99-15476. Dietary Supplements; Center for Food Safety and Applied Nutrition Strategy; Public Meeting  

  • [Federal Register Volume 64, Number 117 (Friday, June 18, 1999)]
    [Notices]
    [Pages 32880-32881]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 99-15476]
    
    
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    DEPARTMENT OF HEALTH AND HUMAN SERVICES
    
    Food and Drug Administration
    [Docket No. 99N-1174]
    
    
    Dietary Supplements; Center for Food Safety and Applied Nutrition 
    Strategy; Public Meeting
    
    AGENCY: Food and Drug Administration, HHS.
    
    ACTION: Notice.
    
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    SUMMARY: The Food and Drug Administration (FDA) is announcing a second 
    public meeting to solicit comments that will assist the Center for Food 
    Safety and Applied Nutrition (CFSAN) to develop an overall strategy for 
    achieving effective regulation of dietary supplements under the Dietary 
    Supplement Health and Education Act (DSHEA). This meeting is intended 
    to give the public an opportunity to comment on the development of the 
    strategy.
    
    DATES: The public meeting will be held on July 20, 1999, from 9 a.m. to 
    5 p.m. Submit written comments by August 20, 1999.
    
    ADDRESSES: The public meeting will be held at the Oakland Federal 
    Bldg., third fl. auditorium, north tower, 1301 Clay St., Oakland, CA.
    
    FOR FURTHER INFORMATION CONTACT: Janet B. McDonald, Office of 
    Regulatory Affairs (HFR-PA-145), Food and Drug Administration, 1431 
    Harbor Bay Pkwy., Alameda, CA 94502-7070, 510-337-6845, FAX 510-337-
    6708, ``e-mail jmcdonal@ora.fda.gov.''
    
    SUPPLEMENTARY INFORMATION:
    
     I. Introduction
    
         This public meeting is the second of two meetings to seek 
    stakeholder comments on the development of an overall strategy for 
    achieving effective regulation of dietary supplements under the Federal 
    Food, Drug, and Cosmetic Act, as amended by DSHEA. The first meeting 
    was held on June 8, 1999, in Washington, DC. These two meetings build 
    upon themes that emerged from a broader stakeholder meeting sponsored 
    by CFSAN in June 1998. That meeting addressed the nonfood safety 
    initiative programs that are managed by CFSAN and identified some basic 
    themes including: (1) The need to maintain a credible FDA program, 
    including compliance, enforcement, and consumer outreach activities 
    that will help ensure consumer confidence in FDA regulated products; 
    (2) the need to maintain a solid, science based program staffed with 
    highly qualified scientists; and (3) the recognition that FDA's 
    assistance to consumers and the regulated industry is important.
    
     II. Registration and Requests for Oral Presentations
    
         If you would like to attend the public meeting, you must register 
    with the contact person (address above) by July 9, 1999, by providing 
    your: Name, title, business affiliation, address, telephone, and fax 
    number. To expedite processing, registration information may also be 
    faxed to 510-337-6708. If you need special accommodations due to 
    disability, please inform the contact person when you register.
         If you wish to make an oral presentation during the meeting, you 
    must inform the contact person of that desire when you register to 
    attend and submit: (1) A brief written statement of the general nature 
    of the evidence or arguments that you wish to present, (2) the names 
    and addresses of the persons who will give the presentation, and (3) 
    the approximate length of time that you are requesting for your 
    presentation. Depending on the number of people who register to make 
    presentations, we may have to limit the time allotted for each 
    presentation.
    
    [[Page 32881]]
    
     III. CFSAN's 1999 Program Priorities Document
    
         The meeting announced in this notice, as well as the meeting that 
    took place on June 8, 1999, in Washington, DC, are in response to 
    CFSAN's 1999 Program Priorities document that calls for the development 
    of an overall dietary supplement strategy in conjunction with other 
    agency units and stakeholders. A copy of the priorities document is 
    available on the Internet on FDA's Website at ``http://
    vm.cfsan.fda.gov/dms/cfsan199.html''.
         The priorities document states that the overall strategy should 
    address all elements of the dietary supplement program including: (1) 
    Boundaries between dietary supplements and conventional foods, between 
    dietary supplements and drugs, and between dietary supplements and 
    cosmetic products; (2) claims; (3) good manufacturing practices; (4) 
    adverse event reporting; (5) laboratory capability; (6) research needs; 
    (7) enforcement; and (8) resource needs. FDA's objective in developing 
    this strategy is to ensure consumer access to safe dietary supplements 
    that are truthfully and not misleadingly labeled. FDA intends to 
    develop this strategy by following a process of openness, flexibility, 
    efficiency, and commitment to public health.
         FDA has identified four criteria for priority ranking the tasks 
    encompassed in the strategy. These criteria are: (1) Enhancement of 
    consumer safety, (2) development of health-related product labeling 
    regulation, (3) improvement in efficiency of operation, and (4) closure 
    on unresolved regulatory issues.
         This meeting also addresses activity undertaken by the agency to 
    solicit comments in accordance with section 406(b) of the Food and Drug 
    Administration Modernization Act of 1997 (Pub. L. 105-115) (21 U.S.C. 
    393(b)).
    
     IV. Agenda and Goals
    
         To help focus comments for the July 20, 1999, meeting, FDA 
    requests that oral and written input regarding an overall strategy for 
    achieving effective regulation of dietary supplements address the 
    following questions:
         1. In addition to ensuring consumer access to safe dietary 
    supplements that are truthfully and not misleadingly labeled, are there 
    other objectives that an overall dietary supplement strategy should 
    include?
         2. Are the criteria for prioritizing the tasks within the 
    supplement strategy appropriate? Which specific tasks should FDA 
    undertake first?
         3. What factors should FDA consider in determining how best to 
    implement a task (i.e., use of regulations, guidance, etc.)?
         4. What tasks should be included under the various dietary 
    supplement program elements in the CFSAN 1999 Program Priorities 
    document?
         5. Are there current safety, labeling, or other marketplace issues 
    that FDA should address quickly through enforcement actions to ensure, 
    for example, that consumers have confidence that the products on the 
    market are safe, truthfull, and not misleadingly labeled?
         6. Toward what type or area of research on dietary supplements 
    should FDA allocate its research resources?
         7. Given FDA's limited resources, what mechanisms are available, 
    or should be developed, to leverage FDA's resources to meet effectively 
    the objective of the strategy?
    
     V. Comments
    
         Interested persons may, on or before August 20, 1999, submit 
    written comments to the Dockets Management Branch (HFA-305), Food and 
    Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 
    You may also send comments to the Dockets Management Branch via e-mail 
    to ``FDA Dockets@bangate.fda.gov'' or via the FDA Website ``http://
    www.fda.gov''. You should annotate and organize your comments to 
    identify the specific issues to which they refer. You must submit two 
    copies of comments, identified with the docket number found in brackets 
    in the heading of this document, except that you may submit one copy if 
    you are an individual. You may review received comments in the Dockets 
    Management Branch between 9 a.m. and 4 p.m., Monday through Friday.
    
     VI. Transcripts
    
         You may request transcripts of the meeting in writing from the 
    Freedom of Information Office (HFI-35), Food and Drug Administration, 
    5600 Fishers Lane, rm. 12A-16, Rockville, MD 20857, approximately 15 
    working days after the meeting at a cost of 10 cents per page. You may 
    also examine the transcript of the meeting at the Dockets Management 
    Branch (address above) between 9 a.m. and 4 p.m., Monday through 
    Friday, as well as on the FDA Website ``http://www.fda.gov''.``http://
    vm.cfsan.fda.gov/dms/cfsan199.html''.
    
        Dated: June 11, 1999.
    Margaret M. Dotzel,
    Acting Associate Commissioner for Policy Coordination.
    [FR Doc. 99-15476 Filed 6-17-99; 8:45 am]
    BILLING CODE 4160-01-F
    
    
    

Document Information

Published:
06/18/1999
Department:
Food and Drug Administration
Entry Type:
Notice
Action:
Notice.
Document Number:
99-15476
Dates:
The public meeting will be held on July 20, 1999, from 9 a.m. to 5 p.m. Submit written comments by August 20, 1999.
Pages:
32880-32881 (2 pages)
Docket Numbers:
Docket No. 99N-1174
PDF File:
99-15476.pdf