representations made or suggested by statement,
word, design, device, sound, or any combination
thereof with respect to treatment, including a rep-
resentation made or suggested by a label.
(2) DANGER.—The term ‘‘danger’’ means any
serious negative reaction that—
(A) occurred as a result of a method of
treatment;
(B) would not otherwise have occurred;
and
(C) is more serious than reactions fre-
quently experienced with accepted treatments
for the same or similar health problems.
(3) DEVICE.—The term ‘‘device’’ has the same
meaning given such term in section 201(h) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C.
321(h)).
(4) DRUG.—The term ‘‘drug’’ has the same
meaning given such term in section 201(g)(1) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C.
321(g)(1)).
(5) FOOD.—The term ‘‘food’’ has the same
meaning given such term in section 201(f) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C.
321(f)).
(6) HEALTH CARE PRACTITIONER.—The term
‘‘health care practitioner’’ means any properly li-
censed medical doctor, osteopath, chiropractor, or
naturopath.
(7) LABEL.—The term ‘‘label’’ has the same
meaning given such term in section 201(k) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C.
321(k)).
(8) LEGAL REPRESENTATIVE.—The term ‘‘legal
representative’’ means a parent or an individual who
qualifies as a legal guardian under State law.
(9) 
TREATMENT.—The 
term 
‘‘treatment’’
means the use of any food, drug, device, or proce-
dure.
SEC. 3. ACCESS TO MEDICAL TREATMENT.
(a) IN GENERAL.—Notwithstanding any other provi-
sion of law, and except as provided in subsection (b), an
individual shall be permitted to be treated by a health care
practitioner with any method of medical treatment that
such individual desires or the legal representative of such
individual authorizes if—
(1) such practitioner agrees to treat such indi-
vidual; and
(2) the administration of such treatment falls
within the scope of the practice of such practitioner.
(b) TREATMENT REQUIREMENTS.—A health care
practitioner may provide any method of treatment to an
individual described in subsection (a) if—
(1) there is no evidence that such treatment it-
self, when taken as prescribed, is a danger to such
individual;
(2) in the case of an individual whose treatment
is the administration of a food, drug, or device that
has not been approved by the Food and Drug Ad-
ministration—
(A) such individual has been informed that
such food, drug, or device has not yet been ap-
proved or certified by the Food and Drug Ad-
ministration for use of the medical condition of
such individual; and
(B) such food, drug, or device (or informa-
tion accompanying the administration of such
food, drug, or device) contains the following
warning:
‘‘WARNING: This food, drug, or de-
vice has not been proved safe and effective
by the Federal Government and any indi-
vidual who uses such food, drug, or device,
does so at his or her own risk.’’;
(3) such individual has been informed of the
nature of the treatment, including—
(A) the contents of such treatment;
(B) any reasonably foreseeable side effects
that may result from such treatment; and
(C) the results of past applications of such
treatment by the health care practitioner and
others;
(4) except as provided in subsection (c), there
have been no claims, including advertising and label-
ing claims, made with respect to the efficacy of such
treatment; and
(5) such individual—
(A) has been provided a written statement
that such individual has been fully informed
with respect to the information described in
paragraphs (1) through (4);
(B) desires such treatment; and
(C) signs such statement.
(c) CLAIM EXCEPTIONS.—Subsection (b)(4) shall not
apply to an accurate and truthful reporting by a practi-
tioner of the results of the practitioner’s administration
of a treatment in recognized journals or at seminars, con-
ventions, or similar meetings, if the only financial gain of
such practitioner with respect to such treatment is the
payment received from an individual or representative of
such individual for the administration of such treatment
to such individual.
SEC. 4. REPORTING OF A DANGEROUS TREATMENT.
If a practitioner, after administering such treatment,
discovers that the treatment itself (when taken as pre-
scribed) was a danger to the individual receiving the treat-
ment, the practitioner shall immediately report to the Sec-
retary of Health and Human Services the nature of the
treatment, the results of such treatment, the complete pro-
tocol of such treatment, and the source from which such
treatment or any part thereof was obtained.
SEC. 5. TRANSPORTATION OF MEDICATION AND EQUIP-
MENT.
Notwithstanding any other provision of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 201 et seq.),
a person may introduce or deliver into interstate com-
merce medication or equipment for use in accordance with
this Act.
SEC. 6. RESTRICTIONS ON LICENSING BOARDS.
A licensing board that issues licenses to health care
practitioners may not deny, suspend, or revoke the license
of a health care practitioner solely because such practi-
tioner provides treatment to which section 3 applies.
SEC. 7. PENALTY.
A health care practitioner who violates any provisions
under this Act shall not be covered by the protections
under this Act and shall be subject to all other applicable
laws and regulations.
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