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CBD: A legal and regulatory update

FDA believes CBD is not a permissible dietary ingredient, but it has the option to consider circumstances that allow it to be used in a supplement.

Over the past few years, cannabidiol (CBD) has become a household term. Moms, dads, brothers, sisters and even grandparents know what CBD is. At the least, they have probably heard of it. Cannabis sativa L. is a plant that includes both marijuana and hemp. CBD is a naturally occurring cannabinoid found in the cannabis plant. Hemp has a much lower concentration of delta-9 tetrahydrocannabinol (THC), the psychoactive chemical found in high amounts in marijuana.

On Dec. 20, 2018, President Donald Trump signed the Agriculture Improvement Act of 2018 (2018 Farm Bill), changing the landscape for companies involved in the hemp industry. Prior to the 2018 Farm Bill, the 2014 Farm Bill governed the growing and cultivation of hemp in the United States. The 2014 Farm Bill allowed for the growing and cultivation of “industrial hemp,” which was defined 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.” The 2018 Farm Bill significantly broadens the definition of “hemp” to mean “the plant Cannabis sativa L. and any part of that plant, including the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids, salts and salts of isomers, whether growing or not, with a delta-9 tetrahydrocannabinol concentration of not more than 0.3 percent on a dry weight basis.” Notably, the 2018 Farm Bill simply states “hemp” in its definition, rather than “industrial hemp,” and it includes the specific parts of the plant and its chemical constituents.

The second, and arguably most impactful distinction between the 2014 Farm Bill and the 2018 Farm Bill, is that the 2018 version amends the Controlled Substances Act (CSA). The first line of hemp provisions in the 2014 Farm Bill stated, “Notwithstanding the Controlled Substances Act…”. As a result, under the 2014 Farm Bill, the only parts of the hemp plant permitted were those parts specifically excluded as a controlled substance from the CSA: “the mature stalks of such plant, fiber produced from such stalks, oil or cake made from the seeds of such plant, any other compound, manufacture, salt, derivative, mixture, or preparation of such mature stalks (except the resin extracted therefrom), fiber, oil, or cake or the sterilized seed of such plant which is incapable of germination.” Notably, these parts of the hemp plant contain negligible amounts of CBD and other cannabinoids. The 2018 Farm Bill specifically amended the CSA to exempt all parts and constituents of the hemp plant from the definition of “marijuana” and as a result, “hemp” is no longer a controlled substance.

The third most significant change is how the two versions differ with respect to who is permitted to grow and cultivate hemp. The 2018 Farm Bill removed the restriction on growing and cultivating “for purposes of research.”

The 2018 Farm Bill provided that if a state or Indian tribe wants to have primary regulatory authority over the production of hemp in its state or tribal territory, it must submit a plan to the Secretary of Agriculture, under which the state or tribal territory will monitor and regulate production. The Secretary has 60 days following the receipt of a state or tribal plan to either approve or disapprove its plan.

If a state or tribal territory does not submit a plan, or its plan is not approved, the production of hemp in that state or territory will be subject to a plan established by the Secretary. Furthermore, the 2018 Farm Bill will allow farmers to obtain crop insurance for their hemp plants.

So now, CBD can be sold as a dietary supplement, right? Not quite. While the 2018 Farm Bill provided for the growing and cultivating of hemp, removing the plant from the CSA, along with other changes that benefit the hemp industry, it does not affect the status of CBD as a dietary supplement, food or cosmetic. FDA has clearly stated products containing CBD cannot be sold as dietary supplements and it’s not legal in interstate commerce to sell a food to which CBD has been added.

FDA cited the investigational new drug application filed by GW Pharmaceuticals for its anti-seizure prescription drug Epidiolex®, stating those clinical investigations were made public before CBD was sold in the United States as a dietary supplement. This provision of the Federal Food, Drug and Cosmetic Act effectively “blocks” CBD from being sold as a dietary supplement, unless FDA promulgates regulations under the authority given to the Secretary of Health and Human Services. In fact, FDA Commissioner Scott Gottlieb, M.D., issued a press release the day the 2018 Farm Bill was signed into law. In his press release, the commissioner stated “pathways remain available for the FDA to consider whether there are circumstances in which certain cannabis-derived compounds might be permitted in a food or dietary supplement. Although such products are generally prohibited to be introduced in interstate commerce, the FDA has authority to issue a regulation allowing the use of a pharmaceutical ingredient in a food or dietary supplement. We are taking new steps to evaluate whether we should pursue such a process.” In addition to his comments about a potential pathway, the commissioner revealed FDA’s plans to hold a public meeting soon about cannabis-derived products.

The signing of the 2018 Farm Bill and the statements by the commissioner offer hope that the health and nutrition industry may potentially see FDA enact regulation and/or guidance permitting CBD to be marketed and sold as a dietary supplement. Stay tuned for updates in this constantly evolving landscape of CBD and hemp-derived products.

Jonathan Manfre, Esq. (Jay), is an associate attorney at Collins Gann McCloskey & Barry PLLC. For dietary supplement companies, Manfre regularly provides a legal review of the labels, websites, marketing and advertising to help ensure that companies are compliant with FDA and FTC regulations. He has been weight training for more than twelve years, has competed in two bodybuilding competitions, and has been a consumer of dietary supplements since the age of 18. He is extremely familiar with the dietary/sports nutrition industry and very knowledgeable when it comes to effects and function of these supplements.

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