FDA Commissioner Gottlieb resigns; leaving CBD status in limbo

  • FDA Commissioner Gottlieb resigns; leaving CBD status in limbo

    According to The Washington Post, U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb, resigned March 5, effective in about a month.

    During his tenure, Gottlieb has supported and advanced food safety, labeling initiatives, and standards of identity. More recently, he has faced the complex issue of how to regulate CBD, a derivative from hemp. The 2018 Farm Bill removed hemp and hemp-derived CBD from the U.S. Controlled Substances Act, but it also stipulated that the FDA would retain control over how hemp products, including CBD, could be added to food, drugs, and cosmetics.

    At a congressional hearing on February 27, Gottlieb reiterated a rulemaking process for CBD would not be “straightforward.” As he explained to the House Committee on Appropriationsthe substance can’t be added to consumer products—food or dietary supplements—because it is “the subject of substantial clinical investigation.” He informed the committee that he would be convening a high level working group made up of senior officials and reporting directly to him to examine the issues.

    Gottlieb also announced that the FDA intends to hold a public meeting to solicit comments sometime in April, although an exact date for that meeting hasn’t been announced. And even after the public meeting is held, Gottlieb posited that comments may reveal that it’s going to result in a regulatory process that could take years. “If we determine that the pathway is going to be a multiyear process, I will go back to Congress to see if there’s another framework,” explained Gottlieb. “Congress intended for there to be a pathway for CBD to be available in different forms.”

    With Gottlieb leaving next month, hemp, CBD, and food manufacturers are left to wonder when, or if, a review will happen.

    Crosspost from IFT newsletter 3.6.2019

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