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?
FDA is not aware of any evidence that would call into question its current conclusions that THC and CBD products are excluded from the dietary supplement definition under section 201(ff)(3)(B) of the FD&C Act. 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.
2. How does the 2018 Farm Bill define hemp? What does it mean for FDA-regulated products?
A. In December 2018, FDA completed its evaluation of three generally recognized as safe (GRAS) notices for the following hemp seed-derived food ingredients: hulled hemp seed, hemp seed protein powder, and hemp seed oil. FDA had no questions regarding the company’s conclusion that the use of such products as described in the notices is safe. Therefore, these products can be legally marketed in human foods for the uses described in the notices, provided they comply with all other requirements. These GRAS notices related only to the use of these ingredients in human food. To date, FDA has not received any GRAS notices for the use of hemp-derived ingredients in animal food (see Question #25).
Signs that your pet may be suffering adverse effects from ingesting cannabis may include lethargy, depression, heavy drooling, vomiting, agitation, tremors, and convulsions.
Schedule III drugs, substances, or chemicals are defined as drugs with a moderate to low potential for physical and psychological dependence. Schedule III drugs abuse potential is less than Schedule I and Schedule II drugs but more than Schedule IV. Some examples of Schedule III drugs are:
Schedule V drugs, substances, or chemicals are defined as drugs with lower potential for abuse than Schedule IV and consist of preparations containing limited quantities of certain narcotics. Schedule V drugs are generally used for antidiarrheal, antitussive, and analgesic purposes. Some examples of Schedule V drugs are:
Combination products with less than 15 milligrams of hydrocodone per dosage unit (Vicodin), cocaine, methamphetamine, methadone, hydromorphone (Dilaudid), meperidine (Demerol), oxycodone (OxyContin), fentanyl, Dexedrine, Adderall, and Ritalin
Schedule I drugs, substances, or chemicals are defined as drugs with no currently accepted medical use and a high potential for abuse. Some examples of Schedule I drugs are:
Drugs, substances, and certain chemicals used to make drugs are classified into five (5) distinct categories or schedules depending upon the drug’s acceptable medical use and the drug’s abuse or dependency potential. The abuse rate is a determinate factor in the scheduling of the drug; for example, Schedule I drugs have a high potential for abuse and the potential to create severe psychological and/or physical dependence. As the drug schedule changes– Schedule II, Schedule III, etc., so does the abuse potential– Schedule V drugs represents the least potential for abuse. A Listing of drugs and their schedule are located at Controlled Substance Act (CSA) Scheduling or CSA Scheduling by Alphabetical Order. These lists describes the basic or parent chemical and do not necessarily describe the salts, isomers and salts of isomers, esters, ethers and derivatives which may also be classified as controlled substances. These lists are intended as general references and are not comprehensive listings of all controlled substances.
However, the list of FDA approved drugs that contain cannabis-derived compounds remains limited to a single CBD-based product: an epilepsy medicine called Epidiolex, made by GW Pharmaceuticals. Any other medication is technically not approved under federal law and would, therefore, be considered illegal at the federal level, which is why CBD producers are not permitted to make health claims about their products.
Interestingly, recent research seems to back up the position that CBD is not a drug in this sense that it isn’t normally detected during a drug screening. Most U.S. employers, for instance, abide by the guidelines set forth by the Substance Abuse and Mental Health Services Administration (SAMHSA), which includes detection for THC but not for CBD. Most employment drug tests specifically look for the presence of THC or THC metabolites, but it’s highly unlikely that CBD oil will show up on a drug test.
Under federal law, CBD that is derived from cannabis plants with more than .3% THC is considered illegal, as the intoxicating cannabinoid remains a Schedule I substance. If the cannabis plant has more than .3% THC, then all substances derived from it — including any CBD extracted from the plant — are considered by the DEA to be a federally restricted Schedule I substance.
The DEA and US Food and Drug Administration (FDA) are in charge of determining which substances should be added, removed, or re-classified. Schedule I substances are presumed to be the most dangerous with a high potential for abuse and no perceived health benefit and tend to be the most heavily criminalized, while Schedule V substances as defined as drugs with the lowest potential for abuse. Examples of Schedule I drugs include heroin, methamphetamines, LSD, and cannabis.
Two of the most abundant cannabinoids produced by the cannabis plant are THC, which produces the plant’s renowned intoxicating effects, and CBD, which is a non-intoxicating compound and appears to provide many therapeutic and medicinal qualities. This combination of cannabis compounds are also key in understanding how the Schedule I classification applies to CBD products.
In the United States, the Drug Enforcement Agency (DEA) classifies different controlled substances drugs by grouping them into five separate categories, or “schedules.” These five schedules were a result of the Federal Controlled Substances Act (CSA), a part of the Comprehensive Drug Abuse Prevention and Control Act of 1970, which was signed into law by former President Richard Nixon.
To meet federal legal criteria, CBD oil must contain no more than 0.3 percent THC. Photo by: Gina Coleman/Weedmaps