Scott Gottlieb, the commissioner of the Food and Drug Administration, announced this week that he will resign at the end of the month, citing family reasons. For once, this may actually be true, as there is yet no indication of White House pressure in the decision. The news took many by surprise in the industries the FDA regulates.\u00a0<\/p>\n
Gottlieb, a physician who was previously the FDA\u2019s deputy commissioner for Medical and Scientific Affairs under Obama, was appointed by Trump to lead the agency in May 2017. Since then, he has been seeking to reduce teenage vaping, and to lower nicotine levels and ban menthol in cigarettes. Captains of the tobacco industry are\u00a0left to wonder<\/a>\u00a0whether his ambitious regulatory efforts will continue in an administration that generally takes a\u00a0laissez-faire\u00a0approach to business.<\/p>\n Wells Fargo<\/a>\u00a0analyst Bonnie Herzog was quoted by\u00a0Investor\u2019s Business Daily<\/a>\u00a0saying Gottlieb\u2019s resignation would be a \u201cpositive\u201d for the tobacco industry. And indeed, tobacco stocks rose upon the news.<\/p>\n In contrast,\u00a0CNBC<\/a>\u00a0reports that biotechnology stocks were falling on March 6 after news broke of Gottlieb\u2019s resignation.\u00a0<\/p>\n And then, there\u2019s cannabis. One critical thing that is left ambiguous as Gottlieb prepares to leave office is\u00a0the legal status of hemp-derived CBD<\/a>\u00a0as a food additive or ingredient, following\u00a0the passage of the 2018 Farm Bill<\/a>, which removed hemp-derived CBD from the Controlled Substances List but left it regulated by the Food, Drug & Cosmetics Act.\u00a0MarketWatch<\/a>\u00a0reports that cannabis stocks took a \u201ctumble\u201d on news of the resignation.\u00a0<\/p>\n Investor\u2019s Business Daily<\/a>\u00a0paints a more mixed picture.\u00a0In the 24 hours after the announcement,\u00a0Aurora Cannabis<\/a>\u00a0was up 12 percent, and\u00a0Canopy Growth<\/a> rose 2.3 percent \u2014 while Tilray<\/a>\u00a0lost 0.5 percent, Aphria was down 0.5 percent and\u00a0CannTrust<\/a>\u00a0fell 0.7 percent.<\/p>\n Just a week before his resignation announcement, Gottlieb said public meetings would be held in April to hear from stakeholders on the CBD question. As\u00a0MarketWatch<\/a>\u00a0reported then, cannabis stocks took a boost on word of the imminent meetings. Now, the CBD industry is left in what MarketWatch calls \u201climbo.\u201d<\/p>\n Long a Schedule I controlled substance, like other cannabinoids, CBD derived from hemp (low-THC strains of cannabis) was legalized in December with Trump\u2019s\u00a0signing of the 2018 Farm Bill<\/a>. But\u00a0Gottlieb cautioned<\/a>\u00a0upon passage of the Farm Bill that the FDA was responsible for regulating CBD as a food additive or ingredient, or in drug products. Until the agency updated its regulations, the cannabinoid would remain illegal where its use in edibles, cosmetics and other such preparations is concerned.<\/p>\n Gottlieb\u2019s plan to hold meetings on the matter next month came in response to a\u00a0letter sent by members of Congress<\/a>\u00a0calling on the FDA to provide \u201cimmediate leadership\u201d on the question. This, in turn, was prompted by the crackdown unleashed by health authorities in New York City as well as Maine and Ohio on CBD-infused edibles \u2014 citing their illegality under current FDA regulations.<\/p>\n The FDA\u2019s\u00a0Marijuana Questions and Answers<\/a>\u00a0page currently states that CBD as a food additive or dietary supplement is not legal.<\/p>\n Ironically, it was Gottlieb\u2019s FDA that helped mount pressure for CBD\u2019s legalization last June when it approved the CBD-based anti-seizure drug\u00a0Epidiolex<\/a>. This put the DEA on the spot, forcing a reconsideration of CBD\u2019s status as a controlled substance. In its September decision, the DEA\u00a0split the hair very finely<\/a>\u00a0\u2014 removing Epidiolex from Schedule I, but not CBD itself.\u00a0<\/p>\n Now that the DEA has essentially been overruled by the Farm Bill, the FDA is the last barrier to its free use other than as a pure extract.\u00a0<\/p>\n Analyst Brett Hundley of\u00a0Seaport Global Securities<\/a>\u00a0spoke about what Gottlieb\u2019s resignation could mean for the medical and ingredient (M&I) cannabis market.\u00a0Smarter Analyst<\/a>\u00a0website quoted him saying: \u201cWe have been watching for developing guidelines on full CBD legalization in the U.S\u2026 Now, with Gottlieb\u2019s resignation, additional questions related to his successor\u2019s views and the Senate confirmation process could cloud CBD\/M&I market growth even further. We acknowledge that CBD has still found its way onto many store shelves across the U.S., but it is our view that approval by the FDA will unleash considerably more in the way of market growth\u2026 Until this happens, we see the U.S. CBD market remaining relatively constrained.\u201d<\/p>\n Hundley added on a guardedly optimistic note that former short-list candidates for FDA commissioner have viewed CBD approval favorably. \u201c[B]ut we also worry about the Senate confirmation process and what happens to an FDA (and its review of CBD) that goes on too long without a leader in place.\u201d\u00a0<\/p>\n TELL US<\/strong>, how do you think the government should regulate hemp-derived CBD?<\/p>\n The post FDA Chief Resigns, Leaves CBD Purveyors in the Lurch<\/a> appeared first on Cannabis Now<\/a>.<\/p>\n
Scott Gottlieb, the commissioner of the Food and Drug Administration, announced this week that he will resign at the end of the month, citing family reasons. For once, this may actually be true, as there is yet no indication of White House pressure in the decision. The news took manyContinue Reading<\/a><\/span><\/p>\n","protected":false},"author":190,"featured_media":0,"comment_status":"false","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[6726,50,136,6855,1170,5014,81,6607],"tags":[],"_links":{"self":[{"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/posts\/33447"}],"collection":[{"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/users\/190"}],"replies":[{"embeddable":true,"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/comments?post=33447"}],"version-history":[{"count":1,"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/posts\/33447\/revisions"}],"predecessor-version":[{"id":33448,"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/posts\/33447\/revisions\/33448"}],"wp:attachment":[{"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/media?parent=33447"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/categories?post=33447"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/tags?post=33447"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}Hemp-Derived CBD\u00a0Industry in \u2018Limbo\u2019\u00a0<\/strong><\/h4>\n
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\nRead More: FDA Chief Resigns, Leaves CBD Purveyors in the Lurch<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"