I
107TH CONGRESS
2D SESSION
H. R. 3811
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
FEBRUARY 27, 2002
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; REFERENCE; TABLE OF CON-
TENTS.
(a) SHORT TITLE.—This Act may be cited as the
‘‘Health Information Independence Act of 2001’’.
(b) REFERENCE.—Whenever in this Act an amend-
ment or repeal is expressed in terms of an amendment
to, or repeal of, a section or other provision, the reference
shall be considered to be made to a section or other provi-
sion of the Federal Food, Drug, and Cosmetic Act.
(c) TABLE OF CONTENTS.—The table of contents of
this Act is as follows:
Sec. 1. Short title; reference; table of contents.
Sec. 2. Findings.
Sec. 3. Definitions.
Sec. 4. Health claims.
Sec. 5. Independent scientific review.
Sec. 6. Legal effect of health claim recommendation by Independent Scientific
Reviewers.
Sec. 7. Department of Health and Human Services budget allocation for inde-
pendent scientific reviews.
SEC. 2. FINDINGS.
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, ju-
risdiction over health claims evaluation must be re-
moved from the Food and Drug Administration and
placed in the hands of Independent Scientific Re-
viewers who do not harbor a bias against food and
dietary supplement health claims.
SEC. 3. DEFINITIONS.
Section 201 (21 U.S.C. 321) is amended by adding
at the end the following:
‘‘(kk) 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