There is a considerable interest in the development of therapies and other consumer products derived from marijuana and its elements, including cannabidiol (CBD). FDA acknowledges the potential opportunities that cannabis or cannabis-derived substances may use and acknowledges the substantial interest in these possibilities. However, FDA knows that some companies are marketing items containing marijuana and cannabis-derived substances in methods that break the Federal Food, Drug and Cosmetic Act (FD&C Act) which might put the health and security of customers at risk.
FDA has a number of resources offered that address cannabis and cannabis-derived items, such as CBD, and the company wishes to make sure that consumers and other stakeholders have access to these resources in a central area. Below are a variety of regularly asked questions and responses on this topic. A.
The most commonly understood substances are delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD). Parts of the Marijuana sativa plant have been controlled under the Controlled Substances Act (CSA) given that 1970 under the drug class “Marihuana” (frequently referred to as “cannabis”) [21 U.S.C. 802( 16)] “Marihuana” is listed in Arrange I of the CSA due to its high potential for abuse, which is attributable in large part to the psychoactive effects of THC, and the absence of a currently accepted medical usage of the plant in the United States.
At the federal level, the Farming Enhancement Act of 2018, Pub. L. 115-334, (the 2018 Farm Costs) was signed into law on Dec. 20, 2018. Amongst other things, this new law changes specific federal authorities relating to the production and marketing of hemp, defined as “the plant Marijuana sativa L.
3 percent on a dry weight basis.” These changes include removing hemp from the CSA, which suggests that cannabis plants and derivatives which contain no more than 0. 3 percent THC on a dry weight basis are no longer controlled compounds under federal law. The 2018 Farm Expense, however, clearly maintained FDA’s authority to regulate products including marijuana or cannabis-derived compounds under the FD&C Act and area 351 of the general public Health Service Act (PHS Act).