Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research Guidance for Industry - Final Guidance

The commenter argues that the proposed guidance fails to acknowledge that cannabis can be regulated as a botanical dietary ingredient under the Dietary Supplement Health and Education Act (DSHEA). They request that the FDA revise the guidance to recognize DSHEA compatibility to break the current regulatory deadlock between the FDA and DEA regarding cannabis scheduling.

Unity Through Crisis argues that there is a fundamental policy contradiction between the FDA's approval of synthetic cannabis-derived drugs and the federal government's classification of the cannabis plant as having no medical use. They urge the FDA to resolve this hypocrisy to ensure the scientific and moral integrity of clinical research.

The commenter opposes the requirement for a New Drug Application (NDA) for cannabis-derived products, arguing that the regulatory burden is based on prejudice rather than science. They also argue that the government fails to acknowledge that these products are intended for adult use and that there is a lack of evidence regarding specific harm to minors.