[Federal Register Volume 67, Number 44 (Wednesday, March 6, 2002)]
[Notices]
[Pages 10228-10229]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-5240]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Ethical Nutritional, L.L.C.; Denial of Application

    On or about March 21, 2000, the Deputy Assistant Administrator, 
Office of Diversion Control, Drug Enforcement Administration (DEA), 
issued an Order to Show Cause (OTSC) by certified mail to Ethical 
Nutritional, L.L.C. (Ethical), located in Pomona, California, notifying 
it of an opportunity to show cause as to why the DEA should not deny 
its application, dated October 28, 1998, for a DEA Certificate of 
Registration as an importer of Schedule I controlled substances 
pursuant to 21 U.S.C. 952(a), proposing to import marijuana and peyote 
to manufacture and distribute homeopathic substances containing the 
Schedule I controlled substances for human consumption, a purpose not 
in conformity with the provisions of the Controlled Substances Act, 
pursuant to 21 U.S.C. 812(b)(1), 822(b), 823(f)(4), and 841(a)(1). The 
order also notified Ethical that, should no request for hearing be 
filed within 30 days the right to a hearing would be waived.
    The OTSC was received on or about March 29, 2000, as indicated by 
the signed postal return receipt. On or about April 25, 2000, Ethical, 
through counsel, filed with the Office of Administrative Law Judges 
(ALJ) a request for extension of time to respond to the OTSC; an 
extension was granted until May 25, 2000. On May 21, 2000, the 
Government filed a Motion for Summary Disposition. On May 26, 2000, 
Ethical, through counsel, filed a Memorandum stating that Ethical ``no 
longer intends to pursue the importation of Peyote and Marijuana. 
Accordingly, no response to the Order to Show Cause * * * will be 
submitted.'' On June 8, 2000, the ALJ issued a Termination Order 
finding that Ethical had waived its right to a hearing. Since that 
time, no further response has been received from the applicant nor any 
person purporting to represent the applicant. Therefore, the 
Administrator of the DEA, finding that (1) thirty days having passed 
since receipt of the Order to Show Cause, and (2) no further request 
for a hearing having been received, concludes that Ethical is deemed to 
have waived its right to a hearing. After considering relevant material 
from the investigative file in this matter, the Administrator now 
enters his final order without a hearing pursuant to 21 CFR 1301.43(e) 
and 1301.46.
    The Administrator finds that on or about May 28, 1998, Ethical was 
initially registered and issued DEA Certificate of Registration 
RE0235083, as a manufacturer of controlled substances in Schedules I-V. 
Ethical submitted an application, dated May 20, 1998, to be registered 
as an importer of inter alia the Schedule I controlled substances 
marijuana and peyote, pursuant to 21 U.S.C. 823(a). Ethical proposed to 
import these substances for the production of homeopathic remedies for 
human consumption. Ethical did not assert that the proposed importation 
of these substances was for any purpose authorized pursuant to 21 
U.S.C. 952(a)(2).
    The Administrator finds that Ethical's application is fundamentally 
incompatible with the Controlled Substances Act (CSA). Pursuant to the 
CSA, Schedule I controlled substances by definition have ``a high 
potential for abuse,'' ``no currently accepted medical use in treatment 
in the United States,'' and ``a lack of accepted safety for use * * * 
under medical supervision.'' 21 U.S.C. 812(b). Accordingly, the CSA 
prohibits the use of Schedule I controlled substances for human 
consumption outside of research that has been approved by the Food and 
Drug Administration (FDA) and registered with DEA. 21 U.S.C. 822(b), 
823(f), 841(a)(1); 21 CFR 5.10(a)(9),

[[Page 10229]]

1301.18, 1301.32. See, e.g. Kuromiya v. United States, 78 F.Supp. 2d 
367 and 37 F.Supp. 2d 717 (E.D.Pa. 1999) (upholding constitutionality 
of CSA provisions prohibiting use of marijuana).
    Ethical proposes to import marijuana and peyote to manufacture 
products that will be marketed for human consumption. This proposed use 
of Schedule I controlled substances is not permissible under the CSA.
    Ethical does not attempt to show that it proposes to engage in FDA-
approved research. Nor has Ethical attempted to establish the statutory 
elements required to become a registered importer of Schedule I 
controlled substances pursuant to 21 U.S.C. 952(a)(2). Further, the 
Administrator finds no evidence that allowing the proposed importer 
registration would be consistent with the public interest pursuant to 
21 U.S.C. 958(a).
    For the above-stated reasons, the application of Ethical must be 
denied.
    Accordingly, the Administrator of the Drug Enforcement 
Administration, pursuant to the authority vested in him by 21 U.S.C. 
823 and 824 and 28 CFR 0.100(b) and 0.104, hereby orders that the 
application for a DEA Certificate of Registration submitted by Ethical 
Nutritional, L.L.C., be, and it hereby is, denied. This order is 
effective March 6, 2002.

    Dated: February 22, 2002.
Asa Hutchinson,
Administrator.
[FR Doc. 02-5240 Filed 3-5-02; 8:45 am]
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