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 August 25, 2019. 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?
Relavant 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:
- Alaska Department of Law. 3 AAC 306 Regulations for the Marijuana Control Board. 2019; 11-97. https://www.commerce.alaska.gov/web/Portals/9/pub/MCBStatutesAndRegulations/MarijuanaRegulations.pdf
- Arkansas State Board of Health; Department of Health. Rules and Regulations Governing Medical Marijuana Registration, Testing, and Labeling in Arkansas. 2018; 1-28. https://www.healthy.arkansas.gov/images/uploads/rulesMedical_Marijuana_Emergency_Rule_4-27-2017_ (Signed).pdf
- Bureau of Cannabis Control. Text of Regulations. California Code of Regulation, Title 16, Division 42;1-92. https://www.bcc.ca.gov/law_regs/readopt_text_final.pdf
- Code of Colorado Regulations. Marijuana Enforcement Division. Retail Marijuana Rules, 1 CCR 212-2. 2018; 137-227. https://www.colorado.gov/pacific/sites/default/files/ColoradoRegister.pdf1%20CCR%20212%20-2%20Retail%20Effective%2002022018.pdf
- Department of Consumer Protection. Palliative Use of Marijuana. Title 21a. Consumer Protection. 2016; 4-56. https://eregulations.ct.gov/eRegsPortal/Browse/getDocument?guid=%7B00889165-0000-CCDC-9970-EDC81BF4A87D%7D
- Department of Health and Social Services. 4470 State of Delaware Medical Marijuana Code. 2018; 1-21. http://regulations.delaware.gov/AdminCode/title16/Department%20of%20Health%20and%20Social%20Services/Division%20of%20Public%20Health/Health%20Systems%20Protection%20(HSP)/4470.shtml
- Florida Statutes. Title XXIX. Chapter 381. PublicHealth. 381.986 Medical Use of Marijuana. 2018; 1-13. http://www.leg.state.fl.us/statutes/index.cfm?App_mode=Display_Statute&URL=0300-0399/0381/Sections/0381.986.html
- Learn/Laws and Regulations: Florida. WEEDMAPS. 2018; 8-10. https://weedmaps.com/learn/laws-and-regulations/florida/
- Department of Health. Adoption of Chapter 11-850 Hawaii Administrative Rules. Medical Marijuana Dispensaries. 2015; 46-59. http://health.hawaii.gov/opppd/files2015/06/11-850.pdf
- Illinois Department of Agriculture. Notice of Adopted Rules. 2014: 1-98. https://www2.illinois.gov/sites/mcpp/Documents/AGR%20-%20Final%20Rule.pdf
- 128th Maine Legislature. PUBLIC Law, Chapter 409: An Act To Implement a Regulatory Structure for Adult Use Marijuana. 2019; 5-72. https://legislature.maine.gov/legis/bills/bills_128th/chapters/PUBLIC409.asp
- Subtitle 62 Natalie M. Laprade Medical Cannabis Commission. Maryland Medical Cannabis Law. 2015; 2-10. https://mmcc.maryland.gov/Documents/Subtitle%2033_Sept2015_Corrected.pdf
- Division of State Documents for the State of Maryland. Contents of Certificate of Analysis. http://www.dsd.state.md.us/comar/comarhtml/10/10.62.15.05.htm
- Cannabis Control Commission. 935 CMR 500.000: Adult Use of Marijuana. 2018; 5-78. https://mass-cannabis-control.com/wp-content/uploads/2018/03/Reposted-031218-CCC-Final-Regulations-with-disclaimer.pdf
- Department of Licensing and Regulatory Affairs Bureau of Medical Marihuana Regulation. Medical Marihuana Facilities Licensing Act. 2018; 21-24. https://www.michigan.gov/documents/lara/Medical_Marihuana_Facilities_Licensing_Emergency_Rules_5-24-18_634830_7.pdf
- Revisor of Statutes, State of Minnesota. Medical Cannabis Manufacturer Quality Control Assurance Program. 2015; 1-3. https://www.revisor.mn.gov/rules/4770.0500/version/2015-02-20T11:53:06-06:00
- Before the Department of Public Health and Human Services of the State of Montana. Notice of adoption, amendment, and repeal. 2018; 323-324. https://dphhs.mt.gov/Portals/85/marijuana/37-820adp-arm.pdf
- Nevada Department of Taxation. Revised Proposed Regulation of the Department of Taxation. LCB File No. R092-17. 2017; 5-13. https://tax.nv.gov/uploadedFiles/taxnvgov/Content/FAQs/R-092-17-V6-Department-Track-Changes.pdf
- New Hampshire Department of Health and Human Services. Therapeutic Cannabis Program Registry Rules. 2014; 12-20. https://www.dhhs.nh.gov/oos/tcp/documents/hec402ipannotated.pdf
- N.J.A.C. Medicinal Marijuana Program Rules. Medicinal Marijuana Program. 2011; 45-87. https://www.state.nj.us/health/medicalmarijuana/documents/final_rules.pdf.
- New Jersey State Senate. State of New Jersey 218th Legislature; 5.
- New Mexico Department of Health. Title 7(Health). Chapter 34 (Medical Use of Cannabis), Part 4 (Licensing Requirements for Producers, Couriers, Manufacturers, and Laboratories).2015. http://22.214.171.124/parts/title07/07.034.0004.html
- Title 10 (Health) of the Official Compilation of Codes. Rules and Regulations of the State of New York; 2-71. https:/www.health.ny.giv/regulations/medical_marijuana/docs/regulations.pdf
- North Dakota Department of Health, Division of Medical Marijuana. North Dakota awards contract for laboratory services for Medical Marijuana Program [press release]. May 18, 2018. https://www.ndhealth.gov/mm/PDF/Press_Releases/2018-5-18_ND_Awards_Contract_for_Laboratory_Services_for_Medical_Marijuana_Program.pdf
- Article 33-44 Medical Marijuana. https://www.legis.nd.gov/information/acdata/pdf/33-44-01.pdf
- Ohio Administrative Code. Ohio Laws and Rules. 3796:4-2-03 Testing Laboratory Sample Procurement. Accessed August 9, 2019. http://codes.ohio.gov/oac/3796:4-2-03
- Ohio Legislative Service Commission. Sub. H.B. 523. Bill Summary. Accessed August 9, 2019. https://www.legislature.ohio.gov/download?key=5399&format=pdf
- Ohio Administrative Code. Ohio Laws and Rules. 3796:2-2-08 Cultivator Records and Reporting Requirements. Accessed August 9, 2019. http://codes.ohio.gov/oac/3796:2-2-08
- Ohio Administrative Code. Ohio Laws and Rules. 3796:1-1 Definitions. Accessed August 9, 2019. http://codes.ohio.gov/oac/3796%3A1-1
- Ohio Administrative Code. Ohio Laws and Rules. 3796:2-2-06 Testing Laboratory Testing. Accessed August 9, 2019. http://codes.ohio.gov/oac/3796:2-2-06
- Oregon Legislature. Chapter 475B. Cannabis Regulation. 2019; 50-60. https://www.oregonlegislature.gov/bills_laws/ors/ors475B.html
- Pennsylvania Department of Health Office of Medical Marijuana. Guidance for quality testing and sampling by approved laboratories. 2018; 1-9. https://www.health.pa.gov/topics/Documents/Programs/Medical%20Marijuana/2018.8.10%20MM%20%20Updated%20Guidance%20for%20Quality%20Testing%20and%20Sampling%20by%20Approved%20Laboratories.pdf
- Rhode Island Department of State. Licensing Analytical Laboratories for Sampling and Testing Medical Marijuana (216-RICR-60-05-6). 2018; 1-39. https://rules.sos.ri.gov/regulations/part/216-60-05-6
- Texas Department of Public Safety, Regulatory Services Division. Compassionate Use / Low-THC Cannabis Program Administrative Rules. 2017. https://www.dps.texas.gov/RSD/CUP/Laws/adminRules.pdf
- Washington State Legislature. Quality assurance testing. WAC 246-70-050. 2016; 1. http://app.leg.wa.gov/WAC/default.aspx?cite=246-70-050
- Washington State Legislature. Chapter 314-55 WAC. Marijuana License, Application Process, Requirements, and Reporting. 2018; 40. https://lcb.wa.gov/publications/rules 2013%20Proposed%20Rules/OTS-5501-3Final.pdf