Ingredients that are derived from parts of the cannabis plant that do not contain THC or CBD might fall outside the scope of this exclusion, and therefore might be able to be marketed as dietary supplements. However, all products marketed as dietary supplements must comply with all applicable laws and regulations governing dietary supplement products. For example, manufacturers and distributors who wish to market dietary supplements that contain “new dietary ingredients” (i.e., dietary ingredients that were not marketed in the United States in a dietary supplement before October 15, 1994) generally must notify FDA about these ingredients (see section 413(d) of the FD&C Act [21 U.S.C. § 350b(d)]). Generally, the notification must include information demonstrating that a dietary supplement containing the new dietary ingredient will reasonably be expected to be safe under the conditions of use recommended or suggested in the labeling. A dietary supplement is adulterated if it contains a new dietary ingredient for which there is inadequate information to provide reasonable assurance that the ingredient does not present a significant or unreasonable risk of illness or injury (see section 402(f)(1)(B) of the FD&C Act [21 U.S.C. 342(f)(1)(B)]).
A. The FDA is aware that there are potential adverse health effects with use of cannabis products containing THC in pregnant or lactating women. Published scientific literature reports potential adverse effects of cannabis use in pregnant women, including fetal growth restriction, low birth weight, preterm birth, small-for-gestational age, neonatal intensive care unit (NICU) admission, and stillbirth. [1, 2, 3] Based on published animal research, there are also concerns that use of cannabis during pregnancy may negatively impact fetal brain development. [4, 5, 6 ] The American College of Obstetricians and Gynecologists (ACOG) recommends that women who are pregnant or contemplating pregnancy should be encouraged to discontinue cannabis use. In addition, ACOG notes that there are insufficient data to evaluate the effects of cannabis use on breastfed infants; therefore, cannabis use is discouraged when breastfeeding.  Pregnant and lactating women should talk with a health care provider about the potential adverse health effects of cannabis use.
There is a significant interest in the development of therapies and other consumer products derived from cannabis and its components, including cannabidiol (CBD). FDA recognizes the potential opportunities that cannabis or cannabis-derived compounds may offer and acknowledges the significant interest in these possibilities. However, FDA is aware that some companies are marketing products containing cannabis and cannabis-derived compounds in ways that violate the Federal Food, Drug and Cosmetic Act (FD&C Act) and that may put the health and safety of consumers at risk. The agency is committed to protecting the public health while also taking steps to improve the efficiency of regulatory pathways for the lawful marketing of appropriate cannabis and cannabis-derived products. FDA has a number of resources available that address cannabis and cannabis-derived products, such as CBD, and the agency wants to ensure that consumers and other stakeholders have access to these resources in a centralized location.
Below are a number of frequently asked questions and answers on this topic.
Research and Expanded Access
A. We understand that parents are trying to find treatments for their children’s medical conditions. However, the use of untested drugs can have unpredictable and unintended consequences. Caregivers and patients can be confident that FDA-approved drugs have been carefully evaluated for safety, efficacy, and quality, and are monitored by the FDA once they are on the market. The FDA continues to support sound, scientifically-based research into the medicinal uses of drug products containing cannabis or cannabis-derived compounds, and will continue to work with companies interested in bringing safe, effective, and quality products to market. With the exception of Epidiolex, Marinol, and Syndros, no product containing cannabis or cannabis-derived compounds (either plant-based or synthetic) has been approved as safe and effective for use in any patient population, whether pediatric or adult.
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.
This has put CBD into an interesting legal position, leading to confusion of whether CBD oil is a federally restricted Schedule I substance or is now federally legal. At the federal level, legality all depends on what type of plant the CBD comes from, as well as how much THC is present in both the original plant and the final product.
In the United States, the Drug Enforcement Agency (DEA) classifies different controlled substances drugs by grouping them into five separate categories. Photo by: Photo by Gina Coleman/Weedmaps
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.
Interestingly, recent research seems to back up the position that CBD is not a drug in this sense that it isn’t normally detected during a drug screening. Most U.S. employers, for instance, abide by the guidelines set forth by the Substance Abuse and Mental Health Services Administration (SAMHSA), which includes detection for THC but not for CBD. Most employment drug tests specifically look for the presence of THC or THC metabolites, but it’s highly unlikely that CBD oil will show up on a drug test.
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. Photo by: Gina Coleman/Weedmaps
Federal classification of CBD is one of the biggest areas of confusion still surrounding CBD, CBD oil, and other CBD-infused products, leaving some to wonder: Is CBD or CBD oil a Schedule I drug?
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.