I have actually been thinking about this and I am not opposed to herbs, but wondering what properties a specific herb might have and then what it would do to help, mood or digestion.This info is FYI though and herbs should be considered to their source and properties.It is also being mentioned above tto take one at a time to see specific effects. If they work for you great.Botanical ProductsAmista Anne Lone, PharmD Botanical products have been widely used for centuries; however, recent innovations in medicine and trends toward alternative approaches have elicited many questions health professionals must answer. Are these products safe and efficacious? What position does the FDA take on dietary supplements? What liability issues does this present? Variations in Plant Origin[1] The efficacy of an herbal product depends on an unknown combination of a compound acting synergistically. In other words, as the purity of an herbal product increases, the efficacy may decrease. This may be due to possible secondary metabolites in the herb itself. These secondary metabolites may not have well-defined functions in the plant. They may give protection to the plant, which increases the plant survival, but they may also be biologically active. It is important for the healthcare practitioner to know of the production process of botanical products in order to make an effective decision about whether to recommend a certain product. There are 2 variations to plants that may alter the "chemically active" component--natural variations and manufacturing variations: Natural Variations Genetics Species variation Ontogeny (stage of development) Growth, reproduction Plant part Stems, leaves, roots, flowers, fruits Environment Temperature, rainfall, day length, altitude, atmosphereic composition, soil Manufacturing Variations Drying Time between collection and drying Time allowed for drying from when picked Temperature used for drying Storage Moisture reabsorption Loss of volatile oils Molds, infestation, sterilization Adulteration Mishandling of product Extraction Procedure Type of solvent Amount of fine plant material exposed to Solvent Degree of agitation Temperature Number of times sample extracted Age of extract Exposure to oxygen and light Solvents Water (tea) -- hydrophilic constituent volatile if warm Ethanol -- less hydrophilic constituent Hexane -- very lipophilic constituent Analytical Methods Analytical methods were developed to detect and separate individual compounds. The methods to extract compounds should be reproducible and quantitative. Trial analysis is performed to show consistency. Below are the 5 main analytical methods used: TLC Thin-layer chromatography HPLC High-powered liquid chromatography GC Gas chromatography MS Mass spectrometry NMR Nuclear magnetic resonance Use of analysis helps to monitor the consistency of the production process from batch to batch of one manufacturer. It also aids in the identification of plant material. Standardization Standardization is achieved by choosing at least 1 compound and monitoring its concentration in each batch of product (and modifying batches to meet the standard). Standardization is not directly related to efficacy because it does not assess the total chemical composition of the product. It shows consistency, but not necessarily efficacy. Quality Herbal Preparations The best preparations are those that have been studied in clinical trials and have received positive outcomes. The second-best preparations are those that match the requirements of monographs and clinical trials. A monograph should contain the following items: Description of the plant Known and active constituents of the plant Plant identification Therapeutic indications Dosage forms (ie, extract, tea, dried, solvent) Method/duration of administration Contraindications Drug interactions Any known pharmacokinetics Some of the available resources are listed below. Resource Pros Cons German Commission E Therapeutic information Not detailed Comprehensive listing of herbs Not referenced Acceptable combination products Dated material ESCOT Monograph Therapeutic information 50 herbs to date Clinical trial synopses in vivo Detailed information Referenced Review of Natural Products Therapeutic information Comprehensive Referenced Updated periodically When considering which herbal product to recommend, there are a few questions that you should ask. Ask about the quality control (ie, the protocols for drying, storage, or extraction procedures). Find out whether analysis procedures are done. Ask about standardization (ie, are standardization requirements met -- and if so, how?) Monitor the patients' outcomes, and have the patients monitor their own outcomes as well. FDA Regulations on Dietary Supplements[2] In the United States, over $12 billion per year is spent on medications, including over-the-counter medications. One third of this is spent on botanicals. This is a major global concern, because dietary supplements are unregulated by the FDA or by any other US organization. There has been a sweeping change in legislation since 1994, when the Dietary Supplement Health and Education Act (DSHEA) was passed. This act defined dietary supplements and made provisions for the manufacturers to follow. The FDA has become increasingly involved in the safety concerns on dietary supplements, and has developed a task force dedicated full time to dietary supplement issues. Boundary Issues Specific areas were addressed to distinguish dietary supplements from conventional foods and from other drugs. The FDA looked at its intended use and whether it was used previously as a drug. Medical foods were defined as those products that were used for a specific disease with distinctive nutrient needs. These products must be used under the constant supervision of a healthcare professional. Dietary supplements are intended to supplement the normal diet, whereas drugs are intended to treat, prevent, or cure a disease. Structure/Function Claims The FDA is working to provide a final resolution for describing the role of a substance in humans in reference to structure or function claims that a manufacturer makes about a certain product. Currently, the manufacturer has 30 days post-marketing to submit structure/function claims to the FDA. They must include on the label the following disclaimer: "This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease." Safety Standards Dietary supplements are exempted from food additive requirements. Currently, manufacturers are responsible for providing safe products but are not regulated to do so. Good manufacturing practices (GMPs) are being revamped to provide guidelines in 4 areas: (1) GMP current status, (2) safety activity, (3) early warning, and (4) labeling. In 1997 the FDA published an advance notice of proposed rulemaking for GMPs. The FDA has listed proposed rules for GMPs as their top priority, and should have the final results published in late 2000. Outreach and data collection are in progress. Post-marketing monitoring of adverse event reports, product sampling, scientific literature, and other sources are being addressed. Early warnings to the public of potentially dangerous products have been implemented. The FDA has initiated actions to remove GBL (gammabutyrolactone, a precursor to GHB) and GHB from the marketplace because of the 55 adverse events 1 death that have been reported. They have also limited ephedra dosing to 20 mg/day as a maximum because of the overwhelming incidence of adverse events reported. The FDA has also implemented a requirement to add nutrition labeling to products. A supplement facts panel and the part of the plant used must be listed as well. What's Next for Dietary Supplements? Issues that will be addressed in the months and years to come include striking a balance between availability and safety. Currently, the Federal Trade Commission regulateds advertising. In response to the overwhelming interest in the Internet, the FDA is looking at policy issues that address the type of information being placed on Web sites and the regulations that may or may not need to be implemented in this area. Liability Issues for Pharmacists Using Botanicals[3] Using botanical products in caring for patients carries with it a certain risk. A comparison of adverse drug reactions (ADRs) for prescriptions versus botanicals has not been made. Between $30 and $100 billion is spent on medication-related errors of prescription drugs. The question is, how much of that is due to dietary supplements? To date, hundreds of cases have been brought to the courts concerning prescription medications. There are no cases, however, that mention botanical products or herbals. Legal Risks There are potential risks involved with medications and botanical products. These include, but are not limited to, the following: Strict liability Negligence Warranties Obligation to warn Strict liability includes the sale of a defective product (ie, adulterated to label warning), the sale of a product that is unreasonably or inherently dangerous (ie, through the manufacturing process, design, or failure to warn). Liability is incurred when a knowingly defective or an unreasonably or inherently dangerous productleaves the hands of the defendant, or the plaintiff, and results in an injury. Negligence comes to play when there is an obvious defect or patent defect (ie, a lack of child-proof caps). Negligence is inferred when there is no evidence of the defendant's negligence and the plaintiff could have done nothing to prevent it. A product must be warranted safe. Even though dietary supplements do not fall under the same FDA regulations that prescriptions drugs do, there is still an inherent obligation, whether it be written or implied, that for the manufacturer to produce a safe product. The obligation to warn the patient who is known to be using a prescription medication about possible adverse interactions between that medication and the known dietary supplement in question. The obligation covers closed package labeling as well. Fraud Fraud includes intentional misrepresentation or misleading silence. There are 2 types of fraud; deceit and concealment. Deceit is known as affirmative fraud. It is purposed as false information, known falsity, or an act that is done for the purpose of defrauding. Concealment is the act of being deliberately misleading by silence - that is, purposefully avoiding the duty to disclose by intentionally suppressing material facts with the object of creating a false impression. Other Violations Statutory liabilities Licensing violations Lack authority to use/prescribe Failure to follow regulations Failure to renew license Personal health or character problems Regulatory violations Failure to meet standards Basic requirements omitted (ie, warnings, nutrition labeling) Marketing violations DSHEA FTCA misrepresentations Antitrust Act: limited use permitted, price fixing Summary When recommending botanical products, it is important to be aware of the manufacturing process. This awareness will help you to identify the quality of the product and the presence of other agents that may be included in the product. Review the published literature and identify outcomes for the use of botanicals in clinical trials. The focal point in gaining quality botanical product information is to follow the same drug information procedures you would follow for FDA-approved medications. References 1.Hall AM. Botanical products. In: Program and abstracts of The American Society of Health-System Pharmacist Midyear Clinical Meeting 1999; December 5-9, 1999; Orlando, Florida. Abstract 3612433. 2.McDonald J. FDA regulations on dietary supplements. In: Program and abstracts of The American Society of Health-System Pharmacist Midyear Clinical Meeting 1999; December 5-9, 1999; Orlando, Florida. Abstract 3613063. 3.Skinner WJ. Liability issues for pharmacists using botanicals. In: Program and abstracts of The American Society of Health-System Pharmacist Midyear Clinical Meeting 1999; December 5-9, 1999; Orlando, Florida. Abstract3613200.------------------
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