{"id":17408,"date":"2024-06-02T18:16:43","date_gmt":"2024-06-02T17:16:43","guid":{"rendered":"https:\/\/drugprevent.org.uk\/ppp\/?p=17408"},"modified":"2024-09-22T17:47:06","modified_gmt":"2024-09-22T16:47:06","slug":"is-cbd-a-controlled-substance-dea-yes-fda-no","status":"publish","type":"post","link":"https:\/\/drugprevent.org.uk\/ppp\/2024\/06\/is-cbd-a-controlled-substance-dea-yes-fda-no\/","title":{"rendered":"Is CBD a controlled substance? DEA: Yes- FDA: No"},"content":{"rendered":"

The communication below was issued by John Coleman, Chairman of DrugWatch International, to summarise the position with CBD and its legal status, as reported on in May 2020.<\/p>\n

The format, as an email, has been retained in this version.<\/p>\n

 <\/p>\n

From:<\/strong> drug-watch-international@googlegroups.com<\/a> <drug-watch-international@googlegroups.com<\/a>> On Behalf Of <\/strong>John J. Coleman, PhD
\nSent:<\/strong> 21 May 2020 17:30
\nTo:<\/strong> drug-watch-international@googlegroups.com<\/a>
\nSubject:<\/strong> Is CBD a controlled substance? DEA: Yes- FDA: No<\/p>\n

 <\/p>\n

In April 2020, the FDA approved a labelling for Epidiolex that specifically stated (at sect. 9.1) \u201cEPIDIOLEX is not a controlled substance.\u201d (see attachment). The DEA\u2019s list of controlled substances as of May 2020 shows \u201cAPPROVED CANNABIDIOL DRUGS, AS DEFINED IN 21 CFR 1308.15(f)\u201d as Schedule V controlled substance. The Code of Federal Regulations section referred to defines this as: \u201c(f) Approved cannabidiol drugs. (1) A drug product in finished dosage formulation that has been approved by the U.S. Food and Drug Administration that contains cannabidiol (2-[1R-3-methyl- 6R-(1-methylethenyl)-2-cyclohexen-1-yl]-5-pentyl-1,3- benzenediol) derived from cannabis and no more than 0.1 percent (w\/w) residual tetrahydrocannabinols.\u201d (See attachment)<\/p>\n

 <\/p>\n

It should be noted that the scheduling of Epidiolex and CBD was not done in the usual manner by both FDA and DEA performing medical and scientific evaluations and assessments of abuse potential but, instead, the placement of CBD in the Epidiolex formulation is Schedule V was done upon an Order by the Attorney General pursuant to notification by the Secretary of State that the drug is required to be controlled (i.e., scheduled) by virtue of its scheduling status in the 1961 Single Convention on Narcotic Drugs. The U.S. ratified this treaty and, as a result, the Constitution requires that treaty obligations be enforceable as domestic law. The Attorney General could undo the scheduling by simply rescinding his Order or issuing a replacement Order setting forth the removal of CBD and the approved formulation of Epidiolex from Schedule V.<\/p>\n

 <\/p>\n

I\u2019ve checked the Federal Register and there is nothing indicating that the Attorney General has removed CBD or Epidiolex from Schedule V as of May 20, 2020. I will make additional inquiries to see what\u2019s going on here. The FDA\u2019s label (prescribing information) is a legal certification of an approved drug\u2019s uses and indications \u2013 as is the Attorney General\u2019s Order (delegated to DEA) of 9\/28\/2018, described in 83 FR 48953. (See attachment)<\/p>\n

 <\/p>\n

John Coleman<\/p>\n

Source:\u00a0 www.drugwatch.org<\/a><\/p>\n

<<<<<<<<<<<<<<<<<<<<<<<<<<<<<<<<<<<<<<<<<DEA>>>>>>>>>>>>>>>>>>>>>>>>>>>>><\/p>\n

Links to view the articles related to the above presentation<\/strong><\/span>:<\/strong><\/p>\n

First click on the link, then click on the image that appears:<\/p>\n