[Congressional Bills 107th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3811 Introduced in House (IH)]







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 Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE; REFERENCE; TABLE OF CONTENTS.

    (a) Short Title.--This Act may be cited as the ``Health Information 
Independence Act of 2001''.
    (b) Reference.--Whenever in this Act an amendment 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 provision 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 
                            independent 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 consumer 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 suppression of nutrient-disease 
        information is a violation 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 
        American people.
            (4) The history of the Food and Drug Administration review 
        of nutrient-disease relationships reveals 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 constitutional requirements and 
        the intent of Congress, 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 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 consecutive years as 
        a professor or assistant or associate professor in a department 
        of medicine, biochemistry, epidemiology, pharmacology, 
        pharmacognosy, 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 petitioner;
            ``(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 specified 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 reviewed 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 independent 
        professional judgment, free of any external influence and any 
        unscientific bias that might interfere 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 
                        inserting ``food or dietary supplement 
                        intended''; and
                            (ii) by striking ``food which'' and 
                        inserting ``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 labels 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 disclaimer or 
disclaimers as the Independent Scientific Reviewer may also recommend.
    ``(ii) The duties of the Secretary described in subclause (i) are 
nondelegable and may be discharged only by the Secretary.'';
            (3) by striking subparagraph (4) and redesignating 
        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 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 possess a Ph.D. 
        or an M.D., or both, and have been either a full-time professor 
        or a full-time assistant or associate professor for at least 
        the past 5 consecutive 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 association.
            ``(2) Scientists who qualify to be Independent Scientific 
        Reviewers will be selected at random by the Secretary to review 
        all publicly available scientific evidence on a particular 
        nutrient-disease association, must supply copies of all 
        evidence reviewed to the Secretary, and must supply a written 
        evaluation 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 Reviewer 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 supporting 
                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 support 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, assistant professor, 
                or associate professor in a department of medicine, 
                biochemistry, epidemiology, pharmacology, 
                pharmacognosy, or nutrition at a university that is 
                accredited by an organization 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 
                petitioner;
                    ``(C) you will evaluate any health claim petition 
                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 complete written 
                evaluation of it along with all scientific 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 professional 
                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 result in 
        disbarment from the Independent Scientific Review program and 
disallowance of all compensation for any review undertaken.
    ``(b) Confirmation of Independent Scientific Reviewer Status.--No 
later than 30 days after the Secretary's receipt of a request, 
including the certifications required under subsection (a)(4), from a 
person who seeks to serve as an Independent Scientific Reviewer, the 
Secretary shall notify that person whether he or she satisfies the 
qualification criteria specified in such subsection and is, thereby, 
eligible to be selected to serve as an Independent Scientific Reviewer.
    ``(c) Random Selection of Independent Scientific Reviewer To 
Evaluate Health Claim.--No later than 15 days after a health claim 
petition is filed with the Secretary, the Secretary shall select an 
Independent Scientific Reviewer at random and shall provide that person 
with a complete copy of the health claim petition for evaluation. 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 
evaluation of the health claim.
    ``(d) All Publicly Available Scientific Evidence Shall Be 
Reviewed.--Upon receipt of a health claim petition, the Independent 
Scientific Reviewer shall acquire and evaluate all publicly available 
scientific evidence relevant to the claim. The Independent Scientific 
Reviewer shall determine whether credible scientific evidence supports 
the health claim.
    ``(e) Every Health Claim Shall Be Recommended 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 Reviewer 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 Reviewer finds the 
claim to convey a potentially misleading connotation, the Independent 
Scientific Reviewer shall also recommend that the health claim be 
approved accompanied by a concise disclaimer carefully worded to render 
the claim nonmisleading.
    ``(f) Health Claims Not Recommended for Approval.--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 Reviewer the sum of $40,000 no later than 60 days after the 
Secretary receives all publicly available scientific evidence reviewed 
and a complete evaluation of the health claim. If the Secretary finds 
that the Independent Scientific Reviewer has submitted a false 
certification under subsection (a)(4), the Secretary may debar the 
Independent Scientific Reviewer from the Independent Scientific Review 
program and shall refrain from paying the $40,000 fee.''.

SEC. 6. LEGAL EFFECT OF HEALTH CLAIM RECOMMENDATION BY INDEPENDENT 
              SCIENTIFIC REVIEWERS.

    Chapter IV (21 U.S.C. 341 et seq.), as amended by section 5 of this 
Act, is amended by inserting after section 403D the following new 
section:

             ``legal effect of health claim recommendations

    ``Sec. 403E. (a) Secretary's Response to Health Claim Evaluations 
by Independent Scientific Reviewers.--No later than 30 days after the 
Secretary receives from an Independent Scientific Reviewer copies of 
all publicly available scientific evidence reviewed and a complete 
written evaluation of a health claim, the Secretary shall--
            ``(1) make the evaluation and all scientific evidence 
        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 Independent 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 Recommendations of Independent 
Scientific Reviewers Immediately 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 appeal for review of an order of the 
Secretary pursuant to subsection (a) directly to the United States 
Court of Appeals for the District of Columbia Circuit within 90 days of 
the date of publication of the order in the Federal Register.''.

SEC. 7. DEPARTMENT OF HEALTH AND HUMAN SERVICES BUDGET ALLOCATION FOR 
              INDEPENDENT SCIENTIFIC REVIEWS.

    (a) Costs of Implementation.--All costs associated with 
implementing this Act shall be borne by the Department 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 petitions 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 eliminate 
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.
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