{"id":7962,"date":"2017-12-29T23:28:14","date_gmt":"2017-12-29T23:28:14","guid":{"rendered":"https:\/\/www.denverpost.com?p=2904420&amp;preview_id=2904420"},"modified":"2017-12-29T23:28:14","modified_gmt":"2017-12-29T23:28:14","slug":"cbd-tbd-cannabinoids-on-local-grocery-shelves-but-for-how-long","status":"publish","type":"post","link":"https:\/\/cannitrol.com\/blog\/cbd-tbd-cannabinoids-on-local-grocery-shelves-but-for-how-long\/","title":{"rendered":"CBD, TBD: Cannabinoids on local grocery shelves, but for how long?"},"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\/cbd-tbd-cannabinoids-on-local-grocery-shelves-but-for-how-long\/\" send=\"true\" layout=\"standard\" width=\"450\" show_faces=\"false\" font=\"arial\" action=\"like\" colorscheme=\"light\"><\/fb:like><\/div><div class=\"media_block\"><\/div>\n<div class=\"row\">\n<div class=\"large-10 large-centered small-12 columns\">\n<div class=\"entry-meta-date\">Published: Dec 29, 2017, 2:51 pm \u2022 Updated: Dec 29, 2017, 4:28 pm<span class=\"single-comments-link\" \/><\/div>\n<p class=\"byline\">By <span class=\"author\"><a class=\"url fn n\" href=\"http:\/\/www.thecannabist.co\/author\/awallace\/\" rel=\"author\">Alicia Wallace<\/a><\/span><em>, The Cannabist Staff<\/em><\/p>\n<p>Bottles of hemp-derived oils sit behind glass, under lock and key, at Alfalfa\u2019s natural foods store in Boulder, Colo.<\/p>\n<p>Some 2,000 miles away from cannabis-friendly Colorado, a Naples, Fla., <a href=\"http:\/\/www.thecannabist.co\/2017\/10\/09\/luckys-market-cbd-oil-hemp-extracts-nationwide\/89449\/\">Lucky\u2019s Market displays nearly a dozen brands of CBD-rich extracts, powders and salves<\/a>.<\/p>\n<p>These traditional retailers either could be offering a glimpse into the future where CBD products are sold like fish oil, or they could be enjoying a fleeting moment in the course of history for the non-psychoactive cannabis compound.<\/p>\n<p>As health food grocers such as Alfalfa\u2019s and Lucky\u2019s stock CBD products on store shelves, a novel cannabis-based pharmaceutical product that could upend the cottage industry is chugging through the U.S. Food and Drug Administration approval pipeline.<\/p>\n<p>But it\u2019s not just the FDA that will decide how hemp-derived, cannabinoid-rich products should be classified and whether they can be legally sold. <\/p>\n<p>Battles for the cannabis compound\u2019s future wage <a href=\"http:\/\/www.thecannabist.co\/2017\/06\/26\/cbd-oil-medical-marijuana-federal-charlottes-web\/82258\/\">on Capitol Hill<\/a>, where the legislative churn includes provisions that could strengthen or threaten CBD\u2019s legality; <a href=\"http:\/\/www.thecannabist.co\/2017\/04\/05\/hemp-lawsuit-federal-court-dea-rule-marijuana-extracts\/76635\/\">in the federal courts,<\/a> where semantics reign supreme as definitions of hemp, marijuana and their chemical components hang in the balance; and <a href=\"http:\/\/www.thecannabist.co\/2017\/12\/13\/cbd-international-law-who-scheduling\/94537\/\">at the United Nations\u2019 World Health Organization<\/a>, where a brain trust examines all facets of cannabis and its chemical components.<\/p>\n<p>\u201cAny number of levers could change (CBD\u2019s legal status) dramatically, and they\u2019re all coming to a head,\u201d said Rod Kight, an Asheville, N.C.-based corporate and bankruptcy attorney who also represents cannabis businesses. Kight also authors the <a href=\"http:\/\/kightoncannabis.com\/\">\u201cKight on Cannabis\u201d blog<\/a> covering cannabis legal topics, including the confusion swelling around hemp-derived products.<\/p>\n<p>The future of hemp-derived CBD may be a hodgepodge of court battles, regulations and laws, but at the foundation for potential change is the status of the marketplace now, he said. <\/p>\n<p>\u201cWe\u2019re at a place also where I think the commercial applications and the evolution of the marketplace is driving policy,\u201d he said.<\/p>\n<h3> Retail Revolution <\/h3>\n<p>Selling Alfalfa\u2019s executives on the value of stocking hemp extracts in their two Boulder County stores wasn\u2019t difficult, said Sarah Shebanek, the company\u2019s wellness buyer.<\/p>\n<p>The natural grocer has a history of ushering in new and innovative products. <\/p>\n<p>From Alfalfa\u2019s first iteration in the 1980s and \u201990s to its resurrection in 2011, the grocer often served as a brick-and-mortar launching pad for local entrepreneurs and fledgling producers.<\/p>\n<p>But CBD came with some added wrinkles.<\/p>\n<p>\u201cIt was definitely, \u2018Proceed with Caution,&#8217;\u201d Shebanek said.<\/p>\n<p>Alfalfa\u2019s officials did their due diligence by striking up conversations with attorneys as well as local and state health officials before taking the leap, she said.<\/p>\n<p>Today, Alfalfa\u2019s sells 14 brands of hemp extracts, a nearly fivefold increase from when Shebanek came on board in April 2016. All but one of the brands sold are grown and processed in Colorado, she said.<\/p>\n<p>Daring to carry these items added a rebellious element to Alfalfa\u2019s reputation \u2014 and generated a lot of business in the process, she said.<\/p>\n<p>Growth has been \u201cexponential,\u201d Shebanek said, noting that hemp extracts are consistently among the store\u2019s top-selling items.<\/p>\n<p>\u201cI feel like this is going to grow like no other category we\u2019ve seen,\u201d she said.<\/p>\n<p>National sales projections for hemp CBD products have been equally lofty.<\/p>\n<p>The Brightfield Group, a Chicago-based cannabis market analytics firm, pegs the hemp CBD market at about $174 million for 2016. Their crystal ball gaze sees sales skyrocketing to $1.6 billion by 2021.<\/p>\n<p>\u201cGrowth is continuing from a relatively small base, and there is still much room to grow for hemp CBD,\u201d Bethany Gomez, Brightfield Group\u2019s director of research, said in an emailed statement. <\/p>\n<p>\u201cIn a recent survey,\u201d she said, \u201cWe found that of the general population, 92 percent of people were in favor of the legalization of medical marijuana, but only 28 percent would be willing to take it themselves. On the other hand, 72 percent were open to taking CBD or non-psychoactive medical marijuana products to alleviate their conditions, either minor or major.<\/p>\n<p>\u201cEducation levels are still low about these products, but the word is getting out at a rapid clip, and this is where the bulk of demand will come from moving forward.\u201d<\/p>\n<h3>Allaying fears<\/h3>\n<p>For some retailers and producers, engaging in the CBD trade can be dubious, if not downright scary.<\/p>\n<p>In September, discount retailer <a href=\"http:\/\/www.thecannabist.co\/2017\/09\/28\/cw-hemp-cbd-oil-extracts-target-com\/88914\/\">Target Corp.\u2019s website briefly carried a selection of CBD-rich extracts<\/a> made by Colorado\u2019s CW Hemp. Target pulled the oils just hours after The Cannabist reported on the development \u2014 a move that legal and drug policy experts said would be groundbreaking but also possibly illegal. <\/p>\n<p>In October, <a href=\"http:\/\/www.thecannabist.co\/2017\/11\/01\/fda-warning-letters-cbd-health-claims-cw-hemp\/91378\/\">producers within the artisan hemp extract market were smacked with a stark reminder<\/a> from the U.S. Food and Drug Administration that their operations stand on unstable ground.<\/p>\n<p>The agency warned CW Hemp and three other producers of CBD extracts of illegally marketing their products. The firms made baseless health claims that their products could cure cancer and a myriad other ailments, officials said.<\/p>\n<p>\u201cThe FDA has issued several warning letters for similar violations in 2015 and 2016, and will continue to monitor and take swift action against companies that egregiously promise and sell unproven treatments,\u201d Michael Felberbaum, an FDA spokesman, wrote via email to The Cannabist. \u201cWhen a product is in violation of the FD&amp;C (Federal Food Drug &amp; Cosmetic) Act, the FDA considers many factors in deciding whether or not to issue warning letters.<\/p>\n<p>\u201cThose factors include, among other things, agency resources and the threat to the public health.\u201d<\/p>\n<p>The missives are par for the course for the FDA, said Bob Hoban, a Denver-based attorney specializing in cannabis business matters. Hoban\u2019s firm also is representing hemp industry groups in two separate <a href=\"http:\/\/www.thecannabist.co\/2017\/06\/26\/cbd-oil-medical-marijuana-federal-charlottes-web\/82258\/\">federal appeals court challenges of DEA positions<\/a>. <\/p>\n<p>\u201cIf there was really something behind this, I think you would have seen actual enforcement,\u201d Hoban said.<\/p>\n<p>Hoban said he doesn\u2019t \u201cdisagree for a second\u201d with the FDA\u2019s stance about unsubstantiated health claims.<\/p>\n<p>\u201cThere\u2019s a difference between cannabis-based medicine and what we see in the marketplace,\u201d Hoban said. \u201c(These hemp extract producers) are always going to operate in the food and supplement space.\u201d<\/p>\n<p>And in that space, medical claims are a giant no-no.<\/p>\n<p>But whether that space is even a plausible shelter for CBD extracts remains unclear. The FDA has been openly sour on the idea of CBD as a dietary supplement, and three of the four recent warning letters included friendly reminders that CBD-rich hemp extracts could not and should not be classified as dietary supplements.<\/p>\n<p>What defines a dietary supplement is rooted in the FDA\u2019s legal framework, the Federal Food, Drug and Cosmetic Act. Under the Act, a substance is excluded from the dietary supplement definition if it\u2019s an active ingredient in an approved drug product or authorized for investigation as a new drug for which clinical investigations are under way and made public, according to the FDA.<\/p>\n<p>An exception to those rules is if the substance was marketed as a dietary supplement or conventional food prior to the drug\u2019s approval or before the new drug investigations were authorized.<\/p>\n<p>The FDA\u2019s basis for excluding CBD from supplement consideration is that the agency considers the compound an active ingredient in two investigational pharmaceutical drugs: <a href=\"https:\/\/www.gwpharm.com\/about-us\/news\/sativex%C2%AE-commences-us-phase-iiiii-clinical-trial-cancer-pain\">Sativex<\/a>, a THC-CBD oral spray formulation for the treatment of muscle stiffness and spasms associated with Multiple Sclerosis, and Epidiolex, an oral solution formulation of plant-derived CBD for treating symptoms of rare seizure disorders.<\/p>\n<p>\u201cBased on available evidence,\u201d the exception doesn\u2019t apply for CBD, FDA officials say.<\/p>\n<p>As recent as last year, the FDA has rebuffed challenges from proprietors or attorneys who have claim that certain hemp extracts should qualify for that exception, according to The Cannabist\u2019s review of FDA correspondence obtained via a Freedom of Information Act request. <\/p>\n<p>In response to a letter claiming that Dixie X Hemp CBD Wellness Products were marketed on or before Sept. 13, 2012, FDA officials chimed back with two key dates: the Nov. 26, 2007, press release announcing the start of clinical trials for Sativex and the May 7, 2014, press release announcing the opening of the Investigational New Drug application for Epidiolex.<\/p>\n<p>Separately, the FDA has given similarly worded denials to companies and individuals that tried to submit hemp-based CBD extracts as new dietary ingredients, according to filings available at regulations.gov.<\/p>\n<p>Both Sativex and Epidiolex were developed by GW Pharmaceuticals plc, a London-based biopharma company that operates in the United States as Greenwich Biosciences.<\/p>\n<p>Sativex, which has received regulatory approval in 30 countries, has not been approved for use in the United States, and no American-based studies are planned at this time, GW officials told The Cannabist. <\/p>\n<p>Epidiolex, however, <a href=\"http:\/\/www.thecannabist.co\/2017\/11\/03\/cbd-epidiolex-fda-nda-gw-pharmaceuticals-pharmaceutical-drug\/91562\/\">is nearing FDA approval<\/a>. <\/p>\n<p>The concept of a CBD-based drug has <a href=\"http:\/\/www.thecannabist.co\/2017\/10\/06\/cbd-epidiolex-gw-pharmaceuticals-fda-hemp-industry\/89387\/\">caused much hand-wringing among proponents of hemp extracts<\/a>. Some fear approval could lay the framework for the pharmaceutical industry gaining full control of the cannabis plant and its slew of potentially medicinally beneficial compounds.<\/p>\n<p><a href=\"http:\/\/www.thecannabist.co\/2017\/12\/29\/high-minded-marijuana-podcast-cannabist-s01e05\/95592\/\">GW officials have repeatedly said<\/a> their firm is focused on the sole objective of developing FDA-approved cannabinoid medicines for doctors and patients seeking additional options beyond what\u2019s available in the market today. <\/p>\n<p>\u201cWe\u2019re not really interested in curtailing the activities of the artisanal world or of the dispensary world,\u201d said Steve Schultz, GW\u2019s director of investor relations. \u201cWhat we\u2019re interested in doing is making a medicine available that we believe is in demand. In speaking with physicians, in speaking with patients and patient advocacy groups, we hear over and over again that there is substantial demand for an FDA-approved medicine that has the hallmarks of a modern medicine.<\/p>\n<p>\u201cWe\u2019re not looking to involve ourselves in trying to curtail activity outside of our focus. We\u2019re just looking to do the best job possible for the objective that we have at hand.\u201d<\/p>\n<p><strong>Listen: <a href=\"http:\/\/www.thecannabist.co\/2017\/12\/29\/high-minded-marijuana-podcast-cannabist-s01e05\/95592\/\">Interviews with Steve Schultz, GW\u2019s director of investor relations, and Alice Mead, GW\u2019s vice president of U.S. professional relations on the Cannabist\u2019s High Minded Podcast<\/a><\/strong><\/p>\n<p>Not all hemp advocates, however, are heading down the worst-case-scenario route. <\/p>\n<p>\u201cWe really see a two-track future,\u201d said Jonathan Miller, general counsel for the U.S. Hemp Roundtable, a Lexington, Ky.-based 501(c)(4) nonprofit organization lobbying for the passage of <a href=\"http:\/\/www.thecannabist.co\/2017\/08\/15\/industrial-hemp-farming-act-congress-comer-polis\/85923\/\">the Industrial Hemp Farming Act of 2017.<\/a><\/p>\n<p>On one end of the spectrum would be CBD-based pharmaceutical formulations approved for certain medical conditions, allowed to make medical claims and eligible for insurance reimbursement, Miller speculated.<\/p>\n<p>On the other end would be CBD-rich extract products available akin to how fish oil supplements are sold.<\/p>\n<p>\u201cYou wouldn\u2019t be able to use your insurance, wouldn\u2019t be able to make medicinal claims,\u201d Miller said. \u201cBut just like fish oil today, people who view these products as good for their health and wellness will be able to go to the store and buy them.\u201d<\/p>\n<p>The U.S. Hemp Roundtable has taken the position that existing law and court opinions favor the legality of hemp extracts. The passage of the Industrial Hemp Farming Act would eliminate any confusion by <a href=\"http:\/\/www.thecannabist.co\/2017\/06\/08\/hemp-products-united-states-farming\/80796\/\">removing hemp from the purview of the Controlled Substances Act<\/a>, Miller said.<\/p>\n<p>In an opinion statement issued Oct. 2, 2017, Miller stated that the sale of hemp-derived CBD is legitimized by decisions out of the Ninth U.S. Circuit Court of Appeals and the language of the federal Agricultural Act of 2014, or Farm Bill.<\/p>\n<p>Miller envisions appropriate levels of standards for the over-the-counter hemp extracts. The roundtable is establishing the architecture of a self-regulated organization to help define guidelines, practices and protocols for hemp-derived products such as CBD-rich extracts.<\/p>\n<p>\u201cThe consumer will have a level of comfort about what they\u2019re buying is safe and effective,\u201d he said.<\/p>\n<p>The FDA\u2019s position on the matter stands at odds with the 2014 Farm Act and the provisions of the pilot programs of many hemp-producing states, Kight claimed. That also means that the FDA does not enforce food safety standards \u2014 known as Good Manufacturing Practices \u2014 with respect to hemp foods and supplements, he added.<\/p>\n<p>In the absence of official oversight, some companies have voluntarily complied with federal GMP standards and some states have started developing food safety policies that address hemp-derived products, cannabis attorney Kight said.<\/p>\n<p>Colorado is one such state. This summer, state officials established a new policy for regulating hemp foods.<\/p>\n<p>\u201cI see this as a trend that will be picked up by other states,\u201d Kight said.<\/p>\n<p>Colorado regulators sought to solve a problem: Colorado law allows for the production of industrial hemp; however state law \u2014 which mirrors federal law \u2014 prohibits the use of hemp stalk and flower in food, primarily because of the presence of unapproved food ingredients, in particular cannabidiol. <\/p>\n<p>\u201cThis is an innovative, novel industry,\u201d said Jeff Lawrence, director of the Colorado Division of Environmental Health and Sustainability. \u201cIt\u2019s brand new to us. The processes that they go through aren\u2019t, but the commodity is.\u201d<\/p>\n<p>State regulators worked closely with hemp industry leaders during the 2017 legislative session, he said. The policy was looked at as a \u201cfirst, best step\u201d with all parties leaving the door open for future legislation.<\/p>\n<p>The Colorado Department of Public Health &amp; Environment this summer released a set of Good Manufacturing Practice guidelines for industrial hemp in food. The conditions outline aspects such as utilizing hemp plant parts from a state or country with an approved industrial hemp program; meeting the \u201cstandard of identity\u201d of no more than 0.3 percent of THC; labeling hemp and CBD; including a statement that the \u201cFDA has not evaluated this product for safety or efficacy\u201d; ensuring no health claims are made.<\/p>\n<p>The policy also makes it clear that the guidelines are for use within the bounds of Colorado and are not meant to \u201cestablish or infer conformance\u201d with federal laws. <\/p>\n<p>The \u201cFDA looks at the CBD in a little different light than us, and that\u2019s where we have a little bit of divergence,\u201d Lawrence said.<\/p>\n<h3>Political endgame<\/h3>\n<p>With the feds and the nascent industry apparently dancing to different tunes, the finale of the cannabis compound\u2019s convoluted regulatory dance seems destined for the courtroom, industry analysts say.<\/p>\n<p>Were the feds to crack down tomorrow, the CBD industry won\u2019t just bow out, said Tami Wahl, a principal of the Washington, D.C.-based Liaison Group, a federal cannabis lobbying firm. Wahl previously served as a regulatory attorney specializing in the pathways to market for natural products and dietary supplement.<\/p>\n<p>Rather than just stand as wallflowers while the FDA makes its moves, Wahl suggested industry members get on the floor and dance.<\/p>\n<p>Businesses should take a proactive approach and form a working group, coalesce and present a blueprint for CBD\u2019s position in the marketplace, she said.<\/p>\n<p>\u201cDo you want to continue on the status quo right now \u2026 or do you want to take the lead on how you want this to look in five to 10 years,\u201d she said.<\/p>\n<p>Wahl cautioned that sellers of CBD-rich products should pay meticulous attention to meeting or exceeding compliance requirements of their respective regulatory pathway \u2014 be that food, dietary supplement, beverage or other substances authorized under state law.<\/p>\n<p>Accelerants for enforcement could include unsafe products or threats to public safety, she said.<\/p>\n<p>The FDA, akin to fellow government agencies, has limited resources, she said. If public safety is not at risk, Wahl envisions ample opportunity for the pharmaceutical and alternative options to coexist, \u201cAs long as people are being responsible and playing by the rules,\u201d she said.<\/p>\n<p>Epidiolex\u2019s approval could force the federal government to lay down its hand, Kight said.<\/p>\n<p>Kight imagines that \u201cfull-spectrum\u201d hemp products \u2014 including the host of cannabinoids, terpenes and phytonutrients from the plant \u2014 may have more legal standing than CBD isolate products.<\/p>\n<p>\u201cWe\u2019re at the point of the evolution of hemp and cannabinoid-based health products that I think we do need to start talking isolate versus full-spectrum extract and that type of thing, which has been in the market,\u201d he said. \u201cAnd I think the FDA again will recognize that at some point in the future. <\/p>\n<p>\u201cWho knows when, but I think it will draw that distinction.\u201d<\/p>\n<div class=\"entry-meta-author\">\n<div class=\"authorimage\"><a class=\"url fn n\" href=\"http:\/\/www.thecannabist.co\/author\/awallace\/\" rel=\"author\"><img src=\"https:\/\/cannitrol.com\/blog\/\/wp-content\/uploads\/2017\/12\/cbd-tbd-cannabinoids-on-local-grocery-shelves-but-for-how-long.jpg\" class=\"authormug\" \/><\/a><\/div>\n<p class=\"author-desc\">Alicia Wallace joined The Cannabist in July 2016, covering national marijuana policy and business. In her 14 years as a business news reporter, her coverage has spanned topics such as the economy, natural foods, airlines, biotech, retail,&#8230;<\/p>\n<\/div><\/div>\n<\/p><\/div>\n<p><!-- .row --> <\/p>\n","protected":false},"excerpt":{"rendered":"<div class=\"media_block\"><\/div>\n<p>CBD products are showing up at places like Alfalfa&#8217;s and Lucky&#8217;s, and the FDA and DEA are working to regulate such sales. <\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[330,6811,233,7153,77,5667,9,6833,5019,1,3,61,1736],"tags":[2908,6816,2811,7155,2655,5673,6835,5022],"_links":{"self":[{"href":"https:\/\/cannitrol.com\/blog\/wp-json\/wp\/v2\/posts\/7962"}],"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=7962"}],"version-history":[{"count":0,"href":"https:\/\/cannitrol.com\/blog\/wp-json\/wp\/v2\/posts\/7962\/revisions"}],"wp:attachment":[{"href":"https:\/\/cannitrol.com\/blog\/wp-json\/wp\/v2\/media?parent=7962"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/cannitrol.com\/blog\/wp-json\/wp\/v2\/categories?post=7962"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/cannitrol.com\/blog\/wp-json\/wp\/v2\/tags?post=7962"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}