• As many of our readers may know, marijuana is listed as a Schedule I substance under federal law. However, individual state laws do not always conform to the federal standard. In eight states, the sale and possession of marijuana is legal for both medical and recreational use, and twenty-three states and the District of Columbia allow some degree of medical marijuana use. To date, the Food and Drug Administration (FDA) has not approved a marketing application for marijuana for any indication. However, the FDA is aware of some marijuana products marketing claims of health benefits.
  • At an October 3rd hearing before Congress on a separate matter, FDA Commissioner Scott Gottlieb hinted that the Agency may start cracking down on claims that marijuana has health benefits that have not been proven. “I see people who are developing products who are making claims that marijuana has antitumor effects in the setting of cancer,” Commissioner Gottlieb said. “It’s a much broader question about where our responsibility is to step into this.” Conducting clinical research using marijuana involves interactions with several federal agencies, including the Drug Enforcement Administration (DEA) and the National Institute on Drug Abuse (NIDA), which means a decision regarding marijuana does not fall solely to the FDA. And while the FDA supports adequate and well-controlled clinical trials which may lead to the development of safe and effective marijuana products to treat medical conditions, the FDA has yet to find any product that contains or is derived from botanical marijuana to be safe or effective for the treatment of any disease or condition.
  • FDA appears to be considering rules around the plant, with Commissioner Gottlieb admitting, “We’ll have some answers to this question very soon because I think we do bear some responsibility to start to address these questions.”