Amid the CBD Craze, FDA Is Urged to Loosen Rules on Food and Supplements

Photo Credit: Jacquelyn Martin/AP/Shutterstock
May 31, 2019

By Spencer Feingold and Chloe Aiello

The Food and Drug Administration on Friday held its first public hearing on cannabidiol (CBD) as the marijuana extract continues to flood the market with largely unregulated products ranging from pet food to edibles.

The hearing comes as federal regulators continue to grapple over how to handle cannabis and the CBD industry, which has been lauded for its health and taxation benefits but remains in a legal grey zone. The Food and Drug Administration's (FDA) is not expected to announce regulatory changes following the hearing but said it will use the information presented during its hearing when considering policy options.

"This lack of research, and therefore lack of evidence, to support CBD's broader use in FDA regulated products, including in food and dietary supplements, has resulted in unique complexities for regulation including many unanswered questions relating to safety … what if children access CBD products?" Dr. Ned Sharpless, the FDA's acting commissioner, said in an opening statement. "These and many other questions represent important and significant gaps in our knowledge."

In addition to closing "gaps" in understanding Friday's hearing focused largely on assessing the health effects of CBD and pathways for bringing the product into the regulated mainstream.

Sharpless added that "our biggest concern is the marketing of products that out the health and safety of consumers at risk such as those claiming to prevent, diagnose, mitigate, treat, or cure serious diseases such as cancer."

As many as 100 speakers, including health professionals, manufacturers, CBD users, consumer advocacy groups, and legal experts are expected to participate through the course of the all-day event. More than 500 people registered to witness the hearing in-person with several hundred more registered to watch online.

In April, then-FDA commissioner Dr. Scott Gottlieb called for the hearing, saying in a statement that it is critical that the FDA addresses "unanswered questions about CBD and other cannabis and cannabis-derived products to help inform the FDA's regulatory oversight of these products — especially as the agency considers whether it could be appropriate to exercise its authority to allow the use of CBD in dietary supplements and other foods."

Up until December 2018, CBD was classified as an illegal drug under the federal Controlled Substances Act. The FDA's removal of CBD from the list and its approval last year of Epidiolex, a CBD-based treatment for seizures, helped open up the market for wide-ranging products.

Yet, the FDA argues that the market's explosion could pose a risk to the U.S. consumer since it has not yet been fully vetted for consumption, and the industry lacks basic production standards.

"As we continue to take a closer look at these products, we are also working to better understand potential risks of CBD on special populations like children, adolescents, pregnant and lactating women, or on different types of animals, including pets," Dr. Amy Abernethy, the FDA's principal deputy commissioner and acting-chief information officer, said in a tweet last week.

Several speakers at the hearing, nonetheless, stressed that CBD poses little threat to the health and safety of users — whether they be dogs, cancer patients, or everyday consumers.

"An overwhelming preponderance of evidence suggests that cannabis derived compound have minimal safety concerns," Andrew Kline, the National Cannabis Industry Association's director of public policy, said at the hearing.

The hearing also focused on clarifying the fractured regulatory regimes around CBD. Even after CBD was removed from federal controlled substances list, the FDA has issued numerous warning letters to suppliers, informing them that they are selling illegal and unapproved CBD products — even to companies operating in states that have fully legalized marijuana and its byproducts.

"Hemp derived CBD is in strong demand. We ask the FDA to act quickly because there is significant confusion in the market," Kline added.