CBD oil is massively popular, and when you look at the anecdotal evidence, it’s easy to see why. A quick Google search reveals myriad testimonials about the physical and mental illnesses it can treat or cure, from anxiety to cancer. Although no medication is a cure-all, there’s empirical evidence to back up CBD’s effectiveness in alleviating symptoms such as inflammation, nausea, and insomnia. But is it even legal?
The FDA will now oversee CBD; to what extent is yet to be determined.
CBD, short for cannabidiol, is one of the two main cannabinoids in the cannabis plant; the other is THC, or tetrahydrocannabinol. The latter is the one that gets you high, and it’s why cannabis remains federally illegal. However, you can buy CBD-oil vape cartridges at smoke shops, CBD gummies at gas stations, and CBD-infused treats at pet stores.
“With the recent passing of the  Farm Bill, hemp-derived CBD was removed from the Controlled Substances Act and officially made legal nationwide,” says Elle Welch, Marketing and Communications Manager of Mary’s Medicinals, a manufacturer of hemp- and cannabis-derived topicals. “Prior to this, companies were operating under and complying to an industrial hemp pilot program.”
She’s referring to the 2014 version of the U.S. Food and Drug Administration (FDA) Farm Bill, which created an exception to the U.S. Drug Enforcement Administration’s (DEA) categorization of cannabis as a Schedule 1 controlled substance. That exception was industrial hemp research. This limited redefinition of the word “cannabis” applied to any plant with a THC concentration of less than 0.3 percent.
The 2014 Farm Bill allowed state departments of agriculture to grow hemp – not marijuana -- “for purposes of research conducted under an agricultural pilot program or other agricultural or academic research.” However, the FDA didn’t specify how to procure the hemp seeds, specifically define “research,” or address CBD production specifically. There was no guidance for out-of-state transportation of seeds or product.
“Hemp-derived CBD companies use various courier services,” says Welch. Denver-based Mary’s has a side line called Mary’s Nutritionals, which they sell online; the THC-containing Medicinals are only sold in licensed dispensaries. The CBD for the Nutritionals line, she says, is grown in-state.
Procuring the original hemp seeds, then, is somewhat shrouded in secrecy, but if the plants are grown in-state and conform to THC limitations, they’re legal. Shipping to other states, however, isn’t. Transporting any form of cannabis, including hemp, across state lines violates Justice Department guidelines. In an effort to comply with federal law, companies that produce CBD products sometimes import hemp from outside the U.S. (Welch is clear that Mary’s doesn’t do this, saying, “Our hemp-derived CBD is grown in Colorado on Elite Botanicals farm and held to the highest quality farming principles. Some overseas countries do not adhere to those same standards.”)
With the passage of the 2018 version of the Farm Bill, which designates hemp as an agricultural crop, it is no longer classified as industrial. “The signing of the 2018 Farm Bill into law is genuinely historic and monumental,” says investigative journalist Maryam Henein, best known for directing the documentary film Vanishing of the Bees. She sells a organic liposomal CBD through her company Simply Transformative. “The DEA is no longer classifying CBD as Schedule 1. The FDA will now oversee CBD; to what extent is yet to be determined.”
This DEA-to-FDA handoff has both pros and cons. On the one hand, it federally legalizes CBD. On the other hand, FDA Commissioner Scott Gottlieb has stated that CBD is a drug ingredient, and as such, it’s illegal to add it to food or health products without FDA approval. “Selling unapproved products with unsubstantiated therapeutic claims is not only a violation of the law, but also can put patients at risk, as these products have not been proven to be safe or effective,” Gottlieb’s official statement reads.
“Of course, we’re not allowed to make any claims,” says Henein. The product descriptions for Simply Transformative products instead provide links to research studies on the conditions (neuropathies, fibromyalgia, joint pain) for which CBD has shown to be effective.
Efficacy and regulation of CBD products will take center stage as we head into a new era of oversight. The gas-station gummies, for example, probably aren’t as effective as oil from non-GMO, pesticide-free hemp that has been decarboxylated, cleanly extracted, and tested for contaminants.
The cannabis industry and producers of cannabis oil are now in the position to educate the FDA, to the degree the FDA chooses to be educated. A CBD-based seizure medication called Epidiolex, produced by GW Pharmaceuticals and Bayer, recently received FDA approval. At a cost to patients of approximately $2700 per month, it’s prohibitively expensive. Whether or not the FDA will allow small business to make the same claims as big business remains to be seen.
Gottleib’s statement says that while CBD is no longer a Schedule 1 drug, shipping foods and supplements containing it is still illegal. This is another Epidiolex-based complication: CBD is now an FDA-approved ingredient in a prescription drug, and the FDA doesn’t allow prescription-drug ingredients in foods and supplements. In 2019, the agency will begin to work out future CBD regulation.
In the meantime, if you want to try CBD, educate yourself on the way products differ. Purchase products with minimal ingredients that reveal the extraction method used. Choose organically grown, pesticide-free, non-GMO hemp (or cannabis, if you live in a legal state). If you purchase your CBD oil in a dispensary, a knowledgeable budtender can tell you more about where it comes from and who makes it. If you order online, look for legitimate customer testimonials, and ask friends for recommendations. Buy locally, if possible – and it’s going to become more and more possible now that the government has made hemp a commodity crop, allowing farmers to obtain crop insurance and get loans from U.S. banks.
The 2018 Farm Bill is good news for both growers and patients. With luck – and continued activism by cannabis advocates – CBD will become more potent, purer, and more accessible in 2019 and beyond.