[Federal Register Volume 65, Number 64 (Monday, April 3, 2000)]
[Notices]
[Pages 17509-17510]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-8112]


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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