can create hysteria within the media. Solution : train and certify practitioners with a ³Compounding and GMP Protocol² exam. 2. Raw herb importers do not have to comply with the new Dietary cGMPs but they still have to comply with the old Food cGMPs from DSHEA. Only manufacturers are responsible for herb species ID (organoleptic or, if needed chemical testing : TLC). So if a practitioner buys from a raw herb importer, who will be responsible for the ID testing? I bet the practitioner will be held with the responsibility under the current Interim Final Rule of the cGMPs, if there was a patient problem; unless the regulation pertaining to herbalists and school pharmacies is appropriately defined. I was unclear yesterday if Crane could submit a question to FDA by Sept.24,2007 asking for clarification. As a small company, I and others were left with the impression that we could not even ask a question until our compliance date of June 2010. These are only my first concerns. To be continued within the AAAOM Herb Committee....... As far as Crane¹s compounding goes, we almost fully compliant with the new cGMPs right now. Our only issue is that we have to test 5 KPC singles/formulas in the USA (with the same limits as KP tests in Taiwan and in Switzerland/Germany for their COA) to prove that our ingredients for each custom ³batch² conforms to the specifications that Crane determines (ie, the KP standards : international standards). All the rest of our current SOPs (Standard Operating Procedures) bring us into compliance : 1. Personnel 2. Physical Plant and Grounds 3. Equipment and Utensils 4. Quality Control, PPCS(Production and Process Control System 5. Manufacturing 6. Packaging and Labeling 7. Returned Dietary Supplements 8. Product Complaints The playing has definitely shifted and given the manufacturing problems in China (perceived or real), we have a substantial challenge to prove that our medicinal herb products are safe and effective. Thanks, Bill Egloff Crane Herb Company Crane Herb Pharmacy > > > > > Bob, so us small fish are happy about this conversation, do you have any sense > of what it > means for Blue Poppy, Crane etc... in terms of changes in your operations? > Doug > > >> > On Jul 12, 2007, at 12:41 PM, Bob Flaws wrote: >> > >>> > > Good news. Just got off an AHPA conference call seminar on the new FDA >>> > > cGMPs for dietary and herbal supplements. The FDA representative said >>> > > that these GMPs had nothing to do with practitioners treating their >>> > > patients one to one. So practitioners with clinic dispensaries don't >>> > > have to worry about complying with these GMPs. The FDA guy said they >>> > > have no interest in policing the dispensing of appropriately trained >>> > > and certified professional practitioners. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted July 13, 2007 Report Share Posted July 13, 2007 Thank you, Bill. As I understand it, for the small practitioner it would mean that they would only want to buy from a raw-herb distributor who can guarantee compliance. This is going to put pressure on those companies in China.Is this correct? It seems our school herbs come in packets pretty much straight out of the fields. Doug , William Egloff <bill wrote: > > Hi Doug, > For Crane, we will have 3 years to comply with the new cGMPs as a > distributor and as a manufacturer. > > Every company is still digesting the new regulations and I want to be brief, > but I presume you are asking about our compounding pharmacy, individual > practitioners and school pharmacies. > > 1. Certainly ³appropriately trained and certified & #65533;has to be defined. When > the FDA understands how practitioners currently compound custom > prescriptions, any patient complaint (serious Adverse Event Report) could > trigger a reevaluation of the practitioners status. For instance, > unprocessed Fu Zi has created some real problems (Kidney loss); this was not > related to a specific practitioner but the FDA and ³their spokesmen & #65533;can > create hysteria within the media. Solution : train and certify > practitioners with a ³Compounding and GMP Protocol & #65533;exam. > 2. Raw herb importers do not have to comply with the new Dietary cGMPs but > they still have to comply with the old Food cGMPs from DSHEA. Only > manufacturers are responsible for herb species ID (organoleptic or, if > needed chemical testing : TLC). So if a practitioner buys from a raw herb > importer, who will be responsible for the ID testing? I bet the practitioner > will be held with the responsibility under the current Interim Final Rule of > the cGMPs, if there was a patient problem; unless the regulation pertaining > to herbalists and school pharmacies is appropriately defined. > > I was unclear yesterday if Crane could submit a question to FDA by > Sept.24,2007 asking for clarification. As a small company, I and others were > left with the impression that we could not even ask a question until our > compliance date of June 2010. > > These are only my first concerns. To be continued within the AAAOM Herb > Committee....... > > As far as Crane¹s compounding goes, we almost fully compliant with the new > cGMPs right now. Our only issue is that we have to test 5 KPC > singles/formulas in the USA (with the same limits as KP tests in Taiwan and > in Switzerland/Germany for their COA) to prove that our ingredients for each > custom ³batch & #65533;conforms to the specifications that Crane determines (ie, the > KP standards : international standards). > All the rest of our current SOPs (Standard Operating Procedures) bring us > into compliance : > 1. Personnel > 2. Physical Plant and Grounds > 3. Equipment and Utensils > 4. Quality Control, PPCS(Production and Process Control System > 5. Manufacturing > 6. Packaging and Labeling > 7. Returned Dietary Supplements > 8. Product Complaints > > > The playing has definitely shifted and given the manufacturing problems in > China (perceived or real), we have a substantial challenge to prove that our > medicinal herb products are safe and effective. > > Thanks, > Bill Egloff > Crane Herb Company > Crane Herb Pharmacy > > > > > > > > > > > Bob, so us small fish are happy about this conversation, do you have any sense > > of what it > > means for Blue Poppy, Crane etc... in terms of changes in your operations? > > Doug > > > > > >> > On Jul 12, 2007, at 12:41 PM, Bob Flaws wrote: > >> > > >>> > > Good news. Just got off an AHPA conference call seminar on the new FDA > >>> > > cGMPs for dietary and herbal supplements. The FDA representative said > >>> > > that these GMPs had nothing to do with practitioners treating their > >>> > > patients one to one. So practitioners with clinic dispensaries don't > >>> > > have to worry about complying with these GMPs. The FDA guy said they > >>> > > have no interest in policing the dispensing of appropriately trained > >>> > > and certified professional practitioners. > > > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted July 13, 2007 Report Share Posted July 13, 2007 On Jul 13, 2007, at 1:32 AM, convergentmedical wrote: > > Is it possible that the FDA would temporarily conduct enforcement > actions against individual herbal practitioners, perhaps to wrest the > market away from them, for the benefit of some other competing group? > Has the FDA ever engaged in such political actions before? Are you > well aware of the history and tactics of the FDA's enforcement > division with respect to CAM? > > David Kailin, Ph.D., M.P.H., L.Ac. Apropos of this, let me c & p a tidbit from the HSI newsletter: Dear Reader, Have you ever wondered if the " threats to our health care freedoms " are just a little bit exaggerated? If so, you should know that the FDA has put the question to rest with a recently issued rule titled " Final Rule for Current Good Manufacturing Practices (CGMPs) for Dietary Supplements. " With this rule, our health care freedoms have suddenly changed course and headed south. ----------- BFF!!! ----------- Most supplement manufacturers already test their ingredients to ensure potency and purity. Under the new FDA rule, tests and testing reports will be mandatory. And while that may sound reasonable on the surface (as long as you're comfortable with increased government meddling, of course), FDA officials know full well that the rule will drive many supplement makers out of business, while having only a negligible effect on the largest manufacturers. As you may be aware, many of the largest supplement manufacturers are owned by pharmaceutical companies whose executives will be delighted to have fewer competitors. A recent column written by Certified Clinical Nutritionist Byron J. Richards highlights these four revealing quotes that are actually contained within the FDA publication of the new rule: 1) " We find that this final rule will have a significant economic impact on a substantial number of small entities. " 2) " Establishments with above average costs, and even establishments with average costs, could be hard pressed to continue to operate. " 3) " The regulatory costs of this final rule will also discourage new small businesses from entering the industry. " And I saved the absolute worst for last: 4) " We expect that the majority of these costs will be borne by consumers of dietary supplements, who will likely respond to the increase in prices by reducing consumption. " That's one big, beautiful gift for drug company executives, with lots'n'lots of love, from their Best Friends Forever at the FDA. You and me and other U.S. supplement consumers? Too bad for us. ----------- All-time high ----------- As you might expect, many " experts " and academics in the mainstream see this new rule as the beginning of a regulatory paradise. But it's only the first step. The problem, in their view, is that the FDA still hasn't done enough. Over at ABC News, Keith Ayoob, an associate professor of pediatrics at Albert Einstein College of Medicine, offered this insight: " The big pharm companies that do supplements will be compliant. The ones I'm more worried about are the fringe companies that produce nothing but supplements. " Apparently Prof. Ayoob didn't spot the fine print about those worrisome fringe operations being driven out of business. Meanwhile, his naïve faith in the compliant nature of big pharm companies is charming. I think it's safe to say he doesn't read the e- Alert. Janell Mayo Duncan, the senior counsel for Consumers Union (which publishes Consumer Reports), told the Associated Press: " Consumers still have no idea if a given product works, or whether it is dangerous. " I'm guessing Ms. Duncan is blithely unaware of the irony that the very same can be said of a wide range of prescription drugs, which are regulated in exactly the way she apparently would like to see supplements regulated. And finally, David Katz of Yale told ABC: " In many countries - Germany, in particular - nutrient supplements are regulated like drugs. The U.S. has lagged behind in that area. " Unfortunately, it looks like the U.S. is finally beginning to catch up with a ridiculous system that doesn't recognize the huge and obvious differences between fish oil and Lipitor. The new rule goes into effect in late August, and smaller supplement companies will have about three years to fully comply. So by summer 2010 we should see supplement prices reach an all-time high - right alongside an all-time high of anger from U.S. supplement consumers. Just passing along somebody else's 2cents. ann Quote Link to comment Share on other sites More sharing options...
Guest guest Posted July 13, 2007 Report Share Posted July 13, 2007 I'm loathe to suggest things that other people should do but having just read the story about Chinese corruption in the drug business, I'm wondering if anyone is thinking of setting up a stamp of approval from an (newly formed) American organization? Doug , William Egloff <bill wrote: > > Hi Doug, > For Crane, we will have 3 years to comply with the new cGMPs as a > distributor and as a manufacturer. > > Every company is still digesting the new regulations and I want to be brief, > but I presume you are asking about our compounding pharmacy, individual > practitioners and school pharmacies. > > 1. Certainly ³appropriately trained and certified & #65533;has to be defined. When > the FDA understands how practitioners currently compound custom > prescriptions, any patient complaint (serious Adverse Event Report) could > trigger a reevaluation of the practitioners status. For instance, > unprocessed Fu Zi has created some real problems (Kidney loss); this was not > related to a specific practitioner but the FDA and ³their spokesmen & #65533;can > create hysteria within the media. Solution : train and certify > practitioners with a ³Compounding and GMP Protocol & #65533;exam. > 2. Raw herb importers do not have to comply with the new Dietary cGMPs but > they still have to comply with the old Food cGMPs from DSHEA. Only > manufacturers are responsible for herb species ID (organoleptic or, if > needed chemical testing : TLC). So if a practitioner buys from a raw herb > importer, who will be responsible for the ID testing? I bet the practitioner > will be held with the responsibility under the current Interim Final Rule of > the cGMPs, if there was a patient problem; unless the regulation pertaining > to herbalists and school pharmacies is appropriately defined. > > I was unclear yesterday if Crane could submit a question to FDA by > Sept.24,2007 asking for clarification. As a small company, I and others were > left with the impression that we could not even ask a question until our > compliance date of June 2010. > > These are only my first concerns. To be continued within the AAAOM Herb > Committee....... > > As far as Crane¹s compounding goes, we almost fully compliant with the new > cGMPs right now. Our only issue is that we have to test 5 KPC > singles/formulas in the USA (with the same limits as KP tests in Taiwan and > in Switzerland/Germany for their COA) to prove that our ingredients for each > custom ³batch & #65533;conforms to the specifications that Crane determines (ie, the > KP standards : international standards). > All the rest of our current SOPs (Standard Operating Procedures) bring us > into compliance : > 1. Personnel > 2. Physical Plant and Grounds > 3. Equipment and Utensils > 4. Quality Control, PPCS(Production and Process Control System > 5. Manufacturing > 6. Packaging and Labeling > 7. Returned Dietary Supplements > 8. Product Complaints > > > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted July 13, 2007 Report Share Posted July 13, 2007 Thanks for the update Bob. Is it true that the FDA is refusing all products and herbs that contain animal / insect ingredients? On the last go-around when they banned various herbs, they said they were going to exempt us practitioners, but it ended up they stopped things up stream so technically they weren't policing us, just cutting us off. Geoff Quote Link to comment Share on other sites More sharing options...
Guest guest Posted July 13, 2007 Report Share Posted July 13, 2007 For Blue Poppy, it doesn't mean much. Because we employ less than 20 full-time equivalent people, we don't have to comply for three years. However, that being said, we are pretty much in compliance now. We manufacture at a GMP plant in China and have all that paperwork. A review of that paperwork shows GMP procedures, QC, and documentation for all the things required by the new FDA guidelines. We encapsulate and bottle at a GMP plant here in the U.S. and have all that paperwork. All we have to do at our own facility is establish and document in writing GMP procedures for our warehouse. No big deal. We already have a cleaning and sanitation program in place. What we may have to institute are annual or biannual trips to our plant in China to document their compliance to their GMPs. Bob , " " wrote: > > Bob, so us small fish are happy about this conversation, do you have any sense of what it > means for Blue Poppy, Crane etc... in terms of changes in your operations? > Doug > > > > Great news indeed. . . > > > > > > On Jul 12, 2007, at 12:41 PM, Bob Flaws wrote: > > > > > Good news. Just got off an AHPA conference call seminar on the new FDA > > > cGMPs for dietary and herbal supplements. The FDA representative said > > > that these GMPs had nothing to do with practitioners treating their > > > patients one to one. So practitioners with clinic dispensaries don't > > > have to worry about complying with these GMPs. The FDA guy said they > > > have no interest in policing the dispensing of appropriately trained > > > and certified professional practitioners. > > > > > > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted July 13, 2007 Report Share Posted July 13, 2007 For Blue Poppy, it doesn't mean much. Because we employ less than 20 full-time equivalent people, we don't have to comply for three years. However, that being said, we are pretty much in compliance now. We manufacture at a GMP plant in China and have all that paperwork. A review of that paperwork shows GMP procedures, QC, and documentation for all the things required by the new FDA guidelines. We encapsulate and bottle at a GMP plant here in the U.S. and have all that paperwork. All we have to do at our own facility is establish and document in writing GMP procedures for our warehouse. No big deal. We already have a cleaning and sanitation program in place. What we may have to institute are annual or biannual trips to our plant in China to document their compliance to their GMPs. Bob , " " wrote: > > Bob, so us small fish are happy about this conversation, do you have any sense of what it > means for Blue Poppy, Crane etc... in terms of changes in your operations? > Doug > > > > Great news indeed. . . > > > > > > On Jul 12, 2007, at 12:41 PM, Bob Flaws wrote: > > > > > Good news. Just got off an AHPA conference call seminar on the new FDA > > > cGMPs for dietary and herbal supplements. The FDA representative said > > > that these GMPs had nothing to do with practitioners treating their > > > patients one to one. So practitioners with clinic dispensaries don't > > > have to worry about complying with these GMPs. The FDA guy said they > > > have no interest in policing the dispensing of appropriately trained > > > and certified professional practitioners. > > > > > > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted July 13, 2007 Report Share Posted July 13, 2007 " Is it true that the FDA is refusing all products and herbs that contain animal / insect ingredients? " Not for us, at least not yet. Passage through customs is taking longer and longer, but nothing of ours has been permanently denied entry. Bob Quote Link to comment Share on other sites More sharing options...
Guest guest Posted July 13, 2007 Report Share Posted July 13, 2007 " Even though it will take several years to fully realize it, the game has just been radically changed. I expect that when FDA considers the time opportune, it will lower the ax on individual herbal practitioners who are not CGMP compliant. " That seems paranoid to me and I seriously doubt this is going to happen. The guy from the FDA made it very clear that the FDA is not interested in applying these rules to one-on-one practitioners. He also made it clear that the enforcement arm of the FDA is driven by the latest cause celebre in terms of allocating resources. Think melamine. They only have so many resources. They simply do not have the personpower go after individual practitioners. This guy clearly recognized the validity of " duly educated and certified practitioners " doing what they have been trained and certified to do and specifically said this does not come under their idea of " manufacturing. " Bob Quote Link to comment Share on other sites More sharing options...
Guest guest Posted July 13, 2007 Report Share Posted July 13, 2007 I agree that the FDA will likely leave practitioners alone. If there is an increase in adverse events, though, that could change. I'm wondering if we will begin to see more adverse effects from Fu Zi. There is a trend in China now (one of my teachers calls it a fad) to use very high doses of Fu Zi (over 30 grams) for long periods of time. This trend has recently spread to the U.S. While most Fu Zi-related adverse events I have read about involve unprocessed or poorly-processed Fu Zi, this new trend might make it more likely to have adverse events from processed Fu Zi. I'm concerned that it could be the next herb that we will lose access to. - Bill > 1. Certainly ³appropriately trained and certified² has to be defined. When > the FDA understands how practitioners currently compound custom > prescriptions, any patient complaint (serious Adverse Event Report) could > trigger a reevaluation of the practitioners status. For instance, > unprocessed Fu Zi has created some real problems (Kidney loss); this was not > related to a specific practitioner but the FDA and ³their spokesmen² can > create hysteria within the media. Solution : train and certify > practitioners with a ³Compounding and GMP Protocol² exam. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted July 13, 2007 Report Share Posted July 13, 2007 USP (US Pharmacopeia) has a program for dietary supplements in place but it is very expensive and, I don¹t believe it is focused on multi-herb formulas. It was presented in Hong Kong last August at the MCMIA conference for herb manufacturers wanting to enter the US market. 4-5 years ago, herb companies had discussions with Cal. Dept. of Health Services and Dr.Richard Ko about a branding logo of quality manufacturing and testing would have been done by CA DHS; but too many companies thought the process and cost would be too burdensome. Well, look what we have to face now. Irradiation of herbs is illegal (currently) but it would make sense to develop a logo of purity indicating non-irradiation, non-GMO and organic (when possible with international certification). And, there is already falsification of organic herb certification in China. Yes, appropriate costs will be passed along to patients/consumers. But if we don¹t invest our money and vision in every aspect of high quality botanical medicine being available, we will be reacting to regulators, legislators and the media¹s over-reaction to to the inevitable health problems brought on by companies that are only looking for a quick profit. What kind of medicine do YOU want to invest in? Bill Egloff > > > I'm loathe to suggest things that other people should do but having just read > the story > about Chinese corruption in the drug business, I'm wondering if anyone is > thinking of > setting up a stamp of approval from an (newly formed) American organization? > Doug Quote Link to comment Share on other sites More sharing options...
Guest guest Posted July 13, 2007 Report Share Posted July 13, 2007 Obviously, things have changed for the worst in the last 3 months in terms of assuring quality products from China. It would be nice to say to a patient, look this has been certified from an organization of American origin. I wouldn't even mind if it was a cabal of Crane, Blue Poppy, etc... Doug , William Egloff <bill wrote: > > USP (US Pharmacopeia) has a program for dietary supplements in place but it > is very expensive and, I don¹t believe it is focused on multi-herb formulas. > It was presented in Hong Kong last August at the MCMIA conference for herb > manufacturers wanting to enter the US market. > > 4-5 years ago, herb companies had discussions with Cal. Dept. of Health > Services and Dr.Richard Ko about a branding logo of quality manufacturing > and testing would have been done by CA DHS; but too many companies thought > the process and cost would be too burdensome. > > Well, look what we have to face now. > Irradiation of herbs is illegal (currently) but it would make sense to > develop a logo of purity indicating non-irradiation, non-GMO and organic > (when possible with international certification). > And, there is already falsification of organic herb certification in China. > > Yes, appropriate costs will be passed along to patients/consumers. But if we > don¹t invest our money and vision in every aspect of high quality botanical > medicine being available, we will be reacting to regulators, legislators and > the media¹s over-reaction to to the inevitable health problems brought on by > companies that are only looking for a quick profit. > > What kind of medicine do YOU want to invest in? > Bill Egloff > > > > > > > > I'm loathe to suggest things that other people should do but having just read > > the story > > about Chinese corruption in the drug business, I'm wondering if anyone is > > thinking of > > setting up a stamp of approval from an (newly formed) American organization? > > Doug > > > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted July 13, 2007 Report Share Posted July 13, 2007 USP and NSF both have quality-assurance programs, but they are VERY expensive. Only the largest companies can afford to participate. The new GMP's will actually help in that regard, since compliance is a less expensive quality asurance program. - Bill , William Egloff <bill wrote: > > USP (US Pharmacopeia) has a program for dietary supplements in place but it > is very expensive and, I don¹t believe it is focused on multi-herb formulas. > It was presented in Hong Kong last August at the MCMIA conference for herb > manufacturers wanting to enter the US market. > > 4-5 years ago, herb companies had discussions with Cal. Dept. of Health > Services and Dr.Richard Ko about a branding logo of quality manufacturing > and testing would have been done by CA DHS; but too many companies thought > the process and cost would be too burdensome. > > Well, look what we have to face now. > Irradiation of herbs is illegal (currently) but it would make sense to > develop a logo of purity indicating non-irradiation, non-GMO and organic > (when possible with international certification). > And, there is already falsification of organic herb certification in China. > > Yes, appropriate costs will be passed along to patients/consumers. But if we > don¹t invest our money and vision in every aspect of high quality botanical > medicine being available, we will be reacting to regulators, legislators and > the media¹s over-reaction to to the inevitable health problems brought on by > companies that are only looking for a quick profit. > > What kind of medicine do YOU want to invest in? > Bill Egloff > > > > > > > > I'm loathe to suggest things that other people should do but having just read > > the story > > about Chinese corruption in the drug business, I'm wondering if anyone is > > thinking of > > setting up a stamp of approval from an (newly formed) American organization? > > Doug > > > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted July 13, 2007 Report Share Posted July 13, 2007 Its my understanding that standards of practice is created by the practititioners not the FDA or the courts. _____ On Behalf Of convergentmedical Thursday, July 12, 2007 10:33 PM Re: cGMPs for Dietary Supplements Dear Stephen, My larger point is that FDA regulations are drawn on by the courts to establish standards of practice. Even if the FDA exercises its enforcement discretion, we will encounter the new standards as part of the evolving legal definition of the standard of herbal practice. Is it possible that the FDA would temporarily conduct enforcement actions against individual herbal practitioners, perhaps to wrest the market away from them, for the benefit of some other competing group? Has the FDA ever engaged in such political actions before? Are you well aware of the history and tactics of the FDA's enforcement division with respect to CAM? The FDA certainly does many fine things, and I am more than willing to honor the essential services they provide. Yet there is small comfort in the FDA's unwillingness to exempt herbal practitioners from the final rule, providing instead an assurance to consider the use of discretion in enforcement. That's not even a promise to use such discretion. Best Regards, David Kailin, Ph.D., M.P.H., L.Ac. Author, Quality In Complementary & Alternative Medicine http://www.converge <http://www.convergentmedical.com> ntmedical.com _____ << ella for Spam Control >> has removed 1256 Spam messages and set aside 1076 Newsletters for me You can use it too - and it's FREE! www.ellaforspam.com Quote Link to comment Share on other sites More sharing options...
Guest guest Posted July 13, 2007 Report Share Posted July 13, 2007 So far as i'm aware fu zi is presently banned in the UK. _____ On Behalf Of bill_schoenbart Friday, July 13, 2007 8:41 AM Re: cGMPs for Dietary Supplements I agree that the FDA will likely leave practitioners alone. If there is an increase in adverse events, though, that could change. I'm wondering if we will begin to see more adverse effects from Fu Zi. There is a trend in China now (one of my teachers calls it a fad) to use very high doses of Fu Zi (over 30 grams) for long periods of time. This trend has recently spread to the U.S. While most Fu Zi-related adverse events I have read about involve unprocessed or poorly-processed Fu Zi, this new trend might make it more likely to have adverse events from processed Fu Zi. I'm concerned that it could be the next herb that we will lose access to. - Bill > 1. Certainly ³appropriately trained and certified² has to be defined. When > the FDA understands how practitioners currently compound custom > prescriptions, any patient complaint (serious Adverse Event Report) could > trigger a reevaluation of the practitioners status. For instance, > unprocessed Fu Zi has created some real problems (Kidney loss); this was not > related to a specific practitioner but the FDA and ³their spokesmen² can > create hysteria within the media. Solution : train and certify > practitioners with a ³Compounding and GMP Protocol² exam. _____ << ella for Spam Control >> has removed 1257 Spam messages and set aside 1076 Newsletters for me You can use it too - and it's FREE! www.ellaforspam.com Quote Link to comment Share on other sites More sharing options...
Guest guest Posted July 16, 2007 Report Share Posted July 16, 2007 That is correct. Kind regards, Attilio D'Alberto Doctor of (Beijing, China) BSc (Hons) TCM MBAcC Editor Times +44 (0) 1189 612512 <http://www.chinesemedicinetimes.com/forum/index.php> www.chinesemedicinetimes.com/forum/index.php <http://www.chinesemedicinetimes.com/wiki/CMTpedia> www.chinesemedicinetimes.com/wiki/CMTpedia On Behalf Of Michael Tierra 13 July 2007 19:09 RE: cGMPs for Dietary Supplements So far as i'm aware fu zi is presently banned in the UK. _____ @ <%40> [@ <%40> ] On Behalf Of bill_schoenbart Friday, July 13, 2007 8:41 AM @ <%40> Re: cGMPs for Dietary Supplements I agree that the FDA will likely leave practitioners alone. If there is an increase in adverse events, though, that could change. I'm wondering if we will begin to see more adverse effects from Fu Zi. There is a trend in China now (one of my teachers calls it a fad) to use very high doses of Fu Zi (over 30 grams) for long periods of time. This trend has recently spread to the U.S. While most Fu Zi-related adverse events I have read about involve unprocessed or poorly-processed Fu Zi, this new trend might make it more likely to have adverse events from processed Fu Zi. I'm concerned that it could be the next herb that we will lose access to. - Bill > 1. Certainly ³appropriately trained and certified² has to be defined. When > the FDA understands how practitioners currently compound custom > prescriptions, any patient complaint (serious Adverse Event Report) could > trigger a reevaluation of the practitioners status. For instance, > unprocessed Fu Zi has created some real problems (Kidney loss); this was not > related to a specific practitioner but the FDA and ³their spokesmen² can > create hysteria within the media. Solution : train and certify > practitioners with a ³Compounding and GMP Protocol² exam. _____ << ella for Spam Control >> has removed 1257 Spam messages and set aside 1076 Newsletters for me You can use it too - and it's FREE! www.ellaforspam.com Quote Link to comment Share on other sites More sharing options...
Guest guest Posted July 17, 2007 Report Share Posted July 17, 2007 Dear Michael, Standards of practice have multiple sources. State and national professional associations have a duty to create standards of practice. Institutions such as hospitals and clinics might further define standards of practice. Standards are also defined through laws and regulations. There are federal regulatory agencies like FDA and OSHA, and also State regulatory agencies, such as State acupuncture licensing boards. The courts become practical arbiters of standards in the course of making legal decisions. The FDA CGMP final rule sets standards for herbal practice. Even if the FDA chooses not to enforce those standards on individual herbalists for a while, those standards will eventually be considered by the courts as definitive standards of herbal practice. Thus failure to come into compliance will constitute not only regulatory infraction, but also breach of duty, which is one of the components of negligence. Ignore the FDA CGMP final rule at your peril. The impact of FDA regulations and findings tends to be quite broad. Do you remember way back when the FDA declared acupuncture needles to be experimental devices? Consider the multiple effects that had. No profession can successfully create and maintain standards in ignorance and contravention of the surrounding and pre-existing context of legal, regulatory, and social standards. Best Regards, David Kailin, Ph.D., M.P.H., L.Ac. Author, Quality In Complementary & Alternative Medicine http://www.convergentmedical.com , " Michael Tierra " <mtierra wrote: > > Its my understanding that standards of practice is created by the > practitioners not the FDA or the courts. > > _____ Quote Link to comment Share on other sites More sharing options...
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