| Title | Content |
|---|---|
| Agriculture Act of 2014 | Known as the "Farm Bill,", this was signed by President Obama on February 7, 2014. Section 7606 highlights the "Legitimacy of Industrial Hemp Research," authorizing industrail hemp (Cannabis plants containing 0.3% or less THC by weight) to be used in research and pilot programs by institutions of higher education or State6
|
| Cannbinoids | 2 |
| Cannabis | 3 |
| Cannabis Oil* | 4 |
| Cannabis Sativa L. | 5 |
| CBD Oil*/Hemp CBD Oil* | 6 |
| CBD-Rich Extracts* | 7 |
| DEA-Drug Scheduling | 8 |
| Dietary Supplement | 9 |
| Endocannabinoids | 10 |
| Endocannabinoids Receptors | 11 |
| Endocannabinoids Systems | 12 |
| Entourage Effect* | 13 |
| FDA-Approved Formulation of CBD* | 14 |
| FDA-Approved Medication | 15 |
| Hemp | 16 |
| Hemp Oil*/Hempseed Oil | 17 |
| Marijuana | 18 |
| Medical Marijuana (MM)* | 19 |
| Nutraceutical* | 20 |
| Phytocannabinoids | 21 |
| Recreational Marijuana (RM)* | 22 |
| Synthetic Cannabinoids | 23 |
| Terpenes/Terpenoids | 24 |
| Whole Plant | 25 |
Of the thousands of cannabinoid products being sold in the market, only a handful undergo testing for quality, safety, and effectiveness.
This map shows how cannabinoid products are regulated by each state, in comparison to FDA-approved medications.
Valid as of February 25, 2019. Check a state’s website for the most up-to-date information.
Alaska allows cultivators to bring the samples for testing to a licensed third-party facility. Although the samples are thoroughly tested, there is no DEA involvement, and everything is managed by the state alone. The frequency of these tests is not specified. These issues can create inconsistencies.
A third-party state-licensed facility.
The cultivator.
The Marijuana Control Board (state) alone enforces the law, with no DEA involvement in the dispensing and tracking systems.
The cultivator is responsible for transporting the samples to the testing facility. Sample batch sizes are based on predetermined guidelines.
Alaska allows cultivators to bring the samples for testing to a licensed third-party facility. Although the samples are thoroughly tested, there is no DEA involvement, and everything is managed by the state alone. The frequency of these tests is not specified. These issues can create inconsistencies.
A third-party state-licensed facility.
The cultivator.
The Marijuana Control Board (state) alone enforces the law, with no DEA involvement in the dispensing and tracking systems.
The cultivator is responsible for transporting the samples to the testing facility. Sample batch sizes are based on predetermined guidelines.
Only certain cannabinoid products have undergone or are undergoing a federal testing and approval process.
The rigorous FDA-approval process is undertaken in an effort to establish the efficacy, safety, and quality of a medicine before use by the general public. FDA-approved medicines are available by prescription in both specialty and/or retail pharmacies, not dispensaries.1
Cannabinoid products that have not undergone the FDA approval process are sold in dispensaries and online. These should not be considered substitutes or generics for FDA-approved medicines.2,3
Cannabinoids have been developed for many years, but only 4 have been approved by the FDA and moved out of Schedule I. The following is a brief overview of approved cannabinoids and how they are scheduled.4-7
Studied in placebo-controlled, publicly disclosed clinical trials with large patient samples to determine efficacy, safety, and recommended dosing.1
Randomized clinical studies have not been conducted. Public disclosure of smaller, informal studies not required.3
Produced according to regulated, current good manufacturing practices (cGMP). FDA-approved medications must adhere to strict specifications that ensure batch consistency and stable shelf life.11,12
Testing standards vary from state to state, and some states require no testing. There are no federal standards; FDA does not inspect the manufacturing sites for adherence to cGMP.2,3
Meets FDA standards for quality, stability, and consistency. Tested to ensure they contain the consistent concentrations of cannabinoids and other product ingredients listed on the label.13
Nonprescription, non–FDA approved cannabinoid products are subject to inconsistent regulation at the state level. There are no federal standards for testing to ensure accuracy and consistency.2,14
Federally legal as prescribed; similar to other DEA-controlled prescription medicines.4-7
Restrictions to access vary by state. Healthcare providers can “recommend” but not prescribe hemp products or marijuana, as they are illegal at the federal level. Interstate transportation of these products is federally illegal.15
Eligible for insurance coverage.16
Insurance coverage is rare.17
It is not fully clear when hemp-derived cannabinoid products will be federally legal to be sold or how they will be regulated. The FDA stated they will “consider whether there are circumstances in which certain cannabis-derived compounds might be permitted in a food or dietary supplement."
In a statement, the FDA notes that it will continue regulating products containing cannabis or cannabis-derived compounds regardless of whether they are derived from a plant classified as hemp under the Farm Bill.18
For medicines that work through the central nervous system (CNS), developers are required to conduct studies to assess abuse potential and liability. These studies determine if a medicine could make a patient physically dependent and have the potential to be abused or misused.19
For drugs that address an unmet medical need in the treatment of a serious or life-threatening condition, the FDA offers expedited programs to help ensure that therapies are reviewed and made available to patients earlier when they show promise in treating such conditions.20
In some cases involving serious diseases or conditions, the FDA provides a pathway for physicians to request access to drugs for their patients while the drugs are being studied but before they are approved. This is referred to as expanded access or compassionate use.21