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. 4. HEALTH CLAIMS.
Section 403(r) (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
(ii) by striking ‘‘or (5)(D)’’;
(2) in subparagraph (3), by amending clause
(B) to read as follows:
‘‘(B)(i) The Secretary shall promulgate no later than
30 days after receiving an evaluation from an Independent
Scientific Reviewer regulations that authorize use on la-
bels and in labeling of all claims of the type described in
subparagraph (1)(B) recommended for approval by the
Independent Scientific Reviewer together with such dis-
claimer or disclaimers as the Independent Scientific Re-
viewer may also recommend.
‘‘(ii) The duties of the Secretary described in sub-
clause (i) are nondelegable and may be discharged only
by the Secretary.’’;
(3) by striking subparagraph (4) and redesig-
nating subparagraph (5) as subparagraph (4); and
(4) in subparagraph (4) (as so redesignated),
by striking clause (D).
SEC. 5. INDEPENDENT SCIENTIFIC REVIEW.
Chapter IV (21 U.S.C. 341 et seq.) is amended by
inserting after section 403C the following new section:
‘‘INDEPENDENT SCIENTIFIC REVIEW
‘‘SEC. 403D. (a) INVITATIONS TO PARTICIPATE.—
No later than 30 days after the date of the enactment
of the Health Information Independence Act of 2001, and
every 180-days thereafter, the Secretary shall send to
every department of medicine, biochemistry, epidemiology,
pharmacology, pharmacognosy, and nutrition at every uni-
versity that is accredited by an organization recognized by
the Secretary of Education a notice and invitation to par-
ticipate, 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 filed with the Food and Drug Administration.
Health claims are statements of nutrient-disease as-
sociation.
‘‘(2) Scientists who qualify to be Independent
Scientific Reviewers will be selected at random by
the Secretary to review all publicly available sci-
entific evidence on a particular nutrient-disease as-
sociation, must supply copies of all evidence reviewed
to the Secretary, and must supply a written evalua-
tion of that evidence and the health claim to the
Secretary no later than 180 days after receipt of the
health claim petition. The Independent Scientific Re-
viewer shall state whether the claim is supported by
scientific evidence and is, therefore, recommended
for approval. The Independent Scientific Reviewer
should only conclude that the health claim is not
supported by scientific evidence, and, therefore, not
recommended for approval, if the reviewer finds—
‘‘(A) no credible scientific evidence sup-
porting the claim; and
‘‘(B) no disclaimer that could accompany
the claim that could eliminate any potentially
misleading connotation conveyed by the claim.
Recommended disclaimers must be accurate and
concise. Disclaimers should reveal the extent of sup-
port for the claim by stating whether evidence in
support of the claim is less than conclusive, e.g.,
that evidence in support of the claim is preliminary
and inconclusive, suggestive but not conclusive, or
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’s receipt of a request, including the certifications
required under subsection (a)(4), from a person who seeks
‘‘(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. 7. 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.
Æ