Why the FDA Won’t Regulate CBD

In 2018, former President Donald Trump signed the Farm Bill into law. The Farm Bill is the federal government’s primary agricultural and food policy instrument. Every five years, Congress deals with renewing and revising the comprehensive bill. Before 2018, cannabis was not part of the conversation around farm subsidies or crop insurance. With the passing of the Farm Bill, hemp became federally legal.

All hemp is cannabis, but not all cannabis is hemp. When the 2018 Farm Bill legalized hemp, it defined hemp as cannabis containing less than 0.3% THC. This opened the door for other cannabinoids and derivatives, including cannabidiol (CBD), to enter the open market. 

CBD is the second-most abundant compound in cannabis and hemp after tetrahydrocannabinol (THC). While CBD is technically psychoactive, it does not cause intoxication like THC. The Farm Bill outlines that CBD sold to the public, not medical or recreational cannabis, must come from hemp. While there are over 80 different compounds found in cannabis, CBD has gained popularity for its treatment of anxiety and pain. Epidiolex is the first and only FDA-approved prescription CBD to treat seizures. 

The FDA and CBD

On Jan. 26 of this year, the FDA officially stated, “FDA Concludes that Existing Regulatory Frameworks for Foods and Supplements are Not Appropriate for Cannabidiol, Will Work with Congress on a New Way Forward.” Essentially, the FDA is taking a mostly hands-off approach regarding CBD products.

The Farm Bill will expire this year, so the question of whether CBD will be allowed in food or drinks will be negotiated by Congress in the newest version of the Farm Bill. Most CBD products that would be included in food or beverages fall under the category of dietary supplements.

The use of CBD in Epidiolex is largely why the FDA does not want involvement in regulating CBD products. A provision in the FDA’s Federal Food, Drug, and Cosmetic Act states that if a substance, such as THC or CBD, is an active ingredient in a drug that has been approved or is being investigated in clinical trials, those products containing that substance are excluded from the definition of a dietary supplement. Because it’s an ingredient in a drug, the FDA argues that CBD cannot be used in food and drinks. 

With negotiations of CBD being allowed in food or drinks, many other aspects of the Farm Bill must be examined. Other areas of concern are farm subsidies, food-stamp benefits, and many other topics.

During the January announcement, the FDA stated that there is not enough data addressing CBD’s “various safety concerns” to regulate marijuana-derived products as foods or supplements. FDA Deputy Commissioner Dr. Janet Woodcock referenced studies showing CBD can potentially harm the liver, interact with certain medications, and harm the male reproductive system. Studies also show concern about long-term use and exposure to children and pregnant people. 

The Growing CBD Market

CBD continues to grow in popularity and can be found in almost any type of product: food, makeup, and even dog foods. The United States has the largest population of use, with Europe having the second-most use. U.S. sales reached $4.17 billion in 2022, and forecasts predicted the market could quadruple by 2026. 

Research completed by Cross River Therapy reported that:

• By 2024, the percentage of CBD users in the U.S. is expected to increase to 35%.
• Of all U.S. citizens, 33% have tried CBD at least once.
• 54% of U.S. citizens have some familiarity with CBD and other related CBD items made.
• About 64 million people in the U.S. consumed CBD between 2018 and 2019.
• Out of the people that used CBD, 22% claimed that it helped them reduce or entirely replace their over-the-counter and prescription medications. 

Other research shows that the U.S. hemp farmland increased from 25,713 acres in 2017 to 78,176 acres in 2018. In overall cannabis sales, Colorado tops the list, having sold over $1 billion since 2014. The other top sell states for CBD sales in 2019 are California ($730 million), Florida ($291 million), and New York ($215 million). Of the Americans who use CBD, the most common uses are for pain relief (64%), anxiety (49%), and insomnia (42%).