Hope in a Hazy World: Experts Discuss Cannabis Policy

Since cannabis-based products are everywhere, people are confused. It is necessary to build a trusted landscape for safe cannabinoid use. Watch the video to learn more

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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.2 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

FDA-Approved Versus
Non—FDA-Approved Cannabinoid Products

FDA-Approved
Cannabinoid Products

Studied in placebo-controlled, publicly disclosed clinical trials with large patient samples to determine efficacy, safety, and recommended dosing.3

Non—FDA-Approved
Cannabinoid Products

Randomized clinical studies have not been conducted.4 Public disclosure of smaller, informal studies not required.

FDA-Approved
Cannabinoid Products

Produced according to regulated, current good manufacturing practices (cGMP).5, 6 FDA-approved medications must adhere to strict specifications that ensure batch consistency and stable shelf life.

Non—FDA-Approved
Cannabinoid Products

Testing standards vary from state to state, and some states require no testing.7 There are no federal standards; FDA does not inspect the manufacturing sites for adherence to cGMP.1

FDA-Approved
Cannabinoid Products

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.

Non—FDA-Approved
Cannabinoid Products

Nonprescription, non–FDA-approved cannabinoid products are subject to inconsistent regulation at the state level.7 There are no federal standards for testing to ensure accuracy and consistency.1

FDA-Approved
Cannabinoid Products

Federally legal as prescribed; similar to other prescription medicines.1, 8-11

Non—FDA-Approved
Cannabinoid Products

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.12 Interstate transportation of these products is federally illegal.13

FDA-Approved
Cannabinoid Products

Eligible for insurance coverage.14

Non—FDA-Approved
Cannabinoid Products

Insurance coverage is rare.14

An image of a woman wearing a mask, looking through a microscope

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.8-11

Schedule 1, banned substances under a microscope high resolution image

Schedule I, banned substances

  • Federally illegal to possess, obtain, or distribute without proper license15
  • Schedule I substances are thought to have a high potential for abuse and dependence and no currently accepted medicinal qualities16
  • Synthetic cannabinoids are often used illicitly (eg, Spice, K2, etc)17

Commonly Asked Questions

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

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.

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

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. US Food and Drug Administration. What We Do. FDA.gov. 2018. Accessed Dec 3, 2021. https://www.fda.gov/about-fda/what-we-do

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. 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

5. 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

6. 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

7. 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

8. 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

9. Syndros® (dronabinol) oral solution [prescribing information]. Chandler, AZ: Benuvia Therapeutics Inc. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a7801c70-995d-46a2-91ee-141ef427c6b5

10. Cesamet® (nabilone) capsules [prescribing information]. Bridgewater, NJ: Bausch Health US LLC. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=83c7ac15-ece9-47de-b83c-d575544fa449

11. 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

12. Marijuana Policy Project. “Prescribing” Versus “Recommending" Medical Cannabis. Accessed Dec 3, 2021. https://www.mpp.org/issues/medical-marijuana/prescribing-versus-recommending-medical-cannabis/

13. 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

14. 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/

15. Prohibited acts A, 21 U.S.C. § 841, https://www.govinfo.gov/app/details/USCODE-2019-title21/USCODE-2019-title21-chap13-subchapI-partD-sec841. (2019). https://www.govinfo.gov/app/details/USCODE-2019-title21/USCODE-2019-title21-chap13-subchapI-partD-sec841.

16. US Drug Enforcement Administration. Drug Scheduling. Accessed Dec 4, 2021. https://www.dea.gov/drug-information/drug-scheduling

17. Centers for Disease Control and Prevention. Cannabis Frequently Asked Questions. 2025. Accessed Mar 24, 2025. https://www.cdc.gov/cannabis/faq/index.html

18. 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-agencyshttps://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-signing-agriculture-improvement-act-and-agencys

19. 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

20. US Food and Drug Administration. Development & Approval Process Drugs. 2019. Accessed Dec 5, 2021. https://www.fda.gov/drugs/development-approval-process-drugs

21. 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