FDA APPROVAL
All material on this web page and web site are copyrighted 2003 - 2008 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 for 1 specific indication. 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, aspirin, it is not necessary to go through the process again if you want to market your own brand. Aspirin 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 aspirin 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 aspirin, for example, on the FDA website either. The FDA has issued regulations regarding aspirin 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 aspirin. 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.
ZymaDerm IS COMPLIANT WITH FDA REGULATIONS
The above letter is provided by a leading national law firm with extensive experience in matters relating to biotechnology and FDA regulations. The letter has been excerpted for brevity. The original letter is on file in the offices of CBR, Inc. If you would like a copy please send the following:
a) Self-addressed stamped envelope to CBR, Inc., ATTN: FDA Compliance, 340 E. Old Saybrook, Boise, ID 83706
b) Name, address, phone, email, social security number, photocopy of driver’s license
c) Letter must be on your business or professional letterhead.
d) Clear detailed statement as to why you are requesting a copy of the letter and to what purpose you intend to put it.
e) The disclaimer below must be re-written on a separate page, signed, dated, and notarized:
“I am requesting a printed copy of the Letter of Compliance found on your web site regarding ZymaDerm and its compliance with FDA regulations regarding Homeopathic Drugs. I agree that the written copy of the letter itself and all of its contents are privileged information and remain the exclusive property of Center for Biomedical Research, Inc. (CBR, Inc.). I understand and expressly agree that the letter copy and its contents may not be used for any purpose other than that for which it is intended; namely documentation that ZymaDerm and only ZymaDerm, is compliant with FDA regulations for Homeopathic Drugs. I expressly agree that this letter is for my own personal informational use only, and I agree that I will not share the information contained there with any person, company, or agency of any kind without the express written permission of CBR, Inc. I understand and agree that any violation of the above terms will subject me to legal prosecution to the fullest extent possible under the law.”