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dea classification of cbd oil

A. In December 2018, FDA completed its evaluation of three generally recognized as safe (GRAS) notices for the following hemp seed-derived food ingredients: hulled hemp seed, hemp seed protein powder, and hemp seed oil. FDA had no questions regarding the company’s conclusion that the use of such products as described in the notices is safe. Therefore, these products can be legally marketed in human foods for the uses described in the notices, provided they comply with all other requirements. These GRAS notices related only to the use of these ingredients in human food. To date, FDA has not received any GRAS notices for the use of hemp-derived ingredients in animal food (see Question #25).

[1] Gray, et al. Identifying Prenatal Cannabis Exposure and Effects of Concurrent Tobacco Exposure on Neonatal Growth. Clinical Chemistry. 2010; 56(9): 1442-1450.

Regulatory Resources

A. The FDA has sent warning letters in the past to companies illegally selling CBD products that claimed to prevent, diagnose, treat, or cure serious diseases, such as cancer. Some of these products were in further violation of the FD&C Act because they were marketed as dietary supplements or because they involved the addition of CBD to food.

A. Cannabis is a plant of the Cannabaceae family and contains more than eighty biologically active chemical compounds. The most commonly known compounds are delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD). Parts of the Cannabis sativa plant have been controlled under the Controlled Substances Act (CSA) since 1970 under the drug class “Marihuana” (commonly referred to as “marijuana”) [21 U.S.C. 802(16)]. “Marihuana” is listed in Schedule 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 use of the plant in the United States.

While the agency is aware of reports of pets consuming various forms of cannabis, to date, FDA has not directly received any reports of adverse events associated with animals given cannabis products. However, adverse events from accidental ingestion are well-documented in scientific literature. If you feel your animal has suffered from ingesting cannabis, we encourage you to report the adverse event to the FDA. Please visit Reporting Information about Animal Drugs and Devices to learn more about how to report an adverse event related to an animal drug or for how to report an adverse event or problem with a pet food.

Whether CBD is considered a drug ultimately depends on your definition of the word “drug.” On the one hand, if you’re referring to a substance that can be used for medicinal applications, then yes, many people would consider CBD to be a drug that generally promotes health and wellness. This position is backed up by the rapidly growing body of research pointing to CBD’s far-reaching wellness, therapeutic, and medicinal qualities.

However, the list of FDA approved drugs that contain cannabis-derived compounds remains limited to a single CBD-based product: an epilepsy medicine called Epidiolex, made by GW Pharmaceuticals. Any other medication is technically not approved under federal law and would, therefore, be considered illegal at the federal level, which is why CBD producers are not permitted to make health claims about their products.

State laws are the other consideration when it comes to the legal status of CBD. Currently, hemp-derived CBD is legal in most states. As a result, it is increasingly easy to find CBD products in many cities and states despite the technicalities of federal law. Additionally, in certain states with medical marijuana legalization, CBD products containing THC are also permitted for qualifying patients. CBD products with more than .3% THC are also legalized in states with adult-use programs in place.

Is CBD considered a drug?

The 2014 Hemp Farming Bill created a framework for the legal cultivation of industrial hemp without requiring a permit from the DEA. Four years later, the passage of the Hemp Farming Act of 2018 which was signed into law by President Donald Trump in November 2018, introduced a new legal channel through which certain types of CBD can be considered legal. The measure removed industrial hemp plants from its earlier status as a controlled substance, shifting oversight from the DEA to the FDA.

Two of the most abundant cannabinoids produced by the cannabis plant are THC, which produces the plant’s renowned intoxicating effects, and CBD, which is a non-intoxicating compound and appears to provide many therapeutic and medicinal qualities. This combination of cannabis compounds are also key in understanding how the Schedule I classification applies to CBD products.

After the 2018 Farm Bill was signed, FDA Commissioner Scott Gottlieb issued a statement confirming that the agency would oversee and regulate hemp-derived CBD products under the Federal Food Drug & Cosmetic Act (FD&C Act) and that only “cosmetic” CBD products would be allowed. According to the FDA, cosmetics are defined as “articles intended to be rubbed, poured, sprinkled, or sprayed” on the human body, a description that fits many hemp-derived CBD products.

According to the DEA, these categories are based upon the drug’s abuse or dependency potential as well as its acceptable medical use. However, it’s important to note that this classification system has frequently been called into question by people who are concerned that law enforcement uses the CSA to overly criminalize substances that may not actually be as dangerous as the DEA states.