Marijuana is classified as a Schedule I substance under the Controlled Substances Act, meaning it has a high potential for abuse, its medical use is not currently accepted in the United States, and an accepted lack of safety for use under medical supervision. Under federal law, CBD derived from cannabis plants with more than 0.3% THC is also considered a Schedule I drug. The Drug Enforcement Administration (DEA) states that Schedule 5 drugs have a low potential for abuse and are generally painkillers and antidiarrheals. Despite this, there is still much confusion surrounding the legal status of CBD, including the CBD class schedule and whether CBD or CBD oil are Schedule I drugs. Technically, any other drug not approved by federal law would be considered illegal at the federal level, so CBD producers are not allowed to make health claims about their products.
Some of these products further violated the Federal Food, Drug, and Cosmetic Act (FD&C Act) because they were marketed as dietary supplements or because they involved the addition of CBD to food. This change could expedite the process for researchers to study cannabis and its derivatives, including CBD, which falls under the definition of hemp, potentially accelerating the development of new drugs. Therefore, section 811(d)(1) of the FD&C Act expressly requires that this type of scheduling action not proceed through the notice-and-comment rulemaking procedures governed by the Administrative Procedure Act (APA), which generally apply to scheduling actions; instead, it requires that such scheduling action occur through the issuance of an “order”. Under this scheduling order, the United States will remain in compliance with this obligation because the bulk cannabis material used to make the Epidiolex formulation (as opposed to the drug approved by the FDA in final dosage form) will remain on Schedule I of the CSA and will therefore be subject to all applicable quotas and provisions under 21 U. S.
C. 811. It should also be noted that the Single Convention lists work somewhat differently than the CSA lists. Ingredients derived from parts of the cannabis plant that do not contain THC or CBD could fall outside the scope of this exclusion and could therefore be marketed as dietary supplements. According to the FDA, CBD derived from hemp plants is not yet approved for use in medicines or in food and beverage products. The FDA has sent warning letters in the past to companies that illegally sell CBD products that claim to prevent, diagnose, treat or cure serious illnesses such as cancer.
Therefore, it is prohibited to introduce or deliver for introduction into interstate commerce any food (including any food or animal feed) to which THC or CBD has been added. The agency announced Thursday that drugs that include “finished dose formulations” of CBD with a THC lower than 0.1% will be considered Schedule 5 drugs, as long as they have been approved by the U. Food and Drug Administration (FDA). Under this order, Epidiolex (and any generic version of the same formulation that may be approved by the FDA in the future) will be a Schedule V controlled substance.
