Is it legal to purchase and possess CBD?

Cannabidiol, or CBD, is one of many compounds found in the cannabis plant. CBD exerts physiological effects in the body that are both similar to, and different from, tetrahydrocannabinol, or THC. In contrast to THC, its more psychotropic cousin, CBD is not intoxicating and does not deliver the “high” reported by users of cannabis.

CBD is on its way to becoming a darling of the dietary supplement world due to its wide range of purported beneficial effects, including anti-anxiety, anti-inflammation, anti-convulsant and neuroprotection.1,2

While the strength of the clinical evidence supporting these claims in human subjects is still emerging, it is not absent. The U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to a cannabidiol (CBD) botanical extract for the treatment of two rare childhood seizure disorders (i.e. Dravet syndrome, Lennox-Gastaut syndrome).3

CBD is freely available online as a "dietary supplement", and offline in health stores. But, is it legal to purchase without a medical recommendation?

The answer is not simple

CBD is a compound that exists in varying concentrations inside a plant that the Federal Government perceives as a strange case of Dr. Jekyll and Mr. Hyde. Marijuana (i.e. The evil Mr. Hyde) is deemed by the Federal government to have no medical value and a high potential for abuse. As such, marijuana is a Schedule I, Controlled Substance according to the US Drug Enforcement Administration (DEA).

In December of 2016, the DEA clarified that marijuana extracts – including cannabidiol (CBD) – fall under Schedule I drug classification.4

The DEA implements the Controlled Substances Act and may prosecute violators at both the domestic and international level.

CBD also exists in varying concentrations inside hemp (i.e. Dr. Jekyll), which is deemed by the Federal Government to be an industrial crop.

What is the difference between marijuana and hemp?

Hemp is a cannabis sativa L plant that contains less than 0.3% of THC on a dry weight basis. Marijuana is a cannabis sativa L plant that contains more than 0.3% of THC. Same plant, different concentration of THC.

Originally, the distinction was not based on the concentration of THC. It was based on the part of the plant. The 1937 Marijuana Tax Act defined marijuana as: “(A)ll parts of the plant Cannabis sativa L…the seeds thereof…the resin extracted…; but shall not include the mature stalks of such plant…oil or cake made from the seeds of such plant…”.5

This definition, which was adopted in the 1970 Controlled Substances Act, states that certain parts of the plant (“mature stalk” and “sterilized seed”) are exempt from the legal definition of cannabis.

The passage of the Federal Farm Bill in 2014, otherwise known as the Agricultural Act of 2014, changed the definition to define industrial hemp as "the plant Cannabis sativa L. and any part of such plant, whether growing or not, with a delta-9 tetrahydrocannabinol concentration of not more than 0.3 percent on a dry weight basis."6

In January of 2015, the Industrial Hemp Farming Act (H.R. 525 and S. 134) amended the Controlled Substances Act of 1970 to specify that if a cannabis plant contained less than 0.3% THC, it was defined as industrial hemp.7,8 Industrial hemp is not a controlled substance.

This is why you will often see CBD supplements in health food stores, and medical cannabis dispensaries, labeled as “Hemp Extracts” or “Hemp-derived CBD Oil.”

Are these products legal to purchase?

On the state level, CBD extracted from marijuana may or may not be legal, depending on the state and an individual's status. With the passage of Prop 215 in California in 1996, qualifying patients were given legal access to medical cannabis, and its extracts. There are currently 28 states and the District of Columbia with legal medical cannabis laws.9 In these states, where local law enforcement prevails, CBD extracted from marijuana is legal with a medical cannabis authorization.

Given that hemp is no longer a controlled substance, “Hemp Extracts” or “Hemp-derived CBD Oil” dietary supplements should be legal for consumers without a medical cannabis recommendation to purchase. Unfortunately, it's not that simple.

According to the FDA, CBD cannot be purchased by consumers as a dietary supplement ingredient, because…it is not a dietary supplement ingredient.

FDA has concluded that cannabidiol products are excluded from the dietary supplement definition under section 201(ff)(3)(B)(ii) of the Federal Food, Drug, and Cosmetic (FD&C) Act.”10

Dietary supplements can be purchased freely. Drugs (i.e. Medications) cannot, unless they are classified as over-the-counter.

According to the FDA, CBD is a drug (licit not illcit), or more accurately, it is on its way to becoming a drug, even if it comes from hemp. This is because GW Pharmaceuticals has filed an Investigational New Drug application (IND) with the FDA.

Assuming a substance was not "marketed as" a dietary supplement ingredient or a conventional food ingredient prior to the “authorization” of the IND application, “products containing that substance are outside the definition of a dietary supplement.”10

While many argue that CBD was marketed as a dietary supplement prior to the authorization of GW pharmaceutical's IND application, the “FDA has concluded that this is not the case for cannabidiol.”10

If CBD is not a dietary supplement, why can I buy it online and in health stores as a dietary supplement?

Many manufacturers of CBD and “Hemp Extracts” challenge the FDA’s position on CBD. As a result, they are continuing to manufacture their products. The FDA is mulling its options regarding CBD products, “FDA considers many factors in deciding whether or not to initiate an enforcement action.”10

The Bottom Line

Like many aspects of this emerging industry the lines are blurry. What the law states does not necessarily dictate how the law is enforced. CBD from "marijuana" is legally available to qualifying patients residing in states with medical cannabis laws. CBD from "hemp" is currently available to anyone as a dietary supplement ingredient, despite the fact that the FDA does not consider it dietary supplement ingredient.

References

1. Boychuk DG, Goddard G, Mauro G, Orellana MF. The effectiveness of cannabinoids in the management of chronic nonmalignant neuropathic pain: a systematic review. J oral facial pain headache. 2015;29(1):7-14. http://www.ncbi.nlm.nih.gov/pubmed/25635955. Accessed April 9, 2017.

2. Scuderi C, Filippis D De, Iuvone T, Blasio A, Steardo A, Esposito G. Cannabidiol in medicine: a review of its therapeutic potential in CNS disorders. Phyther Res. 2009;23(5):597-602. doi:10.1002/ptr.2625.

3. GW Pharmaceuticals Announces Epidiolex(R) Receives Fast Track Designation From FDA for the Treatment of Dravet Syndrome Nasdaq:GWPH. https://globenewswire.com/news-release/2014/06/06/642288/10084740/en/GW-Pharmaceuticals-Announces-Epidiolex-R-Receives-Fast-Track-Designation-From-FDA-for-the-Treatment-of-Dravet-Syndrome.html. Accessed April 9, 2017.

4. Federal Register :: Establishment of a New Drug Code for Marihuana Extract. https://www.federalregister.gov/documents/2016/12/14/2016-29941/establishment-of-a-new-drug-code-for-marihuana-extract. Accessed April 9, 2017.

5. West DP, American N, Hemp I. Hemp and Marijuana : North.:1-28. http://www.globalhemp.com/1998/02/hemp-and-marijuana.html. Accessed April 24, 2017.

6. Sec. 7606 of the 2014 Farm Bill - Legitimacy of Industrial Hemp Research. http://www.votehemp.com/2014_farm_bill_section_7606.html. Accessed April 27, 2017.

7. Massie T. H.R.525 - 114th Congress (2015-2016): Industrial Hemp Farming Act of 2015. 2015. https://www.congress.gov/bill/114th-congress/senate-bill/134. Accessed April 10, 2017.

8. Massie T. H.R.525 - 114th Congress (2015-2016): Industrial Hemp Farming Act of 2015. 2015. https://www.congress.gov/bill/114th-congress/house-bill/525. Accessed April 10, 2017.

9. Anonymous. State Medical Marijuana Laws. Natl Conf State Legis. 2015. http://www.ncsl.org/research/health/state-medical-marijuana-laws.aspx. Accessed January 13, 2017.

10. Commissioner O of the. Public Health Focus - FDA and Marijuana: Questions and Answers. https://www.fda.gov/newsevents/publichealthfocus/ucm421168.htm#enforcement. Accessed April 10, 2017.

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© Copyright 2016 - 2020 | Dr. Jamie Corroon, ND, MPH | IMPORTANT | All information presented in this website is intended for informational purposes only and not for the purpose of rendering medical advice. Statements made on this website have not been evaluated by the Food and Drug Administration. The information contained herein is not intended to diagnose, treat, cure or prevent any disease. All Rights Reserved