On Sept. 19, U.S. Reps. Morgan Griffith (R-VA) and Brett Guthrie (R-KY) sent a letter to Food and Drug Administration (FDA) Commissioner Dr. Robert Califf to clarify regulatory processes surrounding cannabidiol (CBD), CBD-derived products, and tobacco products.
In the letter, the Congressmen said the FDA’s approach to CBD has created “unnecessary uncertainty” surrounding these products.
“The United States currently has a robust but largely unregulated CBD market, which leads to an unsafe marketplace for consumers,” the Congressmen wrote. “Consumer products that contain CBD – such as dietary supplements, food, and beverages – are currently sold across the country under a patchwork of state laws and regulations that have been developed and promulgated in light of FDA’s inaction. This has even led to multiple cases of children purchasing over-the-counter CBD gummies with unsafe levels of delta-8 THC and suffering harm as a result. This is due to the FDA’s failure to regulate and enforce statutory standards established by Congress that govern CBD and CBD-derived products.”
The Congressmen wrote that despite legislation passed in 2018 that removed hemp-derived CBD from the Controlled Substances Act, CBD is still subject to FDA regulatory authority and is prohibited from being used in any dietary supplements or as a food or beverage additive. They said that the agency has yet to create any regulatory direction for CBD and CBD-derived products to safely come to market. Instead, they asserted, the FDA has sent companies warning letters about unsubstantiated therapeutic claims and denied companies the opportunity to come to market safely.
The lawmakers directed the agency to describe what it has done to gather more scientific data and research on CBD, as well as any analysis the agency may have done in regard to an unregulated CBD market. Additionally, the Congressmen direct the agency to explain why enforcement of CBD products has been so lax.
“FDA’s job of regulating everyday products that Americans consume is too important to allow delayed responses and failures in executing its duties laid out in statute to continue,” said Guthrie. “It is clear, given recent controversies surrounding the agency, that this has become the status quo, and that’s why Congressman Griffith and I are working to get to the root problems at FDA. We ultimately want to ensure this federal agency takes more decisive action when issues are reported and meets its responsibility of making sure products are safe for consumption.”