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What is FDA’s interest in regulating cannabis?

There is a common misconception that rescheduling or descheduling impacts FDA’s role and its authority over cannabis products. While scheduling does impact how the product can be approved and used, the agency has shown little current interest in regulating recreational use of marijuana without more funding and a federal framework, despite its current authority to do so. For this reason, we do not believe reducing its schedule on the Controlled Substances List will change FDA’s current approach. Further, the FDA does not have the resources to engage in an all-out effort to regulate state programs – something that would take political will that is not there now. 

  • The FDA’s current interest in regulating cannabis stems from its public health mission and authority in the Federal Food, Drug, and Cosmetic Act (FD&C Act). For cannabis, the FDA treats it like any other regulated product, regardless of whether it’s classified as marijuana or hemp. 
  • As with all foods and supplements, the FDA must consider them safe — usually through standards such as good manufacturing practices. Because the FDA has not extended those standards to cannabinoids, the FDA considers them adulterants and illegal to use. That means that smokable or edible marijuana products are not approved. As mentioned, it has not sought enforcement action against state programs or individual businesses despite that determination. 
  • As it pertains to enforcement, FDA has said that it has and will continue to monitor the marketplace and take action to protect the public health against companies selling cannabis and cannabis-derived products that are being marketed for therapeutic uses for which they are not approved. So far, it is products that have associated drug claims that are of greatest interest and concern for the FDA.