What Does The Farm Bill Mean For Hemp and CBD Products?
On December 20, President Donald Trump signed the Agricultural Improvement Act of 2018 (also known as the Farm Bill) into law. The bill, which passed in a 389-to-47 vote in the House and by 87-to-13 in the Senate, allocated billions of dollars worth of subsidies to farmers in America and rejected the proposal championed by House Republicans that would have restricted access to the food stamp program by tweaking relevant work requirements.
Most importantly to the American cannabis industry, the 2018 Farm Bill brought about the legalization of hemp — a form of cannabis plant containing less than 0.3% of the psychoactive cannabinoid tetrahydrocannabinol (THC).
The Farm Bill
By legalizing hemp in this way, the United States Department of Agriculture (USDA) can now properly regulate hemp farming and introduce further protections for hemp farmers, such as improving access to insurance by covering hemp under the 1980 Federal Crop Insurance Act, which was also a consequence of the Farm Bill. The regulation of hemp cultivation will be a tandem effort between the USDA and the relevant state-level department of agriculture to adopt a plan for the licensing and regulation of hemp cultivation in each state.
In addition to changing how hemp farming is managed, the passing of the Farm Bill also removed hemp-derived cannabidiol (CBD) from the Controlled Substances Act, in essence federally legalizing hemp-derived CBD products. The bill states that any cannabinoid that is derived from legally cultivated hemp material, in accordance with guidance given in Section 12619 of the Bill, would also be considered legal by extension for use and sale.
As a result, the Farm Bill is expected to be a huge boon to the CBD industry, as well as the wider hemp farming industry. One 2018 CBD study, carried out by the cannabis market research firm The Brightfield Group, projected that if the Farm Bill were to pass the CBD industry could expect to be worth as much as $22 billion by the year 2022, dependent on other political and regulatory variables.
The views of the FDA on CBD products
On the same day that President Trump signed the Farm Bill into law, the US Food and Drug Administration (FDA) released a statement clarifying how the passing of the Farm Bill would affect the operation of the FDA in managing CBD products.
The statement points out that despite the many changes concerning hemp and CBD that were included in the Farm Bill, there are some practices that will remain unaffected — for example, the FDA still has the authority to regulate products that contain cannabis or cannabis-derived compounds under the Federal Food, Drug, and Cosmetic Act and Section 351 of the Public Health Service Act. This means that the FDA is still responsible from a public health perspective to enforce systems that protect the public from things such as products making false medical claims, or otherwise present some form of risk.
“We continue to be concerned at the number of drug claims being made about products not approved by the FDA that claim to contain CBD or other cannabis-derived compounds,” reads the FDA statement. “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 … must go through the FDA drug approval process for human or animal use before they are marketed in the US. 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.”
The advice of the FDA to makers of these products is to either cease marketing these products as beneficial to health and wellness — as is usually suggested in the warning letters that have been sent to firms previously engaging in this behavior — or to go through the proper channels to gain approval from the FDA in order to lawfully market their products as such. The example of this that is given in the FDA statement is that of the anti-epileptic drug Epidiolex, which contains cannabis-derived CBD, but was approved for use even before the passing of the Farm Bill by demonstrating its therapeutic usefulness across multiple clinical trials. Makers of other CBD or hemp-derived products who believe their products do have significant therapeutic or medicinal benefit and have scientific evidence supporting the claims can appeal to the FDA in the same manner.
The FDA and other hemp-derived products
Another important part of the FDA statement explains the federal stance regarding the category of products that are derived from the hemp plant but do not contain CBD or THC.
For three specific hemp-derived ingredients — hulled hemp seeds, hemp seed protein, and hemp seed oil — the FDA has issued “Generally Recognized as Safe” (GRAS) notices, on account of their containing, at a maximum, only trace amounts of CBD or THC, usually picked up as a consequence of harvesting and processing operations. These GRAS notices indicate that these ingredients can be legally used in foods or supplements without the need to go through extra approval steps, provided that the products they are being used in do not make any unsubstantiated medical treatment claims and properly list the hemp-derived items on the product’s ingredient list.
Regarding the role of the FDA in regulating hemp and CBD products in America, the FDA also announced in the statement their intention to hold a public meeting soon where stakeholders and those involved in the hemp industry can share experiences and feedback relating to the FDA’s handling of hemp products.
“[We] recognize the potential opportunities that cannabis or cannabis-derived compounds could offer and acknowledge the significant interest in these possibilities,” concludes the FDA statement. “We’re committed to pursuing an efficient regulatory framework for allowing product developers that meet the requirements under our authorities to lawfully market these types of products.”
