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The Food and Drug Administration (FDA) has missed a congressionally mandated deadline to publish a list of known cannabinoids<\/a> as federal hemp laws are set to change later this year in a way that stakeholders argue will upend the existing market.<\/p>\n As part of appropriations legislation that President Donald Trump signed last year, many hemp products that were legalized during his first term in office under the 2018 Farm Bill will be prohibited once again starting in November. The spending measure included separate provisions, however, to have FDA and other relevant agencies study the cannabinoid marketplace and develop lists of cannabis components.<\/p>\n After the bill was signed, FDA was given 90 days to publish 1) a list of\u00a0 \u201call cannabinoids known to FDA to be capable of being naturally produced\u201d by cannabis 2) a list of \u201call tetrahydrocannabinol class cannabinoids known to the agency to be naturally occurring in the plant\u201d and 3) a list of \u201call other know cannabinoids with similar effects to, or marketed to have similar effects to, tetrahyrocannabinol class cannabinoids.\u201d<\/p>\n Further, the agency was tasked with providing \u201cadditional information and specificity about the term \u2018container\u2019\u201d with respect to hemp product THC serving sizes. In the bill, the term is defined as\u00a0\u201cthe innermost wrapping, packaging, or vessel in direct contact with a final hemp-derived cannabinoid product in which the final hemp-derived cannabinoid product is enclosed for retail sale to consumers, such as a jar, bottle, bag, box, packet, can, carton, or cartridge.\u201d<\/p>\n The lists and information was due last week, on February 10, but FDA did not follow through by the deadline.<\/p>\n A spokesperson for the U.S. Department of Health and Human Services (HHS), of which FDA is a component, told Marijuana Moment last week that it was the agency\u2019s intention to provide the lists in time and that they would be published in the Federal Register. However, that\u2019s yet to materialize\u2014and officials did not provide clarification when asked for an update.<\/p>\n Hemp stakeholders say this missed deadline is all the more reason for Congress to pass legislation delaying the implementation of the pending hemp THC ban that\u2019s set to take effect in November.<\/p>\n \u201cWe\u2019re disappointed, but not surprised,\u201d Jonathan Miller, general counsel of the U.S. Hemp Roundtable, told Marijuana Moment on Tuesday. \u201cThe FDA has been quite slow in meeting congressional deadlines when it comes to hemp in the past, and in some cases ignoring congressional deadlines.\u201d<\/p>\n \u201cBut this just makes it even more imperative for Congress to pass an extension\u201d of the hemp policy change, he said. \u201cThere is a whole lot of work to do, and the FDA is going to be in the middle of this, and there\u2019s not enough time to come up with a thought-out regulatory regime to replace the ban.\u201d<\/p>\n \u201cThis episode makes it clear why we need to have the extension,\u201d Miller said.<\/p>\n The purpose of the FDA directive is related to how federal law will distinguish between legal hemp products under a new, narrower definition in the recently enacted legislation and marijuana, which remains illegal under U.S. law.<\/p>\n Since 2018, cannabis products have been considered legal hemp if they contain less than 0.3 percent delta-9 THC on a dry weight basis.<\/p>\n However, the law that is set to take effect in November specifies that, within one year of enactment, the weight would apply to total THC\u2014including delta-8 and other isomers. It would also include \u201cany other cannabinoids that have similar effects (or are marketed to have similar effects) on humans or animals as a tetrahydrocannabinol (as determined by the Secretary of Health and Human Services).\u201d<\/p>\n The new definition of legal hemp would additionally ban \u201cany intermediate hemp-derived cannabinoid products which are marketed or sold as a final product or directly to an end consumer for personal or household use\u201d as well as products containing cannabinoids that are synthesized or manufactured outside of the cannabis plant or not capable of being naturally produced by it.<\/p>\n Legal hemp products would be limited to a per-container total of 0.4 milligrams of total THC or any other cannabinoids with similar effects.<\/p>\n Hemp stakeholders are paying particularly close attention to the \u201ccontainer\u201d definition for cannabinoid products.<\/p>\n \u201cIt\u2019s going to open up a window into how the FDA is thinking about these issues. And you know, one of the key issues here is, what is a container?\u201d Miller said. \u201cThat could make a really big difference in terms of what products would be eligible.\u201d<\/p>\n \u201cWe\u2019re hopeful that the 0.4 milligrams per container does not stay. We\u2019re hoping to see that change,\u201d he said. \u201cBut, you know, defining what a container is is going to be very important for any regulatory solution.\u201d<\/p>\n The Hemp Enforcement, Modernization, and Protection (HEMP) Act represents a potential alternative to the outright THC ban that was included in the spending bill Trump signed,\u00a0affirmatively allowing the sale of consumable hemp products to adults 21 and older<\/a>. That includes edibles, beverages and inhalable items.<\/p>\n If the legislation is enacted, there would be various regulatory restrictions for the market. For example, packaging couldn\u2019t appeal to youth and would need to be tamper-proof. It would also need to list all cannabinoids present and include QR code linking to a certificate of analysis.<\/p>\n Hemp product makers would be prohibited from adding substances like\u00a0alcohol, caffeine, tobacco, nicotine, melatonin or others \u201cwith effects that could interact with cannabinoids or enhance or alter their effects.\u201d<\/p>\n There would also be manufacturing and testing requirements, and hemp businesses would need to register their facilities.<\/p>\n Additionally, there are provisions mandating the establishment of a total cannabinoid cap on hemp products. The U.S. Department of Health and Human Services (HHS) would be charged with proposing cannabinoid limits within 60 days of enactment.<\/p>\n Meanwhile, alcohol retailers recently came together to\u00a0encourage Congress to delay the enactment of the law Trump signed<\/a>\u00a0to federally recriminalize hemp-derived THC beverages and other products.<\/p>\n The coalition is calling on lawmakers to pass recently introduced legislation, the\u00a0Hemp Planting Predictability Act<\/a>, that would give the hemp industry two more years before a federal ban on THC products would take effect\u2014which stakeholders hope will better position them to negotiate a broader regulatory compromise.<\/p>\n House Oversight and Government Reform Committee Chairman James Comer (R-KY), who is cosponsoring the proposal, appeared at a press conference last month alongside\u00a0farmers who are concerned about the looming federal hemp ban\u2019s impact<\/a>\u00a0on their businesses.<\/p>\n For what it\u2019s worth,\u00a0four in five marijuana consumers say they oppose the recriminalization of hemp THC products<\/a>\u00a0under the spending bill Trump signed in November. However, it should be noted that that poll was conducted weeks before he issued a cannabis rescheduling order and took steps to protect access to full-spectrum CBD.<\/p>\n Trump signed an executive order last month directing the attorney general to complete the process of moving marijuana from Schedule I to Schedule III of the Controlled Substances Act (CSA).<\/p>\n Part of that announcement also hold implications for the forthcoming hemp law. The president\u2019s order also urged Congress to\u00a0examine updating the definition of hemp to ensure that full-spectrum CBD<\/a>\u00a0is accessible to patients.<\/p>\n A further redefinition of hemp would be part of a novel proposal to\u00a0allow Medicare recipients to access non-intoxicating CBD<\/a>\u00a0that\u2019d be covered under the federal health care plan.<\/p>\n To effectuate that, the Centers for Medicare & Medicaid Services (CMS) will be announcing \u201ca model that will allow a number of CMS beneficiaries to benefit from receiving CBD under doctor recommendation at no cost,\u201d a White House official said during a briefing that\u00a0Marijuana Moment first reported leaked details from ahead of the signing event<\/a>.<\/p>\n For what it\u2019s worth, an executive with a hemp company that\u2019s been collaborating with the agency on the initiative said the rules for CBD health care coverage were internally finalized weeks ago<\/a>.<\/p>\n Trump seemed endorse a more flexible CBD policy last summer when he\u00a0shared a video calling for that specific reform while promoting the health benefits of cannabidiol<\/a>, particularly for seniors.<\/p>\n Meanwhile, a separate recently filed Republican-led congressional bill would\u00a0stop the implementation of the hemp ban under the enacted appropriations legislation<\/a>.<\/p>\n \u2014 Hemp businesses and industry groups have warned about the potential ramifications of the ban, but despite his support for states\u2019 rights for cannabis and a recent social media post touting the benefits of CBD, Trump signed the underlying spending measure into law without acknowledging the hemp provisions.<\/p>\n GOP political operative Roger Stone said recently that Trump was\u00a0effectively \u201cforced\u201d by Republican lawmakers to sign the spending bill<\/a>\u00a0with the hemp THC ban language.<\/p>\n However, a White House spokesperson said prior to the bill signing that\u00a0Trump specifically supported the prohibition language<\/a>.<\/p>\n The Democratic governor of Kentucky said that\u00a0the hemp industry is an \u201cimportant\u201d part of the economy that deserves to be regulated<\/a>\u00a0at the state level\u2014rather than federally prohibited, as Congress has moved to do.<\/p>\n Also, a leading veterans organization is warning congressional leaders that the newly approved blanket ban on consumable hemp products\u00a0could inadvertently \u201cslam the door shut\u201d on critical research<\/a>.<\/p>\n The post FDA Misses Deadline To Publish Cannabinoid List And Define Hemp \u2018Containers,\u2019 Drawing Industry Criticism<\/a> appeared first on Marijuana Moment<\/a>.<\/p>\n
The Food and Drug Administration (FDA) has missed a congressionally mandated deadline to publish a list of known cannabinoids as federal hemp laws are set to change later this year in a way that stakeholders argue will upend the existing market. As part of appropriations legislation that President Donald TrumpContinue Reading<\/a><\/span><\/p>\n","protected":false},"author":458,"featured_media":85439,"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\/85438"}],"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=85438"}],"version-history":[{"count":1,"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/posts\/85438\/revisions"}],"predecessor-version":[{"id":85440,"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/posts\/85438\/revisions\/85440"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/media\/85439"}],"wp:attachment":[{"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/media?parent=85438"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/categories?post=85438"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/tags?post=85438"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}
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\nRead More: FDA Misses Deadline To Publish Cannabinoid List And Define Hemp \u2018Containers,\u2019 Drawing Industry Criticism<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"