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.
8. Is it legal for me to sell CBD products?
2. How does the 2018 Farm Bill define hemp? What does it mean for FDA-regulated products?
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:
11. In making the two previous determinations about THC, why did FDA conclude that THC is an active ingredient in a drug product that has been approved under section 505 of the FD&C Act? In making the two previous determinations about CBD, why did FDA determine that substantial clinical investigations have been authorized for and/or instituted, and that the existence of such investigations has been made public?
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.
A. No. There are no other FDA-approved drug products that contain CBD. We are aware that some firms are marketing CBD products to treat diseases or for other therapeutic uses , and we have issued several warning letters to such firms. Under the FD&C Act, any product intended to have a therapeutic or medical use, and any product (other than a food) that is intended to affect the structure or function of the body of humans or animals, is a drug. Drugs must generally either receive premarket approval by FDA through the New Drug Application (NDA) process or conform to a “monograph” for a particular drug category, as established by FDA’s Over-the-Counter (OTC) Drug Review. CBD was not an ingredient considered under the OTC drug review. An unapproved new drug cannot be distributed or sold in interstate commerce.
Taken together, these two changes made by the AIA limit the definition of marihuana to only include cannabis or cannabis-derived material that contain more than 0.3% delta-9-tetrahydrocannabinol (also known as Δ 9 -THC) on a dry weight basis. Thus, to fall within the current CSA definition of
This interim final rule removes FDA-approved products containing CBD from schedule V control, including controls over the importation and exportation of this class of drugs. There is currently only one drug that meets these criteria for decontrol.17 To determine any cost savings resulting from this decontrol action, DEA analyzed its registration, import, and export data. DEA believes all entities that currently handle FDA-approved CBD products also handle other controlled substances. This means the decontrol of this product will not allow these DEA registrants to benefit from any registration-related cost savings. However, like importers of viable hemp seed, importers and exporters of FDA-approved CBD products will no longer be required to obtain import and export permits from DEA.
This interim final rule is required by statute, and will not have tribal implications or impose substantial direct compliance costs on Indian tribal governments.
Implementation of the Agriculture Improvement Act of 2018