{"id":74040,"date":"2024-04-11T09:05:29","date_gmt":"2024-04-11T17:05:29","guid":{"rendered":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/2024\/04\/11\/fda-head-says-theres-no-reason-for-dea-to-delay-rescheduling-marijuana\/"},"modified":"2024-04-11T12:45:43","modified_gmt":"2024-04-11T20:45:43","slug":"fda-head-says-theres-no-reason-for-dea-to-delay-rescheduling-marijuana","status":"publish","type":"post","link":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/2024\/04\/11\/fda-head-says-theres-no-reason-for-dea-to-delay-rescheduling-marijuana\/","title":{"rendered":"FDA Head Says There\u2019s \u2018No Reason For DEA To Delay\u2019 Rescheduling Marijuana"},"content":{"rendered":"<\/p>\n<p>The head of the Food and Drug Administration (FDA) says there\u2019s \u201cno reason\u201d for the Drug Enforcement Administration (DEA) to \u201cdelay\u201d making a marijuana scheduling decision.<\/p>\n<p>FDA Commissioner Robert Califf also said that, \u201cas a child of the sixties,\u201d it would \u201cbe nice if in my lifetime we came up with a regulatory scheme\u201d for cannabis.<\/p>\n<p>At a hearing before the House Oversight and Accountability Committee on Thursday, Rep. Nancy Mace (R-SC) pressed Califf on the timeline for the scheduling review after his agency under the U.S. Department of Health and Human Services (HHS) recommended that DEA move cannabis from Schedule I to Schedule III under the Controlled Substances Act (CSA).<\/p>\n<p>The \u201ctiming of a regulatory decision is something that would be up to the DEA, not up to me,\u201d Califf said. \u201cThere\u2019s no reason for DEA to delay. They have to take into account all the regulations that are in play.\u201d<\/p>\n<p>Asked whether he expects FDA would assume additional regulatory responsibilities if cannabis is rescheduled, the commissioner said that\u2019s a \u201cvery complicated topic,\u201d especially given that this \u201cfalls in this area where state regulation has been dominant.\u201d<\/p>\n<p>\u201cThis is an area where I believe we would be better off if we had guidance from Congress about how to proceed,\u201d Califf said. \u201cMedical marijuana is one thing where there\u2019s a medical purpose and it\u2019s proven through traditional medical pathways, but when it\u2019s used for recreational purposes, there is no medical benefit in that case, it doesn\u2019t fall under our typical regulation.\u201d<\/p>\n<p>Mace, who also recently discussed scheduling issues and the <a href=\"https:\/\/www.marijuanamoment.net\/gop-congresswoman-says-passing-marijuana-banking-bill-would-help-republicans-keep-house-majority\/\" target=\"_blank\" rel=\"noopener\">need for the GOP-controlled House to advance cannabis reform legislation<\/a>, also raised concerns about the prevalence of hemp-derived intoxicating cannabinoids and the lack of regulations around those products.<\/p>\n<p>\u201cWithout revealing too much about my age, I\u2019m a child of the sixties so it\u2019d be nice if, in my lifetime, we came up with a regulatory scheme where\u2014whatever your belief is about use of the product\u2014where the safety issues that you refer to are written into law so that we have a scheme whereby we can regulate it.\u201d<\/p>\n<p>Prohibitionist Rep. Pete Sessions (R-TX) also addressed the cannabis scheduling issue, stating he believes that \u201cFDA did not base its assessment in scientific facts or realities of how marijuana has been abused and used in our country today.\u201d<\/p>\n<p>FDA\u2019s recommendation to reschedule cannabis \u201ccompletely ignores the realities of a drug that is causing enormous consequences of children and adults in our country, high schools, middle schools and communities.\u201d<\/p>\n<p>He then repeated talking points that he and other GOP lawmakers forwarded to DEA Administrator Anne Milgram urging the agency to keep marijuana in Schedule I of the CSA, including criticism of the revised review process FDA used that involved a new a two-pronged analysis instead of a five-factor review that has been used in the past. Opponents of cannabis reform argue this policy shift is evidence of FDA intentionally exercising more discretion to justify its rescheduling recommendation for political, rather than scientific, reasons.<\/p>\n<p>\u201cLet me remind you that a Schedule III does not put marijuana on the market in the United States,\u201d Califf responded. \u201cWith all due respect, I think [cannabis] is differentiable from heroin and, I think, cigarettes.\u201d<\/p>\n<p>He added that \u201cyour colleague just gave exactly the opposite point of view\u201d on marijuana policy, referencing Mace\u2019s comments.<\/p>\n<p><strong>Watch the <a href=\"https:\/\/oversight.house.gov\/hearing\/oversight-of-the-u-s-food-and-drug-administration\/\" target=\"_blank\" rel=\"noopener\">hearing<\/a> with the FDA commissioner in the video below:\u00a0<\/strong><\/p>\n<p \/>\n<p>Meanwhile, Oversight Committee Chairman James Comer (R-KY) said at Thursday\u2019s hearing that FDA is \u201cputting its own bureaucratic priorities over the American people\u201d by refusing to regulate hemp products such as CBD unless it received additional authorization from Congress.<\/p>\n<p>\u201cInstead of using its existing authority, the FDA is requesting new authorities and money that it does not need,\u201d the chairman said. \u201cThis is the FDA putting its own bureaucratic priorities over the American people who can benefit from these products.\u201d<\/p>\n<p>\u201cThe FDA\u2019s refusal to regulate hemp products is creating significant confusion in the market and resulting in products with intoxicants that can be dangerous to Americans who use these products,\u201d he said. \u201cIt has also halted business trying in good faith to enter the market while bad actors continue to thrive.\u201d<\/p>\n<p>Later in the hearing, Comer again criticized FDA for its failure to regulate CBD and the commissioner responded that, under the current system, it\u2019s true that \u201c<span class=\"transcript-snippet__content__body__word ng-star-inserted\" data-highlighted=\"false\" data-playhead=\"false\">good<\/span> <span class=\"transcript-snippet__content__body__word ng-star-inserted\" data-highlighted=\"false\" data-playhead=\"false\">players<\/span> [in the industry] <span class=\"transcript-snippet__content__body__word ng-star-inserted\" data-highlighted=\"false\" data-playhead=\"false\">are<\/span> <span class=\"transcript-snippet__content__body__word ng-star-inserted\" data-highlighted=\"false\" data-playhead=\"false\">penalized<\/span> <span class=\"transcript-snippet__content__body__word ng-star-inserted\" data-highlighted=\"false\" data-playhead=\"false\">because<\/span> <span class=\"transcript-snippet__content__body__word ng-star-inserted\" data-highlighted=\"false\" data-playhead=\"false\">of<\/span> <span class=\"transcript-snippet__content__body__word ng-star-inserted\" data-highlighted=\"false\" data-playhead=\"false\">things<\/span> bad players do.\u201d<\/p>\n<p>Califf said in written testimony submitted to lawmakers that while FDA has concluded it lacks proper authority to implement regulations allowing hemp-derived CBD, \u201cwe recognize that consumers want access to these products.\u201d<\/p>\n<p>\u201cThat is why FDA announced that the Agency is prepared to work with Congress on a new regulatory pathway that would provide access, safeguards, and oversight over products containing CBD in ways that existing pathways cannot,\u201d he said.<\/p>\n<p>\u201cFDA has concluded that a new regulatory regime is needed, which could encourage better information to inform consumers about their choices,\u201d Califf added. \u201cIn the meantime, FDA continues to assess the evolving information base and build awareness for Americans.\u201d<\/p>\n<p>Rep. Gary Palmer (R-AL) asked Califf whether FDA is actively monitoring CBD use among Americans. The commissioner responded that \u201cthis is a similar area where harm reduction through a regulatory strategy is probably our best approach and we need more research on exactly what the facts are.\u201d<\/p>\n<p>\u201cWe\u2019d like to see a regulatory pathway, but as we talked earlier, the FDA is a referee and we need a rulebook\u2014and you guys write the rulebook.\u201d<\/p>\n<p>The hearing comes nearly a year after a House subcommittee held an earlier first-of-its kind meeting where members <a href=\"https:\/\/www.marijuanamoment.net\/watch-live-congressional-committee-addresses-fda-inaction-on-cbd-regulations\/\" target=\"_blank\" rel=\"noopener\">examined the impacts of FDA inaction on developing the CBD regulations<\/a>.<\/p>\n<p>Last year, Comer said that his panel would be <a href=\"https:\/\/www.marijuanamoment.net\/congressional-committee-launches-investigation-into-fdas-decision-not-to-regulate-cbd\/\" target=\"_blank\" rel=\"noopener\" data-google-interstitial=\"false\">launching an investigation into the matter<\/a>, and he requested that FDA turn over documents related to its decision not to regulated the cannabinoid. Even before the agency made that decision, the congressman expressed his\u00a0<a href=\"https:\/\/www.marijuanamoment.net\/new-gop-congressional-panel-chairman-plans-to-grill-fda-on-lack-of-hemp-and-cbd-regulations\/\" target=\"_blank\" rel=\"noopener\" data-google-interstitial=\"false\">intent to address the lack of rules<\/a>.<\/p>\n<p>On marijuana, the commissioner\u2019s comments on Thursday come as the Biden administration continues to tout its role in issuing cannabis pardons and directing the marijuana scheduling review, including in a <a href=\"https:\/\/www.marijuanamoment.net\/biden-touts-marijuana-scheduling-review-and-pardons-in-new-proclamation-for-second-chance-month\/\" target=\"_blank\" rel=\"noopener\">presidential proclamation declaring April \u201cSecond Chance Month.\u201d<\/a><\/p>\n<p>President Joe Biden also discussed the marijuana actions in a <a href=\"https:\/\/www.marijuanamoment.net\/biden-promotes-marijuana-reform-in-state-of-the-union-address-a-historic-first\/\" target=\"_blank\" rel=\"noopener\" data-google-interstitial=\"false\">historic context last month, during his State of the Union address<\/a>.<\/p>\n<p>Vice President Kamala Harris also urged DEA to\u00a0<a href=\"https:\/\/www.marijuanamoment.net\/watch-live-vp-harris-talks-marijuana-ahead-of-white-house-meeting-with-cannabis-pardon-recipients\/\" target=\"_blank\" rel=\"noopener\" data-google-interstitial=\"false\">finish its review and reschedule marijuana \u201cas quickly as possible\u201d<\/a> while meeting pardon recipients for a roundtable event at the White House last month. Behind closed doors, <a href=\"https:\/\/www.marijuanamoment.net\/kamala-harris-says-we-need-to-legalize-marijuana-for-first-time-since-joining-biden-ticket-signaling-potential-shift-ahead-of-election\/\" target=\"_blank\" rel=\"noopener\" data-google-interstitial=\"false\">she also said \u201cwe need to legalize marijuana.\u201d<\/a><\/p>\n<p>A DEA official recently said\u00a0it sometimes takes up to six months for\u00a0<a href=\"https:\/\/www.marijuanamoment.net\/dea-officials-discuss-marijuana-scheduling-timeline-seeking-to-correct-misperceptions-that-decisions-are-made-in-a-shroud-of-secrecy\/\" target=\"_blank\" rel=\"noopener\" data-google-interstitial=\"false\">DEA to complete its analysis of health officials\u2019 scheduling recommendations<\/a>\u2014which is just about how long it has now been since the agency began its current cannabis assessment.<\/p>\n<p>Meanwhile, last month, HHS Secretary Xavier Becerra defended his agency\u2019s rescheduling recommendation during a Senate committee hearing and also told cannabis lobbyist Don Murphy that he should <a href=\"https:\/\/www.marijuanamoment.net\/top-biden-health-official-defends-marijuana-rescheduling-recommendation-against-criticism-from-gop-senator\/\" target=\"_blank\" rel=\"noopener\" data-google-interstitial=\"false\">pay DEA a visit and \u201cknock on their door\u201d for answers about the timing<\/a>\u00a0of their decision.<\/p>\n<p>Certain DEA officials are\u00a0<a href=\"https:\/\/www.marijuanamoment.net\/dea-officials-reportedly-at-odds-with-biden-admin-over-marijuana-rescheduling-push\/\" target=\"_blank\" rel=\"noopener\" data-google-interstitial=\"false\">reportedly resisting the Biden administration\u2019s rescheduling push<\/a>, disputing the HHS findings on marijuana\u2019s safety profile and medical potential, according to unnamed sources who spoke with The Wall Street Journal.<\/p>\n<p>In January, meanwhile, a coalition of hemp industry organizations\u00a0<a href=\"https:\/\/www.marijuanamoment.net\/watch-live-congressional-committee-addresses-fda-inaction-on-cbd-regulations\/\" target=\"_blank\" rel=\"noopener\">called on the House Energy and Commerce Committee to hold a hearing<\/a>\u00a0addressing the ongoing lack of FDA regulations for products made with constituents of the crop such as CBD.<\/p>\n<blockquote class=\"wp-embedded-content\" data-secret=\"OrktcDN5yW\">\n<p><a href=\"https:\/\/www.marijuanamoment.net\/pennsylvania-lawmakers-talk-marijuana-justice-and-equity-issues-at-hearing-following-new-legalization-bills-introduction\/\" target=\"_blank\" rel=\"nofollow noopener\">Pennsylvania Lawmakers Talk Marijuana Justice And Equity Issues At Hearing Following New Legalization Bill\u2019s Introduction<\/a><\/p>\n<\/blockquote>\n<p \/>\n<p>The post <a href=\"https:\/\/www.marijuanamoment.net\/watch-live-fda-commissioner-testifies-on-hemp-regulatory-issues-at-congressional-hearing\/\" target=\"_blank\" rel=\"nofollow noopener\">FDA Head Says There\u2019s \u2018No Reason For DEA To Delay\u2019 Rescheduling Marijuana<\/a> appeared first on <a href=\"https:\/\/www.marijuanamoment.net\" target=\"_blank\" rel=\"nofollow noopener\">Marijuana Moment<\/a>.<\/p>\n<p>&#013;<br \/>\n&#013;<br \/>\nRead More: <a href=\"https:\/\/www.marijuanamoment.net\/watch-live-fda-commissioner-testifies-on-hemp-regulatory-issues-at-congressional-hearing\/\" target=\"_blank\" rel=\"nofollow noopener\">FDA Head Says There\u2019s \u2018No Reason For DEA To Delay\u2019 Rescheduling Marijuana<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The head of the Food and Drug Administration (FDA) says there\u2019s \u201cno reason\u201d for the Drug Enforcement Administration (DEA) to \u201cdelay\u201d making a marijuana scheduling decision. FDA Commissioner Robert Califf also said that, \u201cas a child of the sixties,\u201d it would \u201cbe nice if in my lifetime we came up<span class=\"more-link\"><a href=\"https:\/\/cannabiscultivatornews.com\/home\/index.php\/2024\/04\/11\/fda-head-says-theres-no-reason-for-dea-to-delay-rescheduling-marijuana\/\">Continue Reading<\/a><\/span><\/p>\n","protected":false},"author":458,"featured_media":0,"comment_status":"false","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[18,81,126],"tags":[],"_links":{"self":[{"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/posts\/74040"}],"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\/458"}],"replies":[{"embeddable":true,"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/comments?post=74040"}],"version-history":[{"count":1,"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/posts\/74040\/revisions"}],"predecessor-version":[{"id":74041,"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/posts\/74040\/revisions\/74041"}],"wp:attachment":[{"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/media?parent=74040"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/categories?post=74040"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/tags?post=74040"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}