The Farm Bill and the Future of CBD
Omnibus Farm Bill Legalizes Hemp
After years in legal limbo, hemp is now legal in the US. President Trump signed the 2018 farm bill into law on the afternoon of December 20, 2018. The omnibus farm bill is how the federal government sets agricultural policy and is renewed every 4-5 years.
Making up just one small piece of the farm bill was the long anticipated removal of hemp from the list of federally controlled substances. Hemp is defined as cannabis (Cannabis sativa L.) that contains less than 0.3 percent of delta-9 tetrahydrocannabinol (THC), the psychoactive component in marijuana. This is 3 times the USDA threshold of 0.1 percent THC.
With a stroke of the pen, hemp is now out the reach of the Drug Enforcement Administration (DEA) but the US Food and Drug Administration (FDA) plans on stepping in to fill the void. In a statement released by the FDA, it was stated that any grower who exceeds the maximum THC level of 0.3 percent will face prosecution.
The law also enshrined the authority of the FDA to regulate hemp, cannabis and cannabis derived compounds such as cannabidiol (CBD). Although some are cheering this law as the first step towards marijuana legalization, the cannabis plant will remain heavily regulated for the foreseeable future.
The US Department of Agriculture will also play a role in hemp agriculture. Each state will be required to submit a plan for how they will regulate hemp production. In the event that the state does not submit a plan, producers can work directly with the federal government. It will be interesting to see how this process plays out. Will hemp really be treated like corn and soybeans? One thing we know for sure, the end product CBD will receive special attention.
Enter the FDA
No matter what twists and turns await hemp growers, and consumers, the legalization of hemp is a game changer. It has a wide range of valuable applications including clothing, supplements and of course CBD. CBD is a non-intoxicating derivative of the cannabis plant that has been credited with a wide range of therapeutic benefits.
The FDA immediately greeted the new farm bill by voicing concerns about CBD health claims and emphasized the legal purgatory in which medical marijuana continues to reside. Their deeply held reservations about the value of cannabis as a healing modality is outlined on their FDA and Marijuana: Questions and Answers resource page.
The FDA’s eagerness to crack down on therapeutic claims made about natural products is nothing new, nor is it surprising that pharmaceutical giants have far fewer difficulties overcoming these obstacles.
As of June 2018, GW Pharmaceuticals was able to market Epidiolex, a CBD pharmaceutical isolate used to treat epilepsy. This is the only FDA approved CBD treatment on the market. The irony is that your average CBD product derived from raw cannabis is much more closely related to the actual hemp plant. Yet the more natural products are the ones facing major production and marketing barriers.
This obstacle strewn path may sound familiar to anyone who has tracked the ark of the vaping industry. The FDA has been extremely reluctant to embrace “grassroots” movements like CBD and e-cigarettes. Their knee jerk reaction is always to seize control and assert their legal mandate.
The Future of CBD
Despite the apparent victory of hemp advocates, CBD’s future as a health supplement remains hazy. Companies that market CBD as preventing, diagnosing, treating or curing serious diseases will face enforcement action.
In response to the farm bill FDA Commissioner Scott Gottlieb wrote, “Cannabis and cannabis-derived products claiming in their marketing and promotional materials that they’re intended for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases (such as cancer, Alzheimer’s disease, psychiatric disorders and diabetes) are considered new drugs or new animal drugs and must go through the FDA drug approval process for human or animal use before they are marketed in the U.S.”
Gottlieb could not have made the FDA’s skepticism about CBD more clear when he wrote:
“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.”
Cracking down on disreputable companies making unsubstantiated claims is certainly within the FDA’s purview, but they are taking it a step further. For example, CBD cannot be put into food or drinks because it is considered a pharmaceutical ingredient. This obstacle may soon tumble due to pressure from Coca-Cola. Despite a press release to the contrary, it is widely thought that the beverage giant is waiting in the wings with a CBD beverage. Bloomberg reported in September that they are in talks with Aurora Inc. to develop a line of cannabis infused beverages to prop up their profits, which has suffered due to flat soda sales.
Navigating the FDA drug approval process is not easy, even pharmaceutical giants encounter unexpected delays and prohibitive expenses. This infographic on the FDA’s website outlines the 12 step approval process. Although there is an accelerated program, it is only open for drugs that treat serious disease AND fill an unmet medical need. Only about 1,000 drugs have met the criteria for this treatment in the last 26 years. In the unlikely event that CBD is added to the list, it won’t because of Hemp Farmer Brown’s legal prowess but because of pressure from a drug industry titan looking to corner the market.
The FDA announced they would hold a public meeting in the near future to investigate CBD further and outline their regulatory approach. Now that hemp is off the controlled substances schedule, it seems likely that there will be classes of CBD products.
As noted earlier, only the CBD isolate Epidiolex has been approved by the FDA at this time. So what does the future have in store for the countless other CBD products available over-the-counter. Will these products fall under the DSHEA statute from 1994 that governs and regulates dietary supplements in perpetuity? If the new FDA e-cig regulations have taught us anything, it is that federal regulators will not hold the reigns loosely.
Another interesting twist is that the US Department of Health and Human Services has owned the patent to CBD since 2003. Patent 6,630,507 focuses on the antioxidant properties of CBD and its potential to address autoimmune and neurodegenerative diseases such as Alzheimer’s and dementia. Expect a wave of new patents as companies stake their claims in a market that is expected to skyrocket in value.
The Long Road to Legalization
Regardless of how the FDA and USDA end up handling CBD, the removal of hemp from the controlled substance list was long overdue. Despite the lack of the psychoactive properties, until December 21, 2018 hemp was considered to be no different that heroin or LSD in the eyes of the federal government.
This legal anachronism dates back to the 1970 controlled substances act, which categorized the entire cannabis sativa plant as illegal. The controlled substances act was merely the final nail in the coffin of legality, the Marihuana Tax Act of 1938 had already ended the legal production of hemp in the United States, ending a tradition that dated back at least 335 years.[i]
2014 Farm Bill
In 2014, the house version of the previous farm bill provided the first sign that the federal death grip on marijuana cultivation was loosening. It permitted research institutions such as universities to grow hemp, if such growing was allowed in the state where the institution was located.
This pilot program allowed the tightly monitored cultivation of hemp but it did not address the intrusive oversight by the DEA. In total, over 25,000 acres in 19 states were dedicated to hemp cultivation through the pilot program. These farms are the primary source of legally manufactured CBD oil.
Hemp Shows Enormous Growth Potential
Twenty five thousand acres may appear to be an impressive total, but it is hardly reflective of the potential demand for hemp-based products. Grand View Research estimates that the market for hemp grown in the US could reach $10.6 billion by 2025.
The Industrial Hemp Farming Act of 2015 (Senate Bill 134) was designed to provide a permanent solution to the vexing issue of hemp legalization. It would have removed industrial hemp from the controlled substances list. The bill eventually died in committee and it was not until this week that the hemp-CBD issue was finally addressed.
Republican Senator Majority leader Mitch McConnell has staunchly supported industrial hemp legalization for years. It has been said that all politics is local and his primary motivation appears to be that hemp legalization will benefit Kentucky farmers.
The 2018 farm bill, officially named the Agricultural Improvement Act of 2018, received by bipartisan support. It passed the Senate 87-13 on Tuesday and cleared the house easily by a vote of 387-47. The bill allocates $867 billion over the next decade and essentially mirrored the priorities of the previous farm bill.
The 2014 farm bill had been delayed two years and the current bill also encountered plenty of roadblocks along the way. Due by September 30, an earlier version was defeated in May. This was due to Democratic opposition to new work requirements for the supplemental nutritional assistance program (SNAP) and a Freedom Caucus gambit to fast track a vote on immigration policy.
Interstate commerce of hemp products also remains heavily regulated by the FDA, “it’s unlawful under the FD&C Act to introduce food containing added CBD or THC into interstate commerce, or to market CBD or THC products as, or in, dietary supplements, regardless of whether the substances are hemp-derived.”
Another issue is that payment providers like PayPal have lengthy lists of banned items that they will not process, including e-cigarettes. These policies will probably be loosened a bit in coming months but this is not a foregone conclusion.
The FDA declare that hulled hemp seeds, hemp seed protein and hemp seed are Generally Recognized as Safe (GRAS). These products are available for sale outside of the FDA’s restrictive authority.