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FYI: Medscape Expert columnJune H. McDermott, MS Pharm, MBA, FASHP, is ClinicalAssistant Professor, School of Pharmacy, University of NorthCarolina at Chapel Hill. Thomas M. Motyka, DO, is ClinicalAssistant Professor, University of North Carolina School ofMedicine, Chapel Hill.Assessing the Quality of BotanicalPreparationsJune H. McDermott, MS Pharm, MBA, and Thomas M.Motyka, DO[Medscape, 2000. � 2000 Medscape, Inc.]IntroductionThe passage of the Dietary Supplement Health and EducationAct of 1994 (DSHEA) stimulated 5 years of unprecedentedgrowth of the herbal and nutritional supplement industry.Although there is evidence that this growth is slowing down,[1]the US public is using increasing numbers of herbal andnutritional products in conjunction with or as replacements forconventional medicine.[2] As front-line providers of healthinformation, physicians and pharmacists are barraged withquestions about the safety and efficacy of these substances. Ofprimary concern is the quality and reliability of the productsavailable in the marketplace today.[1] This article reviews themajor issues related to product quality and standardization ofbotanical preparations. In the absence of definitive guidelines,we present an outline of issues for healthcare professionals toconsider when making recommendations regarding botanicalproducts.The ProblemThe passage of DSHEA opened the floodgates to allow anarray of herbal and nutritional supplements to enter themarketplace. These products, unlike those produced by thepharmaceutical industry, do not require the approval of theFood and Drug Administration (FDA). Safety and efficacyprior to marketing are not guaranteed, and no outsidemonitoring of the identity or potency of the herbals is produced.Instead, the manufacturer must ensure, at some later point, thesafety of the supplement. Reports of problems related to the quality of herbalsupplements can be found throughout the lay and professionalliterature. These reports fall into 4 categories: intentionaladdition of an active drug that is responsible for therapeutic oradverse effects; unintentional substitution of the herbal with atoxic species; environmental contamination of the herb with achemical or pathogen; and suboptimal or varying amounts ofactive ingredient within a formulation. Examples of these problems include the adulteration oftraditional Chinese herbal creams, intended for dermatologicalproblems, with dexamethasone[3] and contamination of plantainwith Digitalis lanata.[4] Digitalis lanata is a source oflanatosides or cardiac glycosides. Approximately 2700 kg ofthis contaminated plantain were shipped to numerousdistributors and manufacturers over a 2-year period.[4]The problem of inadequate standardization of activeingredients is highlighted by a quality analysis on St. John'swort products conducted as part of a Los Angeles Timesinvestigative series on alternative medicine. Three of the 10brands tested had no more than half the potency they claimed.[5]Another report examined 10 ginseng products, finding a widerange in total ginsenosides (2.3-23.2 mg).[6]The potential for botanical products to become contaminatedwith other adulterants such as heavy metals or microbialpathogens also exists, although we did not locate any reports ofsuch problems. One final obvious problem, easily addressed, islabeling of botanical preparations. Labels often do not includeproper dosing guidelines or warnings. Factors Influencing the Pharmaceutical Quality ofBotanical Preparations[7]Authenticity of Plant SpeciesThe plant should be accurately identified using macroscopicand microscopic techniques. It should be referred to by itsbotanical Latin binomial name, which includes the genus,species, and author citation to ensure correct identification. Theuse of common names can cause serious problems because thesame name may be applied to several different plants.Plant Part UsedThe part of the plant (eg, flower, leaf, seeds, bark, root,rhizome) that is used for the preparation should be identified.This is important, since different plant parts contain differentchemicals and different concentrations of the chemicals leadingto varying pharmacological activities.Environmental FactorsMany factors play a role in the quality of chemicals found in theplant, including growing conditions such as soil, altitude, andclimate.Harvesting and Storage ConditionsThe level of chemical constituents in plant parts can varyduring the growth cycle. The optimum harvest time must bedetermined individually. For example, ginsenosides from theroot of the ginseng are concentrated in the fall, which is whenharvesting occurs. However, if the active ingredients are foundin the flowers, harvest may be early to mid summer. Storageconditions, including temperature, light, and humidity, will alsoinfluence the chemical profile.Contamination of Herbal IngredientsHerbal products should be grown without exposure topesticides, herbicides, toxic metals, and other contaminants.Storage and processing should prevent introduction of animalparts or excretions, fungi, and bacteria. This issue ofcontamination holds true for nutritional supplements as well.Researchers at the Mayo Clinic analyzed several samples of5-hydroxytryptophan (5-HTP) and found traces of a chemicalcontaminant, known as "peak X," which has been linked toeosinophilia-myalgia syndrome.[8]Good Manufacturing ProceduresThe quality of the final product is determined by the quality ofthe plant and the manufacturing procedures used in processing.Plant extracts are dependent on the solvent used as well as theextraction conditions, including extraction time andtemperature. Chemical and chromatographic testing to profileor fingerprint the principal constituents should be obtained andreported. Binders and fillers in the final products should beidentified. Stability and expiration dating should beestablished. Lot numbers and test results should be logged.Standardization of ExtractsThe pharmacologically active constituents have been identifiedand the manufacturer guarantees a specific quantity of thesesubstances in the final product. In some cases where activechemicals have not been identified, the lead substances --typically compounds found in the plant or plant part used -- arereference points for standardization.Use of Whole PlantsTraditional medicine systems support the use of the whole plantor plant part and not just the extract of isolated chemicals. It isthought that there is synergism or antagonism among the manyconstituents and that the pharmacological activity depends ontheir combined effects. The use of products, containing wholeplant parts instead of fillers and binders, and standardized tospecific marker chemicals can guarantee quality from atraditional point of view.The Industry's ResponseThe nutritional supplement industry is responding to the needfor standardized and safe products. The National NutritionalFoods Association (NNFA), the largest and oldest nonprofittrade association for the dietary supplement industry, hasestablished a Good Manufacturing Practices (GMPs)Certification Program for its members.[9] The program requiresthird-party inspections of the manufacturing facilities todetermine whether the NNFA standards are being met. Thesestandards include specifications for the testing of raw andfinished materials, equipment maintenance, record keeping,cleanliness, and staff training. As a symbol of meeting NNFA'sGMPs, the manufacturer will be allowed use of a seal to beplaced on all product labels, ensuring the consumer of a qualityproduct. Participation in this program is required for all NNFAmembers supplying dietary supplements and will be phased inby the year 2002. The Institute for Nutraceutical Advancement (INA) is adivision of Industrial Laboratories, which provides analyticalservices to the natural products industry. INA has developed aMethods Validation Program (MVP) designed to validate anddistribute analytical methods for testing marker compounds inherbal products. They have currently validated and publishedmethods related to 6 botanical species. The United StatesPharmacopoeia is interested in publishing the INA methods inthe US Pharmacopoeia/National Formulary (USP/NF) asstandards for testing.[10,11] This procedure would be similar tothat established for pharmaceuticals. Finally, a privately held company, ConsumerLab.com, hasbegun a program for the independent testing of herbal productsand dietary supplements. Products passing the testingprocedures can carry a certification seal on their label,assuring consumers of a quality product.ConclusionsBotanical products present challenges from a regulatory andsafety perspective because plants contain a wide variety ofpotentially active constituents with synergistic potential. Inaddition, plants within the same species exhibit a broad rangeof chemical profiles. There is potential for wide variations inquality and content of botanicals based on the source of rawmaterials and the manufacturing process. Potential problemsinclude both intentional and unintentional contamination as wellas inconsistent concentration of active ingredients. In the absence of oversight from government or other thirdparties, health professionals need to assess for themselves thequality of each botanical product before they can speakconfidently about product quality and safety. We havepresented major issues of which pharmacists, physicians, andother practitioners should be aware when making judgmentsabout quality. Unfortunately, despite recent industry attempts toself-regulate, there are no definitive standards by which tojudge herbal supplements. It is likely that widely acceptedstandards by which to judge the most popular herbals willevolve out of current efforts regarding chemical identificationand measurement of active ingredients. Economies of scaledictate that standards for less commonly used plants will takemuch longer to evolve. We recommend that all health professionals take some time tolearn about the major issues involved and begin to learn aboutthe quality standards of herbal products that their patients aretaking. This may mean asking manufacturers about their qualitycontrol measures. Given the vast number of suppliers, thisbecomes difficult for busy clinicians. We look forward toprogress toward better standards and a means of assuring saferuse of botanical preparations.------------------ http://www.ibshealth.com/
 

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I am not againsts herbs, I just think you should be careful with them and try to take them one at a time, to see if they work if your going to use them. I also think it is a good idea to let your doctor know you take them and what ones.------------------ http://www.ibshealth.com/
 

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Hi Eric:When I go to my doc I always take a list of all the meds, vitamins and herbs I am taking. Some of the docs here are even starting to ask people ahead of time what they are taking, which is good.I'm thinking it might be a good idea to carry that info in my wallet too, in case of an emergency, like they say you should with meds.
JeanG
 

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Thanks, Eric, valuable info! My health food store made me aware of this awhile ago when I was buying spirolina. I bought a brand grown organically under the California Organic Food Act of 1990 w/o herbicides, pesticides, or preservatives. That seemed to be the best I could do. I don't take a lot of supplements but certification labels sound like a good idea! The brand I have says "Certified Quality Microalgae" on the label but doesn't say certified by who?
 

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