By: Joshua Waldrop
The Food and Drug Administration announced that it will hold a public hearing regarding CBD regulations on May 31, according to Marijuana Moment. The aim is to offer a forum for stakeholders to offer statements and information about CBD for the agency to consider as it evaluates regulatory options.
“The goal of the hearing is to obtain additional scientific data and other information related to cannabis and cannabis-derived compounds, both from botanical and synthetic sources, to inform our regulatory oversight of these products,” said the agency in a notification regarding the hearing. “FDA does not intend for this hearing to produce any decisions or new positions on specific regulatory questions, but this hearing is expected to be an important step in our continued evaluation of cannabis and cannabis-derived compounds in FDA-regulated products.”
Though the 2018 U.S. Farm Bill legalized hemp-derived CBD, the FDA has stopped short of approving it as a dietary additive due to having previously been approved as a drug in the form of the prescription medication Epidiolex. A technicality in the FDA’s own regulations states that a substance cannot be approved for general dietary if it has already been approved as an active drug for pharmaceutical medication.
While there are actions the agency can take to relieve current restrictions regarding CBD in food and beverage, outgoing FDA Commissioner Scott Gottlieb has expressed concerns regarding unanswered safety questions that the agency may deem need more testing, such as CBD effects on pregnant women, proper dosing recommendations, and “maximum acceptable daily intake from all products.”
“The public hearing will give stakeholders an opportunity to provide the FDA with additional input relevant to the agency’s regulatory strategy related to existing products, as well as the lawful pathways by which appropriate products containing cannabis or cannabis-derived compounds can be marketed, and how we can make these legal pathways more predictable and efficient,” said Comm. Gottlieb. “We hope to gain additional information and data for the FDA to consider with respect to products containing cannabis and cannabis-derived compounds, including CBD.”
Last year, the FDA sent a recommendation to the Drug Enforcement Agency (DEA) that CBD be reclassified stating that the cannabinoid “didn’t meet the requirements for federal control.” Soon after the passing of last year’s U.S. Farm Bill that legalized hemp and hemp-derived CBD, Commissioner Gottlieb reaffirmed the agency’s commitment to monitoring developments and results of scientific studies in reevaluating the FDA’s options for potentially loosening the restrictions on CBD’s use in general consumables. However, Gottlieb also reaffirmed the agency’s commitment to enforcing and penalizing companies who make unsubstantiated medical claims as well as concern over the nation’s two largest drugstore chains, CVS and Walgreens, announcing the addition of CBD-infused products to their shelves, reports CNBC.
“We expressed concern yesterday, I did, about Walgreens and CVS stepping into this market,” said Comm. Gottlieb. “So you now see big-box stores seeking to market CBD products for some uses where the claims seem to be potentially over the line, for the treatment of pain for example.”
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