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

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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), Start Printed Page 102291301.18, 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.

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Dated: February 22, 2002.

Asa Hutchinson,

Administrator.

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[FR Doc. 02-5240 Filed 3-5-02; 8:45 am]

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