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The FDA Is Asking For Comments On Cannabis

by Faith Fidura October 12, 2018
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The Food and Drug Administration (FDA) is asking for comments on 16 different drugs – and cannabis is one of them. 

The FDA is requesting interested persons to submit comments concerning abuse potential, actual abuse, medical usefulness, trafficking, and impact of scheduling changes on availability for medical use of the following 16 drug substances:

Cannabis and Cannabis-Related Substances
  • Cannabis plant and resin
  • Extracts and tinctures of cannabis
  • Delta-9-Tetrahydrocannabinol
  • Isomers of THC
Synthetic Cannabinoids
  • ADB-FUBINACA
  • FUB-AMB(MMB-FUBINACA_AMB-FUBINACA)
  • ADB-CHMINACA
  • CUMYL-4CN-BINACA
Fentanyls
  • Cyclopropyl fentanyl
  • Methoxyacetyl fentanyl
  • Ortho-fluorofentanyl
  • Parafluoro butyrfentanyl
  • Paramethoxybutyrfentanyl
(Meth)cathinone
  • N-ethylnorpentylone
Medicines
  • Tramadol
  • Pregabalin

These comments will be considered in preparing a response from the United States to the World Health Organization (WHO) regarding the abuse liability and diversion of these drugs. WHO will use this information to consider whether to recommend that certain international restrictions be placed on these drugs.

If you’d like to submit a comment, you can do so the following ways: 

Electronic Submission:
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.

Written/Paper Submission:
Mail/Hand delivery/Courier Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All submissions received must include the Docket No. FDA-2018-N-3685.

For more information and detailed instruction on comment submission, view the original Notice issued by the FDA.