Sen. Ron Wyden (D-OR) said on Tuesday that it is “fully unacceptable” for the Food and Drug Administration (FDA) to suggest it may take up to five years to issue rules on the lawful marketing of hemp-derived CBD in the food supply.
In a letter to the heads of FDA and the U.S. Department of Health and Human Services (HHS), the senator discussed the “significant economic gains” that hemp producers stand to make since the crop was federally legalized under the 2018 Farm Bill.
To that end, he urged FDA to take certain steps to streamline the regulatory process for CBD so that it can be added to food items or health supplements more expediently. Former FDA Commissioner Scott Gottlieb testified in March that because CBD hasn’t been previously introduced in the food supply and currently exists as an FDA-approved drug, developing such rules may take an act of Congress or would otherwise take the agency several years to act on its own.
Wyden said that he is “pleased” that FDA has recognized it was the intent of Congress to provide for the lawful marketing of hemp products and applauded the agency for holding a public meeting to hear from industry stakeholders about the issue. He also acknowledged that FDA retains regulatory authority over hemp and its derivatives under the Farm Bill.
“However, I, and many in the CBD industry, find FDA’s indication that it may take three to five years to issue a final regulation authorizing the lawful use of hemp-derived CBD in foods and dietary supplements fully unacceptable,” he wrote. “The regulatory confusion and uncertainty surrounding CBD cannot continue for that length of time.”
The senator said that FDA should issue “enforcement discretion guidance” by August 1 and follow up on that by issuing an interim final rule as soon as possible while the agency develops permanent final regulations for CBD. The U.S. Department of Agriculture (USDA) said on Monday that it hoped to issue its own regulations on hemp production in August.
“I further urge you to streamline processes for submitting and prioritizing review of resulting new dietary ingredient and [generally recognized as safe] notifications for hemp-derived CBD ingredients, including, without limitation, dedicating necessary agency staff to the process,” he wrote. “I feel strongly the FDA must undertake a process to make lawful a safe level for conventional foods and dietary supplements containing hemp-derived CBD.”
“I believe this approach is both justified and necessary to address the unprecedented circumstances presented by the current availability of and demand for these products,” he said.
Last week, the House of Representative approved an amendment to an appropriations bill directing FDA to “undertake a process to make lawful a safe level for conventional foods and dietary supplements containing cannabidiol (CBD) so long as the products are compliant with all other FDA rules and regulations.”
Read Wyden’s CBD letter to FDA below:
062519 Wyden Letter to FDA … by on Scribd
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