What is Homeopathy?
The first basic principles of homeopathy were formulated by Samuel Hahnemann in the late 1700's. Homeopathy, or homeopathic medicine, is a natural approach to wellness that has been practiced around the world for more than a century. The goal of this treatment is to encourage your body to return to a normal state of balance and health. Our remedies use a traditional approach to prepare and administer minute doses of therapeutic ingredients that gently assist the body by stimulating your own energies and healing potential -- blending the concepts of yesterday with today's technology in the achievement of good health and well being.
What are Homeopathic Dilutions?
The term "homeopathy" is of Greek origin, coming from the words homeo (similar) and pathos (suffering or disease). Homeopathy is based on the theory that the symptoms of many ailments such as cough, cold, flu, teething, muscular and arthritic pain, etc. can be alleviated by ultra-dilute "micro" doses of mineral, botanical or zoological substances which, in higher doses, produce similar symptoms in healthy people.
Homeopathic remedies begin as plants, animals, or minerals. The active compounds are extracted from these sources, creating what is known as a mother liquid or tincture. After extraction, the tincture is diluted in a series of carefully measured steps. With each successive dilution step, the medication is shaken, or "succussed." Once the dilution steps have been completed, the finished medication is formulated into several different dosage forms such as pellets, tablets, creams and gels which can be administered orally, or topically as recommended.
Each ingredient in a homeopathic medication has a potency, which describes the dilution level of that ingredient in the medication. You can find the potency of each ingredient in the Drug Facts box located on a carton of our homeopathic medicines, in the section listing the Active Ingredients. For example, if "Chamomilla 3X HPUS" is listed as an active ingredient, then the active ingredient is Chamomilla. The 3X indicates the potency, and HPUS indicates that the medication was prepared according to the guidelines of the Homeopathic Pharmacopeia of the United States.
What does the "X" listed after the active ingredient stand for?
Homeopathic potencies are expressed as a letter and number combination such as "3X". In this case, the number "3" indicates the number of dilutions performed, while the letter "X" indicates that each successive dilution step was made at dilution of 1/10.
A 1X attenuation describes a dilution of one part to ten parts, a 2X attenuation describes a dilution of one to a hundred and a 3X attenuation describes a dilution of one to a thousand. Therefore the three serial dilutions called for in order to produce a 3X active ingredient effectively dilutes by 1,000 times the original extract of the active homeopathic ingredient.
The HPUS explains the "X" dilution as being "prepared by dissolving one (1) part by weight of the soluble basic substance in a sufficient quantity of purified water or other appropriate medium (menstruum), specified in the drug monograph, to produce ten (10) parts by volume of liquid dilution (attenuation) which is designated 1X." The Decimal Attenuation Scale procedure is described as "The 1/10 (10%) solution corresponds to the 1X liquid attenuation. One milliliter (1.0 ml) of 1X liquid attenuation is vigorously shaken (succussed) with nine milliliters (9.0 ml) of diluent to produce ten milliliters (10.0 ml) of 2X attenuation. Subsequent attenuations are prepared by succussing 1.0 ml of the preceding attenuation with 9.0 ml of diluent to produce 10.0 ml of the succeeding attenuation."
Regulatory Compliance for Manufacturing and Labeling
The FDA Compliance Policy Guide Sec. 400.400 outlines the "Conditions Under Which Homeopathic Drugs May be Marketed." The complete guidance may be reviewed at CPG Sec. 400.400 Conditions Under Which Homeopathic Drugs May be Marketed
This guidance outlines how homeopathic medicines have been regulated as drug products by the United States Food and Drug Administration (FDA) since the passing of The Federal Food, Drug, and Cosmetic Act of 1938. This act recognizes the drugs and standards in the Homeopathic Pharmacopeia of the United States (HPUS) as official. It also requires that their marketing and manufacturing be done in accordance with these HPUS labeling provisions (Sections 502 and 503 of the Act) and Title 21 of the Code of Federal Regulations (CFR) regarding FDA Good Manufacturing Practices (GMPs) (21 CFR parts 201, 210 and 211). Homeopathic products are not, however, subject to premarket evaluation by the Food and Drug Administration for safety or efficacy. Nor is the FDA aware of scientific evidence to support homeopathy as effective.
Through the standardization of manufacturing and by establishing a recognizable and uniform approach to labeling and packaging, various regulations offer consumers increased safety and convenience. For example, depending on their strength, many active ingredients that are listed in the Homeopathic Pharmacopoeia of the United States (HPUS) are able to be marketed as conventional over-the-counter (OTC) drugs. "Homeopathic products intended solely for self-limiting disease conditions amenable to self-diagnosis (of symptoms) and treatment may be marketed OTC.1" As such, the packaging indicates each homeopathic active and its purpose in the product, the "Uses" for the product, any applicable Warnings, Directions for recommended dosage / mode of application and inactive ingredients, all in standard "Drug Facts" format.
1 U.S. Food and Drug Administration. Sec. 400.400 Conditions Under Which Homeopathic Drugs May be Marketed. Available at http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm074360.htm
Q. Do any of your products contain lactose?
A. All of our products are lactose free and many are based on traditional sucrose pellets that allow for proper absorption. In the case of our children's products, this is also a benefit for children with lactose digestive complications and mothers who are trying to limit their children's intake of lactose based products.
Q. At what age can I begin giving your products to my child?
A. Our products may be used at the first signs of teething, such as drooling, redness in the gum area, and irritability, all the way through the entire process. Teething in children usually begins as early as three months of age to as late as twelve months and beyond. While there is no consistent pattern among all children, the lower front teeth (incisors) are usually the first to appear followed by the upper front within a couple of months.
Q. Do your products have side effects?
A. Homeopathic remedies work together with your body to help encourage it to return to a normal state of balance. Their active ingredients are in high dilutions.
As with all medicines however you should contact your health care provider if symptoms continue unimproved for more than 5 days, and should keep out of the reach of children.
Q. How do I administer these remedies to my child?
A. For our pellet products, we recommend crushing the pellet in a spoon, then dissolving in one half teaspoon of water before giving to your child. Also, try not to handle the pellets. Pour the desired amount into the cap or spoon then administer as directed.
Q. Do you test any of your products on animals?
A. No, we do not test our products on animals. At Humphreys Pharmacal animal testing is against our company philosophy. We produce the gentlest products from the finest ingredients available.
Q. Do you use any harsh preservatives such as parabens in your products?
A. No, we are sensitive about the ingredients we use. They contain no artificial colors or harsh preservatives such as parabens.
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