Pingree Leads Bipartisan Letter to FDA Urging Legal Pathway for CBD
Washington, September 19, 2019
Congresswoman Chellie Pingree (D-Maine) and Congressman James Comer (R-Ky.) today sent a bipartisan letter signed by 25 members of Congress to the U.S. Food and Drug Administration (FDA), urging the agency to quickly provide legal clarity and establish a regulatory pathway for food products containing hemp-derived cannabidiol (CBD).
“During these challenging times for the agricultural economy, farmers are excited to plant legal hemp and are eagerly awaiting the U.S. Department of Agriculture’s (USDA) soon-to-be released regulatory framework that will enable farmers to invest in a new crop. Business and consumer interest in CBD and hemp products has skyrocketed, and companies are already capitalizing on the growing demand,” wrote the lawmakers. “However, FDA’s current regulatory posture on CBD has created significant regulatory and legal uncertainty for participants in this quickly evolving industry. We are discouraged by FDA’s estimation that a rulemaking process could span 3 to 5 years. We believe there are more expeditious measures that FDA could take that would establish regulatory clarity while pursuing enforcement actions against bad actors.”
In the letter, Pingree and Comer called for prompt guidance regarding enforcement discretion as well as issuance of an interim final rule to establish a clear regulatory framework for CBD as a dietary supplement and food additive. Given the widespread availability of CBD products, booming consumer demand, and the surge in industrial hemp farming, Pingree and Comer urged the FDA issue legal guidance quickly.
Full text of the letter can be found here.
The 2018 Farm Bill legalized the production of hemp. However, because CBD is the active ingredient in Epidiolex, a drug that has undergone substantial clinical trials, food products containing CBD are currently prohibited under the Federal Food, Drug, and Cosmetic Act. In May 2019, FDA held a public meeting to solicit input from the public on a regulatory pathway for CBD. FDA received over 4,000 public comments on the docket regarding CBD, which closed on July 16, 2019.
Pingree first wrote to the FDA in February 2019 to request guidance regarding legal pathways for food products containing CBD. In April 2019, Pingree questioned then-FDA Commissioner Gottlieb as a member of the House Agriculture Appropriations Subcommittee about the agency’s timeline for issuing guidance regarding CBD edibles. A video of her questioning in committee is available here.
Maine Governor Janet Mills took action this April to legalize intrastate commerce of CBD products. Hemp production in Maine has increased substantially, from 500 acres of hemp production in Maine last year to 1,500 acres this year. The majority of Maine hemp farmers use or sell their crop for CBD-related products.