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 existence of substantial clinical investigations regarding THC and CBD have been made public. For example, two such substantial clinical investigations include GW Pharmaceuticals’ investigations regarding Sativex. (See Sativex Commences US Phase II/III Clinical Trial in Cancer Pain )
The FDA will continue to facilitate the work of companies interested in appropriately bringing safe, effective, and quality products to market, including scientifically-based research concerning the medicinal uses of cannabis. Additional information concerning research on the medical use of cannabis is available from the National Institutes of Health, particularly the National Cancer Institute (NCI) and National Institute on Drug Abuse (NIDA).
Research and Expanded Access
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. All ingredients in animal food must be the subject of an approved food additive petition or generally recognized as safe (GRAS) for their intended use in the intended species. If an animal food contains an ingredient that is not the subject of an approved food additive petition or GRAS for its intended use in the intended species, that animal food would be adulterated under section 402(a)(2)(C)(i) of the FD&C Act [21 U.S.C. § 342(a)(2)(C)(i)]. In coordination with state feed control officials, CVM also recognizes ingredients listed in the Official Publication (OP) of the Association of American Feed Control Officials (AAFCO) as being acceptable for use in animal food. At this time, there are no approved food additive petitions or ingredient definitions listed in the AAFCO OP for any substances derived from hemp, and we are unaware of any GRAS conclusions regarding the use of any substances derived from hemp in animal food. Learn more about animal food ingredient submissions here.
23. What should I do if my child eats something containing cannabis?
 Trezza, et al. Effects of perinatal exposure to delta-9-tetrahydrocannabinol on the emotional reactivity of the offspring: a longitudinal behavioral study in Wistar rats. Psychopharmacology (Berl) 2008; 198(4): 529-537.
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.
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
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.
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:
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.
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?
Marijuana, containing both CBD and more THC than hemp, has demonstrated therapeutic benefits for people with epilepsy, nausea, glaucoma and potentially even multiple sclerosis and opioid-dependency disorder.
Another big difference among hemp, marijuana and CBD is how the law treats them.
Hemp, marijuana and cannabanoidals
Trey Malone receives funding from the U.S. Department if Agriculture, the Charles Koch Foundation, and the Michigan Department of Agriculture and Rural Development.
The defining difference between hemp and marijuana is their psychoactive component: tetrahydrocannabinol, or THC. Hemp has 0.3% or less THC, meaning hemp-derived products don’t contain enough THC to create the “high” traditionally associated with marijuana.
There is no standardized dosage of CBD. Some retailers may have enough knowledge to make a recommendation for first-timers. There are also online resources – like this dosage calculator.