```

[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3156 Introduced in House (IH)]

109th CONGRESS
  1st Session
                                H. R. 3156

   To amend the Federal Food, Drug, and Cosmetic Act with respect to 
                          dietary supplements.

_______________________________________________________________________

                    IN THE HOUSE OF REPRESENTATIVES

                             June 30, 2005

  Mrs. Davis of California (for herself, Mr. Waxman, and Mr. Dingell) 
 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 with respect to 
                          dietary supplements.

    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 ``Dietary Supplement Access and 
Awareness Act''.

SEC. 2. DIETARY SUPPLEMENTS; PRODUCT LISTING; REPORTING, POSTMARKET 
              SURVEILLANCE, AND OTHER PROVISIONS REGARDING SAFETY.

    (a) In General.--Chapter IV of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 341 et seq.) is amended by adding at the end the 
following section:

``SEC. 416. DIETARY SUPPLEMENTS; PRODUCT LISTING; REPORTING, POSTMARKET 
              SURVEILLANCE, AND OTHER PROVISIONS REGARDING SAFETY.

    ``(a) Limitation on Applicability.--Notwithstanding the other 
subsections of this section, this section does not apply to any dietary 
supplement that meets the conditions described in paragraphs (1) and 
(2), as follows:
            ``(1) The supplement bears or contains one or more of the 
        following dietary ingredients:
                    ``(A) A vitamin.
                    ``(B) A mineral.
                    ``(C) A concentrate, metabolite, constituent, 
                extract, or combination of any vitamin or mineral.
            ``(2) The supplement does not bear or contain--
                    ``(A) an herb or other botanical, an amino acid, or 
                a dietary substance for use by man to supplement the 
                diet by increasing the total dietary intake; or
                    ``(B) a concentrate, metabolite, constituent, 
                extract, or combination of any ingredient specified in 
                subparagraph (A).
    ``(b) Product Listing.--Every person who is required under section 
415 to register with the Secretary with respect to manufacturing or 
processing a dietary supplement shall, in the form and manner 
prescribed by the Secretary, report to the Secretary twice each year, 
once during the month of June and once during the month of December, 
the following information:
            ``(1) A list of each dietary supplement manufactured or 
        processed by the person for commercial distribution in the 
        United States, other than dietary supplements previously 
        included on a list reported under this subsection by the 
        person.
            ``(2) The labeling for each of the dietary supplements on 
        the list.
            ``(3) A listing of the major ingredients of each dietary 
        supplement on the list (including active ingredients, as 
        applicable), except that the Secretary may require the 
        submission of a quantitative listing of all ingredients in such 
        a supplement if the Secretary finds that such submission is 
        necessary to carry out the purposes of this Act.
            ``(4) If, since the date the person last made a report 
        under this subsection (or if the person has not previously made 
        such a report, since the effective date of this section), the 
        person has discontinued the manufacture or processing of a 
        dietary supplement included on a list reported under this 
        subsection by the person--
                    ``(A) notice of such discontinuance;
                    ``(B) the date of such discontinuance; and
                    ``(C) the identity of such supplement.
            ``(5) Such other information describing the dietary 
        supplements as the Secretary may by regulation require.
    ``(c) Reporting of Information on Adverse Experiences.--
            ``(1) Serious experiences.--Each person who is a 
        manufacturer or distributor of a dietary supplement shall 
        report to the Secretary any information received by such person 
        on serious adverse experiences regarding the supplement. Such a 
        report shall be submitted to the Secretary not later than 15 
        days after the date on which the person receives such 
        information.
            ``(2) Investigation and follow-up.--A person submitting a 
        report under paragraph (1) on a serious adverse experience 
        shall promptly investigate the experience, and if additional 
        information is obtained, shall report the information to the 
        Secretary not later than 15 days after obtaining the 
        information. If no additional information is obtained, records 
        of the steps taken to seek additional information shall be 
        maintained by the person.
            ``(3) Authority of secretary.--In addition to requirements 
        established in this subsection, the Secretary may establish 
        such requirements regarding the reporting of information on 
        adverse experiences as the Secretary determines to be 
        appropriate to protect the public health. The Secretary may 
        establish waivers from requirements under this subsection 
        regarding such information if the Secretary determines that 
        compliance with the requirement involved is not necessary to 
        protect the public health regarding such supplements.
            ``(4) Definitions.--For purposes of this subsection:
                    ``(A) The term `adverse experience regarding a 
                dietary supplement' means any adverse event associated 
                with the use of such supplement in humans, whether or 
                not such event is considered to be related to the 
                supplement by a person referred to in paragraph (1) who 
                obtains the information.
                    ``(B) The term `serious', with respect to an 
                adverse experience regarding a dietary supplement, 
                means an adverse experience that--
                            ``(i) results in death; a life-threatening 
                        condition; inpatient hospitalization or 
                        prolongation of hospitalization; a persistent 
                        or significant disability or incapacity; or a 
                        congenital anomaly, birth defect, or other 
                        effect regarding pregnancy, including premature 
                        labor or low birth weight; or
                            ``(ii) requires medical or surgical 
                        intervention to prevent one of the outcomes 
                        described in clause (i).
    ``(d) Postmarket Surveillance.--The Secretary may by order require 
a manufacturer of a dietary supplement to conduct postmarket 
surveillance for the supplement if the Secretary determines that there 
is a reasonable possibility that a use or expected use of the 
supplement may have serious adverse health consequences.
    ``(e) Authority to Order Demonstration of Safety.--
            ``(1) In general.--If the Secretary has reasonable grounds 
        for believing that a dietary supplement may be adulterated 
        under section 402(f)(1), the Secretary may by order require the 
        manufacturer to demonstrate to the Secretary that the 
        supplement is not so adulterated.
            ``(2) Distribution of product pending completion of 
        process.--
                    ``(A) In general.--Subject to subparagraph (B), a 
                dietary supplement may not be considered adulterated 
                under section 402(f)(1) during the pendency of a 
                demonstration under paragraph (1) by the manufacturer 
                of the supplement and during the pendency of the review 
                under paragraph (4) by the Secretary with respect to 
                the demonstration.
                    ``(B) Imminent hazard to public health or safety.--
                This subsection does not affect the authority of the 
                Secretary under section 402(f)(1)(C).
            ``(3) Timeframe for demonstration.--
                    ``(A) In general.--An order under paragraph (1) 
                shall provide that the demonstration under such 
                paragraph by a manufacturer is required to be completed 
                not later than the expiration of 180 days after the 
                date on which the order is issued, except that the 
                Secretary may extend such period if the Secretary 
                determines that an extension is appropriate. Any 
                information submitted for such purpose by the 
                manufacturer after the expiration of the applicable 
                period under the preceding sentence may not be 
                considered by the Secretary, except to the extent that 
                the Secretary requests the manufacturer to provide 
                additional information after such period.
                    ``(B) Completion date of demonstration.--A 
                demonstration under paragraph (1) shall be considered 
                complete on the expiration of the applicable period 
                under subparagraph (A), or on such earlier date as the 
                manufacturer informs the Secretary that the 
                manufacturer has completed the demonstration, or on 
                such earlier date as the Secretary reasonably concludes 
                that the manufacturer has no further information to 
                provide to the Secretary as part of the demonstration 
                or that the manufacturer is not in substantial 
                compliance with the order under paragraph (1).
            ``(4) Review by secretary.--Once a demonstration under 
        paragraph (1) by a manufacturer is completed, the Secretary 
        shall review all relevant information received by the Secretary 
        pursuant to the demonstration or otherwise available to the 
        Secretary and make a determination of whether the Secretary 
        considers the dietary supplement involved to be adulterated 
        under section 402(f)(1). Such determination shall be made not 
        later than 180 days after the completion of the demonstration.
            ``(5) Requirements regarding demonstrations.--The Secretary 
        may, by order or by regulation, establish requirements for 
        demonstrations under paragraph (1).
            ``(6) Relation to other procedures.--In the case of a 
        dietary supplement with respect to which the Secretary has not 
        issued an order under paragraph (1), this subsection may not be 
        construed as preventing the Secretary from acting pursuant to 
        section 402(f)(1) to the same extent and in the same manner as 
        would apply in the absence of this subsection. In the case of a 
        dietary supplement with respect to which the Secretary has 
        issued an order under paragraph (1), a determination under 
        paragraph (4) that the supplement is not adulterated under 
        section 402(f)(1) does not prevent the Secretary from making a 
        determination, on the basis of additional information obtained 
        by the Secretary, that the supplement is so adulterated.
    ``(f) Sales to Minors; Significant Risk.--
            ``(1) Criteria.--Not later than the expiration of the two-
        year period beginning on the date of the enactment of the 
        Dietary Supplement Access and Awareness Act, the Secretary 
        shall by regulation establish criteria for making a 
        determination that a dietary supplement may pose a significant 
        risk to individuals who are under the age of 18 (referred to in 
        this section individually as a `minor').
            ``(2) Product determination; prohibited act.--The Secretary 
        may, by order or by regulation, make a determination described 
        in paragraph (1) with respect to a dietary supplement. 
        Effective upon the expiration of a period designated by the 
        Secretary in publishing such determination in the Federal 
        Register, the act of selling the dietary supplement to a minor 
        shall be deemed to be an act which results in such supplement 
        being misbranded while held for sale. During the two-year 
        period referred to in paragraph (1), an order making such a 
        determination may be issued notwithstanding that criteria have 
        not yet been established in accordance with such paragraph.
    ``(g) Recordkeeping on Safety Issues.--
            ``(1) In general.--The Secretary shall by regulation 
        require manufacturers of dietary supplements to maintain 
        records regarding reports of serious adverse experiences under 
        subsection (c) and records regarding compliance with section 
        402.
            ``(2) Retention period.--Regulations under paragraph (1) 
        shall specify the number of years for which records required in 
        such paragraph are required to be retained, except that, if 
        under section 402(g)(1) the Secretary makes a determination 
        that expiration date labeling is necessary for dietary 
        supplements, records regarding dietary supplements in a lot 
        shall be retained for not less than one year after the 
        expiration date of supplements in the lot.''.
    (b) Prohibited Acts.--
            (1) In general.--Section 301 of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 331) is amended by adding at the end 
        the following:
    ``(hh) The failure of a person to comply with any requirement under 
section 416, other than an order under subsection (e)(1) of such 
section.''.
            (2) Adulterated dietary supplements.--
                    (A) Order regarding demonstration of safety.--
                Section 402 of the Federal Food, Drug, and Cosmetic Act 
                (21 U.S.C. 342) is amended by adding at the end the 
                following:
    ``(i) If it is a dietary supplement and the manufacturer of the 
supplement fails to comply with an order of the Secretary under section 
416(e)(1) that is issued with respect to the supplement.''.
                    (B) Certain court procedures; determination of 
                unreasonable risk.--Section 402(f) of the Federal Food, 
                Drug, and Cosmetic Act (21 U.S.C. 342(f)) is amended--
                            (i) in subparagraph (1), by striking the 
                        matter after and below clause (D) of such 
                        subparagraph; and
                            (ii) by adding at the end the following 
                        subparagraph:
    ``(3)(A) For purposes of clause (A) or (B) of subparagraph (1), the 
Secretary shall consider a dietary supplement or dietary ingredient as 
presenting an unreasonable risk of illness or injury if the Secretary 
determines that the risks of such product outweighs its benefits, as 
indicated by a relative weighing of the known and reasonably likely 
risks of the product against its known and reasonably likely benefits. 
In the absence of a sufficient benefit, the presence of even a 
relatively small risk of a serious adverse health effect to a user may 
be considered by the Secretary as unreasonable.
    ``(B) A determination by the Secretary under clause (A) with 
respect to the risk of a product may be made on the basis of any 
science-based evidence of risk, without the need to prove that the 
substance has actually caused harm in particular cases. The Secretary 
shall consider any relevant evidence including but not limited to 
scientific data about the toxicological properties of a dietary 
ingredient or its mechanism of action; known effects of 
pharmacologically related compounds, including those regulated as 
drugs; the results of clinical studies, including observational 
studies; and adverse event reports.
    ``(C) A determination that a product presents an unreasonable risk 
may be made under clause (A) by the Secretary even though there are 
uncertainties as to the levels of a dietary ingredient that may present 
a risk.''.
            (3) Trade secrets.--Section 301(j) of the Federal Food, 
        Drug, and Cosmetic Act (21 U.S.C. 331(j)) is amended by 
        inserting ``416,'' after ``414,''.
    (c) Inspection Authority.--Section 704(a) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 374(a)) is amended--
            (1) in paragraph (1), by inserting after the second 
        sentence the following: ``In the case of any person who 
        manufactures, processes, packs, transports, distributes, holds, 
        or imports a dietary supplement with respect to which an order 
        under section 416(e)(1) has been issued, the inspection shall 
        extend to all records, files, papers, processes, controls, and 
        facilities bearing on whether the dietary supplement is 
        adulterated under section 402(f)(1).''; and
            (2) in paragraph (2), in the matter preceding subparagraph 
        (A), by striking ``third sentence'' and inserting ``fourth 
        sentence''.

SEC. 3. EDUCATION PROGRAMS REGARDING DIETARY SUPPLEMENTS.

    (a) Health Care Professionals.--
            (1) In general.--The Secretary of Health and Human Services 
        (referred to in this section as the ``Secretary''), acting 
        through the Commissioner of Food and Drugs, shall carry out a 
        program to educate health professionals on the importance of 
        reporting to the Food and Drug Administration adverse health 
        experiences that are associated with dietary supplements.
            (2) Authorization of appropriations.--For the purpose of 
        carrying out paragraph (1), there is authorized to be 
        appropriated $5,000,000 for fiscal year 2006, in addition to 
        any other authorization of appropriations that is available 
        with respect to such purpose.
    (b) Consumers.--
            (1) In general.--The Secretary, acting through the 
        Commissioner of Food and Drugs, shall carry out a program to 
        educate consumers of dietary supplements on the importance of 
        informing their health professionals of the dietary supplements 
        and drugs the consumers are taking.
            (2) Authorization of appropriations.--For the purpose of 
        carrying out paragraph (1), there is authorized to be 
        appropriated $5,000,000 for fiscal year 2006, in addition to 
        any other authorization of appropriations that is available 
        with respect to such purpose.
                                 <all>
```