Part of the draw to CBD oil in areas where marijuana has been legalized is the fact that it has been touted as helping treat a host of medical problems. Some of the medical issues people claim that the oil treats include epileptic seizures, anxiety, inflammation, and sleeplessness. However, there is very little evidence backing up these claims with the exception of treating epilepsy.
And despite the fact that the 2018 Farm Bill removed CBD from the definition of marijuana in the Controlled Substances Act, it is still subject to the same laws and regulations as other substances monitored by the FDA. Unfortunately, though, there is very little regulatory oversight of CBD oil in general—even though vaping is one of the most popular ways of using the oil. In fact, the FDA has not yet determined how to regulate CBD vaping products just yet.
What Is CBD Oil?
But many people are hoping those regulations will happen soon. Even the CBD industry is concerned and asking for oversight. For instance, without more regulations, organizations like the U.S. Hemp Authority are unable to certify CBD oils as it does with CBD topicals, tinctures, and edibles. And, until that happens, consumers have very little way of knowing what they are getting when they purchase a CBD oil.
Although the CDC has traced many of the EVALI hospitalizations back to vitamin E acetate, a substance used to dilute oils used in vaping, the risks of vaping CBD oil are not without risk, especially if the vape pens are obtained from illicit dealers, online sources, or friends. At least 26 of the EVALI cases were hospitalized after vaping CBD oil.
Vaping has been around for more than a decade now and is growing in popularity—especially among teens and young adults. One of the newest trends impacting this growing vape culture is the desire to vape cannabidiol (CBD) oil. In fact, using this oil in vape pens is becoming increasingly popular and the industry is expected to grow exponentially over the next few years according to the Brightfield Group, a firm that studies the CBD market.
19. Can patients gain access to cannabis or cannabis-derived products for medical use through Right to Try?
10. Is it legal, in interstate commerce, to sell a food (including any animal food or feed) to which THC or CBD has been added?
These GRAS conclusions do not affect the FDA’s position on the addition of CBD and THC to food.
Research and Expanded Access
A. General information about the import/export of drug products regulated by FDA can be found online here. The Drug Enforcement Administration (DEA) is the federal agency responsible for enforcing the controlled substance laws and regulations in the U.S. and, as such, should be consulted with respect to any regulations/requirements they may have regarding the import or export of products containing cannabis. Please see here for information about importing or exporting food ingredients.
We are aware that state and local authorities are fielding numerous questions about the legality of CBD. There is ongoing communication with state and local officials to answer questions about requirements under the FD&C Act, to better understand the landscape at the state level, and to otherwise engage with state/local regulatory partners.
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. Under section 301(ll) of the FD&C Act [21 U.S.C. § 331(ll)], it is prohibited to introduce or deliver for introduction into interstate commerce any food (including any animal food or feed) to which has been added a substance which 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 a drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public. There are exceptions, including when the drug was marketed in food before the drug was approved or before the substantial clinical investigations involving the drug had been instituted or, in the case of animal feed, that the drug is a new animal drug approved for use in feed and used according to the approved labeling. However, based on available evidence, FDA has concluded that none of these is the case for THC or CBD. FDA has therefore concluded that it is a prohibited act to introduce or deliver for introduction into interstate commerce any food (including any animal food or feed) to which THC or CBD has been added. FDA is not aware of any evidence that would call into question these conclusions. Interested parties may present the agency with any evidence that they think has bearing on this issue. Our continuing review of information that has been submitted thus far has not caused us to change our conclusions.