![](\"https:\/\/cannabiscultivatornews.com\/home\/wp-content\/uploads\/2022\/12\/2757-1.png\")
<\/p>\n <\/p>\n
The Food and Drug Administration (FDA) is looking to collect additional data to fill in gaps in evidence about the safety of cannabis-derived products, while at the same time touting recent action it took to help a state agency crack down on a company selling delta-8 THC gummies that regulators say are linked to \u201cserious adverse events.\u201d<\/p>\n
FDA has faced significant criticism in recent years over the lack of regulations allowing for the marketing of hemp-derived cannabinoids like CBD in the food supply or as dietary supplements. The agency has maintained that it needs to gather more data, and possibly receive some legislative support from Congress, while simultaneously taking limited enforcement action against certain businesses that sell cannabis products derived from hemp.<\/p>\n
As part of its data collection effort, FDA posted a sources sought notice this month, soliciting information about \u201cthe availability and capability of qualified small business sources\u201d to carry out research about \u201cproduct problems (e.g., quality concerns), adverse events, and misinformation sources based on real world data (RWD) to help fill knowledge gaps\u201d with respect to cannabinoid products.<\/p>\n
The agency said<\/a> that, since hemp and its derivatives were legalized under the 2018 Farm Bill, \u201cboth the availability of and demand for [cannabis-derived products] have surged, prompting the FDA\u2019s Cannabis Product Committee (CPC) to identify critical needs to address the Agency\u2019s evidence gaps in the Cannabis-Derived Products Data Acceleration Plan (DAP).\u201d<\/p>\n The notice outlines data priorities for potential facilities capable of helping to fill those evidence gaps.<\/p>\n For example, FDA wants information about \u201cnew and emerging risks, and safety signals identified in online data sources\u201d such as the dark web, as well as analysis on that collected data and \u201cinformation on the current scientific literature.\u201d<\/p>\n Additionally, the agency said it\u2019s looking to see what businesses are capable of developing \u201creports on findings\u2026including summaries, manuscripts, and presentations\/webinars synthesizing the considered data, with clearance obtained through FDA management for sharing with diverse stakeholders.\u201d<\/p>\n Theoretically, this is the type of information that FDA could use to develop regulations for cannabis product marketing\u2014but in the meantime, it\u2019s been taking enforcement action against certain hemp businesses selling items with questionable packaging or content. That\u2019s mostly involved sending warning letters to select companies, but it also recently tipped off Minnesota regulators about a product line that it received consumer complaints about.<\/p>\n The information that FDA sent to the Minnesota Board of Pharmacy led to a lawsuit against the delta-8 THC company Northland Vapor, which is accused of violating the state\u2019s unique THC edibles law that was enacted this year<\/a>.<\/p>\n \u201cWe\u2019re working together with our state partners to protect the public from harmful products,\u201d FDA Principal Deputy Commissioner Janet Woodcock said in a press release<\/a> from the Minnesota board.<\/p>\n \u2014 FDA_ORA (@FDA_ORA) December 5, 2022<\/a><\/p>\n<\/blockquote>\n\n The joint investigation by FDA and the Board of Pharmacy started in early November, and more than 140,000 packages of delta-8 THC gummies, as well as about 2,300 bottles of THC syrup were confiscated. The products allegedly contained significantly more THC per serving than is permitted under the state\u2019s cannabis law.<\/p>\n Further, regulators said the products were packaged in a way that could appeal to children and that the company failed to provide the state with required product testing results.<\/p>\n LEARN MORE about the health risks of delta-8 tetrahydrocannabinol (delta-8 THC) in this #FDAConsumerUpdate<\/a>: https:\/\/t.co\/domMNqhVvP<\/a><\/p>\n \u2014 FDA_ORA (@FDA_ORA) December 5, 2022<\/a><\/p>\n<\/blockquote>\n\n \u201cTo protect the public, the Board of Pharmacy embargoed this noncompliant product and is seeking an order from the court to destroy the noncompliant product as well as an order from the court to prevent Northland Vapor from manufacturing and selling edible cannabinoid products that violate state law. It is estimated the retail value of these embargoed products exceeds $7 million,\u201d the board said. \u201cThe FDA inspection is ongoing.\u201d<\/p>\n The federal-state enforcement operation launched several months after FDA partnered with Hawaii law enforcement<\/a> in a \u201cunique\u201d surveillance operation that led to the arrests of two people associated with a cannabis business who were suspected of violating state drug laws.<\/p>\n Also, last month, FDA sent warning letters to five companies<\/a> that sell foods and beverages containing CBD.<\/p>\n The agency didn\u2019t specify why it targeted those particular five companies out of the many more that market similar cannabidiol-infused consumables, but it said that they sell products \u201cthat people may confuse for traditional foods or beverages which may result in unintentional consumption or overconsumption of CBD.\u201d<\/p>\n Bipartisan lawmakers have repeatedly pressed FDA to create that marketing pathway for CBD in the food supply and as dietary supplements.<\/p>\n Reps. Morgan Griffith (R-VA) and Brett Guthrie (R-KY) sent a letter to FDA Commissioner Robert Califf in September, demanding answers over the\u00a0continued lack of regulations for CBD<\/a>\u00a0for those purposes.<\/p>\n Griffith and other bipartisan lawmakers\u00a0sent a separate, related letter to the FDA commissioner<\/a>\u00a0in August. They expressed frustration over the \u201ccompletely insufficient response\u201d the agency provided in response to their bill calling for hemp-derived CBD to be permitted and regulated as a food additive.<\/p>\n After the\u00a0CBD Product Safety and Standardization Act<\/a>\u00a0was filed in December 2021, the sponsors sought technical assistance from FDA to advise on key provisions. But four months after they sent the inquiry, FDA returned a \u201cone-page\u201d response that was \u201csimply a reformatting of a document provided to Congress over two years ago,\u201d the lawmakers said<\/p>\n At a House Appropriations subcommittee hearing in May, FDA\u2019s Califf recognized that the agency\u00a0had moved slowly with rulemaking for CBD<\/a>\u00a0in the food supply, stating that the situation \u201clooks pretty much the same in terms of where we are now\u201d as compared to when he first worked on the issue in 2016.<\/p>\n He said the FDA has taken steps to research the safety profile of cannabinoids to inform future rules, but he also punted the criticism about inaction to Congress, saying he doesn\u2019t feel that \u201cthe current authorities we have on the food side or the drug side necessarily give us what we need to have to get the right pathways forward.\u201d<\/p>\n \u201cWe\u2019re going to have to come up with something new,\u201d Califf said. \u201cI\u2019m very committed to doing that.\u201d<\/p>\n Stakeholders have strongly encouraged FDA to live up to its authority and provide guidelines and clarity for the industry. But the agency has largely limited its regulatory enforcement authority to sending warning letters to certain CBD businesses and denying cannabinoid marketing applications.<\/p>\n In May, for example, the agency simply\u00a0sent warning letters to four cannabis companies<\/a>\u00a0for allegedly making unsanctioned claims about the medical benefits of CBD products they\u2019ve marketed for animals.<\/p>\n FDA also warned consumers about\u00a0marijuana-infused copycat food products<\/a>\u00a0that resemble popular brands and the risks of accidentally ingesting THC, particularly for children.<\/p>\n The agency separately\u00a0issued its first set of warnings<\/a>\u00a0to companies over the allegedly illegal sale of products containing the increasingly popular cannabinoid delta-8 THC.<\/p>\n It sent five warning letters to companies that are marketing products with the intoxicating compound and making what the agency says are unsanctioned claims about their therapeutic potential.<\/p>\n In May, a top Republican on a key congressional committee also called on leadership to\u00a0schedule a hearing to hold FDA accountable<\/a>\u00a0for its lack of action to set regulations for CBD and delta-8 THC products.<\/p>\n As Congress Stalls On Marijuana Banking, New Report Details Public Safety Risk Of Cash-Intensive Dispensaries<\/a><\/p>\n<\/blockquote>\n\n Photo courtesy of Kimberly Lawson.<\/em><\/p>\n The post FDA Looks To Collect More Cannabis Data As It Touts Federal-State Partnership In Enforcement Action Against Delta-8 THC Business<\/a> appeared first on Marijuana Moment<\/a>.<\/p>\n
The Food and Drug Administration (FDA) is looking to collect additional data to fill in gaps in evidence about the safety of cannabis-derived products, while at the same time touting recent action it took to help a state agency crack down on a company selling delta-8 THC gummies that regulatorsContinue Reading<\/a><\/span><\/p>\n","protected":false},"author":458,"featured_media":59141,"comment_status":"false","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[18,81],"tags":[],"_links":{"self":[{"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/posts\/59140"}],"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=59140"}],"version-history":[{"count":1,"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/posts\/59140\/revisions"}],"predecessor-version":[{"id":59142,"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/posts\/59140\/revisions\/59142"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/media\/59141"}],"wp:attachment":[{"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/media?parent=59140"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/categories?post=59140"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/tags?post=59140"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}\n
![\"❗\"](\"https:\/\/cannabiscultivatornews.com\/home\/wp-content\/uploads\/2022\/12\/2757.png\")
ALERT: FDA recently forwarded a complaint re: a serious adverse event associated w\/Wonky Confection\u2019s Death by Gummy Bears delta-8 THC product to the MN Board of Pharmacy, resulting in a state action against this firm. LEARN MORE: https:\/\/t.co\/TYA5qQaKW6<\/a> pic.twitter.com\/38nlJfh2jQ<\/a><\/p>\n\n
\n
\n
\nRead More: FDA Looks To Collect More Cannabis Data As It Touts Federal-State Partnership In Enforcement Action Against Delta-8 THC Business<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"