A. No. Based on available evidence, FDA has concluded that THC and CBD products are excluded from the dietary supplement definition under sections 201(ff)(3)(B)(i) and (ii) of the FD&C Act, respectively. Under those provisions, if a substance (such as THC or CBD) is an active ingredient in a drug product that has been approved under 21 U.S.C. § 355 (section 505 of the FD&C Act), 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 outside 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.
In this edition of Cannabis Conversations, Project CBD Director, Martin A. Lee, discusses the benefits of CBD, the "entourage effect" and the microbiome with Dr. Ethan Russo. A neurologist, scientist, and widely published author, Dr. Russo is currently the director of research and development at the International Cannabis and Cannabinoids Institute in Prague (www.icci.science).
Our bodies are thought to produce endocannabinoids by the billions every day. “We always thought the ‘runner’s high’ was due to the release of dopamine and endorphins. But now we know the euphoria is also from an endocannabinoid called anandamide,” its name derived from the Sanskrit word for bliss, says Joseph Maroon, M.D., clinical professor and vice chairman of neurosurgery at the University of Pittsburgh Medical Center. We produce these natural chemicals all day, but they fade quickly because enzymes pop up to destroy them. That’s where CBD comes in: By blocking these enzymes, CBD allows the beneficial compounds to linger. This is why Amanda Oliver, 31, a career consultant in Charleston, SC, pops a CBD gummy bear each night before bed. “I used to lie there tossing and turning as my mind raced from work projects to whether I had set the home alarm,” Oliver says. One piece of candy with 15 mg of CBD is enough to shut off her brain and facilitate sleep. She also swears by the CBD oil she takes at the height of her period, which she says quells her debilitating cramps.
Contras: También podría ser un desafío determinar la cantidad de CBD que recibes con las tinturas, ya sea del gotero o de cada aplicación, especialmente si la botella muestra solo el contenido total de CBD y no detalla la cantidad por dosis. De ser necesario, pide ayuda a un vendedor minorista o saca tu calculadora para calcular la cantidad de CBD por dosis. El precio por botella podría ser mayor para un producto con un contenido de CBD más alto por dosis.
Los extractos de aceites de THC o de canabidiol (CBD) muy concentrados, se están promoviendo de manera ilegal como posibles curas para el cáncer. La actividad anticancerígena y la inocuidad de estos aceites no se han evaluado en ningún ensayo clínico. Debido a que el CDB es un posible inhibidor de ciertas enzimas del sistema citocromo P450, el uso de aceites de CBD muy concentrados junto con terapias convencionales que se metabolizan mediante esas enzimas, podría aumentar la toxicidad o disminuir la efectividad de estas terapias.[6,7]