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The industry is on uncertain ground regarding the U.S. manufacture, sale and distribution of cannabidiol (CBD) as a dietary ingredient in a dietary supplement or as a finished dietary supplement product. CBD is subject to federal statutes and regulations, some of which are implemented and enforced by FDA and others by DEA. State statutes and regulations also come into play. Companies involved with CBD must stay abreast of the regulatory climate as the market develops.

Regulatory ambiguity in defining the terms CBD, hemp and ‘marihuana’ leaves room for uneasiness in the CBD industry. For a legal green light, CBD must not be considered marihuana as part of the Controlled Substances Act, and it must qualify as a dietary ingredient pursuant to the Dietary Supplement Health and Education Act of 1994 (DSHEA), an extension of the Federal Food Drug and Cosmetic Act (FDCA). The 2014 Farm Bill also instituted pro-CBD provisions concerning the propagation of industrial hemp.

  • The U.S. president, attorney general and agency heads largely influence enforcement discretion.
  • FDA expressly stated it prioritizes situations involving drug safety, effectiveness or health fraud.
  • A lawsuit against DEA seeks to exempt CBD from a final rule establishing a marihuana extract drug code.