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Legal Disclaimer
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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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