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
WATCHSee 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
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.17 Public disclosure of smaller, informal studies not required.
FDA-Approved
Cannabinoid Products
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.
Non--FDA-Approved
Cannabinoid Products
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
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.19 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, 10-13
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.20 Interstate transportation of these products is federally illegal.21
FDA-Approved
Cannabinoid Products
Eligible for insurance coverage.8
Non--FDA-Approved
Cannabinoid Products
Insurance coverage is rare.8
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
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.
References
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]. Palo Alto, CA: Jazz Pharmaceuticals, 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
