With the Farm Bill passing in December of 2018, hemp consumers, producers, farmers and enthusiasts were more than thrilled. However, the celebration did not last long before FDA Commissioner Scott Gottlieb, M.D., released a statement assuring the public they will continue to crack down on cannabis or cannabis-derived products like any other FDA-regulated products. While the passing of the farm bill is highly beneficial to current and future hemp farmers, it seems hemp-based CBD producers and sellers are at a stand still.
Hemp is extremely versatile in it’s uses. Aside from the promising benefits CBD and other cannabinoids found in hemp have to offer, we know that hemp seeds (whole or processed) contain a significant amount of protein, nutrients and essential fatty acids. Not only is hemp good for the body, but hemp’s sturdy fibers have also made it a great candidate for paper, plastics, auto paneling, building materials, and textiles. And to top it all off, it is a highly sustainable crop! While we are excited about the potential uses of hemp when it comes to common industrial commodities as well as the positive environmental impact that comes with switching to hemp derived products, we should all be cautious of what the future holds for its medicinal uses. CBD, or cannabidiol, is one of the many cannabinoids found in hemp and marijuana. Unlike THC, CBD is non-psychoactive and has various therapeutic characteristics, as do the other natural cannabinoids found in this plant. The hemp and CBD industry is growing and will only continue to do so, with or without the FDA’s stamp of approval.
While we believe this industry could very likely benefit from a larger governing body when it comes to regulation and implementing safe practices for high quality products, we worry about another powerful group stepping into the space with it. A player that could possibly taking over the industry completely: Big Pharma.
So far, it appears that Big Pharma has only dipped its big toe in the CBD market. Earlier this year, Epidiolex was approved by the FDA as the first plant-derived cannabinoid prescription medicine. Epidiolex is intended for treatment of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome, two rare childhood-onset epilepsies. On the surface, this seems like a step in the right direction, but in reality, it further confuses the legality of CBD.
According to a Q&A posted on the FDA website the Federal Food, Drug and Cosmetic Act, the FDA considers any product for human consumption containing the active ingredient (e.g., CBD) of an FDA-approved pharmaceutical drug (e.g., Epidiolex) “adulterated and misbranded.” According to an Aug. 2018 article by East Bay Express, hemp farmer and activist, Veronica Carpio, believes the FDA approval of Epidiolex could give the federal government the strongest legal grounds yet to justify a crackdown on CBD (and cannabis in general) while simultaneously laying the groundwork for Big Pharma to take over the medical marijuana industry nationwide.
The article continues, now that Epidiolex has been approved, the FDA must prepare a “medical and scientific analysis” of the new drug for the DEA, the U.S. Drug Enforcement Agency. The DEA could then decide to move CBD from Schedule I in the Controlled Substances List to Schedule II-V, “meaning only pharmaceutical companies, doctors, and pharmacists would be allowed to legally produce, prescribe, and distribute CBD, respectively, in compliance with federal law.” In other words, this would monopolize the industry and give Big Pharma total control (and cash) over this plant.
According to Justia.com, GW Pharmaceuticals holds around 100 patents related to the medical efficacy of cannabis. These patents cover everything from cannabinoid extraction processes to cannabinoid-based drug formulas used to treat almost any illness/disease you could think of. The patents for the formulas include treating ailments such as cancer, obesity, bulimia, tumors, inflammatory bowel disease, psychosis, Alzheimer’s disease, schizophrenia and common mood disorders.
Although many cannabinoid tests are being done (promising tests with the number of patents GW holds), producers and sellers of CBD are not allowed to make any health claims on the subject. The FDA website is littered with warning letters to a wide range of CBD companies, both on the local and national level.
A Sept. 2018 Forbes article mentions a hemp activist and entrepreneur, Joy Beckerman, who has spent decades building the U.S. hemp movement and assists many of the world’s leading hemp advocacy and industry groups. Beckerman had an important message for hemp supporters. She urges them to be “more vigilant than ever about federal and state-level law and policy moves going forward. ‘Special interests and residual hysteria will continue to try to get in there, to stomp on the little guy, and on consumer rights and safety, and to over-regulate, so it’s more important than ever that we organize and engage,’” she said.
We encourage any and all hemp CBD users and supporters to find out what you can do to make your voice heard in this industry. We’ve found a few resources that you might find helpful when trying to navigate your role in this space. The NCIA, National Cannabis Industry Association, outlines a variety of ways we can take action, like contacting your elected official. Another helpful resource is Vote Hemp, which covers laws and legislations as well as how to advocate in the hemp industry.