Update 12/12/18! Congress has passed the 2019 Farm Bill which, if signed into law by the President, will lift federal restrictions on hemp production. As CBD is derived from hemp, this could lead to changes in the legal status of CBD oil products which, as noted in the article below, are actually not legal to market as dietary supplements under current federal law. FDA has previously stated that CBD products are “excluded from the definition of dietary supplements”. (Furthermore, FDA still considers any product marketed with claims or implied claims to treat, cure, mitigate, or diagnose and disease to be a drug product which may not be legally marketed as a dietary supplement.) We will continue to provide additional updates to the regulatory status of CBD oil, so check back here soon!
Law enforcement officials have taken regulatory action against cannabidiol (CBD) oil, a popular dietary supplement marketed for it for relaxation, anti-inflammatory, pain relief, and other benefits. For example, the Drug Enforcement Agency (DEA) has seized CBD oil products held for sale in retail stores, and FDA has issued warning letters to companies marketing CBD oil as dietary supplements. Yet, the product remains widely available in stores across the United States. Hence, the legal status of CBD oil remains a confusing issue even to federal and local regulatory agencies at this time.
In spite of CBD oil being a popular product in the United States, FDA has stated in warning letters that CBD products are “excluded from the dietary supplement definition” and thus are subject to drug regulation under the Federal Food, Drug, and Cosmetic Act. In addition, CBD is a controlled substance under the Controlled Substances Act.
FDA appears to focus its attention on products that are marketed using claims of treating, curing, diagnosing, or preventing any disease. The Agency has issued warning letters to firms for marketing CBD products as dietary supplements with claims of treating cancer, diabetes, high blood pressure, arthritis, mental disorders, and other conditions. FDA charged these products as unapproved new drugs.
In order to legally market a drug in the United States, a new drug application must be approved by the FDA for the product. FDA recently approved a CBD drug used for treating epilepsy, and this drug has been placed in the schedule 5 list of controlled substances, which clears the way for the product to be sold as a drug in the US. However, CBD products not approved by FDA for drug use remain as schedule 1 controlled substances which are not permitted for medical use under federal law.
In summary, CBD oil remains a popular product sold in stores across America though federal officials have taken enforcement action against the product. FDA currently maintains its position that in order to sell a CBD product in the United States, it must be covered by a new drug application. The issue remains the subject of much debate, so stay tuned to www.fdaspecialist.com for further developments!