[Congressional Bills 106th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3001 Introduced in House (IH)]







106th CONGRESS
  1st Session
                                H. R. 3001

 To amend the Federal Food, Drug, and Cosmetic Act to promote clinical 
  research and development on dietary supplements and foods for their 
 health benefits; to establish a new legal classification for dietary 
  supplements and foods with health benefits, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                            October 1, 1999

 Mr. Pallone introduced the following bill; which was referred to the 
    Committee on Commerce, and in addition to the Committee on the 
 Judiciary, for a period to be subsequently determined by the Speaker, 
 in each case for consideration of such provisions as fall within the 
                jurisdiction of the committee concerned

_______________________________________________________________________

                                 A BILL


 
 To amend the Federal Food, Drug, and Cosmetic Act to promote clinical 
  research and development on dietary supplements and foods for their 
 health benefits; to establish a new legal classification for dietary 
  supplements and foods with health benefits, 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 AND REFERENCE.

    (a) Short Title.--This Act may be cited as the ``Nutraceutical 
Research and Education Act''.
    (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.

SEC. 2. FINDINGS AND STATEMENT OF PURPOSE.

    (a) Findings.--The Congress finds the following:
            (1) Consumers spend annually an estimated $12,000,000,000 
        on dietary supplements and billions more on medical and similar 
        foods. Nevertheless, the health benefits of these products have 
        not, in most cases, been demonstrated by clinical testing or 
        other means. In consequence, specific health claims may not be 
        advanced for them. Consumers are thus left uncertain as to the 
        value of these products in promoting health and well-being, and 
        preventing or reducing the risk of disease, including the 
        management of a disease or condition. The companies that 
        produce these products desire to provide them to consumers with 
        specific health claims based on clinical testing. The Federal 
        Government demands sound scientific evidence of safety and 
        effectiveness in order to fulfill its statutory mandate to 
        protect and promote the public health.
            (2) Because dietary supplements and similar foods are 
        natural products widely available without a strong proprietary 
        position, a person who now finances the cost of research 
        successfully demonstrating the health benefits of such a 
        product receives no special economic benefit in the marketplace 
        to repay that cost. Others, who have not contributed to those 
        research costs, may nevertheless embrace the findings of that 
        research to support identical claims for their own versions of 
        the product. Without economic incentive to research and develop 
        new products, those who would finance the cost of research are 
        presently focusing their efforts on promotional activities to 
        the disservice of the public interest and health.
            (3) It is in the national interest to encourage clinical 
        research into the health benefits of dietary supplements, 
        medical foods, and other foods.
            (4) Current regulatory and epistemological chaos exists 
        with regard to health claims for foods, dietary supplement, and 
        medical foods. It is in the national interest to provide a 
        category of products that have recognized health benefits but 
        are not drugs and to recognize that these products are safe 
        when used as indicated on their labeling.
            (5) It is necessary to promote research into the health 
        benefits of dietary supplements, medical foods, and other foods 
        and to require that these health benefits be established by the 
        results of clinical studies.
            (6) It is necessary to establish a regulatory system within 
        the Food and Drug Administration for reviewing health claims of 
        health benefits of such products which is less burdensome than 
        the traditional regulatory scheme for drugs and to stimulate 
        the industry to devote resources to proving the health claims 
        anticipated under this Act since such claims relate to the 
        possibility of preventing or reducing the risk of disease, 
        including the management of a disease or health condition.
            (7) It is necessary to update the present regulatory scheme 
        to reflect the fact that such products can safely prevent 
        disease and health conditions, manage or improve health, or 
        reduce the risk of disease.
    (b) Statement of Purpose.--It is the purpose of this Act to--
            (1) promote research into the health benefits of dietary 
        supplements, medical foods, and other foods;
            (2) establish a simplified process within the Food and Drug 
        Administration for reviewing, on a case by case method, health 
        claims of health benefits of such nutraceutical products made 
        under a petition under section 403(r)(4) of the Federal Food, 
        Drug, and Cosmetic Act (21 U.S.C. 343(r)(3));
            (3) prescribe a period of exclusive marketing protection 
        for a person that demonstrates the health benefits of a dietary 
        supplement, medical food, or other food, and who markets such 
        product in association with approved labeling that describes 
        its contribution to human health; and
            (4) confirm the health benefits of these products as 
        determined by clinical trials, and disseminate this information 
        to the public and the health care profession, so that the 
        public and the health care profession may integrate this 
        knowledge into practice.

SEC. 3. DEFINITIONS.

    Section 201 (21 U.S.C 321) is amended by adding at the end the 
following:
    ``(kk) The term `nutraceutical' means a dietary supplement, food, 
or medical food, as respectively defined in paragraphs (f) and (ff) and 
section 5(b)(3) of the Orphan Drug Act (21 U.S.C. 360ee(b)(3)), that--
                    ``(1) possesses health benefits; and
                    ``(2) is safe for human consumption in such 
                quantity, and with such frequency, as required to 
                realize such properties.
    ``(ll) The term `health benefit', when used with reference to a 
nutraceutical, means a benefit which prevents or reduces the risk of a 
disease or health condition, including the management of a disease or 
health condition or the improvement of health.

SEC. 4. HEALTH CLAIMS.

    (a) Nutraceutical Health Claim.--Section 403(r)(5)(D) (21 U.S.C. 
343(r)(5)(D)) is amended by inserting before the period the following: 
``except that in the case of a claim made with respect to a 
nutraceutical, the regulation shall be issued by the Secretary under 
subparagraph (4)(D)''.
    (b) Petition.--Section 403(r)(4) (21 U.S.C. 343(r)(4)) is amended 
by adding at the end the following:
    ``(D)(i) Any person may file a petition with the Secretary to issue 
a regulation relating to a claim for a nutraceutical described in 
subparagraph (5)(D).
    ``(ii) A petition filed under subclause (i) shall be prepared in 
such form, and submitted in such manner, as the Secretary may 
prescribe, and, with respect to the product sought to be introduced as 
a nutraceutical, shall contain the following:
            ``(I) A report of at least 1 clinical trial which has been 
        conducted on the product which is the subject of the petition. 
        Such clinical trial results shall address the potential health 
        benefits of the product and its safety. The results of the 
        clinical trial must demonstrate and characterize the beneficial 
        relationship or the significance of the relationship of the 
        nutraceutical in such product to a disease or its affects on a 
        health related condition, health problem, or health status. The 
        clinical trial must have a sufficient size to prove the 
        benefits and may have as its endpoints either surrogate markers 
        or clinical endpoints to support the claim. The application may 
        also include epidemiological or preclinical studies in support 
        of the clinical trial. The amount of evidence necessary to 
        sustain a claim will be determined by the Secretary on a case 
        by case basis.
            ``(II) Evidence that it is safe for human consumption in 
        such quantity, and with such frequency, as required to provide 
        the health benefits.
            ``(III) A complete description, in the case of a processed 
        product, as to its ingredients or chemical composition.
            ``(IV) Information adequate to enable the Secretary to 
        determine, where pertinent, that the methods used in, and the 
        facilities and controls used for, processing and packing the 
        product are sufficient to preserve its identity, strength, 
        quality, and purity.
            ``(V) Such samples of the product as the Secretary may 
        require.
            ``(VI) A specimen of the labeling proposed to be used with 
        the product, when introduced or delivered for introduction into 
        commerce as a nutraceutical, that accurately and completely 
        describes its health benefits under its stated conditions of 
        use.
    ``(iii) Within 7 days of the receipt of a petition, the Secretary 
shall cause it to be published in the Federal Register to provide 
notice to the public that the petition has been filed. Such notice 
shall contain the name of the petitioner, date and time of filing, a 
summary and description of the proposed product, and the nature of the 
proposed health claim.
    ``(iv) When a petition is filed for a nutraceutical claim under 
subparagraph (5)(D), no other petition for a product which is the same 
as or similar to the product for which a petition has been filed and no 
other petition for a claim which is the same or similar to the claim 
for which a petition has been filed may be filed until final action has 
been taken on the first petition.
    ``(v) A person who files a petition for a claim for a nutraceutical 
claim under subparagraph (5)(D) may apply to the Secretary to amend the 
petition when the amendment is required by a change in the product due 
to new and unexpected findings in research on the product or the 
disease or condition for which the product is being proposed.
    ``(vi) The Secretary shall refer any petition filed for a 
nutraceutical claim under subclause (i) to the Advisory Council on 
Nutraceuticals established under section 7 of the Nutraceutical 
Research and Education Act.
    ``(vii) The Secretary shall take final action on a petition which--
            ``(I) was filed under subclause (i), and
            ``(II) was determined by such Advisory Council on 
        Nutraceuticals to be worthy of review,
not later than 6 months after the date the petition is filed.''.

 SEC. 5. MARKET PROTECTION FOR NUTRACEUTICAL.

    (a) In General.--Section 403(r) is amended by adding at the end the 
following:
    ``(8) If the Secretary issues a regulation in response to a 
petition filed under subparagraph (4) relating to a claim for a 
nutraceutical described in subparagraph (5)(D), the Secretary may not 
issue another regulation for an essentially identical nutraceutical 
claim during the 10-year period that begins on the date that the 
Secretary approved the original petition, except that--
            ``(A) if a petition is submitted for an essentially 
        identical nutraceutical claim for a nutraceutical the intended 
        use of which provides greater effectiveness, greater safety, or 
        otherwise a major contribution to patient care, the Secretary 
        may issue a regulation under subparagraph (4)(D) for such 
        claim; or
            ``(B) if a petition is subsequently revoked, another 
        petition may be submitted to the Secretary for an essentially 
        identical nutraceutical claim.''.
    (b) Misbranding.--Section 402 (21 U.S.C. 342) is amended by adding 
at the end the following:
    ``(h) If it is a nutraceutical and it has not had a petition 
approved under section 403(r)(4)(D).''.

SEC. 6. GOOD MANUFACTURING PRACTICES.

    Section 402(g) (21 U.S.C 342(g)) is amended by--
            (1) inserting ``, including a nutraceutical'' after 
        ``dietary supplement'' in subparagraph (1); and
            (2) inserting ``, including nutraceuticals'' after 
        ``dietary supplements'' in subparagraph (2).

 SEC. 7. ADVISORY COUNCIL ON NUTRACEUTICALS.

    (a) Establishment.--There is established within the Food and Drug 
Administration an advisory council to be known as the ``Advisory 
Council on Nutraceuticals''.
    (b) Duties.--The Advisory Council shall evaluate the merit of each 
petition filed for a nutraceutical health claim under section 
403(r)(4)(D) of the Federal Food, Drug, and Cosmetic Act, including the 
proposed labeling of the product that is the subject of the petition, 
and submit its evaluation to the Secretary. The evaluation of the 
Advisory Council shall determine if a petition is worthy of review by 
the Food and Drug Administration and whether it conflicts with any 
other petition.
    (c) Membership.--
            (1) In general.--The Advisory Council shall consist of ex 
        officio members and not more than 6 additional members 
        appointed by the Secretary. The ex officio members shall be 
        nonvoting members.
            (2) Ex officio members.--The ex officio members of the 
        Advisory Council shall be the Secretary, the Director of the 
        National Institutes of Health (hereinafter in this Act referred 
        to as the ``Director of NIH''), and such additional officers or 
        employees of the United States as the Secretary determines 
        necessary for the Advisory Council to carry out its functions.
            (3) Other members.--The members of the Advisory Council who 
        are not ex officio members shall be appointed by the Secretary 
        from among individuals distinguished in the fields of health, 
        nutrition, or biomedical research.
    (d) Compensation.--Members of the Advisory Council who are officers 
or employees of the United States shall serve on the Advisory Council 
as part of their official duties, and shall not receive additional 
compensation therefor. Other members of the Advisory Council shall 
receive, for each day (including traveltime) they are engaged in the 
performance of Advisory Council functions, compensation at rates not to 
exceed the daily equivalent of the annual rate in effect for grade ES-1 
(5 U.S.C. 5382). Such other members, when performing Advisory Council 
functions (including travel to and from Advisory Council meetings), 
shall be entitled to travel expenses (including per diem in lieu of 
subsistence) as authorized by section 5703 of title 5, United States 
Code, for persons in the Government service employed intermittently.
    (e) Term.--The term of office of an appointed member of the 
Advisory Council is 4 years, except that any member appointed to fill a 
vacancy for an unexpired term shall be appointed for the remainder of 
such term and the Secretary shall make appointments to the Advisory 
Council in such a manner as to ensure that the terms of the members do 
not all expire in the same year. A member may serve after the 
expiration of the member's term for 180 days after the date of such 
expiration. A member who has been appointed for a term of 4 years may 
not be reappointed to the Advisory Council before 2 years from the date 
of expiration of such term of office. If a vacancy occurs in the 
Advisory Council among the appointed members, the Secretary shall make 
an appointment to fill the vacancy within 90 days from the date the 
vacancy occurs.
    (f) Chair.--The Secretary shall select the chair of the Advisory 
Council from among the appointed members. The term of office of the 
chair shall be 2 years.
    (g) Meetings and Procedures.--The Advisory Council shall meet at 
the call of the chair, or at the direction of the Director of the 
National Institutes of Health, but with sufficient frequency to ensure 
prompt evaluation of every nutraceutical petition referred to it by the 
Secretary. The Advisory Council shall adopt rules governing its 
procedures.
    (h) Federal Advisory Committee Act.--Meetings and proceedings of 
the Advisory Council shall not be subject to the Federal Advisory 
Committee Act (5 U.S.C. Appendix).

 SEC. 8. NUTRACEUTICAL INDEX.

    The Secretary shall maintain, and periodically publish in the 
Federal Register, an index that shall list--
            (1) the name and description of each nutraceutical for 
        which there is an approved petition, the name and address of 
        the applicant, and the date upon which the Secretary approved 
        the petition; and
            (2) each petition pending with the Secretary, the date upon 
        which it was filed with the Secretary, the name and address of 
        the applicant, and a description of the nutraceutical and the 
        claim made for the nutraceutical that is the subject of that 
        petition.

 SEC. 10. SMALL BUSINESS ANTITRUST EXEMPTION.

    (a) Exemption.--It shall not be unlawful under the antitrust laws 
for 2 or more small businesses to agree to combine their resources to 
meet the requirements of section 403(r) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 353(r)) for claims of health benefits of a 
nutraceutical.
    (b) Definitions.--
            (1) Antitrust laws.--The term ``antitrust laws'' has the 
        meaning given such term in subsection (a) of the first section 
        of the Clayton Act (15 U.S.C. 12(a)), except that such term 
        includes section 5 of the Federal Trade Commission Act (15 
        U.S.C. 45) to the extent such section applies to unfair methods 
        of competition.
            (2) Nutraceutical.--The term ``nutraceutical'' has the 
        meaning given such term in section 201(k)(k) of the Federal 
        Food, Drug, and Cosmetic Act (21 U.S.C. 321(k)(k)).
            (3) Small business.--The term ``small business'' has the 
        meaning given such term in section 736(d)(3)(A) of the Federal 
        Food, Drug, and Cosmetic Act (21 U.S.C. 379h(d)(3)(A)).

 SEC. 11. EFFECTIVE DATE.

    This Act and the amendments made by this Act shall take effect 90 
days after the date of its enactment.
                                 <all>