{"id":9602,"date":"2023-02-02T17:03:04","date_gmt":"2023-02-02T17:03:04","guid":{"rendered":"https:\/\/cannabisindustryjournal.com\/?post_type=news_article&amp;p=36214"},"modified":"2023-02-02T17:03:04","modified_gmt":"2023-02-02T17:03:04","slug":"fda-punts-on-cbd-rules","status":"publish","type":"post","link":"https:\/\/cannitrol.com\/blog\/fda-punts-on-cbd-rules\/","title":{"rendered":"FDA Punts on CBD\u00a0Rules"},"content":{"rendered":"<div id=\"wp_fb_like_button\" style=\"margin:5px 0 5px 5px;float:right;height:100px;\"><script src=\"http:\/\/connect.facebook.net\/en_US\/all.js#xfbml=1\"><\/script><fb:like href=\"https:\/\/cannitrol.com\/blog\/fda-punts-on-cbd-rules\/\" send=\"true\" layout=\"standard\" width=\"450\" show_faces=\"false\" font=\"arial\" action=\"like\" colorscheme=\"light\"><\/fb:like><\/div><p>On December 20, 2018, Former President Trump <a href=\"https:\/\/cannabisindustryjournal.com\/news_article\/farm-bill-analysis-is-hemp-legal-now\/\">signed the Farm Bill<\/a> into law, which removed hemp-derived cannabidiol (CBD) from the Controlled Substances Act, stripped the DEA\u2019s authority from hemp and gave states the ability to regulate hemp markets of their own, with approval from the USDA.<\/p>\n<p><a href=\"https:\/\/cannabisindustryjournal.com\/wp-content\/uploads\/2017\/11\/100.jpeg\"><img loading=\"lazy\" class=\"alignright size-medium wp-image-8775\" src=\"https:\/\/cannitrol.com\/blog\/wp-content\/uploads\/2023\/02\/fda-punts-on-cbd-rules.jpg\" alt=\"FDAlogo\" width=\"200\" height=\"105\" \/><\/a>When that Farm Bill became law, it paved the way for state-sanctioned hemp and CBD product markets and it seemed as if the floodgates were opening for legal CBD, but some caveats and gray areas remained. The same day the Farm Bill became law, the FDA released a statement asserting their authority, threatening enforcement actions for things like unsubstantiated drug marketing claims.<\/p>\n<p>Over the past four years, the FDA has dealt with <a href=\"https:\/\/cannabisindustryjournal.com\/news_article\/fda-issues-warnings-to-15-cbd-companies-updates-safety-concerns\/\">dozens of enforcement actions involving CBD products<\/a>. The agency said they were \u201cworking quickly to further clarify our regulatory approach,\u201d but that seems categorically false given how long it took them to tell the public they don\u2019t know what to do. Finally, after four years and change of comment periods, industry frustration, warning letters and state-sanctioned gray markets, <a href=\"https:\/\/www.fda.gov\/news-events\/press-announcements\/fda-concludes-existing-regulatory-frameworks-foods-and-supplements-are-not-appropriate-cannabidiol?utm_medium=email&amp;utm_source=govdelivery\">the FDA announced they need help from Congress.<\/a><\/p>\n<figure id=\"attachment_36215\" aria-describedby=\"caption-attachment-36215\" class=\"wp-caption alignleft\"><a href=\"https:\/\/cannabisindustryjournal.com\/wp-content\/uploads\/2023\/02\/JanetWoodcock181_large_final_FLAG_900x900.jpg\"><img loading=\"lazy\" class=\"size-medium wp-image-36215\" src=\"https:\/\/cannitrol.com\/blog\/wp-content\/uploads\/2023\/02\/fda-punts-on-cbd-rules-1.jpg\" alt=\"\" width=\"200\" height=\"200\" \/><\/a><figcaption id=\"caption-attachment-36215\" class=\"wp-caption-text\">Janet Woodcock, M.D., principal deputy commissioner at the FDA<\/figcaption><\/figure>\n<p>Last week, the FDA published a statement from Janet Woodcock, M.D., principal deputy commissioner, that says, to paraphrase, they\u2019ve given up. Industry stakeholders have long agreed that the food and dietary supplements regulatory framework is adequate for CBD products, citing minimal public health risk and a pre-existing framework that CBD could fit into easily. \u201cThe FDA\u2019s existing foods and dietary supplement authorities provide only limited tools for managing many of the risks associated with CBD products,\u201d says Dr. Woodcock. \u201cUnder the law, any substance, including CBD, must meet specific safety standards to be lawfully marketed as a dietary supplement or food additive.\u201d<\/p>\n<p>The reasoning behind the agency\u2019s unwillingness to regulate it as a dietary supplement is because of safety concerns, like potential liver damage, possible drug interactions and reproductive harm. Scientific data available to the FDA shows that they cannot say that CBD is generally recognized as safe (GRAS). \u201cToday we are announcing that after careful review, the FDA has concluded that a new regulatory pathway for CBD is needed that balances individuals\u2019 desire for access to CBD products with the regulatory oversight needed to manage risks,\u201d says Dr. Woodcock. \u201cThe agency is prepared to work with Congress on this matter.\u201d<\/p>\n<div class=\"sharedaddy sd-sharing-enabled\">\n<div class=\"robots-nocontent sd-block sd-social sd-social-icon-text sd-sharing\">\n<h3 class=\"sd-title\">Share this:<\/h3>\n<\/p><\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>On December 20, 2018, Former President Trump signed the Farm Bill into law, which removed hemp-derived cannabidiol (CBD) from the Controlled Substances Act, stripped the DEA\u2019s authority from hemp and gave states the ability to regulate hemp markets of their own, with approval from the USDA. When that Farm Bill became law, it paved the [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[9220,8459,7814,5062,8502,52,330,8509,8769,8461,5179,8503,98,8458,609,7143,8770,8564,9221,147,8565,7444,9222,1964,5334,2254,6288,6556,184,2299,8605,6430,77,8469,6431,9,2561,8504,9223,8471,9224,8472,5235,421,5236,8518,8520,8477,1,3,8522,1260,61,1736],"tags":[9225,8481,7815,5063,8528,2632,2908,8535,8779,8483,5181,8529,2676,8480,3182,7144,8780,8586,9226,2725,8587,7449,9227,4532,5350,4821,6292,2415,2762,4866,8620,6433,2655,8491,6434,35,8530,9228,8493,9229,8494,5237,2999,5238,8544,8546,8499,8548,3830],"_links":{"self":[{"href":"https:\/\/cannitrol.com\/blog\/wp-json\/wp\/v2\/posts\/9602"}],"collection":[{"href":"https:\/\/cannitrol.com\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/cannitrol.com\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/cannitrol.com\/blog\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/cannitrol.com\/blog\/wp-json\/wp\/v2\/comments?post=9602"}],"version-history":[{"count":0,"href":"https:\/\/cannitrol.com\/blog\/wp-json\/wp\/v2\/posts\/9602\/revisions"}],"wp:attachment":[{"href":"https:\/\/cannitrol.com\/blog\/wp-json\/wp\/v2\/media?parent=9602"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/cannitrol.com\/blog\/wp-json\/wp\/v2\/categories?post=9602"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/cannitrol.com\/blog\/wp-json\/wp\/v2\/tags?post=9602"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}