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All information in this web site and retreat are provided for educational purposes only 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 and in retreat sessions is not meant to be used for diagnosing, prescribing, treating, curing or preventing any disease or illness. The information contained on this web site and retreat has not been evaluated by the Food and Drug Administration (FDA) but 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 or during any of the techniques of taught 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.

SpinalAwareness.com declares that discussing the body-mind-spirit complex's structure and function serves to make the online constitutionally protected First Amendment free speech "conversation" between anyone at SpinalAwareness.com and the person who seeks our products or services clearly educational and removes any intent to prescribe for a particular disease or illness.

SpinalAwareness.com 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 SpinalAwareness.com and the products and services SpinalAwarenes.com offers "do not diagnose, mitigate, treat, cure, or prevent disease" or illness or symptoms as defined by the FDA and the State of California. 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]

SpinalAwareness.com 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 SpinalAwareness.com 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]

[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.

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