April 28, 2003

Public Docket Open for Comments on Consumer Health Information for Better Nutrition

The FDA Task Force on Consumer Health Information for Better Nutrition has established a public docket (03N-0069) to receive views and comments from interested stakeholders.

The Task Force is interested in learning about stakeholder views on all aspects of the Task Force effort. The Task Force is specifically interested in learning about the views on how to help facilitate the flow of information to consumers about the role of sound dietary practices in achieving and maintaining good health, while assuring that such information is truthful, non-misleading, and based on sufficient scientific evidence. Also of interest are stakeholder views on how to help American consumers make sound dietary decisions through the use of health claims for conventional foods, thereby reducing the risk of certain diseases and improving public health. The Task Force is especially interested in learning about stakeholder views on the following questions:

1. What body of scientific evidence do you think should be adequate for a qualified health claim?
   
   
2. What types of safety concerns should be factored into FDA decision-making?
   
   
3. What specific claims do you think are currently ready for consideration under the new guidance?
   
   
4. On what issues are disclaimers valuable, or not valuable, in preventing consumers from being misled, and do you have data to support your view?
   
   
5. What kinds of empirical data should FDA rely upon to show that consumers are, or are not, mislead by claims?
   
   
6. Should conventional foods and dietary supplements be treated the same or treated differently, and why?

The Task Force would appreciate receiving your comments by Tuesday, May 27, 2003. Written comments should be submitted to Dockets Management Branch (FDA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, Maryland 20852. Comments may also be submitted electronically to http://www.fda.gov/dockets/ecomments or by email to FDADOCKETS@oc.fda.gov. The comments must include the docket number 03N-0069. All comments submitted to the public docket are public information and may be posted to the FDA website for public viewing.

For information about the FDA Task Force on Consumer Health Information for Better Nutrition, visit the FDA website at http://www.fda.gov/bbs/topics/NEWS/2002/NEW00859.html.

FDA Announces a Satellite Downlink Public Meeting On Forthcoming Proposed Rules on Maintenance and Inspection of Records for Foods and Administrative Detention

FDA has published a notification in the Federal Register announcing a public meeting to discuss two soon-to-publish proposed regulations implementing aspects of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act). The full Federal Register notice announcing the public meeting can be viewed at http://www.fda.gov/OHRMS/DOCKETS/98fr/03-8576.htm.

The proposed regulations will address maintenance and inspection of records for foods (Docket No. 02N-0277) and administrative detention (Docket No. 02N-0275). FDA expects to publish shortly in the Federal Register the proposed rules implementing each of these provisions. The purpose of the satellite downlink public meeting is to provide information on the proposed rules to the public, to encourage the submission of comments to the dockets, and to provide the public an opportunity to ask questions or to provide comment. The public meeting will be held on May 7, 2003, from 1 to 3 p.m. eastern standard time. The Federal Register notice lists locations where the satellite downlink may be viewed.

There will also be live simulcast in English (channel 6.8), French (channel 5.8), and Spanish (channel 6.2). Videostream copies of the satellite downlink meeting will be available in English, Spanish, and French on CD-ROM within 10 working days after the meeting. Copies of the meeting will also be available on videotape cassettes in English, Spanish, and French in NTSC (VHS), PAL, PAL-N, and SECAM formats. Within 3 weeks of the satellite downlink public meeting, written transcripts in English, French, and Spanish will be available for viewing at the Dockets Management Branch and posted on FDA's website.

The Bioterrorism Act, as well as FDA's implementation plan and public meetings related to this Act can be viewed at the Bioterrorism Act link on FDA's home page, or directly at: http://www.fda.gov/oc/bioterrorism/bioact.html.

New CFSAN Website: Information for Health Professionals

CFSAN's Internet home page has a new link for health professionals. The new Health Professionals link appears under the Special Interest Areas heading on the CFSAN home page. The Information for Health Professionals website provides direct links to information that would be of particular interest to health professionals, minimizing the task of searching for the same information throughout CFSAN's website. The categories of information presented include: CFSAN Recent News; Safety Alerts, Recalls and Warnings; Food Safety; Dietary Supplements; Infant Formula; and Other CFSAN Information, such as Food Allergens and Cosmetics. In addition, the site provides links to other FDA, Federal, and non-Federal web sites for health professionals. The new Internet site can be accessed directly at http://www.cfsan.fda.gov/~dms/hpro-toc.html