ings, or to others, so long as the reporting practi-
tioner has no direct or indirect financial interest in 
the reporting of the material and has received no fi-
nancial benefits of any kind from the manufacturer, 
distributor, or other seller for such reporting. Such 
reporting may not be used by a manufacturer, dis-
tributor, or other seller to advance the sale of such 
treatment. 
(2) STATEMENTS BY A PRACTITIONER TO A PA-
TIENT.—Subsection (b)(1)(D) shall not apply to any 
statement made by a health care practitioner di-
rectly to a patient or prospective patient. A health 
care practitioner shall not be held liable for any ad-
vertising claims made by others unless the practi-
tioner is a party in the dissemination of the informa-
tion in such claims. 
(3) DIETARY
SUPPLEMENTS
STATEMENT.— 
Subsection (b)(1)(D) shall not apply to statements 
or claims permitted under sections 403B and 
403(r)(6) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 343–2 and 343(r)(6)). 
SEC. 4. REPORTING OF A DANGEROUS MEDICAL TREAT-
MENT. 
(a) HEALTH CARE PRACTITIONER.—If a health care 
practitioner, after administering a medical treatment, dis-
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covers that the treatment itself was a danger to the indi-
vidual receiving such treatment, the practitioner shall— 
(1) immediately cease the use of such treat-
ment; 
(2) refrain from recommending the use of any 
unapproved drug or medical device that was a part 
of such treatment; 
(3) report to the manufacturer and the Director 
of the Centers for Disease Control and Prevention— 
(A) the nature of such treatment; 
(B) the results of such treatment; 
(C) the complete protocol of such treat-
ment; and 
(D) the source from which such treatment 
or any part thereof was obtained; and 
(4) include as part of the reporting under para-
graph (3), an affidavit pursuant to section 1746 of 
title 28, United States Code, confirming that all 
statements made in the report under such paragraph 
are accurate. 
(b) SECRETARY.—Upon confirmation that a medical 
treatment has proven dangerous to individuals, the Sec-
retary shall properly disseminate information with respect 
to the danger of the medical treatment and prohibit the 
further use of such treatment. 
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SEC. 5. REPORTING OF A BENEFICIAL MEDICAL TREAT-
MENT. 
If a health care practitioner, after administering a 
medical treatment that is not an approved drug or medical 
device for a life-threatening medical condition or condi-
tions, discovers that such medical treatment has, in the 
opinion of the health care practitioner, positive effects on 
such condition or conditions that are significantly greater 
than the positive effects that are expected from an ap-
proved medical treatment for the same condition or condi-
tions, the practitioner shall— 
(1) make a monthly reporting to the National 
Center for Complementary and Alternative Medicine 
at the National Institutes of Health of— 
(A) the nature of such medical treatment 
(which is not a conventional medical treatment); 
(B) the general results of such treatment 
administered in the month involved; and 
(C) the protocol of such treatment; and 
(2) provide an affidavit pursuant to section 
1746 of title 28, United States Code, confirming 
that all statements made in the monthly reporting 
under paragraph (1) are accurate and truthful. 
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SEC. 6. TRANSPORTATION AND PRODUCTION OF FOOD, 
DRUGS, DEVICES, AND OTHER EQUIPMENT. 
(a) IN GENERAL.—Notwithstanding any other provi-
sion of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 201 et seq.), an individual may— 
(1) introduce or deliver into interstate com-
merce a food, drug, device, or any other equipment; 
and 
(2) produce, transport, receive and hold a food, 
drug, device, or any other equipment, 
solely for use in accordance with this Act if there have 
been no advertising claims by the manufacturer, dis-
tributor, or seller of the food, drug, device, or equipment 
involved. 
(b) RULE OF CONSTRUCTION.—Nothing in this Act 
shall be construed to limit or interfere with the authority 
of a health care practitioner to prescribe, recommend, pro-
vide, or administer to a patient for any medical condition 
or disease any unapproved drug or medical device that is 
lawful under the law of the State or States in which the 
health care practitioner practices. 
SEC. 7. OTHER LAWS NOT AFFECTED BY THIS ACT. 
Nothing in this Act shall be construed to— 
(1) apply to the manufacturer, distribution, 
possession, or use of any drug that is a controlled 
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substance under the Controlled Substances Act (21 
U.S.C. 801 et seq.); 
(2) apply to statements or claims permitted or 
authorized under sections 403 and 403B of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 343, 
343–2); or 
(3) in any way adversely affect the distribution 
or sale of dietary supplements (as defined in section 
201(ff) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 321(f))). 
SEC. 8. PENALTY. 
A health care practitioner who knowingly violates any 
provision of this Act shall not be covered by the protec-
tions under this Act and shall be subject to all other appli-
cable laws and regulations. 
Æ 
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