A. THC (dronabinol) is the active ingredient in the approved drug products, Marinol capsules (and generics) and Syndros oral solution. CBD is the active ingredient in the approved drug product, Epidiolex.
FDA continues to be concerned at the proliferation of products asserting to contain CBD that are marketed for therapeutic or medical uses although they have not been approved by FDA. Often such products are sold online and are therefore available throughout the country. Selling unapproved products with unsubstantiated therapeutic claims is not only a violation of the law, but also can put patients at risk, as these products have not been proven to be safe or effective. This deceptive marketing of unproven treatments also raises significant public health concerns, because patients and other consumers may be influenced not to use approved therapies to treat serious and even fatal diseases.
A. Cannabis is a plant of the Cannabaceae family and contains more than eighty biologically active chemical compounds. The most commonly known compounds are delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD). Parts of the Cannabis sativa plant have been controlled under the Controlled Substances Act (CSA) since 1970 under the drug class “Marihuana” (commonly referred to as “marijuana”) [21 U.S.C. 802(16)]. “Marihuana” is listed in Schedule I of the CSA due to its high potential for abuse, which is attributable in large part to the psychoactive effects of THC, and the absence of a currently accepted medical use of the plant in the United States.
A. The Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA), permits veterinarians to prescribe extralabel uses of approved human and animal drugs for animals under certain conditions. Extralabel use must comply with all the provisions of AMDUCA and its implementing regulation at 21 CFR § 530. Among other limitations, these provisions allow extralabel use of a drug only on the lawful order of a licensed veterinarian in the context of a valid veterinarian-client-patient relationship and only in circumstances when the health of an animal is threatened or suffering, or death may result from failure to treat.
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 )
Studies suggest that the medical use of marijuana may help treat the following conditions or help alleviate the following symptoms: (1)
A study published in May 2018 in JAMA Internal Medicine reported that prescriptions for opioids decreased in states that have medical marijuana laws. Researchers looked at Medicare data from 2010 to 2015 and found that states with active dispensaries saw 3.742 million fewer daily doses of opioids filled by pharmacies. (8)
How Does Marijuana Affect the Body?
In addition to being a potentially powerful treatment for anxiety disorders, a growing body of research is suggesting that CBD may help treat symptoms of neurological disorders such as Parkinson's disease and Alzheimer's disease . (11,12)
Another study, published in October 2014 in JAMA Internal Medicine, found that states with medical cannabis laws had a 24.8 percent lower annual overdose rate than states without such laws. (9)
This NASME report, one of the largest of its kind, looked at more than 10,000 studies published since 1999.
CBD (cannabidiol) and THC (tetrahydrocannabinol) are the most common cannabinoids found in cannabis products.
As part of medical marijuana, THC helps ease things like:
FDA: “FDA approves first drug comprised of an active ingredient derived from marijuana to treat rare, severe forms of epilepsy.”
CBD can also change the way some medicines work. Talk with your doctor about it.
THC is the main psychoactive compound in marijuana. It’s what makes people feel “high.”