Disclaimer and General Release from Liability
Signing this agreement and beginning Pancha Karma or other Ayurvedic Consultations or Programs signals your agreement to the terms listed and detailed in this disclaimer.
- Information presented by the Yogic Medicine Institute(hereby referred to as YMI) is based on Ayurvedic principles practiced for thousands of years, though the information should not be taken or construed as standard medical diagnosis or treatment. For any medical condition, always consult with a qualified physician. Neither Derrick Pawo, nor the YMI representatives nor the YMI Staff, nor their employees, nor their authors shall be held responsible in any way for problems encountered by the use of the products, substances and procedures mentioned in any information presented. Nothing (information, products, consultations, therapies) presented by this organization or by the products is intended to diagnose, mitigate, prescribe, treat, cure or prevent any disease or illness or symptoms as defined by the FDA and the State of California. We declare that the information, products, therapy given or mentioned is neither intended to augment any particular medical therapy or medical drug action nor is any information given intended to diagnose, mitigate, treat, cure, or prevent a disease or class of diseases, illnesses, or symptoms, nor do we treat, prevent, or mitigate adverse events associated with a therapy for a disease, if the adverse events constitute diseases. YMI and its projects declare with respect to all of the products it sells or offers to the public that “The evidence in support of the claims of the products and therapies and advice given is inconclusive and the statements presented have not been evaluated by the Food and Drug Administration. This product or service or consultation is not intended to diagnose, treat, cure, or prevent any disease.”
YMI and our representatives claim the right to constitutionally protected free speech. YMI claims our constitutionally protected religious right to the sacerdotal or spiritual administration of, use of, growth of, harvest of, production of, procurement of, import of, export of, development of, refinement of, study of, formulation of, concoction of, decoction of, powdering of, tincture of, tea-making of, capsulation of, ingestion of, smoking of, gift of, offering of, non-profit sale of, education on, or spiritual recommendation of (spiritual counseling) by our Ayurvedic Practitioners to any of our congregation and to others who freely seek our healing items, services and publications (or by our congregation members to each other or to others who seek our services) of any Tibetan, Nepali and Indian herbs, minerals, metals, mineral herbal bhasma compounds, foods, oils, ghees (clarified herbal butter), vitamins, minerals, and enzymes as spiritual sattvic (“more pure than kosher”) food supplements (see the Food and Drug Administration’s [FDA] DSHEA Act [Dietary Supplement
Health and Education Act ]1) are an integral part of our ancient religious tenets, beliefs, doctrines and practices (as described in the ancient Holy Scriptures cited in our constitution and as taught by the Practitioners, Siddhas, Buddhas, Bodhisattvas, Lineage Holders and Healers of our tradition, and are hence, constitutionally protected religious tenets, beliefs, doctrines and practices. YMI declares that any governmental (federal, FDA, state, or local) or private attempts to seize, confiscate, appropriate, impound, or commandeer in any way the above declared herbs, minerals, metals, mineral herbal bhasma compounds, foods, oils, ghees (clarified herbal butter), vitamins or minerals (which may be the property of the Church, its congregation, Lineage Holders, Practitioners, or other members) or the Bureau for Private Postsecondary and Vocational Education attempt to regulate such above described religious educational practices is in violation of our now declared First, Fourth, Sixth and Ninth Amendment Constitutional rights. We declare that any governmental (federal, FDA, state or local) or private attempts to monitor, restrict, regulate, police, standardize, enforce licensing of, illegalize, oppress, suppress, limit, curb, check or control the above declared utilization or education of such sacred herbs, minerals, metals, mineral herbal bhasma compounds, foods, oils, ghees (clarified herbal butter), vitamins or minerals is in violation of our now formally declared First, Fourth, Sixth and Ninth Amendment Constitutional rights 2 We declare, all rights reserved without prejudice.
- YMI and their projects declare that discussing the body-mind-spirit complex’s structure and functioning according to the January 2000 FDA DSHEA guidelines, when the substance of food or dietary supplement, serves to make the constitutionally protected First Amendment free speech “conversation” between the MSB/YMI, Ayurveda Department and the person who seeks our food supplement products clearly educational and removes any intent to prescribe for a particular disease or illness.
- YMI and their projects declare that we are aware of the FDA’s definition of disease, which is “damage to an organ, part, structure or system of the body such that it does not function properly (e.g. cardiovascular disease), or a state of health leading to dysfunction, (e.g. hypertension); except that diseases resulting from essential nutrient deficiencies (e.g. scurvy, pellagra) are not included in this definition.” Hence, we declare that YMI and their projects and our products and services “do not diagnose, mitigate, treat, cure, or prevent disease”, or illnesses or symptoms as defined by the FDA and the State of California. We declare that the services and products we offer do not “augment a particular therapy or drug action that is intended to diagnose, mitigate, treat, cure, or prevent a disease or class of diseases,” illnesses or symptoms, nor do we “treat, prevent, or mitigate adverse events associated with a therapy for disease, if the adverse events constitute disease.”
- YMI and their projects declare our support of the Food and Drug Administration’s DSHEA Act (Dietary Supplement Health and Education Act) where it supports our contention that herbs, herbal foods, herbal oils, herbal ghees (clarified herbal butter), vitamins, minerals and enzymes are food supplements and neither medicines or remedies.
- YMI and their projects declare our First Amendment Right to free public and private speech (written or oral) regarding the traditional uses of herbs, herbal foods, herbal oils, herbal ghees (clarified herbal butter), vitamins, minerals and enzymes as described in the ancient texts, sutras and scriptures of India, Tibet, China and Nepal.
-The Yogic Medicine Institute declares with respect to all of its products sold or offered to the public that “The evidence in
support of this claim is inconclusive and this statement has not been evaluated by the Food and Drug Administration. This product or service is not intended to diagnose, treat, cure, or prevent any disease.”
- This declaration by YMI and their projects are based on our understanding of the precedent set by the successful “challenge before the U.S. Court of Appeals for the District of Columbia Circuit in Pearson v. Shalala, 164 F. 3d 650 (D.C. Cir 1999), ruled that the agency “(the FDA)” must permit health claims that do not satisfy the ‘significant scientific agreement’ standard as long as the claim can be rendered non-misleading by requiring a disclaimer. The Court examined possible disclaimers in some detail, and suggested that the FDA concerns regarding misleading information could, under many circumstances, be addressed by a disclaimer as simple as “the evidence in support of this claim is inconclusive”. The Court also ruled that the FDA’s unwillingness to define ‘significant scientific agreement’ was a violation of the Administrative Procedures Act, in that the agency did not provide a clear standard that notified manufacturers of the FDA’s requirements, nor did it create a sufficiently clear standard upon which the FDA’s determinations could be reviewed. Comments on the proposed rule argued in light of Pearson that the FDA may not issue a final rule that prohibits disease claims but rather must choose the less restrictive alternative of permitting such claims, provided that they are accompanied with disclaimers.”