Guest guest Posted July 18, 2007 Report Share Posted July 18, 2007 Does this mean the end of the herbal purveyors of Chinatown, in large centers like LA, SF and NYC as we know it? Meaning no more raw herbs or medicines in pill form from China without certification that they comply with cGMP? Does that mean that enforcement will begin in June '08? What of the Australian GMP label on products? Will that suffice for US regulators? And what about the infamous " prop 65 stickers " on all Chinese pill products that " this product contains chemicals known to the state of California to cause cancer, birth defects and other reproductive harm. " Will the new cGMP certification override the necessity of attaching this absurd sticker which scares our patients into questioning if our products are safe? (That's right all of you living outside of California: every chinese pill container from China whether GMP certified or not, has this sticker!) Bill Mosca <mosca wrote: For those who are unaware, FDA has recently finalized cGMP rules for all dietary supplements sold in the US. These rules will phase in over the next 3 years (depending on the size of the manufacturer). The new rules are extensive and require anyone involved in the production or wholesale storage of dietary supplements to establish and implement written procedures and standards to ensure purity and to avoid adulteration of supplements. Herbs and herbal formulas are included in the definition of dietary supplements. As a result of this regulation, herb formula manufacturers will need to perform testing for likely contaminants including microbes, heavy metals, pesticides, etc. So between June 2008 and June 2010, you can start to inquire with dietary supplement manufacturers to see how/ when they plan to comply with the new regs and to find out what they are testing for and what their standards are for various contaminants. I, for one, am happy to see these regs. With the growing whirlwind of recent news items about contamination of Chinese products (toothpaste, toys, seafood, pharmaceuticals, wheat protein, etc), our profession is at risk of potential consumer backlash against any ingestible product associated with China. These new regulations arrive none too soon. All practicing herbalists should note that FDA has NOT exempted individual herbalists from this regulation. However, they have indicated that they will use their " enforcement discretion " when applying the new regs to the individual herbalist. Based upon the information provided by FDA so far, there are a few criteria that you must meet in order to have some level of confidence that FDA will not direct their " enforcement discretion " at you. Namely, you must: 1. Be appropriately trained to prescribe herbs; 2. Provide individualized, appropriate herbal formulations based upon a one-on-one personal consultation; and 3. Avoid the use of dietary supplements or dietary ingredients— including herbs—that pose a known or suspected safety concern. For most practitioners, the new regs shouldn't be an issue as long as FDA continues to follow their own guidelines. But you should start to pay closer attention (if you aren't already) to who is supplying your herbs/formulas and what they are doing as far as GMP. For practitioners who process herbs to produce stock formulations are more likely to be subjected to GMP enforcement by FDA. For example, if you blend and powder a bulk " generic " formula and then encapsulate it, FDA is more likely to consider you for enforcement than if you are custom blending commercial powders for individual patients. --Bill. On Jul 13, 2007, at 7:56 AM, wrote: > Hi Andrea Beth & All, > >> What is the best type of preparation of herbal formulas that would be >> most resistant to growing molds and fungi? Is there any way to >> ascertain that any formula is completely free of fungi and molds? And >> would it be wise not to prescribe any of our therapeutic mushrooms >> (fungi)? Thank you, > > I am no expert on the significance of pathogenic fungi or > mycotoxins in > herbal medicines. Others on this list are more expert on herbal QC > than I. I > hope that they will comment further. > > Here are my comments. > > 1. Herbal manufacturers who use GMP usually test each batch of > products > for contaminants (bacterial & fungal, as well as heavy metals, > pesticides, > etc). > > 2. Pathogenic fungi, like some strains of Aspergillus, Fusarium or > Mucor, > thrive on many plant materials. Many fungi grow best in the > presence of > moisture and oxygen. Therefore, rapid drying of plant material, and > vacuum- > sealing of the dried material helps to prevent / limit fungal growth. > > 3. As herbal dosages usually are small (? 9-21g of dried material/d), > mycotoxin levels would need to be high in the dried material before > they > wouold pose a real threat of toxicity. > > 4. Dried and vacuum-sealed herbal extracts are probably safest as > regards > their levels of pathogenic fungi / mycotoxins. > > 5. Many fungi (including medicinal mushrooms) are non-pathogenic or > beneficial at recommended dose rates. However, some patients may be > allergic or hypersensitive to them. > > For general reading on herbal-medicines toxicity contamination > Mycotoxins > OR fungi OR mold, see: http://tinyurl.com/22p28j > > PS: http://traditionalmedicines.info/HerbalGramJosfBrinkman.doc says: > > General concepts considered to be important in the development and > setting > of specifications include: > > o Characterization. EMEA proposes that to assure consistent product > quality, > comprehensive and relevant specifications for the botanical and > phytochemical aspects of the starting plant material, manufacture, > and the > finished product, should be established. > > o Macroscopical/microscopical characterization. To distinguish the > active > herb from adulterants. > > o Phytochemical characterization. Analysis of active and marker > compounds > including use of chromatographic fingerprinting. > > o Potential impurities/Contaminants/Degradation products. > Specifications for > heavy metals, pesticide residues, microbial contamination, mycotoxins. > > Sun Ten QC [ http://www.suntenglobal.com/news/show.php?ID=14 & page= ] > document says: > > Quality Control > > GMP certified pharmaceutical plants are required to have a complete > set of > protocols for the inspection and the receiving of all medicinal > materials used. > The following are included: > > 1. Source identification: To identify the source of every herbal > material used > with reference to the scientific name of its host/source plant to > avoid any > misuses and/or confusion (Fig. 13). > > 2. Organoleptic examination: Including general features, size, > texture, > surface characters, color, fracture features, flavor, and taste. > > 3. Loss on drying: To examine the water content of the herbal > material in > order to determine the extent of dryness. > > 4. Water-soluble extractives: To examine the contents of water-soluble > constituents. > > 5. Diluted alcohol-soluble extractives: To examine the contents of > alcohol- > soluble constituents. > > 6. Essential oils: Testing whether the main constituents of the herbal > material are evaporative essential oils. > > 7. Total ash: To examine the impurities and soil content in the herbal > material. > > 8. Acid-insoluble ash: To examine the amount/level of inorganic > elements > within the herbal material. > > 9. Thin-Layer chromatography (TLC): To examine whether the herbal > material contains active constituents (qualitative test). > > 10. High-performance liquid chromatography (HPLC): To examine the > amount/level of active constituents (quantitative test), (Fig. 16). > > 11. Atomic absorption spectrometry (AA) or Inductively-coupled > Plasma-MS > (ICP-MS): To examine whether heavy metals within the herbal material > exceeds specified limits. ICP-MS is capable of measuring the > individual > amounts of individual heavy metal content. > > 12. Microbial test: To examine whether the pathological microbes > within the > herbal material exceeds specified limits. > > Once the herbal materials have passed the above tests and comply with > company specifications, they can be imported. Once imported, these > herbal > materials must be sampled and examined again to confirm their > quality and > to verify that they indeed meet the specifications before they can > be used in > the production processes. Furthermore, the processed herbal materials > have an individual set of specifications and are subjected to > another series > of examination. > > The qualified herbal materials are then used to produce scientific > concentrated TCM herbal extracts under GMP conditions in order to > guarantee the quality of the products. > > http://www.mohp.gov.eg/Sec/Statistics/NPAHT.pdf says: > > Mycotoxins: Heavy contamination of herbal drugs with yeast and moulds > during inappropriate drying and storage (humidity and high > temperature) > resulted in the growth of mycotoxin-producing fungi, of particular > concern is > contamination of herbs with aflatoxin producing strains, such as > Aspergillus > spp. A large variety of mycotoxins have been identified among the > important > toxins in herbs areaflatoxins, patulin, luteoskyrin, ergot > alkaloids, ochratoxins > and zearlenone. They vary widely in their structure and toxicity to > liver, while > ochratoxins are nephrotoxic. > > Quite small amounts of mycotoxins contaminating herbs can represent > significant health hazards. Daily intake of 2-6mg aflatoxins > (30-90ug/kg body > weight) over a period of several weeks can be sufficient to produce > fatal > hepatitis. The main aflatoxins produced by aspergillus flavus are > B1 and B2 > where as A. parasiticus produces two additional aflatoxins G1 and > G2. The > most potent aflatoxin group is B1, which has also been shown to have > teratogenic and embryotoxic properties, also other aflatoxins can > be acutely > toxic, hepatotoxic, carcinogenic, mutagenic, teratogenic and > immunosuppressive to most mammalian species. In order to reduce > undesirable microbial contamination and to prevent the development of > other living organisms, some plant materials may require > sterilization before > storage, either by ethylene oxide, methyl chloride or by gamma > radiation and > infra-red. > > Best regards, > > > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted July 19, 2007 Report Share Posted July 19, 2007 Raw unprocessed herbs are regulated as foods. Generally speaking, they must (in theory) already conform to the existing cGMP for foods and are unaffected by this new regulation. Herbal purveyors in Chinatown are subject to the new cGMP regs if they make custom formulas. But FDA has indicated that they will not typically enforce these regs if the herbalist is adequately trained and produces formulas based on a 1-on-1 consultation. If the herbalist makes their own patents, they are clearly a manufacturer and must conform to the new regs. All patents--imported or not--must comply with the new cGMP. The regs will start taking effect in June 2008 for manufacturers with over 500 employees. Very small manufacturers will have until June 2010. There is no requirement for " GMP certification, " only compliance with the regs. Certification is typically performed by a 3rd party, as FDA will not " certify " anyone; they only enforce the regs when they have been violated. It is up to each manufacturer to develop a quality plan and product specifications that will assure both purity and the absence of adulteration. The new regs are specifically " loose " in this regard to allow each manufacturer to create a plan that is best suited for their particular products. As for Australian GMP labeling (or any other certification labeling)... This reg cannot be complied with simply through labeling. There are specific requirements regarding development of written quality plans and product specs as well as their implementation. Many other certification systems may already have requirements that exceed the US regs, but each manufacturer will have to ensure that the existing certifications meet or exceed US standards. The new cGMP has nothing to do with California's Prop 65 and should not change anything in this regard. --Bill. On Jul 18, 2007, at 12:36 AM, yehuda frischman wrote: > > Does this mean the end of the herbal purveyors of Chinatown, in > large centers like LA, SF and NYC as we know it? Meaning no more > raw herbs or medicines in pill form from China without > certification that they comply with cGMP? Does that mean that > enforcement will begin in June '08? What of the Australian GMP > label on products? Will that suffice for US regulators? And what > about the infamous " prop 65 stickers " on all Chinese pill products > that " this product contains chemicals known to the state of > California to cause cancer, birth defects and other reproductive > harm. " Will the new cGMP certification override the necessity of > attaching this absurd sticker which scares our patients into > questioning if our products are safe? (That's right all of you > living outside of California: every chinese pill container from > China whether GMP certified or not, has this sticker!) > > Bill Mosca <mosca wrote: > For those who are unaware, FDA has recently finalized cGMP rules for > all dietary supplements sold in the US. These rules will phase in > over the next 3 years (depending on the size of the manufacturer). > > The new rules are extensive and require anyone involved in the > production or wholesale storage of dietary supplements to establish > and implement written procedures and standards to ensure purity and > to avoid adulteration of supplements. Herbs and herbal formulas are > included in the definition of dietary supplements. > > As a result of this regulation, herb formula manufacturers will need > to perform testing for likely contaminants including microbes, heavy > metals, pesticides, etc. So between June 2008 and June 2010, you can > start to inquire with dietary supplement manufacturers to see how/ > when they plan to comply with the new regs and to find out what they > are testing for and what their standards are for various contaminants. > > I, for one, am happy to see these regs. With the growing whirlwind > of recent news items about contamination of Chinese products > (toothpaste, toys, seafood, pharmaceuticals, wheat protein, etc), our > profession is at risk of potential consumer backlash against any > ingestible product associated with China. These new regulations > arrive none too soon. > > All practicing herbalists should note that FDA has NOT exempted > individual herbalists from this regulation. However, they have > indicated that they will use their " enforcement discretion " when > applying the new regs to the individual herbalist. > > Based upon the information provided by FDA so far, there are a few > criteria that you must meet in order to have some level of confidence > that FDA will not direct their " enforcement discretion " at you. > Namely, you must: > > 1. Be appropriately trained to prescribe herbs; > 2. Provide individualized, appropriate herbal formulations based upon > a one-on-one personal consultation; and > 3. Avoid the use of dietary supplements or dietary ingredients— > including herbs—that pose a known or suspected safety concern. > > For most practitioners, the new regs shouldn't be an issue as long as > FDA continues to follow their own guidelines. But you should start > to pay closer attention (if you aren't already) to who is supplying > your herbs/formulas and what they are doing as far as GMP. > > For practitioners who process herbs to produce stock formulations are > more likely to be subjected to GMP enforcement by FDA. For example, > if you blend and powder a bulk " generic " formula and then encapsulate > it, FDA is more likely to consider you for enforcement than if you > are custom blending commercial powders for individual patients. > > --Bill. On Jul 13, 2007, at 7:56 AM, wrote: > >> Hi Andrea Beth & All, >> >>> What is the best type of preparation of herbal formulas that >>> would be >>> most resistant to growing molds and fungi? Is there any way to >>> ascertain that any formula is completely free of fungi and molds? >>> And >>> would it be wise not to prescribe any of our therapeutic mushrooms >>> (fungi)? Thank you, >> >> I am no expert on the significance of pathogenic fungi or >> mycotoxins in >> herbal medicines. Others on this list are more expert on herbal QC >> than I. I >> hope that they will comment further. >> >> Here are my comments. >> >> 1. Herbal manufacturers who use GMP usually test each batch of >> products >> for contaminants (bacterial & fungal, as well as heavy metals, >> pesticides, >> etc). >> >> 2. Pathogenic fungi, like some strains of Aspergillus, Fusarium or >> Mucor, >> thrive on many plant materials. Many fungi grow best in the >> presence of >> moisture and oxygen. Therefore, rapid drying of plant material, and >> vacuum- >> sealing of the dried material helps to prevent / limit fungal growth. >> >> 3. As herbal dosages usually are small (? 9-21g of dried material/d), >> mycotoxin levels would need to be high in the dried material before >> they >> wouold pose a real threat of toxicity. >> >> 4. Dried and vacuum-sealed herbal extracts are probably safest as >> regards >> their levels of pathogenic fungi / mycotoxins. >> >> 5. Many fungi (including medicinal mushrooms) are non-pathogenic or >> beneficial at recommended dose rates. However, some patients may be >> allergic or hypersensitive to them. >> >> For general reading on herbal-medicines toxicity contamination >> Mycotoxins >> OR fungi OR mold, see: http://tinyurl.com/22p28j >> >> PS: http://traditionalmedicines.info/HerbalGramJosfBrinkman.doc says: >> >> General concepts considered to be important in the development and >> setting >> of specifications include: >> >> o Characterization. EMEA proposes that to assure consistent product >> quality, >> comprehensive and relevant specifications for the botanical and >> phytochemical aspects of the starting plant material, manufacture, >> and the >> finished product, should be established. >> >> o Macroscopical/microscopical characterization. To distinguish the >> active >> herb from adulterants. >> >> o Phytochemical characterization. Analysis of active and marker >> compounds >> including use of chromatographic fingerprinting. >> >> o Potential impurities/Contaminants/Degradation products. >> Specifications for >> heavy metals, pesticide residues, microbial contamination, >> mycotoxins. >> >> Sun Ten QC [ http://www.suntenglobal.com/news/show.php?ID=14 & page= ] >> document says: >> >> Quality Control >> >> GMP certified pharmaceutical plants are required to have a complete >> set of >> protocols for the inspection and the receiving of all medicinal >> materials used. >> The following are included: >> >> 1. Source identification: To identify the source of every herbal >> material used >> with reference to the scientific name of its host/source plant to >> avoid any >> misuses and/or confusion (Fig. 13). >> >> 2. Organoleptic examination: Including general features, size, >> texture, >> surface characters, color, fracture features, flavor, and taste. >> >> 3. Loss on drying: To examine the water content of the herbal >> material in >> order to determine the extent of dryness. >> >> 4. Water-soluble extractives: To examine the contents of water- >> soluble >> constituents. >> >> 5. Diluted alcohol-soluble extractives: To examine the contents of >> alcohol- >> soluble constituents. >> >> 6. Essential oils: Testing whether the main constituents of the >> herbal >> material are evaporative essential oils. >> >> 7. Total ash: To examine the impurities and soil content in the >> herbal >> material. >> >> 8. Acid-insoluble ash: To examine the amount/level of inorganic >> elements >> within the herbal material. >> >> 9. Thin-Layer chromatography (TLC): To examine whether the herbal >> material contains active constituents (qualitative test). >> >> 10. High-performance liquid chromatography (HPLC): To examine the >> amount/level of active constituents (quantitative test), (Fig. 16). >> >> 11. Atomic absorption spectrometry (AA) or Inductively-coupled >> Plasma-MS >> (ICP-MS): To examine whether heavy metals within the herbal material >> exceeds specified limits. ICP-MS is capable of measuring the >> individual >> amounts of individual heavy metal content. >> >> 12. Microbial test: To examine whether the pathological microbes >> within the >> herbal material exceeds specified limits. >> >> Once the herbal materials have passed the above tests and comply with >> company specifications, they can be imported. Once imported, these >> herbal >> materials must be sampled and examined again to confirm their >> quality and >> to verify that they indeed meet the specifications before they can >> be used in >> the production processes. Furthermore, the processed herbal materials >> have an individual set of specifications and are subjected to >> another series >> of examination. >> >> The qualified herbal materials are then used to produce scientific >> concentrated TCM herbal extracts under GMP conditions in order to >> guarantee the quality of the products. >> >> http://www.mohp.gov.eg/Sec/Statistics/NPAHT.pdf says: >> >> Mycotoxins: Heavy contamination of herbal drugs with yeast and moulds >> during inappropriate drying and storage (humidity and high >> temperature) >> resulted in the growth of mycotoxin-producing fungi, of particular >> concern is >> contamination of herbs with aflatoxin producing strains, such as >> Aspergillus >> spp. A large variety of mycotoxins have been identified among the >> important >> toxins in herbs areaflatoxins, patulin, luteoskyrin, ergot >> alkaloids, ochratoxins >> and zearlenone. They vary widely in their structure and toxicity to >> liver, while >> ochratoxins are nephrotoxic. >> >> Quite small amounts of mycotoxins contaminating herbs can represent >> significant health hazards. Daily intake of 2-6mg aflatoxins >> (30-90ug/kg body >> weight) over a period of several weeks can be sufficient to produce >> fatal >> hepatitis. The main aflatoxins produced by aspergillus flavus are >> B1 and B2 >> where as A. parasiticus produces two additional aflatoxins G1 and >> G2. The >> most potent aflatoxin group is B1, which has also been shown to have >> teratogenic and embryotoxic properties, also other aflatoxins can >> be acutely >> toxic, hepatotoxic, carcinogenic, mutagenic, teratogenic and >> immunosuppressive to most mammalian species. In order to reduce >> undesirable microbial contamination and to prevent the development of >> other living organisms, some plant materials may require >> sterilization before >> storage, either by ethylene oxide, methyl chloride or by gamma >> radiation and >> infra-red. >> >> Best regards, >> >> >> >> Quote Link to comment Share on other sites More sharing options...
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