FDA Public Meeting on Dietary Supplement Regulation, Oakland, CA, July 20, Register by July 14; Written Comment Deadline
The U.S. Food and Drug Administration is holding East Coast and West Coast hearings on dietary supplement regulations, and is receiving public comments until August 20. The East Coast meeting already occurred on June 8; the West Coast meeting will be on July 20 in Oakland, California, and those who want to attend or speak must register by July 14. In addition, anyone may submit written comments by August 20, whether or not they attend either of the meetings.Importance--and Comment
We need to follow this issue because there is some backlash against the Dietary Supplement Health and Education Act (DSHEA), a law designed largely by the dietary supplements industry which limits the FDA's ability to regulate many health products. Without this law, dozens if not hundreds of products now on the shelves of health-food stores and drugstores would probably be banned, pending drug-type clinical trials to prove their safety and efficacy--trials which will never be done because the products are low-cost and largely unpatentable. Consumer protectionists and pharmaceutical companies both have interests in restricting public access, for different reasons. The backlash is likely to develop into an important public debate on health, freedom, and regulation in U.S. society.
Our concern is that patients with serious illnesses not be left to pay the full price for the dysfunctional drug-development system, which seldom researches natural or low-cost treatments, strongly preferring expensive proprietary chemicals even when they are more dangerous. Until truly effective treatments are developed, people need a wide choice of safe and plausible options so that they can explore to see what may work for them.
We suggest distinguishing between empowerment-positive regulations (such as accurate labeling, so that customers know what they are buying), empowerment-negative regulations (such as banning a substance completely), and empowerment-neutral regulations (such as prohibiting claims). Our view is that empowerment-negative regulations should be avoided unless they are clearly necessary. Empowerment-neutral regulations can be considered to reduce overall risk by restricting mass marketing and promotion of unproven remedies, without denying treatment options to the individuals who want to try them.
Focus of the Meetings
and Written Comments
The FDA has published seven questions and asked that public comments focus on one or more of those:
"Agenda and Goals
"To help focus comments... 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 [Center for Food Safety and Applied Nutrition] 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 and truthfully 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?"
The CFSAN 1999 Program Priorities document is available at
http://vm.cfsan.fda.gov/~dms/cfsan199.html. This document "calls for the development of an overall dietary supplement strategy in conjunction with other agency units and stakeholders."
How to Attend or Speak
at the Oakland Meeting
This meeting will take place Tuesday, July 20, 1999, 9 a.m. - 5 p.m. at the Oakland Federal Building, Auditorium, 3rd Floor, North Tower, 1301 Clay St., Oakland, California.
"All attendees/speakers MUST pre-register by July 14 by mail, fax, or email to: Janet McDonald, U.S. Food and Drug Administration, 1431 Harbor Bay Parkway, Alameda, CA 94502-7070, 510-337-6845, fax 510-337-6708, email jmcdonal@ora.fda.gov. The following information is needed: name, title, business affiliation, address, telephone number, fax number, and email address. Those wishing to make an oral presentation, either on their own behalf or that of an organization, should so state and provide a brief, written statement of the general nature of the evidence or arguments that they wish to present, name and address of the person giving the presentation, and the length of time requested.
"There will be a five-member FDA panel, including the Director of FDA's Center for Food Safety & Applied Nutrition (Joseph Levitt) and the Director of the Office of Special Nutritionals (Dr. Elizabeth Yetley). A final announcement of the July 20 meeting will appear in the Federal Register around mid-June."
How to Submit Written 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 email to
"FDADockets@bangate.fda.gov" or via the FDA Web site, "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 [Docket No. 99N-1174], 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."
How to Obtain Transcripts
of the Meetings
A transcript of the Washington meeting, and probably of the Oakland meeting as well, will be placed on the FDA Web site http://www.fda.gov, but not for at least two weeks after the meeting. Transcripts can also be obtained through the Freedom of Information Act, or examined at the Dockets Management Branch at the FDA's office in Rockville, Maryland.
