The State of Cannabinoid Testing
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 May 2021. Check a state’s website for the most up-to-date information.
Select a state to view how cannabinoid products are regulated by each state, in comparison to FDA-approved medications.
THE FDA DIFFERENCE
WHAT MATERIALS ARE TESTED?
Relevant State Product Issues
See what really matters when considering cannabinoid-based treatments
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 and the Drug Enforcement Administration (DEA) controlled-substance scheduling
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
Schedule I, banned substances
- Federally illegal to possess, obtain, or distribute without proper license.
- Schedule I substances are thought to have a high potential for abuse and dependence and no medicinal qualties8
- Synthetic cannabinoids are often used illicitly (eg, Spice, K2, Kronic, and Purple Haze)9,10
Non–FDA Approved Cannabinoid Products
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
Commonly Asked Questions
DOES THE PASSAGE OF THE 2018 FARM BILL LEGALIZE NON–FDA APPROVED, HEMP-DERIVED CANNABINOID PRODUCTS?
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
IS ADDITIONAL TESTING REQUIRED FOR CNS MEDICINES?
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
WHEN DO DRUGS GET EXPEDITED REVIEW?
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
WHILE MEDICINES ARE BEING DEVELOPED, CAN THEY BE ACCESSED BY PEOPLE NOT IN CLINICAL STUDIES?
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
1. U.S. Food and Drug Administration. What we do. https://www.fda.gov/about-fda/what-we-do. Updated March 28, 2018. Accessed August 20, 2019.
2. Bonn-Miller M, Loflin M, Thomas B, et al. Labeling accuracy of cannabidiol extracts sold online. JAMA. 2017;318(17):1708-1709.
3. U.S. Food and Drug Administration. Warning letters and test results for cannabidiol-related products. https://www.fda.gov/news-events/public-health-focus/warning-letters-and-test-results-cannabidiol-related-products. July 24, 2019. Accessed August 20, 2019.
4. Marinol [package insert]. North Chicago, IL: AbbVie Inc; 2017.
5. Syndros [package insert]. Chandler, AZ: Insys Therapeutics, Inc; 2018.
6. EPIDIOLEX [package insert]. Carlsbad, CA: Greenwich Biosciences, Inc.; 2018.
7. Cesamet [package insert]. Somerset, NJ: Meda Pharmaceuticals Inc; 2015.
8. United States Drug Enforcement Administration. DEA speeds up application process for research on Schedule I drugs. https://www.dea.gov/press-releases/2018/01/18/dea-speeds-application-process-research-schedule-i-drugs. January 18, 2018. Accessed August 20, 2019.
9. Brakoulias V. Products containing synthetic cannabinoids and psychosis. Aust N Z J Psychiatry. 2012.46(3):281-282.
10. European Monitoring Centre for Drugs and Drug Addiction. European Drug Report 2016: Trends and Developments. http://www.emcdda.europa.eu/publications/edr/trends-developments/2016_en. May 2016. Accessed August 20, 2019.
11. U.S. Food and Drug Administration. Facts about the current good manufacturing practices (CGMPs). https://www.fda.gov/drugs/pharmaceutical-quality-resources/facts-about-current-good-manufacturing-practices-cgmps. Accessed August 13, 2019.
12. U.S. Food and Drug Administration. Guidance for Industry, Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-q7a-good-manufacturing-practice-guidance-active-pharmaceutical-ingredients. Updated August 9, 2018. Accessed August 13, 2019.
13. U.S. Food and Drug Administration. Guidance for industry ANDAs: stability testing of drug substances and products–questions and answers. https://www.fda.gov/files/drugs/published/ANDAs--Stability-Testing-of-Drug-Substances-and-Products--Questions-and-Answers.pdf. Published May 2014. Accessed August 13, 2019.
14. Borchardt D. The cannabis market that could grow 700% by 2020. https://www.forbes.com/sites/debraborchardt/2016/12/12/the-cannabis-market-that-could-grow-700-by-2020/#2370ad214be1. Published December 12, 2016. Accessed August 8, 2019.
15. U.S. Food and Drug Administration. FDA regulation of cannabis and cannabis-derived products: questions and answers. https://www.fda.gov/news-events/public-health-focus/fda-regulation-cannabis-and-cannabis-derived-products-questions-and-answers#farmbill. Updated April 2, 2019. Accessed August 20, 2019.
16. U.S. Food and Drug Administration. The FDA’s drug review process: ensuring drugs are safe and effective. https://www.fda.gov/drugs/drug-information-consumers/fdas-drug-review-process-ensuring-drugs-are-safe-and-effective. Updated November 24, 2017. Accessed August 20, 2019.
17. National Institutes of Health Office of Intramural Research; Office of Animal Care and Use. Guidelines for the use of non-pharmaceutical grade compounds in laboratory animals. https://oacu.oir.nih.gov/sites/default/files/uploads/arac-guidelines/pharmaceutical_compounds pdf. Updated April 27, 2016. Accessed August 20, 2019.
18. U.S. House of Representatives. Agriculture Improvement Act of 2018. https://www.congress.gov/bill/115th-congress/house-bill/2/text. Published December 20, 2018. Accessed August 13, 2019.
19. U.S. Food and Drug Administration. Guidance document: Assessment of abuse potential of drugs; January 2017. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/assessment-abuse-potential-drugs. Updated August 24, 2018. Accessed August 19, 2019.
20. U.S. Food and Drug Administration. Guidance for industry: expedited programs for serious conditions–drugs and biologics. https://www.fda.gov/files/drugs/published/Expedited-Programs-for-Serious-Conditions-Drugs-and-Biologics.pdf. Published May 2014. Accessed August 19, 2019.
21. U.S. Food and Drug Administration. Expanded access. https://www.fda.gov/news-events/public-health-focus/expanded-access. Updated May 6, 2019. Accessed August 8, 2019.
References for State of Cannabinoid Testing:
- Marijuana Control Board. https://www.commerce.alaska.gov/web/amco/MarijuanaRegulations.aspx
- Department of Health Services. https://www.azdhs.gov/licensing/medical-marijuana/index.php
- Medical Marijuana Commission. https://www.dfa.arkansas.gov/medical-marijuana-commission
- Bureau of Cannabis Control. https://bcc.ca.gov/
- Dept. of Food & Agriculture - cultivation licensing.
- Dept. of Public Health - manufactured cannabis safety branch licensing.
- Department of Revenue - Marijuana Enforcement Division. https://sbg.colorado.gov/marijuanaenforcement
- Department of Consumer Protection. https://portal.ct.gov/DCP/Medical-Marijuana-Program/Medical-Marijuana-Program
- Alcoholic Beverage Regulation Administration (ABRA) formerly Department of Health (changed 10/1/2020). https://abra.dc.gov/page/medical-cannabis-program
- Division of Public Health. https://dhss.delaware.gov/dhss/dph/hsp/medmarhome.html
- Department of Health - Office of Medical Marijuana Use (OMMU). https://knowthefactsmmj.com/
- Georgia Access to Medical Cannabis Commission - general oversight. https://www.gmcc.ga.gov/
- State Board of Pharmacy will work with AMMC to develop regulations for dispensing pharmacies.
- Department of Health. https://health.hawaii.gov/medicalcannabis/
- Dept. of Agriculture. https://www2.illinois.gov/cannabis/Pages/default.aspx
- Dept. of Commerce.
- Dept. of Public Health.
- Dept. of Financial and Professional Regulation.
- Dept. of Human Services.
- State Police.
- Office of the Governor.
- Office of Medical Cannabidiol. https://idph.iowa.gov/omc
- Production - Department of Agriculture and Forestry (LDAF). https://www.ldaf.state.la.us/medical-marijuana/
- Dispensaries - Board of Pharmacy.
- Office of Marijuana Policy. https://www.maine.gov/dafs/omp/home
- Medical Cannabis Commission. https://mmcc.maryland.gov/Pages/home.aspx
- Cannabis Control Commission. https://masscannabiscontrol.com/
- Marijuana Regulatory Agency. https://www.michigan.gov/mra/
- Department of Health. https://www.health.state.mn.us/people/cannabis/
- Department of Health. https://msdh.ms.gov/msdhsite/_static/30,0,425.html
- Dept. of Health and Senior Services. https://health.mo.gov/safety/medical-marijuana/index.php
- Department of Revenue. https://mtrevenue.gov/cannabis/
- Cannabis Compliance Board. https://ccb.nv.gov/
- Department of Health and Human Services. https://www.dhhs.nh.gov/oos/tcp/
- Medical: Department of Health. https://www.nj.gov/health/medicalmarijuana/
- Adult use: TBD - legislation still being debated.
- Department of Health. https://www.nmhealth.org/about/mcp/svcs/
- Department of Health. https://www.health.ny.gov/regulations/medical_marijuana/
- Department of Health. https://www.health.nd.gov/mm
- Medical Marijuana Control Program. https://www.medicalmarijuana.ohio.gov/default
- Oklahoma Medical Marijuana Authority (OMMA). https://oklahoma.gov/omma.html
- Adult use: Liquor Control Commission. https://www.oregon.gov/olcc/marijuana/Pages/default.aspx
- Medical: Oregon Health Authority.
- Department of Health. https://www.health.pa.gov/topics/programs/Medical%20Marijuana/Pages/Medical%20Marijuana.aspx
- Department of Health. https://health.ri.gov/healthcare/medicalmarijuana/
- Department of Business Regulation.
- Compassionate Use: Department of Public Safety. https://www.dps.texas.gov/section/compassionate-use-program
- Hemp: Department of Agriculture.
- Department of Health. https://medicalcannabis.utah.gov/
- Department of Agriculture and Food.
- Department of Public Safety (Oversight of the medical cannabis program will move from DPS to the Cannabis Control Board on 3/1/2022). https://medicalmarijuana.vermont.gov/
- Board of Pharmacy. https://www.dhp.virginia.gov/pharmacy/PharmaceuticalProcessing/
- Liquor and Cannabis Board – Licensing and regulation of all marijuana production, processing and sales. https://lcb.wa.gov/
- Department of Agriculture – Pesticides, fertilizers, marijuana-infused edibles processors, industrial hemp.
- Department of Revenue – Taxes, recordkeeping practices.
- Department of Health – Medical marijuana program and marijuana prevention and education program.
- Department of Health and Human Resources. https://dhhr.wv.gov/bph/Pages/Medical-Cannabis-Program.aspx