[Federal Register: April 3, 2000 (Volume 65, Number 64)]
[Notices]
[Page 17509-17510]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03ap00-55]
 
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
 
Food and Drug Administration
 
[Docket No. 95N-0304]
 
 
Dietary Supplements Containing Ephedrine Alkaloids;
Administrative Docket Update; Availability
 
ACTION: Notice.
 
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of certain documents to update the administrative docket
of the proposed rule on dietary supplements containing ephedrine
alkaloids. This action is being taken to ensure that interested persons
are aware of the updated information. Elsewhere in this issue of the
Federal Register, FDA is withdrawing certain provisions of the proposed
rule on dietary supplements containing ephedrine alkaloids, and
establishing a new docket that will contain new adverse event reports
and related information concerning these products.
 
FOR FURTHER INFORMATION CONTACT: Marquita B. Steadman, Center for Food
Safety and Applied Nutrition (HFS-7), Food and Drug Administration,
5630 Fishers Lane, Rockville, MD 20852, 301-827-6733.
 
SUPPLEMENTARY INFORMATION:
 
I. Background (Proposed Rule)
 
    In the Federal Register of June 4, 1997 (62 FR 30678), FDA
published a proposed rule on dietary supplements containing ephedrine
alkaloids (the ``ephedrine alkaloids proposal''). That proposal would
have established a finding that a dietary supplement is adulterated if
it contains 8 milligrams or more of ephedrine alkaloids per single
serving, required that the labels of products that contain ephedrine
alkaloids state, ``Don't use this product for more than 7 days,''
required certain warning statements, and affected other aspects of
product labeling for such products. FDA proposed this action after
receiving over 800 adverse events associated with the use of dietary
supplements that contained, or were suspected to contain, ephedrine
alkaloids, and reviewing scientific literature and other data
concerning ephedrine alkaloids. FDA received approximately 14,775
comments in response to the ephedrine alkaloids proposal.
 
II. Updated Information
 
    FDA is updating the docket for the ephedrine alkaloids proposal
with additional information, most of which was received after
publication of the proposal.
    FDA received 270 additional adverse event reports between February
and September 1997. FDA added these adverse event reports to the
ephedrine alkaloids proposal's docket in two submissions without formal
clinical analysis. FDA did not rely on these 270 reports in the
ephedrine alkaloids proposal because FDA received them after it began
its analysis for the proposal.
    FDA has received additional documentation (e.g., copies of product
labels and labeling, information on how the consumers used the products
at issue and available medical or other clinical records) concerning
 
[[Page 17510]]
 
approximately 17 of the 270 adverse event reports the agency put in the
docket after publication of the ephedrine alkaloids proposal.
Consequently, FDA has reorganized these 17 reports to include the
additional documentation that the agency has received, and it has
redacted the files. FDA is now placing the 17 reorganized and redacted
adverse event charts in the ephedrine alkaloids proposal's docket.
    Should FDA receive additional information on the adverse events
that are part of the administrative docket for the ephedrine alkaloids
proposal, the agency will include it in that docket.
    This updated information may be seen by interested persons at the
Dockets Management Branch (address above) between 9 a.m. and 4 p.m.,
Monday through Friday.
 
    Dated: March 28, 2000.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 00-8112 Filed 3-31-00; 8:45 am]
BILLING CODE 4160-01-F

"Dear Colleague" Letter About August 8, 2000 Public Meeting Concerning the Safety of Dietary Supplements Containing Ephedrine Alkaloids June 8, 2000