03.04.19
FDA will convene a public meeting in April 2019 on the development of a regulatory pathway for the use of cannabidiol (CBD) in dietary supplement and food products, according to FDA Commissioner Scott Gottlieb, MD. The announcement came during the commissioner’s testimony at a hearing of the House Appropriations Committee’s Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies.
The announcement was part of Gottlieb’s response to a question from Rep. Mark Pocan (D-WI) regarding how quickly FDA intends to pursue the “pathways” for consideration of the use of CBD in dietary supplements and foods outlined in Gottlieb’s Dec. 20, 2018, statement following the signing of the 2018 Farm Bill, the American Herbal Products Association (AHPA) noted. In the Dec. 20 statement, Gottlieb emphasized that FDA “has authority to issue a regulation” that would allow naturally-occurring hemp compounds such as CBD in a food or dietary supplement if it determines “that all other requirements in the [FDCA] are met, including those required for food additives or new dietary ingredients.”
In his comments before the House Appropriations Committee, Gottlieb noted the complexity of the issue, and stated that “there is not a good proxy for us doing this through regulation.” According to AHPA, his statement appeared to reference the fact that, in the decades since FDA obtained its authorities to issue regulations permitting an approved or investigational new drug as a food or supplement, the agency has never used them.
The commissioner also commented in response to the initial question from Pocan and a follow-up question from Rep. Chellie Pingree (D-ME) that “[FDA] will come back and have a discussion with Congress” if “this is sufficiently complicated for the agency” or “[FDA] makes a determination that this will be a multi-year regulatory process.”
“AHPA appreciates the FDA’s commitment to promptly explore all regulatory options to properly regulate CBD in dietary supplement and food products, and we will participate actively in the public meeting in April,” said AHPA President Michael McGuffin. “The suggestion that this could be a multi-year process, however, should be of concern to consumers, industry, and the agency, and we encourage FDA to consider interim options in the form of guidance or a statement of enforcement discretion. But if FDA ultimately determines that a congressional action is necessary, we hope the legislature will move quickly to resolve this issue in a manner consistent with the prior Congress’s obvious intent to ensure Americans access to hemp and all its constituents, including CBD.”
The announcement was part of Gottlieb’s response to a question from Rep. Mark Pocan (D-WI) regarding how quickly FDA intends to pursue the “pathways” for consideration of the use of CBD in dietary supplements and foods outlined in Gottlieb’s Dec. 20, 2018, statement following the signing of the 2018 Farm Bill, the American Herbal Products Association (AHPA) noted. In the Dec. 20 statement, Gottlieb emphasized that FDA “has authority to issue a regulation” that would allow naturally-occurring hemp compounds such as CBD in a food or dietary supplement if it determines “that all other requirements in the [FDCA] are met, including those required for food additives or new dietary ingredients.”
In his comments before the House Appropriations Committee, Gottlieb noted the complexity of the issue, and stated that “there is not a good proxy for us doing this through regulation.” According to AHPA, his statement appeared to reference the fact that, in the decades since FDA obtained its authorities to issue regulations permitting an approved or investigational new drug as a food or supplement, the agency has never used them.
The commissioner also commented in response to the initial question from Pocan and a follow-up question from Rep. Chellie Pingree (D-ME) that “[FDA] will come back and have a discussion with Congress” if “this is sufficiently complicated for the agency” or “[FDA] makes a determination that this will be a multi-year regulatory process.”
“AHPA appreciates the FDA’s commitment to promptly explore all regulatory options to properly regulate CBD in dietary supplement and food products, and we will participate actively in the public meeting in April,” said AHPA President Michael McGuffin. “The suggestion that this could be a multi-year process, however, should be of concern to consumers, industry, and the agency, and we encourage FDA to consider interim options in the form of guidance or a statement of enforcement discretion. But if FDA ultimately determines that a congressional action is necessary, we hope the legislature will move quickly to resolve this issue in a manner consistent with the prior Congress’s obvious intent to ensure Americans access to hemp and all its constituents, including CBD.”
