SnoreStop formulas are prepared in accordance with the Homeopathic Pharmacopoeia of the United States (HPUS).
All ingredients in our SnoreStop formulas are recognized as an official collection of accepted drug ingredients by the Federal Food, Drug and Cosmetic Act and are manufactured in FDA-approved laboratories. Each natural ingredient comes either from plant, mineral or protein sources and is present only in harmless microscopic amounts in each dose. There is no measurable amount of active alkaloid Ephedrine or pseudoephedrine in our formula in any of our SnoreStop formulas.
Claims follow requirement in CPG 400.400 and GLP of Sections 502 & 503 of the FDCA (“The Act”) and Part 201 Title 21 of the CFR to include Principle Display Panel of OTC Drug Labeling under 21 CFR 201.62. Uses and claims are taken from various authorized Materia Medica for references. They have not been reviewed by the Federal Drug and Administration.
Why do consumers use Homeopathic medicines?
Consumers purchase Homeopathic medicines because they perceive them to be natural and effective. Many consumers are dissatisfied with the side effects of conventional , Western medicines. They seek the benefits of a natural product. Homeopathy is typically much safer than other OTC medicines.
How is Homeopathy regulated?
Homeopathic products are classified as drugs with the meaning of the Food, Drug, and Cosmetic Act as amended by the FDA Modernization Act of 1997. They may be either prescription or nonprescription products. The FDA does not regulate Homeopathic drugs precisely the same way as other drugs. Although Homeopathic medicines are subject to the same regulations for manufacturing, marketing, and sales as their conventional, Western counterparts, premarket approvals of Homeopathic medicines are subject to the monograph process of the Homeopathic Pharmacopoeia of the United States (HPUS), rather than the IND/NDA process at FDA. As a result, FDA developed a Compliance Policy Guide (CPG 400.400 "Conditions Under Which Homeopathic Medicines May Be Marketed), which gives specific regulatory guidance for the marketing of Homeopathic drugs. The CPG states: 'Nonprescription Homeopathic drug products may be sold for self-limiting conditions recognizable by consumers...labeling must adequately instruct consumers in the product's safe use.'
What is the HPUS?
Homeopathic medicines have an official compendial status in the United States. Royal Copeland, M.D., a Homeopathic physician and U.S. Senator from New York, was the principal author of the federal Food Drug and Cosmetic Act of 1938. Copeland understood the need for a separate Homeopathic compendium, the HPUS, due to the differences between Homeopathic and Western medicine. Since that time, the HPUS/RS has the same official status as the USP/NF. If a drug appears in both pharmacopoeias, it is subject to the requirements of the USP unless it is distinctly marketed, labeled, and offered for sale as a Homeopathic drug. It would then be subject to HPUS/RS requirements.
The HPUS/RS was first published in 1897 and is currently updated through a Revision Service. The Revision Service is published by the Homeopathic Pharmacopoeia Convention of the United States (HPCUS), a private, not-for-profit organization developed exclusively for charitable, educational, and scientific activities. The HPCUS membership includes pharmacists, physicians, biochemists, botanists and other professionals. The HPCUS has several committees to guide the future direction of Homeopathic medicine.
For a drug to be accepted for inclusion in the HPUS, the HPCUS must determine its safety and efficacy. The drug must be manufactured according to the HPUS/RS requirements. An extensive review of all the available documentation by several committees of the Convention is necessary before a monograph is accepted for publication. The HPCUS then decides at which dilution level the agent should be classified: OTC or prescription. A vast majority of Homeopathic medicines marketed in the United sates are nonprescription, thus confirming their safety.
How are Homeopathic medicines different from herbal remedies?
Many pharmacists associate Homeopathy with herbal and nutritional supplements, which are regulated by the Dietary Supplement and Health Education Act (DSHEA). There are key differences between Homeopathic drugs and dietary supplements. OTC Homeopathic medicines must have a drug claim on the product label for self-limiting, self-diagnosable conditions. This is in contrast to dietary supplements, for which only a structure/function claim can be made. In other words, dietary supplements may not make claims for the diagnosis, relief, cure, or mitigation of symptoms of a given condition or illness. Homeopathic medicines are regulated in the same sense as any other drug; therefore, OTC Homeopathic medicines must have a therapeutic indication on their label and make claims for symptomatic relief.