Yesterday, as long anticipated, the Food and Drug Administration (FDA) approved GW Pharmaceutical’s Epidiolex, a cannabidiol (CBD) oral solution for the treatment of seizures associated with two forms of epilepsy. Please see the FDA’s press release here, and this statement from the FDA’s Commissioner.
The US Hemp Roundtable has reviewed the release with its FDA counsel, Amin Talati Upadhye (ATU). Here are our preliminary conclusions:
Fundamentally, Epidiolex’s approval has no legal impact on the sale of hemp-derived CBD.
The FDA focuses its concern on the “proliferation and illegal marketing of unapproved CBD-containing products with unproven medical claims.” The agency notes that its recent Warning Letters have been aimed at companies that make such “unproven medical claims.” The Roundtable applauds the FDA’s efforts to target bad actors in the industry who undermine legitimate hemp-derived products by making unproven claims. We look forward to working with federal and state agency officials through our continuing efforts to develop standards, best practices and a self-regulated organization (SRO) for the industry.
In ATU’s informed opinion, the arguments related to the marketing of hemp-derived CBD as a dietary supplement remain the same as before FDA’s approval of Epidiolex. ATU contends that hemp-derived CBD was marketed as a food or dietary supplement prior to the institution of substantial clinical investigation of Epidiolex that was made public by GW Pharmaceuticals, and even prior to the date on which FDA authorized the article for investigation as a drug. This would mean that dietary supplement versions of hemp-derived CBD would be permissible.
Given that the FDA’s approval of Epidiolex raises the visibility of hemp-derived CBD products, it is even more critical that Congress passes the Hemp Farming Act to permanently establish hemp and hemp-derived products as agricultural commodities, removing them from the purview of the Controlled Substances Act. We encourage supporters of hemp and hemp-derived CBD to use our web portal to contact their Congressmen today to urge them to support passage of the Hemp Farming Act.
Location: 113 Ann Street Parkersburg, WV 26101 Date: 06/05/2018 to 06/09/2018 Time: 11:00am to 4:00pm Phone: (304) 917-9189
Each day we will focus on a different sector of the plan with educational workshops to accompany them. We will offer discounted products all week as well, as this event will be held in our retail store in downtown Parkersburg. Tues – Hemp Paper Education (Workshop to be scheduled to Elishewa Shalom) Wed – Hemp Construction (Presentation – WV hemp harmer Clay Condon has built a hemp house and is a business partner) Thurs – Hemp Nutraceuticals (Presentation – Bonnie Buchman (RN, PhD, MD) discussing cannabinoid therapeutic potential) Fri – How to Farm Hemp (Presentation – Morgan Leach will be presenting the application and developmental process of farming hemp) Sat – Legislative Support (Workshop – Morgan Leach writing your representatives to support industrial hemp legislation at the local, state, and federal level.
Location: 216 East Ave Thomas, WV 26292 Date: 06/08/2018 Time: 5:30pm to 8:00pm Phone: (304)599-4906
Come celebrate Hemp History Week all week long at Tip Top in historic Thomas, WV. There will be a table with hemp fabric swatches, rope, threads, historical information, stickers and buttons during the week and an event on Friday (Grass-fed Burger Night!), June 8, from 5:30-8pm. We will provide hemp treats to sample and New Belgium’s Hemperor HPA hemp beer will be on tap (it’s delicious.) Come on out and experience the many uses of hemp!!!
Location: WV State Fair grounds 947 Maplewood Ave Lewisburg, WV 24901 Date: 06/09/2018 to 06/10/2018 TIme: 8:00pm to 2:00pm Phone: (304)646-3215
Join us to celebrate National Hemp History Week! Learn more of the history of hemp in WV, the nation and the bright future Hemp is bringing back now! “Hemp can be catalyst for agriculture in West Virginia providing farmers with a high yield cash crop, but the real impact will come in the downstream industries that will provide jobs in both the industrial and energy sectors of the state.” Hemp has the potential of becoming a significant commercial industry for the U.S. Currently, the U.S. imports more hemp than any other country in the world, and the total retail value of hemp products sold in the U.S. reached $573 million in 2015, according to Hemp Industries Association. Allowing hemp to be grown domestically on a commercial scale would provide a significant economic boost to U.S. processors and manufacturers”.~Morgan Leach WV Farmers Co-op For the first time since World War II, hemp seeds will be legally planted in West Virginia. Industrial Hemp is the best source of CBD Oil for possible health benefits that rival those of medical marijuana that is legal and available without prescriptions or cards. It is below the FDA legal limit of 0.3% THC. It contains a wealth of cannaboids and healthy Omegas! Industrial hemp is used to produce paper, food, fuel, textiles, fabrics, bioplastics, and building and construction materials. 🌎 By the mid-1600s, hemp had become an important part of the economy in New England, and south to Maryland and Virginia. The Colonies produced cordage, cloth, canvas, sacks and paper from hemp during the years leading up to the Revolutionary War. Most of the fiber was then destined for British consumption, although at least some was used for domestic purposes. Ironically, the first drafts of the Declaration of Independence were penned on hemp paper. 📜 Hemp fiber was so important to the young Republic that farmers were compelled by patriotic duty to grow it, and were allowed to pay taxes with it. George Washington grew hemp and encouraged all citizens to sow hemp widely. Thomas Jefferson bred improved hemp varieties, and invented a special brake for crushing the plant’s stems during fiber processing.
Location: 25 Troubadour Lane Berkeley Springs, WV 25411 Date: 06/09/2018 to 06/09/2018 Time: 8:00am to 12:00am Phone: (304)258-9381
All Grassed Up is joining us to wrap up Hemp History Week 2018! No cover charge, we are here to spread the word, listen to great music and have fun. Petitions and literature will be on hand as well as someone to answer questions and provide information regarding the uses and benefits of industrial hemp. Weather permitting, we will be set up in the park with the outdoor stage. We thank both Promising Leith and All Grassed Up for helping us put these events together for Hemp History Week.
Location: Wetzel County Farmers Market, Bruce Park, New Martinsville, WV 26155 Date: 6/14/18 Time: 3:30-6:00 Phone: n/a
Come see The Garden Path to learn, sample, and find out what you can do to support growing industrial hemp in WV! The Garden Path grows and provides old-time varieties of produce, herbs, and plants grown in as natural environment as possible. It will be a HEMPTASTIC time!
The story of the Rodale Institute’s pioneering research on organic, no-till farming of hemp in Pennsylvania. Their hemp study focuses on hemp’s benefit to soil health and crop rotations within a regenerative agriculture model, and will provide farmers the necessary tools and knowledge to successfully farm hemp commercially once federal prohibition of the crop is lifted. Learn more about Hemp History Week, June 4 -10, 2018, and sign up to get involved at www.hemphistoryweek.com
Mark your calendars and join us in Washington, DC for Hemp Lobby Day on Thursday June 7th and make your voice heard! Last year, hemp advocates conducted over 75 meetings with members and their staff and educated them on the need for legislation to allow for full commercial hemp farming at the state level.To date, thirty-four states have defined industrial hemp as distinct and removed barriers to its production. Join us in helping pass the Hemp Farming Act.
“The Hemp Farming Act of 2018 would remove industrial hemp from Schedule I of the Controlled Substances Act and allows it to be regulated as an agricultural crop. The bill places federal regulatory authority of hemp with USDA and requires State departments of agriculture to file their hemp program plans with USDA but allows them to regulate hemp cultivation per their State specific programs. In addition to defining hemp as cannabis that contains no more than 0.3% THC by dry weight, the bill asserts a ‘whole plant’ definition of hemp, including plant extracts. If passed, the bill would remove roadblocks to the rapidly growing hemp industry in the U.S., notably by authorizing and encouraging access to federal research funding for hemp, and remove restrictions on banking, water rights, and other regulatory roadblocks the hemp industry currently faces. The bill would also explicitly authorize crop insurance for hemp.”
This event is organized by Vote Hemp and Agricultural Hemp Solutions. Click below to sign up to attend and they will schedule meetings with your Senators and Representative and prepare materials to make your day successful. Don’t miss this opportunity to help us make history by bringing back commercial hemp farming in the U.S.
Would you like the chance to meet the new the WV Commissioner of Agriculture, Kent Leonhardt and Dep. Commissioner Joe Hatton?
Well, you’re in luck! We’re hosting an evening with them on March 14th at the VFW Post 7048 in Fairmont! T he evening will include an opportunity to speak about local food and agriculture, hear the Commissioner’s vision for agriculture in WV, and we’ll provide an opportunity for the Commissioner to answer your questions!
The event is FREE and open to the community! Help us know how much food to prepare by RSVPing Here –– you can even toss your question into the hat!
Date: Tuesday, March 14th
Location: VFW Post 7048 1310 Morgantown Ave. Fairmont, WV 26554
PARKERSBURG, W.VA. – Governor Justice is looking for the state’s next niche crop. The West Virginia Hemp Industries Association (WVHIA) launches a Go Fund Me campaign to support industrial hemp as the state’s new niche crop. The WVHIA is a 501(c)(6) non-profit trade association that represents farmers, businesses, researchers and investors working with industrial hemp in West Virginia. They are requesting support for education, advocacy, and outreach efforts to assist in developing the state’s capacity to profit from this new cash crop.
The Pharmacy Board of the state with the highest opioid addiction rate recommends “cannabidiol” (CBD) to protect interests in future drug.
West Virginia has gained a reputation for having the worst opioid problem in the U.S. The state attorney general has been forced to sue pharmaceutical companies for “flooding” the state with pills that have contributed to the widespread addiction crisis. Companies are alleged to have “incentivized” opioid sales through illegal means and show no intentions of stopping.
“Even after we charged them civilly and took civil fines after them, even after they had memorandums of understanding that they knew what to do now, three years later, they started violating the law again,” said Joe Rannazzisi, previously with the DEA for 29 years in an interview with CBS News. 
Their has been considerable debate over the scheduling of CBD after the industry has taken off in America, expected to grow to $2.1 billion by 2020 according to Forbes. The crux of the debate is in the interpretation of the Controlled Substances Act of 1970 (“CSA) and the Agricultural Act of 2014 (“Farm Bill”). Further rules have been proposed by the DEA to include CBD on the schedule under the controversial Marihuana Extract Rule that is currently being challenged by the Hemp Industries Association. The main question for hemp farmers is whether the CBD derived from Hemp permitted under Section 7606 of the Farm Bill is subject to control under the CSA.
According to the Ninth Circuit, that answer is clearly no.
“naturally occurring cannabinoids are not unlawful substances per se. In Hemp Indus. Ass’n. v. DEA, 357 F.3d 1012 (9th Cir. 2004), the Ninth Circuit ruled that naturally occurring cannabinoids in industrial hemp foods, including oil, were never scheduled under the CSA; therefore, the DEA has no jurisdiction. This means that naturally occurring industrial hemp cannabinoids are federally legal in the view of the Ninth Circuit.” Hoban Law Group.
Further, “under the CSA, the DEA can regulate foodstuffs and related products containing natural THC if it is contained within “marijuana,” and can regulate synthetic THC of any kind. But they cannot regulate naturally-occurring THC not contained within or derived from marijuana–i.e., non-psychoactive industrial hemp products–because non-psychoactive industrial hemp is not included in Schedule I, as set forth above. This is because statutes must be interpreted strictly and pursuant to their specific terms, and because the DEA has no authority to regulate drugs that are not scheduled.” Hoban Law Group.
GW Pharmaceuticals has submitted Epidiolex and Sativex to the FDA for approval. The rules state that CBD is not legal for sale as a dietary supplement, provided that CBD has never been “marketed” as a dietary supplement before investigational trials had begun. The FDA claims that there is no evidence that CBD was ever marketed as a supplement, and is therefore not exempt from the rule. However, this finding has been challenged by the Hemp Industries Association and others who saw this coming.
“The industry and I were part of this, we responded in spades in the sense that we provided literally reams of documents and information that shows that CBD was marketed as a dietary supplement long prior to the believed date of application of GW Pharma,” said Hoban, managing partner of the law firm Hoban & Feola, LLC, during an interview for a “Healthy INSIDER Podcast.”
The WV Board of Pharmacy has prompted the WV Legislature to reschedule CBD. Delegate Joe Ellington, Chair for the House Health and Human Resources Committee, is the lead sponsor for amending H.B. 2526. This bill would attempt to amend the state Controlled Substance Act and make CBD sale and use illegal without a prescription. However, CBD has not been defined as a drug by the FDA at this time and is a blatant attempt by the pharmaceutical lobby to monopolize the market before their drugs even get approved. This bill is putting the cart way before the horse by recommending that CBD be placed on the schedule before it is approved by the FDA.
“HB2526 (f) Notwithstanding any provision of the code to the contrary, the sale, wholesale, distribution or prescribing of a cannabidiol in a product approved by the Food and Drug Administration is permitted and shall be placed on the schedule as provided for by the Drug Enforcement Administration.”
The pharmaceutical companies are now fighting for the very drug they lobbied against in the past. The hypocrisy of this situation is astounding. Further, CBD has potential to diminish addictive behaviors according to recent studies, and could be of real benefit to successful treatment and recovery. Big Pharma may now be trying to profit from the very situation they helped to create.
The WVHIA is calling on all West Virginian’s who have been adversely impacted by the opioid crisis to ask their representatives to oppose H.B. 2526 We cannot reward Big Pharma by allowing them to pass this bill. WVHIA Director J. Morgan Leach made the following comment:
“Natural alternatives to pharmaceutical drugs are under attack by Big Pharma. H.B. 2526 attempts to monopolize the CBD market and prevent nutraceutical companies from producing natural versions of their synthetic equivalent. It’s analogous to requiring a prescription for aspirin and then making competing supplements such as turmeric or Vitamin C illegal.”
Just this morning, our governor expressed his support for new niche crops in WV. “We don’t need to have 500 nichecrops,” Justice said. “It may be as simple as having two or three.” The State Journal –Niche Crops Could Make Agriculture Mean Even Bigger Business in W.Va. With your support on H.B. 2453, industrial hemp could be one of those important niche crops that will support our state’s agricultural sector and the diversification of our state’s economy. Expanding access for farmers toenter the pilot program will help establish industrial hemp as a new niche crop for West Virginia. We need cash crops to improve our current farming operations. Expanding the program will increase the supply chain for industrial hemp and justify investment needed for specialized equipment and infrastructure. Please email your delegates in the Agricultural and Natural Resources Committee to vote YES on H.B. 2453 in support of the farmers of this state!
LOCAL FOOD AND FARMS DAY AT THE CAPITOL:FEBRUARY 23
An Alliance of Farm Groups Host Event to Engage with State Legislators
The West Virginia Food & Farm Coalition, the West Virginia Farmers Market Association, and the West Virginia Farmers Cooperative will host the 3rd annual Local Food and Farms Day at the Capitol on February 23rd at 9:00 AM. It will be held in the Upper House Rotunda at the State Capitol with both the press and the public invited. The day will be focused on engaging policymakers and citizens on the opportunities and challenges in developing the local food and agriculture sector in West Virginia.
The three hosting organizations work statewide to build the local food economy by supporting small-scale farmers, farmers markets, and local food businesses so they can best reach West Virginia consumers. An important part of this is advocating for policy that allows for local food enterprises to succeed.
There are three policy priorities this year, 1) the Cottage Foods bill, 2) Rabbit to Restaurant rule, and 3) Surface Owner’s Land Reunion bill. The Cottage Foods bill would expand the current cottage food law to enable home-based processing of low-acid preserves (ie. green beans, ramps, tomatoes) to be sold at venues such as farmers markets. The Rabbit rule would increase the number of rabbits that can be processed from 1,000 to 5,000 rabbits per year per premise to better allow small farmers to safely and profitably sell to local restaurants. The Surface Owner’s Land Reunion bill would give landowners’ right to first bid on the mineral rights if they are being sold at a public tax sale auction, helping to preserve West Virginia’s farmland.
There is a large amount of opportunity to strengthen West Virginia’s economy and its’ citizens health by developing the local food sector. These are objectives that resonates with people on both sides of the political aisle, and provides an exciting avenue for citizens and legislators to work together toward a common bipartisan goal.
Our Founding Fathers were men of great wisdom. In rebellion, they drafted the Declaration of Independence, arguably the most important document in American History. That document represented more than the freedom of our people, it represented our commitment to remain free people. After more than 80 years of unjustified prohibition, we are now free to cultivate a crop that was once considered essential to the wealth and protection of our nation.
We would like to invite you to join the President’s Day Hemp Meeting at Starlings Coffee in honor of George Washington’s birthday and our newfound freedom. We will have presentations from representatives of the West Virginia Hemp Industries Association, members of the West Virginia Farmers Cooperative, and guest members of our state government.
Don’t miss the opportunity to congregate with leaders of this exciting new industry.
Hemp Business Owners, Farmers, Entrepreneurs and Activists to Push for Passage of Industrial Hemp Farming Act in Congress
WASHINGTON, DC – Vote Hemp, the nation’s leading grassroots hemp advocacy organization working to change state and federal laws to allow commercial hemp farming, is organizing a Hemp Lobby Day in coordination with the Hemp Product Expo sponsored by Rep. Jared Polis (D-CO), to occur March 1, and February 28 2017, respectively, on Capitol Hill. Hundreds of hemp business owners, farmers and agronomists, entrepreneurs, and activists from around the country will meet with Congressional representatives in Washington, DC, to garner support for the Industrial Hemp Farming Act, and push Congress to make 2017 the year industrial hemp farming is finally made legal in all 50 states. To register for this event, or sign up for concurrent lobby efforts taking place in states around the country, please SIGN UP HERE.