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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