All information in this web site is provided for educational purposes only; statements contained here are reported in an effort to preserve traditional cultural lore and information. The ideas expressed here are not intended to and cannot be used to diagnose, prescribe, treat, cure or prevent any disease. The information contained on this web site is not meant to be used for diagnosing, prescribing, treating, curing or preventing any disease or illness. The information contained on this web site has not been evaluated by the Food and Drug Administration (FDA) and is presented for informational purposes only, for use in helping to maintain and promote health in cooperation with a physician. Nothing found anywhere on this web site should be construed as an attempt to diagnose, prescribe or recommend in any manner a treatment, cure or preventative for any health ailment or condition.
Blue Lotus Ayurveda, LLC declares that discussing the structure and function of the body-mind-spirit complex according to the January 2000 FDA’s DSHEA guidelines, when the substance is a food or dietary supplement, makes the online (and constitutionally protected First Amendment free speech) “conversation” between anyone at Blue Lotus Ayurveda, LLC and the person who seeks Ayurvedic food supplement products or services clearly educational, and removes any intent to prescribe for a particular disease or illness.
Blue Lotus Ayurveda, LLC declares to be 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 such dysfunctioning (e.g., hypertension); except that diseases resulting from essential nutrient deficiencies (e.g., scurvy, pellagra) are not included in this definition.”[i]
Hence, we declare that Blue Lotus Ayurveda, LLC and the products and services Blue Lotus Ayurveda , LLC offers “do not diagnose, mitigate, treat, cure, or prevent disease” or illness or symptoms as defined by the FDA and the State of North Carolina. We declare that the products and services 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 a disease, if the adverse events constitute diseases.”[ii]
Blue Lotus Ayurveda, LLC declares its support of the Food and Drug Administration’s DSHEA Act [Dietary Supplement Health and Education Act][i] where it supports our contention that herbs, herbal foods, herbal oils, herbal ghees (clarified butter), vitamins, minerals, and enzymes are food supplements and not medicines or remedies.
Blue Lotus Ayurveda, LLC declares its 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 butter), vitamins, minerals and enzymes, and food or herbal supplements in general, as described in the ancient texts, sutras and scriptures of India, Tibet and China, as well as in regards to the information that is available to the public about vaccinations and other health related issues.
Blue Lotus Ayurveda, LLC declares with respect to all of its products and services 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 of Blue Lotus Ayurveda, LLC is 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.”[i]
Blue Lotus Ayurveda, LLC intends the information contained in this Web site to be accurate and reliable. However, errors may occur. Therefore, Blue Lotus Ayurveda, LLC disclaims any warranty of any kind, whether express or implied, as to any matter whatsoever relating to this web site, including without limitation the merchantability or fitness for any particular purpose.
[i] The FDA’s definition of disease, for purposes of 21 U.S.C. 343r(6). From Sec. 101.93 certain kinds of statements for dietary supplements of the DSHEA: Dietary Supplement Health and Education Act. See Dumoff, Alan, J.D., M.S.W., “Defining ‘Disease’: The Struggle for Turf in Dietary-Supplement Regulation,” Alternative and Complementary Therapies, April 2000 issue, p. 101.
[ii] From Sec. 101.93 certain kinds of statements for dietary supplements of the DSHEA: Dietary Supplement Health and Education Act. See Dumoff, Alan, J.D., M.S.W., “Defining ‘Disease’: The Struggle for Turf in Dietary-Supplement Regulation,” Alternative and Complementary Therapies, April 2000 issue, p. 101.