I 
108TH CONGRESS 
2D SESSION 
H. R. 4004
To amend the Federal Food, Drug, and Cosmetic Act to establish a system 
independent of the Food and Drug Administration for the review of 
health claims, to define health claims, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
MARCH 18, 2004
Mr. PAUL 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 to 
establish a system independent of the Food and Drug 
Administration for the review of health claims, to define 
health claims, and for other purposes.
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 Information 
Independence Act’’. 
SEC. 2. FINDINGS. 
The Congress finds as follows:
(1) Access to accurate information at the point 
of sale concerning the effect of nutrients on disease 
is indispensable to the exercise of informed con-
sumer choice in the marketplace and to the health 
and welfare of the American people. 
(2) In 1999, 2000, and 2001, Federal courts 
have held that Food and Drug Administration sup-
pression of nutrient-disease information is a viola-
tion of the First Amendment to the United States 
Constitution. 
(3) Despite those holdings and despite the 
courts’ orders, the Food and Drug Administration 
continues to suppress nutrient-disease information 
that could improve public health, reduce the costs of 
health care, and promote the welfare of the Amer-
ican people. 
(4) The history of the Food and Drug Adminis-
tration review of nutrient-disease relationships re-
veals a strong and unscientific bias against food and 
dietary supplement health claims in direct violation 
of the constitutional mandates of Federal courts and 
the intent of Congress. 
(5) The Food and Drug Administration favors 
suppression of health claims over disclosure, despite
court imposed constitutional requirements to the 
contrary. 
(6) To ensure that health claims are evaluated 
rationally, fairly, and in compliance with constitu-
tional requirements and the intent of Congress, the 
federal government must be denied authority to deny 
the public access to health information absent prob-
able cause that the claims are untrue, misleading or 
pose a danger to human health and jurisdiction over 
health claims evaluation must be removed from the 
Food and Drug Administration and placed in the 
hands of Independent Scientific Reviewers who do 
not harbor a bias against food and dietary supple-
ment health claims. 
SEC. 3. AUTHORITY FOR MAKING HEALTH CLAIMS. 
(a) LIMITATION
ON AGENCY AUTHORITY
TO RE-
STRICT DISTRIBUTION.—Notwithstanding any other pro-
vision of Federal law, the Federal Government shall have 
no authority to restrict the distribution of any dietary sup-
plement or other nutritional food on the basis that the 
manufacturer is making health claims unapproved by the 
Food and Drug Administration if—
(1) the product has a label clearly stating that 
its health claims are not FDA approved; and
(2) such Administration lacks evidence estab-
lishing probable cause that the claims contain mis-
leading information posing a threat to the safety and 
well-being of those who use such product. 
(b) INDEPENDENT REVIEW OF AGENCY DETERMINA-
TION OF EXISTENCE OF PROBABLE CAUSE.—In the event 
that the Food and Drug Administration determines that 
there is probable cause that the claims for a dietary sup-
plement or other nutritional food contain misleading infor-
mation posing a threat to the safety and well-being of 
those who use such product, such Administration shall, be-
fore acting against the product carrying the allegedly of-
fensive claims, submit the claims to review before an inde-
pendent review board as described in the following sections 
of this Act. 
SEC. 4. DEFINITIONS. 
Section 201 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 321) is amended by adding at the end the 
following: 
‘‘(nn) The term ‘Independent Scientific Reviewer’ 
means a person who—
‘‘(1) holds a Ph.D., an M.D., or both, and has 
been employed full-time for at least the past 5 con-
secutive years as a professor or assistant or asso-
ciate professor in a department of medicine, bio-
chemistry, epidemiology, pharmacology, pharmacog-
nosy, or nutrition at a university that is accredited 
by an organization recognized by the Department of 
Education of the United States; 
‘‘(2) has never been employed by, and has never 
been contracted to do work for, the Food and Drug 
Administration or any other agency or office of the 
Department of Health and Human Services (except 
to review health claim petitions under section 
403D); 
‘‘(3) has never been employed by, and has never 
been contracted to do work for, the health claim pe-
titioner; 
‘‘(4) signs an oath pledging to evaluate the 
health claim petition provided to him or her by the 
Secretary in strict accordance with the criteria speci-
fied in section 403D; 
‘‘(5) signs an oath pledging not to discuss with 
any person the fact that he or she is reviewing the 
health claim petition or the substance of the petition 
or the substance of the evaluation before the results 
of the scientific review are supplied in a complete 
written evaluation to the Secretary; 
‘‘(6) signs an oath pledging to supply complete 
copies of all publicly available scientific evidence re-
viewed along with a complete written evaluation of 
the health claim to the Secretary no later than 180 
days after receipt of the health claim petition from 
the Secretary; and 
‘‘(7) signs an oath pledging to exercise inde-
pendent professional judgment, free of any external 
influence and any unscientific bias that might inter-
fere with the objective evaluation of the health 
claim.’’. 
SEC. 5. HEALTH CLAIMS. 
Section 403(r) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 343(r)) is amended—
(1) in subparagraph (1)—
(A) in the matter preceding clause (A)—
(i) by striking ‘‘food intended’’ and in-
serting ‘‘food or dietary supplement in-
tended’’; and 
(ii) by striking ‘‘food which’’ and in-
serting 
‘‘food 
or 
dietary 
supplement 
which’’; and 
(B) in clause (B)—
(i) by inserting after ‘‘health-related 
condition’’ the following: ‘‘(including any 
statement that the nutrient prevents, 
treats, or cures a disease)’’; and
formation Independence Act, and every 180-days there-
after, the Secretary shall send to every department of 
medicine, 
biochemistry, 
epidemiology, 
pharmacology, 
pharmacognosy, and nutrition at every university that is 
accredited by an organization recognized by the Secretary 
of Education a notice and invitation to participate, stating 
the following: 
‘‘(1) Scientists employed by the university in its 
departments of medicine, biochemistry, epidemiology, 
pharmacology, pharmacognosy, or nutrition who pos-
sess a Ph.D. or an M.D., or both, and have been ei-
ther a full-time professor or a full-time assistant or 
associate professor for at least the past 5 consecu-
tive years are invited to apply to the Secretary to be 
Independent Scientific Reviewers in assessing health 
claims made without a label clearing stating its 
health claims are not approved by the Food and 
Drug Administration or such Administration has 
evidence establishing probable cause that the claims 
contain misleading information posing a threat to 
the safety and well-being of those who use the prod-
uct. Health claims are statements of nutrient-disease 
association. 
‘‘(2) Scientists who qualify to be Independent 
Scientific Reviewers will be selected at random by
generally accepted but not yet proven to a conclusive 
degree. 
‘‘(3) Independent Scientific Reviewers must 
complete their reviews within 180 days of receipt of 
a health claim petition from the Secretary. 
‘‘(4) To qualify to be an Independent Scientific 
Reviewer you must certify in writing under penalty 
of perjury that—
‘‘(A) you hold a Ph.D., an M.D., or both, 
and have been employed full-time for at least 
the past 5 consecutive years as a professor, as-
sistant professor, or associate professor in a de-
partment of medicine, biochemistry, epidemi-
ology, pharmacology, pharmacognosy, or nutri-
tion at a university that is accredited by an or-
ganization recognized by the Department of 
Education of the United States; 
‘‘(B) you have never been employed by, 
and have never been contracted to do work for, 
the Food and Drug Administration or any other 
agency or office of the Department of Health 
and Human Services (except to review health 
claim petitions) or for the health claim peti-
tioner;
‘‘(C) you will evaluate any health claim pe-
tition submitted to you in strict accordance with 
the criteria specified in section 403D; 
‘‘(D) you will not discuss with any person 
the fact that you are reviewing the health claim 
petition or the substance of the petition or the 
substance of the evaluation before you submit a 
complete written evaluation of the health claim 
to the Secretary; 
‘‘(E) you will complete your review of the 
health claim petition and will supply your com-
plete written evaluation of it along with all sci-
entific evidence reviewed to the Secretary no 
later than 180 days after receipt of the health 
claim petition from the Secretary; and 
‘‘(F) you will exercise independent profes-
sional judgment, free of any external influence 
and any unscientific bias that might interfere 
with the objective evaluation of the health 
claim. 
‘‘(5) Failure to abide by the above rules will re-
sult in disbarment from the Independent Scientific 
Review program and disallowance of all compensa-
tion for any review undertaken.
‘‘(b) CONFIRMATION OF INDEPENDENT SCIENTIFIC 
REVIEWER STATUS.—No later than 30 days after the Sec-
retary determines that a health claim meets the criteria 
established in section 3 of the Health Information Inde-
pendence Act for government approval, including the cer-
tifications required under subsection (a)(4) of this section, 
from a person who seeks to serve as an Independent Sci-
entific Reviewer, the Secretary shall notify that person 
whether he or she satisfies the qualification criteria speci-
fied in such subsection and is, thereby, eligible to be se-
lected to serve as an Independent Scientific Reviewer. 
‘‘(c) RANDOM SELECTION OF INDEPENDENT SCI-
ENTIFIC REVIEWER TO EVALUATE HEALTH CLAIM.—Not 
later than 15 days after the Secretary determines that a 
health claim meets the criteria established in section 3 of 
the Health Information Independence Act for government 
approval, the Secretary shall select an Independent Sci-
entific Reviewer at random and shall provide that person 
with a complete copy of the health claim petition for eval-
uation. The Secretary shall not reveal the name of the 
Independent Scientific Reviewer to the public or to the 
health claim petitioner until after the Secretary receives 
from the Independent Scientific Reviewer all publicly 
available scientific evidence reviewed and a complete eval-
uation of the health claim.
‘‘(d) ALL PUBLICLY AVAILABLE SCIENTIFIC EVI-
DENCE SHALL BE REVIEWED.—Upon receipt of a health 
claim petition, the Independent Scientific Reviewer shall 
acquire and evaluate all publicly available scientific evi-
dence relevant to the claim. The Independent Scientific 
Reviewer shall determine whether credible scientific evi-
dence supports the health claim. 
‘‘(e) EVERY
HEALTH
CLAIM
SHALL
BE
REC-
OMMENDED
FOR APPROVAL THAT IS SUPPORTED
BY 
CREDIBLE SCIENTIFIC EVIDENCE.—If the Independent 
Scientific Reviewer finds that credible scientific evidence 
supports the health claim, the Independent Scientific Re-
viewer shall recommend to the Secretary that the health 
claim be approved. If the Independent Scientific Reviewer 
finds the scientific evidence in support of the claim less 
than conclusive, suggestive but not conclusive, preliminary 
and inconclusive, or generally accepted but not yet proven 
to a conclusive degree, or if the Independent Scientific Re-
viewer finds the claim to convey a potentially misleading 
connotation, the Independent Scientific Reviewer shall 
also recommend that the health claim be approved accom-
panied by a concise disclaimer carefully worded to render 
the claim nonmisleading. 
‘‘(f) HEALTH CLAIMS NOT RECOMMENDED FOR AP-
PROVAL.—If the Independent Scientific Reviewer finds
that no credible scientific evidence supports the health 
claim and that no disclaimer can eliminate a misleading 
connotation conveyed by the claim, then the Independent 
Scientific Reviewer shall recommend that the Secretary 
not approve the health claim. 
‘‘(g) COMPENSATION FOR INDEPENDENT SCIENTIFIC 
REVIEWERS
AND SANCTIONS
FOR NONCOMPLIANCE.—
The Secretary shall pay each Independent Scientific Re-
viewer the sum of $40,000 no later than 60 days after 
the Secretary receives all publicly available scientific evi-
dence reviewed and a complete evaluation of the health 
claim. If the Secretary finds that the Independent Sci-
entific Reviewer has submitted a false certification under 
subsection (a)(4), the Secretary may debar the Inde-
pendent Scientific Reviewer from the Independent Sci-
entific Review program and shall refrain from paying the 
$40,000 fee.’’. 
SEC. 7. LEGAL EFFECT OF HEALTH CLAIM RECOMMENDA-
TION BY INDEPENDENT SCIENTIFIC REVIEW-
ERS. 
Chapter IV of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 341 et seq.), as amended by section 6 of 
this Act, is amended by inserting after section 403D the 
following new section:
‘‘SEC. 403E. LEGAL EFFECT OF HEALTH CLAIM REC-
OMMENDATIONS. 
‘‘(a) SECRETARY’S RESPONSE TO HEALTH CLAIM 
EVALUATIONS
BY INDEPENDENT SCIENTIFIC REVIEW-
ERS.—No later than 30 days after the Secretary receives 
from an Independent Scientific Reviewer copies of all pub-
licly available scientific evidence reviewed and a complete 
written evaluation of a health claim, the Secretary shall—
‘‘(1) make the evaluation and all scientific evi-
dence reviewed publicly available; and 
‘‘(2) publish in the Federal Register as a final 
and binding order of the Department of Health and 
Human Services the recommendation of the Inde-
pendent Scientific Reviewer verbatim and without 
any alteration in content whatsoever, including the 
claim, whether the claim is approved or disapproved, 
the reasons therefor, and whether the claim must be 
accompanied by a disclaimer and the content of the 
disclaimer, and the reasons therefor. 
‘‘(b) ORDER
ON HEALTH CLAIMS RECOMMENDA-
TIONS OF INDEPENDENT SCIENTIFIC REVIEWERS IMME-
DIATELY APPEALABLE TO THE UNITED STATES COURT 
OF APPEALS FOR THE D.C. CIRCUIT.—Any health claim 
petitioner, or any other aggrieved party, may file an ap-
peal for review of an order of the Secretary pursuant to 
subsection (a) directly to the United States Court of Ap-
peals for the District of Columbia Circuit within 90 days 
of the date of publication of the order in the Federal Reg-
ister.’’. 
SEC. 8. DEPARTMENT OF HEALTH AND HUMAN SERVICES 
BUDGET ALLOCATION FOR INDEPENDENT 
SCIENTIFIC REVIEWS. 
(a) COSTS OF IMPLEMENTATION.—All costs associ-
ated with implementing this Act shall be borne by the De-
partment of Health and Human Services from its existing 
budget. 
(b) OFFSETS.—This Act eliminates the need for the 
Food and Drug Administration to review health claim pe-
titions for foods and dietary supplements. No later than 
six months after the date of the enactment of this Act, 
the Secretary of Health and Human Services shall elimi-
nate staff, reduce operating expenses, and maximize cost 
savings in the Food and Drug Administration’s Center for 
Food Safety and Applied Nutrition to offset the costs of 
implementing this Act. 
SEC. 9. DEFINITION REGARDING DISTINCTION BETWEEN 
FOOD AND DRUGS. 
Section 201(g)(1) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 321(g)(1)) is amended in clause
(B) by inserting ‘‘(other than food, including dietary sup-
plements)’’ after ‘‘articles’’.
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