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.1
This map shows how cannabinoid products are regulated by each state, in comparison to FDA-approved medications.2
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.1
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.9 FDA-approved medicines are available by prescription in both specialty and/or retail pharmacies, not dispensaries.
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.1
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.10-13 The following is a brief overview of approved cannabinoids and how they are scheduled.
Schedule I, banned substances
- Federally illegal to possess, obtain, or distribute without proper license14
- Schedule I substances are thought to have a high potential for abuse and dependence and no medicinal qualities15
- Synthetic cannabinoids are often used illicitly (eg, Spice, K2, Kronic, and Purple Haze)16
Non–FDA Approved Cannabinoid Products
Studied in placebo-controlled, publicly disclosed clinical trials with large patient samples to determine efficacy, safety, and recommended dosing.3
Randomized clinical studies have not been conducted.17 Public disclosure of smaller, informal studies not required.
Produced according to regulated, current good manufacturing practices (cGMP).5, 18 FDA-approved medications must adhere to strict specifications that ensure batch consistency and stable shelf life.
Testing standards vary from state to state, and some states require no testing.19 There are no federal standards; FDA does not inspect the manufacturing sites for adherence to cGMP.1
Meets FDA standards for quality, stability, and consistency.1 Tested to ensure they contain the consistent concentrations of cannabinoids and other product ingredients listed on the label.
Nonprescription, non–FDA-approved cannabinoid products are subject to inconsistent regulation at the state level.19 There are no federal standards for testing to ensure accuracy and consistency.1
Federally legal as prescribed; similar to other prescription medicines.1, 10-13
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.20 Interstate transportation of these products is federally illegal.21
Eligible for insurance coverage.8
Insurance coverage is rare.8
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.”22
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.22
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.23 These studies determine if a medicine could make a patient physically dependent and have the potential to be abused or misused.
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.24
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.25 This is referred to as expanded access or compassionate use.
1. US Food and Drug Administration. FDA and Cannabis: Research and Drug Approval Process. Updated Oct 10, 2020. Accessed Sept 2, 2021. https://www.fda.gov/news-events/public-health-focus/fda-and-cannabis-research-and-drug-approval-process
2. ProCon.org. Legal Medical Marijuana States and DC. Updated Jun, 2021. https://medicalmarijuana.procon.org/legal-medical-marijuana-states-and-dc/
3. US Food and Drug Administration. FDA's Role: ClinicalTrials.gov Information. FDA.gov. 2021. Accessed Feb 18, 2022. https://www.fda.gov/science-research/clinical-trials-and-human-subject-protection/fdas-role-clinicaltrialsgov-information
4. US Food and Drug Administration. Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research Guidance for Industry. 2020. https://www.fda.gov/media/140319/download
5. US Food and Drug Administration. Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients Guidance for Industry. 2016. Accessed Dec 3, 2021. https://www.fda.gov/media/71518/download
6. US Food and Drug Administration. Expiration Dating and Stability Testing for Human Drug Products. 2014. Accessed Dec 6, 2021. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-technical-guides/expiration-dating-and-stability-testing-human-drug-products
7. US Food and Drug Administration. What You Need to Know (And What We’re Working to Find Out) About Products Containing Cannabis or Cannabis-derived Compounds, Including CBD. Updated Mar 5, 2020. Accessed Dec 6, 2021. https://www.fda.gov/consumers/consumer-updates/what-you-need-know-and-what-were-working-find-out-about-products-containing-cannabis-or-cannabis
8. Jahangir M. Medicare and Medical Marijuana: What's Covered and What's Not. 2021. Accessed Dec 6, 2021. https://healthmed.org/medicare-and-medical-marijuana-whats-covered-and-whats-not/
9. US Food and Drug Administration. What We Do. FDA.gov. 2018. Accessed Dec 3, 2021. https://www.fda.gov/about-fda/what-we-do
10. Epidiolex® (cannabidiol) oral solution [prescribing information]. Carlsbad, CA: Greenwich Biosciences, Inc. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8bf27097-4870-43fb-94f0-f3d0871d1eec
11. Marinol® (dronabinol) capsules, for oral use [prescribing information]. North Chicago, IL: AbbVie Inc. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d0efeeec-640d-43c3-8f0a-d31324a11c68
12. Syndros® (dronabinol) oral solution [prescribing information]. Chandler, AZ: Insys Therapeutics Inc. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a7801c70-995d-46a2-91ee-141ef427c6b5
13. Cesamet® (nabilone) capsules, for oral administration [prescribing information]. Costa Mesa, CA: Valeant Pharmaceuticals International. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=83c7ac15-ece9-47de-b83c-d575544fa449
14. Prohibited acts A, 21 U.S.C. § 841 (2019). https://www.govinfo.gov/app/details/USCODE-2019-title21/USCODE-2019-title21-chap13-subchapI-partD-sec841.
15. US Drug Enforcement Administration. Drug Scheduling. Accessed Dec 4, 2021. https://www.dea.gov/drug-information/drug-scheduling
16. Centers for Disease Control and Prevention. About synthetic cannabinoids. 2021. Accessed Dec 1, 2021. https://www.cdc.gov/nceh/hsb/chemicals/sc/About.html
17. Which applicable clinical trials must be registered?, 42 CFR §11.22 (2020). https://www.ecfr.gov/current/title-42/chapter-I/subchapter-A/part-11/subpart-B/section-11.22
18. US Food and Drug Administration. Facts About the Current Good Manufacturing Practices (CGMPs). Updated Jun 1, 2021. Accessed Dec 3, 2021. https://www.fda.gov/drugs/pharmaceutical-quality-resources/facts-about-current-good-manufacturing-practices-cgmps
19. Sarma ND, Waye A, ElSohly MA, et al. Cannabis Inflorescence for Medical Purposes: USP Considerations for Quality Attributes. J Nat Prod. Apr 24 2020;83(4):1334-1351. doi:10.1021/acs.jnatprod.9b01200
20. Marijuana Policy Project. “Prescribing” Versus “Recommending” Medical Cannabis Marijuana Policy Project, . Accessed Dec 3, 2021. https://www.mpp.org/issues/medical-marijuana/prescribing-versus-recommending-medical-cannabis/
21. US Food and Drug Administration. FDA Regulation of Cannabis and Cannabis-Derived Products, Including Cannabidiol (CBD). 2021. Accessed Dec 3, 2021. https://www.fda.gov/news-events/public-health-focus/fda-regulation-cannabis-and-cannabis-derived-products-including-cannabidiol-cbd#farmbill
22. Gottlieb S. Statement from FDA Commissioner Scott Gottlieb, M.D., on signing of the Agriculture Improvement Act and the agency’s regulation of products containing cannabis and cannabis-derived compounds. 2018. https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-signing-agriculture-improvement-act-and-agencys
23. US Food and Drug Administration. Assessment of Abuse Potential of Drugs Guidance for Industry. 2017. Accessed Dec 3, 2021. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/assessment-abuse-potential-drugs
24. US Food and Drug Administration. Development & Approval Process Drugs. 2019. Accessed Dec 5, 2021. https://www.fda.gov/drugs/development-approval-process-drugs
25. US Food and Drug Administration. Expanded Access. Updated Mar 23, 2021. Accessed Feb 15, 2022. https://www.fda.gov/news-events/public-health-focus/expanded-access
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