CBD Oil - Legal in Dietary Supplements?
CBD Oil: Legal in Dietary Supplements?
Q: Is it legal to sell CBD oil in supplement products?
A: At this year’s Arnold Sports Festival in Columbus, the question everyone was asking me was, “Is CBD legal?” Cannabidiol (CBD) is a naturally occurring cannabinoid found in cannabis plants, which produce both marijuana and hemp. Hemp typically has a much lower concentration of tetrahydrocannabinol (THC), the psychoactive chemical found in marijuana that produces a “high.” The World Health Organization reported that pure CBD does not exhibit the effects indicative of abuse, dependence potential, or any public health-related problems.1 So, why is there a question about its legality?
The Agricultural Act of 2014 (Farm Bill) Section 7606, “Legitimacy of Industrial Hemp Research,” allows universities and state departments to grow or cultivate industrial hemp if: “(1) the industrial hemp is grown or cultivated for purposes of research conducted under an agricultural pilot program or other agricultural or academic research; and (2) the growing or cultivating of industrial hemp is allowed under the laws of the state in which such institution of higher education or state department of agriculture is located and such research occurs.”2 The Farm Bill defines “industrial hemp” as “the plant Cannabis Sativa L. and any part of such plant, whether growing or not,” with a THC concentration of “not more than 0.3 percent on a dry weight basis.” Note that the Farm Bill doesn’t permit growing marijuana (as opposed to industrial hemp) and it doesn’t let everyone who wants to grow industrial hemp to do so. Growing hemp must be legal under the state law where the hemp is grown. If a product is manufactured using CBD made from industrial hemp grown and cultivated according to the requirements of the Farm Bill, it’s legal under that law.
However, in December of 2016, the DEA established a new drug code including CBD and other cannabinoids within Schedule I of the Controlled Substances Act (CSA) for “Marijuana Extract.”3 This new scheduling of Marijuana Extract directly conflicts with the definition of industrial hemp in the Farm Bill. DEA addressed the conflict a few months later in a “Clarification of the New Drug Code (7350) for Marijuana Extract,” stating that the “new drug code (7350) established in the final rule does not include materials or products that are excluded from the definition of marijuana set forth in the [CSA]. The new drug code includes only those extracts that fall within the CSA definition of marijuana. If a product consisted solely of parts of the cannabis plant excluded from the CSA definition of marijuana, such product would not be included in the new drug code (7350) or in the drug code for marijuana (7360).”4 So, DEA conceded that CBD from industrial hemp is legal from its perspective so long as the industrial hemp is grown and cultivated legally pursuant to the requirements of the Farm Bill.
But wait. Other regulatory agencies are also in the mix. The FDA has jurisdiction over dietary supplements, so CBD supplement products must comply with supplement regulations including, e.g., current good manufacturing practices, proper labeling and not making claims about diagnosing, treating, curing or preventing disease. Some CBD supplement companies are claiming “relief from” diabetes, anxiety, inflammation and even cancer, and have received FDA warning letters for doing so.5 Also, by definition, a dietary supplement cannot include an article authorized for investigation as a new drug for which substantial clinical investigations have been instituted and made public (unless it was marketed as a supplement or food before the clinical investigations started). FDA warning letters have raised this issue as well, although the Hemp Industry Association (HIA) disagrees with the FDA’s position.6 HIA claims it submitted evidence to the FDA showing that CBD was marketed as a food and dietary supplement long before it was authorized for drug trials, but that the FDA hasn’t acknowledged it.7
Beyond the DEA and FDA, each state has its own laws, rules and regulations and there are still other regulatory bodies that have oversight authority. Companies seeking to market CBD supplement products need to recognize that there’s a level of uncertainty and must stay abreast of the latest legal developments as things evolve.8 Without doubt, the legality of CBD products is the hottest new topic in the supplement market, but the answer is “high-ly” complicated and fact-dependent.
References:
1. http://www.who.int/medicines/access/controlled-substances/5.2_CBD.pdf
2. https://www.gpo.gov/fdsys/pkg/BILLS-113hr2642enr/pdf/BILLS-113hr2642enr.pdf
3. https://www.deadiversion.usdoj.gov/fed_regs/rules/2016/fr1214.htm
4. https://www.deadiversion.usdoj.gov/schedules/marijuana/m_extract_7350.html
5. https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm583188.htm
6. https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm583197.htm
8. Feel free to call Jay Manfre, Esq., in my office at 516-294-0300. Jay’s knowledge of this subject was of great assistance in this column.
Rick Collins, JD, CSCS [www.rickcollins.com] is the lawyer that members of the bodybuilding community and nutritional supplement industry turn to when they need legal help or representation. [© Rick Collins, 2018. All rights reserved. For informational purposes only, not to be construed as legal or medical advice.]
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