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FDA and HHS want your comments on CBD in schedule 1


bax
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https://www.federalregister.gov/documents/2017/08/14/2017-17119/international-drug-scheduling-convention-on-psychotropic-substances-single-convention-on-narcotic

Psychoactive substances to be reviewed by the 39th ECDD:
1. Ocfentanil
2. Furanyl fentanyl (Fu-F)
3. Acryloylfentanyl (Acrylfentanyl)
4. Carfentanil
5. 4-fluoroisobutyrfentanyl (4-FIBF, pFIBF)
6. Tetrahydrofuranylfentanyl (THF-F)
7. 4-fluoroamphetamine (4-FA)
8. AB-PINACA
9. AB-CHMINACA
10. 5F-PB-22
11. UR-144
12. 5F-ADB
13. Etizolam
14. Pregabalin
15. Tramadol
16. Cannabidiol (CBD)

Cannabidiol (CBD) is one of the active cannabinoids identified in cannabis. CBD has been shown to be beneficial in experimental models of several neurological disorders, including those of seizure and epilepsy. In the United States, CBD-containing products are in human clinical testing in three therapeutic areas, but no such products are approved by FDA for marketing for medical purposes in the United States. CBD is a Schedule I controlled substance under the CSA. At the 37th (2015) meeting of the ECDD, the committee requested that the Secretariat prepare relevant documentation to conduct pre-reviews for several substances, including CBD.

IV. Opportunity To Submit Domestic Information

As required by section 201(d)(2)(A) of the CSA, FDA, on behalf of HHS, invites interested persons to submit comments regarding the 17 named drug substances. Any comments received will be considered by HHS when it prepares a scientific and medical evaluation of these drug substances. HHS will forward a scientific and medical evaluation of these drug substances to WHO, through the Secretary of State, for WHO's consideration in deciding whether to recommend international control/decontrol of any of these drug substances. Such control could limit, among other things, the manufacture and distribution (import/export) of these drug substances and could impose certain recordkeeping requirements on them.

Although FDA is, through this notice, requesting comments from interested persons, which will be considered by HHS when it prepares an evaluation of these drug substances, HHS will not now make any recommendations to WHO regarding whether any of these drugs should be subjected to international controls. Instead, HHS will defer such consideration until WHO has made official recommendations to the Commission on Narcotic Drugs, which are expected to be made in early 2018. Any HHS position regarding international control of these drug substances will be preceded by another Federal Register notice soliciting public comments, as required by section 201(d)(2)(B) of the CSA.

DATES:

Submit either electronic or written comments by September 13, 2017.
ADDRESSES:

You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before September 13, 2017. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of September 13, 2017. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.

Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov.

Edited by bax
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