[Federal Register Volume 60, Number 183 (Thursday, September 21, 1995)]
[Notices]
[Page 49194]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-23557]
[[Page 49193]]
_______________________________________________________________________
Part XV
Department of Health and Human Services
_______________________________________________________________________
Food and Drug Administration
_______________________________________________________________________
Ephedrine Alkaloids: Reports of Adverse Events; Availability; Notice
Federal Register / Vol. 60, No. 183 / Thursday, September 21, 1995 /
Notices
[[Page 49194]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 95N-0304]
Ephedrine Alkaloids: Reports of Adverse Events; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of reports of adverse events associated with the
consumption of food products containing ephedrine alkaloids as well as
redacted copies of any accompanying medical records where available. In
addition, a bibliography listing of published medical and scientific
literature relevant to the adverse event reports is available. FDA is
announcing the availability of this information to ensure that all
interested parties have the opportunity to review these documents
before an upcoming meeting of the working group of the Food Advisory
Committee at which the effects of consuming food products that contain
ephedrine alkaloids will be considered.
ADDRESSES: The adverse event reports, redacted accompanying medical
records, and the bibliography listing are available for public
examination in the Dockets Management Branch (HFA-305), Food and Drug
Administration, rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857,
between 9 a.m. and 4 p.m., Monday through Friday. Submit written
comments identified with the docket number found in brackets in the
heading above to Dockets Management Branch (address above).
FOR FURTHER INFORMATION CONTACT: Margaret C. Binzer, Center for Food
Safety and Applied Nutrition (HFS-456), Food and Drug Administration,
200 C St. SW., Washington, DC 20204, 202-205-5372.
SUPPLEMENTARY INFORMATION: FDA will soon be announcing a meeting of a
working group of the Food Advisory Committee to be held in October,
1995. The purpose of the meeting is to have the working group consider
the significance and extent of the serious adverse events associated
with the consumption of food products that contain a source of
ephedrine alkaloids, including ephedrine, pseudoephedrine, and
norpseudoephedrine from Ephedra sinica Stapf. and other related species
(e.g., Ma huang and Chinese ephedra). FDA is announcing the
availability of the adverse event reports associated with these
products and other materials relevant to the working group's
discussion.
To date, FDA has received over 300 adverse event reports
associated with food products containing ephedrine alkaloids. Because
of the volume of adverse event reports received by the agency, the
agency would be unable to respond to any Freedom of Information Act
requests for the reports before this meeting. FDA is, therefore, taking
the unusual step of making available properly redacted copies of the
adverse event reports through Dockets Management Branch to ensure that
all interested parties have access to these documents before this
meeting so that they will be able to fully understand the issues that
are the subject of the working group's discussion.
Copies of the adverse event reports, redacted accompanying medical
records, and a bibliography listing of documents available from other
sources, may be seen in the Dockets Management Branch (address above).
Copies of these documents will not be available at the working group
meeting.
Dated: September 15, 1995.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 95-23557 Filed 9-19-95; 12:43 pm]
BILLING CODE 4160-01-F
