I 
109TH CONGRESS 
1ST SESSION H. R. 4282 
To amend the Federal Food, Drug, and Cosmetic Act concerning foods 
and dietary supplements, to amend the Federal Trade Commission Act 
concerning the burden of proof in false advertising cases, and for other 
purposes. 
IN THE HOUSE OF REPRESENTATIVES 
NOVEMBER 9, 2005 
Mr. PAUL (for himself, Mr. JONES of North Carolina, Mr. DUNCAN, Mr. 
DEFAZIO, Mr. BARTLETT of Maryland, Mr. BURTON of Indiana, Mr. 
MILLER of Florida, and Mr. BISHOP of Utah) introduced the following 
bill; which was referred to the Committee on Energy and Commerce 
A BILL 
To amend the Federal Food, Drug, and Cosmetic Act con-
cerning foods and dietary supplements, to amend the 
Federal Trade Commission Act concerning the burden 
of proof in false advertising cases, and for other pur-
poses. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Health Freedom Pro-
tection Act’’.
SEC. 2. DEFINITIONS. 
The second sentence of subparagraph (1) of section 
201(g) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 321(g)) is amended by inserting ‘‘including a claim 
to cure, mitigate, treat, or prevent disease,’’ after ‘‘for 
which a claim,’’. 
SEC. 3. MISBRANDED FOOD. 
Section 403(r) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 343(r)) is amended— 
(1) in subparagraph (1)(B), by striking ‘‘to a 
disease or a health-related condition’’ and inserting 
‘‘to the cure, mitigation, treatment, or prevention of 
any disease or any health-related condition’’; 
(2) in subparagraph (2)— 
(A) by amending clause (G) to read as fol-
lows: 
‘‘(G) Publications of the United States 
Government shall not be subject to this sub-
paragraph, subparagraph (3), or subparagraph 
5(D). The Secretary shall take no action under 
this Act to restrict, limit, or impede the reprint-
ing and distribution or sale of any publication 
of the United States Government (including 
ones published by or at the request of any de-
partment, agency, institute, center, or academy 
and including content characterizing the rela-
tionship of any nutrient to the cure, mitigation, 
treatment, or prevention of any disease). The 
Secretary shall not construe the distribution or 
sale of a publication of the United States Gov-
ernment in connection with the sale of a food 
or dietary supplement as evidence of an intent 
to sell that food or dietary supplement as a 
drug.’’; and 
(B) by amending clause (H) to read as fol-
lows: 
‘‘(H) Accurate quotations from a publica-
tion of the United States Government referred 
to in clause (G) shall not be subject to this sub-
paragraph, subparagraph (3), or subparagraph 
5(D). The Secretary shall take no action under 
this Act to restrict, limit, or impede the use of 
accurate quotations from a United States Gov-
ernment publication that characterize the rela-
tionship of any nutrient to the cure, mitigation, 
treatment, or prevention of any disease. The 
Secretary shall not construe accurate quotations 
from a United States Government publication 
used in connection with the sale of a food or di-
etary supplement as evidence of an intent to
sell that food or dietary supplement as a 
drug.’’; 
(3) in subparagraph (3), by adding at the end 
the following: 
‘‘(E) The Secretary shall allow with rea-
sonable and concise disclaimers not to exceed 
three sentences claims of the type described in 
subparagraph (1)(B) not authorized under this 
subparagraph or subparagraph (5)(D) unless 
the Secretary determines that— 
‘‘(i) there is no scientific evidence that 
supports the claim; and 
‘‘(ii) the claim is inherently mis-
leading and incapable of being rendered 
nonmisleading through the addition of a 
disclaimer. 
The Secretary shall not use tests of consumer 
perception of product health benefits as a basis 
for a determination under subclause (ii). The 
Secretary shall bear the burden of proof by 
clear and convincing evidence on each element 
of this clause. 
‘‘(F) The Secretary shall not exclude stud-
ies concerning the treatment effects of nutrients 
on disease from the evaluation of any health
claims under this subparagraph or subpara-
graph (1)(B) or (5)(D). 
‘‘(G) Notwithstanding any other provision 
of law, a member of an advisory committee 
under this Act may not, with respect to service 
on a committee evaluating a claim of the type 
described in subparagraph (1)(B), be granted 
an exemption under section 208(b) of title 18, 
United States Code (relating to personal finan-
cial interests). 
‘‘(H) Notwithstanding any prior decisions 
of the Secretary concerning the relationship of 
saw palmetto to benign prostatic hyperplasia, 
the relationship of omega-3 fatty acids and cor-
onary heart disease, the relationship of omega- 
3 fatty acids and sudden death heart attack, 
the relationship of glucosamine or chondroitin 
sulfate and osteoarthritis, or the relationship of 
calcium and bone fractures, the following health 
claims are authorized for use on labels and in 
the labeling of all foods and dietary supple-
ments containing those nutrients: 
‘‘(i) Saw Palmetto may improve urine 
flow, reduce nocturia and reduce voiding
urgency associated with mild benign pros-
tatic hyperplasia (an enlarged prostate). 
‘‘(ii) Omega-3 Fatty Acids may re-
duce the risk of coronary heart disease. 
‘‘(iii) Omega-3 Fatty Acids may re-
duce the risk of sudden death heart attack. 
‘‘(iv) Glucosamine may reduce joint 
stiffness and pain associated with osteo-
arthritis. 
‘‘(v) Chondroitin Sulfate may reduce 
joint stiffness and pain associated with os-
teoarthritis. 
‘‘(vi) Glucosamine and Chondroitin 
Sulfate may reduce joint stiffness and pain 
associated with osteoarthritis. 
‘‘(vii) Calcium may reduce the risk of 
bone fractures.’’; 
(4) in subclause (i) of subparagraph (4)(A)— 
(A) in the first sentence, by striking ‘‘or 
(3)(B)’’ and inserting ‘‘, (3)(B), or (3)(E)’’; 
and 
(B) by striking ‘‘Not later than 100 days’’ 
and all that follows through the end of sub-
clause (i) and inserting ‘‘The Secretary shall 
promulgate regulations authorizing or denying