As discussed above (see Question #2), the 2018 Farm Bill removed hemp from the CSA. This change may streamline the process for researchers to study cannabis and its derivatives, including CBD, that fall under the definition of hemp, which could speed the development of new drugs.
A. No. Based on available evidence, FDA has concluded that THC and CBD products are excluded from the dietary supplement definition under section 201(ff)(3)(B) of the FD&C Act [21 U.S.C. § 321(ff)(3)(B)]. Under that provision, if a substance (such as THC or CBD) is an active ingredient in a drug product that has been approved under section 505 of the FD&C Act [21 U.S.C. § 355], or has been authorized for investigation as a new drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, then products containing that substance are excluded from the definition of a dietary supplement. FDA considers a substance to be “authorized for investigation as a new drug” if it is the subject of an Investigational New Drug application (IND) that has gone into effect. Under FDA’s regulations (21 CFR 312.2), unless a clinical investigation meets the limited criteria in that regulation, an IND is required for all clinical investigations of products that are subject to section 505 of the FD&C Act.
A. The agency has received reports of adverse events in patients using cannabis or cannabis-derived products to treat medical conditions. The FDA reviews such reports and will continue to monitor adverse event reports for any safety signals, with a focus on serious adverse effects. Consumers and healthcare providers can report adverse events associated with cannabis or cannabis-derived products via the FDA’s MedWatch reporting system, either online or by phone at 1-800-FDA-1088. For more information, please see the FDA’s webpage on MedWatch.
Questions and Answers
A. No. The FDA believes that scientifically valid research conducted under an IND application is the best way to determine what patients could benefit from the use of drugs derived from cannabis. The FDA supports the conduct of that research by:
A. Information for patients on Right to Try (RTT) is available on our website. RTT is designed to facilitate access to certain investigational drugs through direct interactions between patients, their physicians and drug sponsors – FDA is not involved in these decisions. Sponsors developing drugs for life-threatening conditions are responsible for determining whether to make their products available to patients who qualify for access under RTT. If you are interested in RTT, you should discuss this pathway with your licensed physician. Companies who develop drugs and biologics, also known as sponsors, can provide information about whether their drug/biologic is considered an eligible investigational drug under RTT and if they are able to provide the drug/biologic under the RTT Act.
The agency also has approved Marinol and Syndros for therapeutic uses in the United States, including for the treatment of anorexia associated with weight loss in AIDS patients. Marinol and Syndros include the active ingredient dronabinol, a synthetic delta-9- tetrahydrocannabinol (THC) which is considered the psychoactive component of cannabis. Another FDA-approved drug, Cesamet, contains the active ingredient nabilone, which has a chemical structure similar to THC and is synthetically derived.
 Hayatbakhsh, et al. Birth Outcomes associated with cannabis use before and during pregnancy. Pediatric Research. 2012; 71 (2): 215-219.
If CBD oil comes from hemp, it is federally legal. If CBD oil comes from marijuana, it is federally illegal. State laws, however, vary widely.
It depends. In terms of federal law, the legality of CBD oil depends largely on where the CBD came from and where it is being used, so it is important to understand some cannabis fundamentals.
America’s relationship with cannabis is complicated. According to federal law, cannabis — including CBD — is still predominantly illegal, although there are exceptions. Even with the continuing federal prohibition of cannabis, most U.S. states have enacted their own cannabis-related laws. As such, CBD oils reside in a legal grey area.
Hemp vs. Marijuana
Every U.S. state allows for the use of cannabis in some form, but each state’s laws are different. For example, Washington state law allows residents to legally consume CBD oil for recreational purposes, whereas South Dakota state law categorizes CBD as a Schedule IV controlled substance and allows citizens to use CBD only in forms that are approved by the Food and Drug Administration, e.g., Epidiolex.
Cannabis is filled with chemicals. Arguably the most well known of these chemicals is tetrahydrocannabinol (THC). Whereas THC is largely responsible for cannabis’ “high," CBD does not result in a high. Supplement manufacturers are making CBD into many forms, including oils, tinctures, pills, and lotions. Some supposed benefits of using CBD include:
Although cultures around the world have used cannabis for centuries, Americans are just now beginning to understand what cannabis and the chemical compounds in it do to the human body. Cannabidiol (CBD) oil, in particular, has become wildly popular for its alleged health benefits, but is CBD oil legal?
Both industrial hemp and marijuana are members of the cannabis family, but they are treated differently under federal law. Industrial hemp, as defined by the federal government, is cannabis that contains less than 0.3% THC by weight. Marijuana is defined as any cannabis that contains more than 0.3% THC by weight.
In states where recreational marijuana is legal, the list of cannabis-derived products greatly expands to include CBD with much higher THC content than 0.3%.
CBD is a compound found in cannabis. There are hundreds of such compounds, which are termed “cannabinoids,” because they interact with receptors involved in a variety of functions like appetite, anxiety, depression and pain sensation. THC is also a cannabinoid.
Great Danes and chihuahuas are distant cousins, like marijuana and hemp. Pixy, CC BY
Hemp, marijuana and cannabanoidals
Consumers concerned about content and the accuracy of CBD products, which are not regulated by the Food and Drug Administration, can look for certification from independent lab testing or by scanning a QR code on product packaging.
Another big difference among hemp, marijuana and CBD is how the law treats them.
Michigan State University provides funding as a founding partner of The Conversation US.
As interest in other cannabinoids, like cannabigerol, or CBG – which some are touting as the new CBD – continues to grow, so too grows the need for further medical research into cannabis.