Cannabidiol’s (CBD) rise to prominence has been met with equal parts discord and dispute. The Agricultural Act of 2014 (also known as the 2014 Farm Bill) allowed for clinical studies of the compound, which have cultivated promising medical applications, leading the Food and Drug Administration (FDA) to approve of Epidiolex, a CBD isolate prescription drug for treating epilepsy. The Agriculture Act of 2018 (2018 Farm Bill) expanded on its predecessor by legalizing hemp, making hemp products such as food, supplements, ointments oils, and smokable devices widely available. The United States Department of Agriculture (USDA) oversees hemp at the federal level and will work closely with states under the 2018 Farm Bill where states can license the cultivation of hemp by submitting regulatory plans to the USDA. Overall, roughly 40 states have implemented hemp programs under the 2014 Farm Bill, and no two states have the same hemp regulations.
The FDA has historically pushed back on CBD, concluding that because CBD is already approved as a prescription drug, it cannot be added to food or dietary supplements in the form of hemp-derived CBD (Hemp CBD). Additionally, the FDA sent warning letters to distributors of Hemp CBD products that make medical claims, causing several states to follow suit, in prohibiting the manufacture or distribution of Hemp CBD products intended for human or pet consumption. Other states ignore the FDA in this area by allowing the use of Hemp CBD in food and supplements. This all further complicates the industry and the hinderances to creating and maintaining a business within it.
Our hemp business attorneys understand how the interplay between federal law, state law, FDA regulation, and USDA regulations complicates things for businesses trying to establish themselves in this budding industry. They are well-versed in the convoluted and sometimes conflicting state and federal laws. Our experience with cannabis dates back to the days of the emerging medical marijuana industry, so we know how challenging inconsistent federal and state laws can be. In addition, we have a team of lawyers versed in international trade, which is becoming an increasingly important market in light of the 2018 Farm Bill and the export and import of hemp and Hemp CBD.
Our hemp business attorneys work on a wide range of businesses within the industry, from small start-ups to major corporations looking to expand into the rapidly growing market. We have worked on the following hemp matters:
- Investigating the source of hemp products to verify that they are not derived from marijuana and do not contain prohibited levels of THC;
- Analyzing risks associated with transporting hemp interstate and internationally;
- Obtaining licenses for the cultivation or processing of hemp;
- Advising clients on best practices for the manufacture, labeling, and distribution of hemp products;
- Responding to complaints and seizures of Hemp CBD products;
- Providing updates to clients as regulations and laws change across the country; and
- Counseling clients on developing policies and regulations from the FDA and USDA.
In addition, each month our attorneys prepare a 50-State Hemp CBD Risk Matrix. This Risk Matrix provides a brief summary of how each of the 50 states regulates products Hemp CBD as it pertains to the following categories:
- Hemp-CBD Requirements: General laws, regulations, restrictions, policies, or requirements for Hemp CBD;
- Consumables: Hemp CBD as used in food, beverages, dietary supplements, and other consumable goods for humans;
- Smokables: How the state treats Hemp CBD in smokable products such as dried flower, vape products, and cigarettes;
- Cosmetics: How the state treats Hemp CBD in cosmetics;
- Enforcement Actions: Whether there has been any adverse enforcement action by law enforcement against Hemp CBD in the last 6 months;
- Select Laws and Regulations: A non-exhaustive selection of relevant authorities on Hemp CBD, including laws, regulations, and policy statements; and
- Pending Laws/Regulations: Authorities that are not yet in effect but will impact the sale and marketing of Hemp CBD products.
If you are interested in obtaining a copy of the Risk Matrix please let us know.
With the guidance of our hemp business attorneys, you can rest easy knowing that your business is in compliance with these complex and evolving laws, and comfortably push your business fullspeed ahead.