FDA APPROVAL:
All material on this web page and web site are copyrighted 2003 - 2011 and protected by law. ZymaDerm is patented. Any infringement of this copyright, trademark, or patent will result in prosecution to the fullest extent possible under the law.
ZymaDerm is compliant with FDA regulations regarding homeopathic remedies as set forth in the Federal Register and as listed in the Homeopathic Pharmacopeia of the United States (HPUS). The HPUS is declared a legal source of information on drug products as an “official compendium” in the Federal Food, Drug, and Cosmetic Act (SEC. 201. (j) of the Act 21 U.S.C. §321). The Federal Food, Drug, and Cosmetic Act deems articles listed in the Homeopathic Pharmacopoeia of the United States as “drugs” and recognizes HPUS as the official compendium of standards for source, composition, and preparation of homeopathic products.
1) What is FDA approval?
FDA approval is the official recognition by the FDA that a drug has undergone clinical testing. This generally involves years of testing and can cost millions of dollars. This is what the large pharmaceutical companies all aim for. FDA approval is required for a new drug. If a drug has already undergone testing and had FDA approval, for example, acetaminophen (Tylenol™), , it is not necessary to go through the process again if you want to market your own brand. Acetaminophen is an FDA approved pain reliever. So if you market your own brand and make it according to the rules set forth in a set of regulations called The OTC Monograph System, you can state that your acetaminophen brand is an FDA approved pain reliever. One needs only to comply with already existing FDA regulations. In the case of ZymaDerm the regulations would be those applicable to homeopathic drugs. A set of regulations equivalent to the Monograph System exists for Homeopathic Drugs, where the FDA recognizes as authoritative the Homeopathic Pharmacopeia of the United States (HPUS). A therapeutic agent that complies with the OTC Monograph System for pharmaceuticals, or the HPUS system for OTC homeopathic drugs, is considered FDA compliant and FDA approved for the indications listed either in the Monograph System for non-homeopathic drugs, or for the indications listed in the HPUS for Homeopathic Drugs. ZymaDerm is FDA approved as a Homeopathic Drug as documented in the legal opinion excerpted below from a leading national law firm specializing in patent law, biotechnology issues, and FDA compliance issues.
1) Why Can't I Find ZymaDerm on the FDA Web Site?
No, and you won't find Albertson's brand of acetaminophen (Tylenol™), for example, on the FDA website either. The FDA has issued regulations regarding acetaminophen and as long as a company complies with the listed regulations, they needn't re-apply for approval. Nor will the FDA keep track of their specific brand of acetaminophen. Likewise with homeopathic preparations. As long as the formulation contains those active ingredients listed in the Homeopathic Pharmacopeia of the United States, the FDA has already issued regulations authorizing approval of those ingredients and will not track, or list, every individual homeopathic prepaparation. That is why you will not find ZymaDerm on the FDA website.
The letter below is provided by a leading national law firm with extensive experience in matters relating to biotechnology and FDA regulations. The original letter is on file in the offices of Naturopathix, Inc.
