Q & A: What does the 2018 Farm Bill mean for CBD Supplements?
On December 20, 2018, President Trump signed into law the 2018 Farm Bill, changing the landscape for companies in the hemp industry. However, the devil is in the details, and companies marketing and selling CBD (cannabidiol) as a dietary supplement need to know what the new Farm Bill says … and what it doesn’t say. While the landscape is fluid and still evolving, here are our thoughts as of the moment.
Q: What’s the difference between the 2014 Farm Bill and the 2018 Farm Bill?
A: There are several differences between the 2014 Farm Bill and the 2018 Farm Bill. The first major difference is the way that “Hemp” is defined. The 2014 Farm Bill allowed for the growing and cultivation of “Industrial Hemp,” which it 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 defines the term “Hemp” as “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 2014 Farm Bill used the term “Industrial Hemp,” while the 2018 Farm Bill simply states “Hemp.” Additionally, the 2018 Farm Bill includes the specific parts of the plant and “all derivatives, extracts, cannabinoids, isomers… etc.” So, in essence, the new definition of hemp is broader than before.
The second, and most impactful distinction between the 2014 Farm Bill and the 2018 Farm Bill is that the 2018 version amends the Controlled Substances Act (CSA). If you recall, the very first line of 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 that were permitted were those parts that were 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.” The 2018 Farm Bill specifically amends the CSA to exempt “Hemp” from the definition of “marihuana” and, as a result, “Hemp” is no longer a controlled substance. That amendment removes Hemp, as defined in the new Farm Bill, from the oversight authority of the Drug Enforcement Administration (DEA).
The third most significant change is how the two versions differ in who is permitted to grow and cultivate Hemp. The 2014 Farm Bill specifically stated that “an institution of higher education or a State department of agriculture may 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 high education or State department of agriculture is located and such research occurs.” The 2018 Farm Bill removes the restriction on growing and cultivating “for purposes of research” and the ability of the individual States to restrict the growing and cultivation of hemp. The 2018 Farm Bill provides that if a State or Indian tribe wants to have primary regulatory authority over the production of hemp in their State or territory, they must submit a plan to the Secretary of Agriculture, under which the State or Indian tribe will monitor and regulate the 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 government does not submit a plan, or their plan is not approved, the production of Hemp in that State or Indian territory will be subject to a plan established by the Secretary. Accordingly, the 2018 Farm Bill makes the growing and cultivation of Hemp legal in all 50 U.S. States and Indian territories.
Q: Are THC levels still important?
A: Yes, the THC limit for Hemp is defined as “not more than 0.3 percent on a dry weight basis.” However, the 2018 Farm Bill amends Schedule I of the CSA to exclude THC that comes from Hemp. As a result, THC that comes from Hemp is no longer a Schedule I controlled substance.
Q: What does the new Farm Bill say about CBD specifically?
A: The 2018 Farm Bill states that Cannabidiol (CBD) that is derived from Hemp is excluded from the CSA. As a result, CBD that is extracted from Hemp is no longer a scheduled substance, meaning that the DEA cannot take action against the possession, transport, or sale of CBD that is derived from Hemp.
Q: Does the 2018 Farm Bill definitively take away the DEA’s authority over CBD?
A: Yes and no. As stated above, the 2018 Farm Bill removed CBD that is derived from Hemp from the Controlled Substances Act, thus removing DEA from the equation. However, CBD can also be extracted from Marijuana, which remains a Schedule I controlled substance, so the DEA still has authority over CBD extracted from Marijuana.
Q: What role do individual State laws play in light of the new Farm Bill?
A: As explained above, the 2018 Farm Bill gives each State and tribal government the ability to monitor and regulate the production of Hemp by submitting a plan to the Secretary of Agriculture. Accordingly, the growing and cultivating of Hemp may be regulated differently in each state according to that State’s specific Hemp production plan. However, if the State you live or conduct business in chooses not to submit a plan, or the plan is disapproved, the Secretary of Agriculture will have a “default” plan in place to regulate and monitor the production of Hemp. At the present time, the default plan has not been publicly revealed.
Q: Does the new Farm Bill allow CBD to be lawfully sold as a dietary supplement?
A: Contrary to some claims, the answer is No. While the 2018 Farm Bill provides for the growing and cultivating of Hemp and removes Hemp from the CSA, along with other changes that benefit the Hemp industry, it does not affect the regulatory status of CBD as a dietary supplement, food, or cosmetic. Dietary supplements are regulated by the Food and Drug Administration (FDA) under the Food, Drug and Cosmetic Act (FDCA). The FDA has made clear that it is of the opinion the CBD is not a permissible dietary ingredient, dietary supplement, or food additive. In fact, the 2018 Farm Bill specifically states that it does not affect or modify the FDCA. As the regulatory agency responsible for dietary supplements, the FDA has the ultimate say when it comes to selling CBD as a supplement, and the FDA has not changed its position that CBD is not a lawful dietary supplement.
Q: Does the new bill change the effect of making claims about CBD products?
A: No. The FDA, along with the Federal Trade Commission (FTC), regulate marketing and advertising, including claims, made about all products sold as dietary supplements in the United States. The FDA and FTC require that all marketing and advertisements made about any dietary supplement be truthful and not misleading and that all claims must be “substantiated.” The standard for adequate substantiation is “competent and reliable scientific evidence.” This means “tests, analyses, research, studies, or other evidence based on the expertise of professionals in the relevant area that has been conducted and evaluated in an objective manner by persons qualified to do so, using procedures generally accepted in the profession to yield accurate and reliable results.” Nothing in the new Farm Bill changes the standards for making claims.
Additionally, dietary supplements are prohibited from making “disease claims.” This means that dietary supplements cannot make claims about their ability to “diagnose, treat, cure, or prevent” any disease. The FDA’s definition of what constitutes a disease is broad. The FDA defines a disease as “damage to an organ, part, structure, or system of the body such that it does not function properly (e.g., cardiovascular disease), or a state of health leading to such dysfunctioning (e.g., hypertension); except that diseases resulting from essential nutrient deficiencies (e.g., scurvy, pellagra) are not included in this definition.” Making disease claims about a CBD product causes the product to be misbranded and adulterated, and consequently illegal to introduce into interstate commerce. Some CBD marketers have been making disease claims about CBD products and have received Warning Letters from FDA. Making disease claims about CBD products, especially after receiving a Warning Letter, increases the possibility of an enforcement action by the government.
Q: What would be needed for CBD to be a legal dietary supplement in all 50 states?
A: In order for CBD to be lawfully sold as a dietary supplement under federal law in the United States, the FDA would need to enact a regulation or issue a guidance about CBD. For now, the FDA considers CBD, and products containing CBD, that are labeled as dietary supplements to be misbranded and adulterated drugs. Up until this point, we have seen FDA’s actions against CBD products focused on those companies that are making impermissible claims that their product can treat, cure, prevent or mitigate diseases and those products whose labeling is not compliant.
We hope this Q & A addresses the most common questions about the new Farm Bill. Should you have any questions about Hemp or CBD, please feel free to contact our law firm at 516-294-0300. Also, sign up for our email list for updates by clicking here.