[Federal Register Volume 62, Number 181 (Thursday, September 18, 1997)]
[Proposed Rules]
[Pages 48968-48969]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-24734]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 111

[Docket No. 95N-0304]
RIN 0901-AA59


Dietary Supplements Containing Ephedrine Alkaloids; Reopening of 
Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; reopening of comment period.

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SUMMARY: The Food and Drug Administration (FDA) is reopening from 
September 18, 1997, to December 2, 1997, the comment period on the 
proposed rule on dietary supplements containing ephedrine alkaloids 
that was published in the Federal Register of June 4, 1997 (62 FR 
30678). This action is being taken to provide a renewed opportunity for 
public comment after the agency has rectified a number of inadvertent 
omissions from the administrative record. FDA is also providing an 
opportunity for comment on adverse event reports (AER's) that FDA has 
received since January 1997 and on new analytical data that FDA is 
adding to the administrative record. Finally, FDA is reopening the 
comment period in response to several requests for extensions of the 
comment period to permit interested persons to submit new scientific 
data.

DATES: Written comments by December 2, 1997.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857.

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, 202-401-9859, FAX 202-260-8957 or 
E-mail ``MBinzer @Bangate.fda.gov''.

SUPPLEMENTARY INFORMATION: In the Federal Register of June 4, 1997, FDA 
published a proposed rule regarding the formulation and labeling of 
dietary supplements containing ephedrine alkaloids. FDA proposed this 
rule in response to serious illnesses and injuries, including multiple 
deaths, associated with the use of dietary supplement products that 
contain ephedrine alkaloids and in response to the agency's 
investigations and analyses of these illnesses and injuries. Interested 
persons were given until August 18, 1997, to comment on the proposal.
    In the Federal Register of August 20, 1997 (62 FR 44247), FDA 
announced that it would reopen the comment period for the proposed rule 
because the agency had identified a number of inadvertent omissions 
(i.e., missing pages in several of the AER's and other minor problems) 
in the administrative record. FDA has reviewed each of the AER's to 
rectify these omissions, which included: Missing product labels or 
labeling, affidavits from consumers or health care professionals, 
investigator followup reports, and individual pages from medical 
records. FDA has recopied each of the AER files and placed them on 
display at the Dockets Management Branch. Any followup materials that 
the agency received after the AER's were made part of the 
administrative record for this rulemaking in June 1997 are now included 
in the corresponding AER. For convenience to the users of the 
administrative record, the agency has also organized the duplicate AER 
files to make it easier to locate them in the record.
    As of January 1997, FDA had received over 800 reports of adverse 
events associated with the use of more than 100 different dietary 
supplements that contained, or were suspected of containing, ephedrine 
alkaloids. Since that time, FDA has continued to receive additional 
AER's associated with the use of these products. FDA is adding the 
AER's that it received between January and August 1997 to supplement 
the administrative record. These documents are filed in the 
administrative record under the title: ``AER's Associated with the Use 
of Dietary Supplements Containing Ephedrine Alkaloids that FDA has 
Received Since the Preparation of the Docket Submission of January 17, 
1997.''
    Since the time that the proposal was published, FDA has received 
the results of chemical analyses for several of the dietary supplement 
products associated with AER's. When an adverse event appears to be 
clinically significant, FDA routinely requests from the consumer a 
sample of the remaining portion of the product related to the AER and 
has its laboratories analyze the sample. These analytical results 
provide supplementary data on levels of ephedrine alkaloids in the 
dietary supplements. FDA is adding these analytical results to the 
administrative record. A summary of these analytical results are filed 
in the administrative record under the title: ``Analytical Results of 
Ephedrine Alkaloid-Containing Dietary Supplements Associated With 
Adverse Events, August 1997.'' These documents will be placed on 
display in the Dockets Management Branch along with the rest of the 
administrative record that FDA has compiled to date.
    In addition, FDA has received several requests for extensions of 
the comment period. These requests stated as grounds for an extension, 
among other things, that there is a need for additional time to review 
the clinical data and other information in the administrative record 
and to submit new scientific data to the agency. Several requests were 
for extensions of 180 days.
    Having carefully considered these requests and given the fact that 
it has added material to the administrative record, the agency has 
decided to reopen the comment period until December 2, 1997. The 
reopening of the comment period will provide interested persons with a 
significant amount of additional time to evaluate all the information 
in the administrative record that underlies the proposal that FDA 
published in June 1997 and to formulate any comments that they deem 
appropriate. The agency particularly encourages small businesses to 
take advantage of this additional opportunity to participate in the 
regulatory process.
    Because of the serious and significant adverse events associated 
with the use of dietary supplements containing ephedrine alkaloids, FDA 
is concerned about the adverse impact that a prolonged comment period 
may have on the public health. For this reason, the agency decided not 
to grant the requests for an additional comment period longer than 75 
days. The agency's decision to reopen the comment period for 75 days 
balances the needs of interested persons

[[Page 48969]]

to review the data in the corrected administrative record and to submit 
comments to the agency with the important public health interests 
involved.
    Moreover, the agency does not intend to provide any additional 
extensions of the comment period. Interested persons will have 75 days 
to consider these materials and comment to the agency, if desired. 
Interested persons already have had 75 days to review the concepts in 
the proposed rule and the data in the administrative record, which 
represent the great bulk of the material in the updated and corrected 
administrative record. Much of the material in the administrative 
record has been on display at the Dockets Management Branch since long 
before the proposed rule was published on June 4, 1997. A notice 
appeared in the Federal Register of September 21, 1995 (60 FR 49194), 
announcing: The availability of AER's associated with the use of 
dietary supplements containing ephedrine alkaloids; redacted copies of 
accompanying medical records, where available; and a bibliography of 
published medical and scientific literature relevant to the AER's. Much 
of the clinical data and other information has been in the 
administrative record either since October 1995, the date of the 
meeting of the Special Working Group on Dietary Supplements Containing 
Ephedrine Alkaloids (Working Group) or since August 1996, the date of 
the meeting of the Food Advisory Committee and Special Working Group. 
Other than the new information announced in this document, the agency 
has not added new data to the administrative record since January 1997. 
Nevertheless, for the reasons mentioned earlier in this notice, the 
agency is providing a new, full 75-day comment period that is equal to 
the comment period that FDA provided when it published the initial 
proposal. Thus, FDA is providing a total of 150 days for comment in 
this proceeding.
    Interested persons may on or before December 2, 1997, submit to the 
Dockets Management Branch (address above) written comments regarding 
this proposal. Two copies of any comments are to be submitted, except 
that individuals may submit one copy. Comments are to be identified 
with the docket number found in brackets in the heading of this 
document. Received comments may be seen in the office above between 9 
a.m. and 4 p.m., Monday through Friday.

    Dated: September 12, 1997.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 97-24734 Filed 9-17-97; 8:45 am]
BILLING CODE 4160-01-F