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Trending Topic: CBD Oil
In just a couple of years, products containing cannabidiol (CBD oil) have gone from virtually unknown to the hottest thing in non-prescription treatments for pain, anxiety and a host of other ailments. A recent survey conducted by BDS Analytics and Arcview Market Research projected that the market for CBD sales in the United States will exceed $20 billion (yes, billion) by 2024.
NCMB’s Policy Committee recommended at the May 2019 Board meeting that NCMB not develop a formal position statement on CBD at this time. The Policy Committee did direct staff to study and develop FAQs to address questions raised by licensees.
At its July 2019 meeting, the Board approved a single FAQ (see below), which discusses the sale of CBD products by medical practices. The FAQ references the Board’s existing position statement on the sale of goods by medical practices while citing recent guidance from the NC Dept. of Agriculture and the U.S. Food and Drug Administration. Licensees are advised to carefully consider the statements of these agencies.
May a licensee sell products or supplements containing Cannabidiol (“CBD”) from his or her medical practice?
The Board has provided guidance on the ethical implications of selling practice-related items by licensees in its position statement on “Sale of Goods from Physician Offices.” Subject to the ethical considerations provided in that position statement and any relevant legal restrictions, licensees are generally permitted to sell practice-related items to their patients. There are, however, dynamic legal considerations related to CBD-containing products with which licensees should be familiar before deciding to sell such products. Both the FDA and the NC Department of Agriculture have issued recent statements about the legality of CBD-containing products.
In December 2018, FDA Commissioner Scott Gottlieb issued a statement explaining that: “it’s unlawful under the FD&C Act to introduce food containing added CBD or THC into interstate commerce, or to market CBD or THC products as, or in, dietary supplements, regardless of whether the substances are hemp-derived. This is because both CBD and THC are active ingredients in FDA-approved drugs and were the subject of substantial clinical investigations before they were marketed as foods or dietary supplements. Under the FD&C Act, it’s illegal to introduce drug ingredients like these into the food supply, or to market them as dietary supplements.” The text of the FDA’s statement can be found here. In addition, the FDA has also provided questions and answers related to the regulation of cannabis-derived products on its website.
Additionally, in February 2019, the NC Department of Agriculture indicated it planned to issue letters containing CBD Advisory Warnings. The Department of Agriculture warns that because the Federal Food, Drug and Cosmetics Act has been adopted and implemented in North Carolina: (1) it is illegal to sell any food containing CBD because CBD is the active ingredient in the FDA-approved drug product Epidiolex; (2) CBD is also excluded from being considered a dietary supplement because it is the active ingredient in Epidiolex; and (3) any product that contains CBD and claims to prevent, mitigate, diagnose, treat or cure diseases is considered a drug and must have prior approval from the FDA. Read a sample NC Dept. of Agriculture Advisory Warning
NCMB’s Policy Committee recommended at the May 2019 Board meeting that NCMB not develop a formal position statement on CBD at this time. The Policy Committee did direct staff to study and develop FAQs to address questions raised by licensees.
At its July 2019 meeting, the Board approved a single FAQ (see below), which discusses the sale of CBD products by medical practices. The FAQ references the Board’s existing position statement on the sale of goods by medical practices while citing recent guidance from the NC Dept. of Agriculture and the U.S. Food and Drug Administration. Licensees are advised to carefully consider the statements of these agencies.
May a licensee sell products or supplements containing Cannabidiol (“CBD”) from his or her medical practice?
The Board has provided guidance on the ethical implications of selling practice-related items by licensees in its position statement on “Sale of Goods from Physician Offices.” Subject to the ethical considerations provided in that position statement and any relevant legal restrictions, licensees are generally permitted to sell practice-related items to their patients. There are, however, dynamic legal considerations related to CBD-containing products with which licensees should be familiar before deciding to sell such products. Both the FDA and the NC Department of Agriculture have issued recent statements about the legality of CBD-containing products.
In December 2018, FDA Commissioner Scott Gottlieb issued a statement explaining that: “it’s unlawful under the FD&C Act to introduce food containing added CBD or THC into interstate commerce, or to market CBD or THC products as, or in, dietary supplements, regardless of whether the substances are hemp-derived. This is because both CBD and THC are active ingredients in FDA-approved drugs and were the subject of substantial clinical investigations before they were marketed as foods or dietary supplements. Under the FD&C Act, it’s illegal to introduce drug ingredients like these into the food supply, or to market them as dietary supplements.” The text of the FDA’s statement can be found here. In addition, the FDA has also provided questions and answers related to the regulation of cannabis-derived products on its website.
Additionally, in February 2019, the NC Department of Agriculture indicated it planned to issue letters containing CBD Advisory Warnings. The Department of Agriculture warns that because the Federal Food, Drug and Cosmetics Act has been adopted and implemented in North Carolina: (1) it is illegal to sell any food containing CBD because CBD is the active ingredient in the FDA-approved drug product Epidiolex; (2) CBD is also excluded from being considered a dietary supplement because it is the active ingredient in Epidiolex; and (3) any product that contains CBD and claims to prevent, mitigate, diagnose, treat or cure diseases is considered a drug and must have prior approval from the FDA. Read a sample NC Dept. of Agriculture Advisory Warning