FDA’s single-molecule fetish for drugs is on a collision course with the CBD industry’s full- and broad-spectrum, multi-molecule ethos. This is the agency’s second open public comment period on CBD and Cannabis.
FDA wants to hear from you regarding its recent report to Congress on CBD.
Submit your comments by clicking on:
This guidance outlines FDA’s current thinking on several topics relevant to clinical research related to the development of drugs containing CBD. Cannabis and cannabis-derived compounds that may be used in drug manufacturing include botanical raw materials, extracts, and highly purified substances of botanical origin.
This guidance does not address development of fully synthetic versions of substances that occur in cannabis, sometimes known as cannabis-related compounds, which are regulated like other fully synthetic drugs. This guidance is limited to the development of human drugs and does not cover other FDA-regulated products (such as foods, animal products).
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date of September 20, 2020.
Docket Number: FDA-2020-D-1079 Issued by: Center for Drug Evaluation and Research
- Content current as of: 07/21/2020
- Regulated Product(s)