[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