[Congressional Bills 108th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4004 Introduced in House (IH)]






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 Representatives 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 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, the federal government must be denied 
        authority to deny the public access to health information 
        absent probable 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 supplement health claims.

SEC. 3. AUTHORITY FOR MAKING HEALTH CLAIMS.

    (a) Limitation on Agency Authority to Restrict Distribution.--
Notwithstanding any other provision of Federal law, the Federal 
Government shall have no authority to restrict the distribution of any 
dietary supplement 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 establishing 
        probable cause that the claims contain misleading information 
        posing a threat to the safety and well-being of those who use 
        such product.
    (b) Independent Review of Agency Determination 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 
supplement or other nutritional food contain misleading information 
posing a threat to the safety and well-being of those who use such 
product, such Administration shall, before acting against the product 
carrying the allegedly offensive claims, submit the claims to review 
before an independent 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 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. 5. HEALTH CLAIMS.

    Section 403(r) of the Federal Food, Drug, and Cosmetic 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 
                        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. 6. INDEPENDENT SCIENTIFIC REVIEW.

    Chapter IV of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
341 et seq.) is amended by inserting after section 403C the following 
new section:

``SEC. 403D. INDEPENDENT SCIENTIFIC REVIEW.

    ``(a) Invitations to Participate.--No later than 30 days after the 
date of the enactment of the Health Information Independence Act, 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 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 product. 
        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 determines that a health claim 
meets the criteria established in section 3 of the Health Information 
Independence Act for government approval, including the certifications 
required under subsection (a)(4) of this section, 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.--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 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. 7. LEGAL EFFECT OF HEALTH CLAIM RECOMMENDATION BY INDEPENDENT 
              SCIENTIFIC REVIEWERS.

    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 RECOMMENDATIONS.

    ``(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. 8. 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.

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 supplements)'' after ``articles''.
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