Because the 2018 Farm Bill removed hemp from the definition of marijuana in the CSA, this change may streamline the process for researchers to study certain cannabis derivatives that have no more than 0.3% THC by dry weight, including cannabinoids such as CBD, which could advance the development of new drugs from those substances.
At present, any CBD food or purported dietary supplement products in interstate commerce is in violation of the FD&C Act due to the statutory provisions discussed above. However, FDA’s biggest concern is the marketing of CBD products that make unsubstantiated therapeutic claims to prevent, diagnose, mitigate, treat, or cure serious diseases, but have not obtained new drug approvals. For example, FDA has seen various CBD products with claims of curing cancer or treating Alzheimer’s disease. The proliferation of such products may deter consumers from seeking proven, safe medical therapies for serious illnesses – potentially endangering their health or life. FDA’s commitment to protect consumers from these unsubstantiated therapeutic claims does not just apply to CBD products – it is a longstanding commitment of the Agency across all the products we regulate.
FDA has also received feedback from stakeholders interested in conducting research with cannabis and CBD. FDA is committed to doing what we can to facilitate and preserve incentives for clinical research. We are concerned that widespread availability of CBD in products like foods or dietary supplements could reduce commercial incentives to study CBD for potential drug uses, which would be a loss for patients.
Preserving Incentives for Research and Drug Development
The passage of the 2018 Farm Bill has led to the misperception that all products made from or containing hemp, including those made with CBD, are now legal to sell in interstate commerce. The result has been that storefronts and online retailers have flooded the market with these products, many with unsubstantiated therapeutic claims. FDA has seen CBD appear in a wide variety of products including foods, dietary supplements, veterinary products, and cosmetics. As this new market emerges, we have seen substantial interest from industry, consumers, and Congress. However, in the midst of the excitement and innovation, FDA’s role remains the same: to protect and promote the public health.
Testimony of Amy Abernethy, Md, Phd., Principal Deputy Commissioner, Office of the Commissioner, Food and Drug Administration, Department of Health And Human Services
before the Senate Committee on Agriculture, Nutrition, and Forestry
The public hearing raised many issues, including the need for more and better data regarding the benefits and risks of CBD, concerns related to manufacturing, adulteration, and unlawfully marketed products, and even as simple as the need for consistent terminology related to cannabis products. We opened a public docket to collect comments as part of the public hearing, and it just closed on July 16, 2019. We received 4,492 comments submitted to the docket, which we have been reviewing. As this issue progresses, we are committed to being transparent with the public about our path forward and providing information that is based on sound science and data.
It has only been seven months since the 2018 Farm Bill removed hemp, which includes low- THC derivatives of cannabis, such as CBD products, from the definition of marijuana in the CSA. I cannot overstate how significant of a policy sea change this has been. Prior to the enactment of the 2018 Farm Bill, the CSA did not differentiate between marijuana and hemp, and all cannabis (with certain exceptions, e.g. sterilized seeds and mature stalks of the plant) was a Schedule I substance and therefore controlled by the Drug Enforcement Administration (DEA). Early interest in clinical research was focused on the development of drugs using THC rather than CBD. More recently, interest in CBD as a drug is increasing, and, as discussed above, FDA approved Epidiolex in 2018, a drug for the treatment of two severe forms of childhood seizures.
Here is a link to the USDA’s full summary of the current Farm Bill and here is the full law as it stands today. Click here for an in-depth look at the history of each U.S. Farm Bill since 1933, including a side-by-side comparison. The current Farm Bill will be up for renewal again sometime during 2023.
Congress later passed a more permanent farm bill, known as the Agricultural Adjustment Act of 1938, with a stipulation to review and update the bill every five years. This was again updated in 2008 to what became known as the Food, Conservation, and Energy Act of 2008. There have been multiple revisions of this farm bill since 2008.
THC is short for tetrahydrocannabinol, the psychoactive component responsible for marijuana’s “high.” This new legislation opened the door for the CBD industry to boom, as the bill legalized hemp oil CBD oil at the federal level. Subsequently, some states have passed additional regulations surrounding CBD, and individuals are advised to check with their city and state government for the most current regulations in their area.
How the Farm Bill Impacts the CBD Industry
The farm bill includes input and collaboration by many industry groups related to our food supply and production, including the American Farm Bureau Federation, the International Dairy Foods Association, the National Corn Growers Association, the Center for Rural Affairs, the Food Research and Action Center, and several more. SNAP (Supplemental Nutrition Assistance Program, formerly known as “food stamps”) is funded by and falls under the farm bill.
Have you heard about the U.S Farm Bill? You might be surprised to learn that when people and news sources refer to the “Farm Bill” they are often referring to the most recent legislation passed regarding a long-standing bill. The most recent Farm Bill (which passed in December of 2018) had a big impact on the cannabis industry, specifically CBD oil and products. Read on to learn more about this key piece of legislation.
President Trump signed the 2018 Farm Bill, which for the most part, continued funding and policies that were put into place in the 2014 Farm Bill, with one major exception: the federal legalization of industrial hemp, a crop that is expected to grow into a $20 billion industry by the year 2022.
date back to the Great Depression era, with the first farm billing passing in 1933 as part of FDR’s New Deal. The original intention was to financially support farmers during an imbalance of supply and demand and to ensure an adequate food supply if famine or drought should occur.
It’s true that hemp policy in the United States has been drastically transformed by this new legislation. However, there remain some misconceptions about what, exactly, this policy change does.
This week, Congress agreed to the final version of the 2018 Farm Bill, and President Trump is expected to sign the legislation within days. But this is not your typical farm bill. While it provides important agricultural and nutritional policy extensions for five years, the most interesting changes involve the cannabis plant. Typically, cannabis is not part of the conversation around farm subsidies, nutritional assistance, and crop insurance. Yet, this year, Senate Majority Leader Mitch McConnell’s strong support of and leadership on the issue of hemp has thrust the cannabis plant into the limelight.
DEA guidance is clear: Cannabidiol is illegal and always has been
One of the goals of the 2014 Farm Bill was to generate and protect research into hemp. The 2018 Farm Bill continues this effort. Section 7605 re-extends the protections for hemp research and the conditions under which such research can and should be conducted. Further, section 7501 of the Farm Bill extends hemp research by including hemp under the Critical Agricultural Materials Act. This provision recognizes the importance, diversity, and opportunity of the plant and the products that can be derived from it, but also recognizes an important point: there is a still a lot to learn about hemp and its products from commercial and market perspectives. Yes, farmers—legal and illegal—already know a lot about this plant, but more can and should be done to make sure that hemp as an agricultural commodity remains stable.
First, as noted above, hemp cannot contain more than 0.3 percent THC, per section 10113 of the Farm Bill. Any cannabis plant that contains more than 0.3 percent THC would be considered non-hemp cannabis—or marijuana—under federal law and would thus face no legal protection under this new legislation.
Second, there will be significant, shared state-federal regulatory power over hemp cultivation and production. Under section 10113 of the Farm Bill, state departments of agriculture must consult with the state’s governor and chief law enforcement officer to devise a plan that must be submitted to the Secretary of USDA. A state’s plan to license and regulate hemp can only commence once the Secretary of USDA approves that state’s plan. In states opting not to devise a hemp regulatory program, USDA will construct a regulatory program under which hemp cultivators in those states must apply for licenses and comply with a federally-run program. This system of shared regulatory programming is similar to options states had in other policy areas such as health insurance marketplaces under ACA, or workplace safety plans under OSHA—both of which had federally-run systems for states opting not to set up their own systems.