Más contenido relacionado


Expo West Keynote Presentation

  1. Sean Octavius Murphy The Certified Business of Disruption (CBD) Founder and Publisher A Division of
  2. Sometime a little before 1994…
  3. That’s it — we’re going to the Naturopath! • Family of MDs on Father’s side • I was chronically sick: Strep Infections, Respiratory Failure, Pills Pills Pills • Momma knows best!
  4. Linda Kantor, ND, MH
  5. 1994
  6. DSHEA
  7. U.S. Retail Hemp Industry (5 Year CAGR) 22% Growth U.S. Hemp Industry (2020) $1.8B Hemp-Derived CBD Industry (2017) $175
  8. disruption Business. a radical change in an industry or business strategy, especially involving the introduction of a new product or service that creates a new market.
  9. an issuing forth suddenly; outburst; eruption
  10. February 7, 2014
  11. Sec. 7606, Farm Bill Amendment
  12. 9,700 3,469 3,020 3,100
  13. 0 20,000 40,000 60,000 80,000 100,000 120,000 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 Global Hemp Acreage Comparison EU Canada US Source: US state agencies for cultivated acres, nova-Institute and EIHA for EU cultivation. Health Canada for Canadian licensed acreage (acres). 2017 unconfirmed estimates for EU and Canada
  14. Hemp as an Ag Commodity CBD as an “Ingredient” Seed Fiber Cannabidiol Extracts Isolates De-hulled Non-viable Whole Viable Whole Bast Hurd Primary Secondary Lignin
  15. U.S. Hemp Cultivation By Type Seed Cannabidiol 55% 30% 15% Fiber
  16. Thank You
  17. Natural & Specialty Channel Tracked Sales Leaders
  18. Total CBD Sales Leaders Hemp-Derived & Marijuana-Derived
  19. Three CBD Market Disruptions to Watch
  20. #1. Canada CBD Market Coming Online M&A Activity Inverell
  21. BIG Alcohol #2. The “BIGS” are Moving In Criticalit y BIG Tobacco BIG Pharma
  22. #3. Exports Slowing to Central & South America: Countries Establishing Domestic Markets
  23. Five NPI Retail Disruptions to Watch
  24. “We’re not afraid to be disruptive and pave the path and be pioneers.” Sandy Wise, Lucky’s Directory of Apothecary #1. Opportunity Arrives in Large NPI Retailors
  25. #2. BIG Hemp Joins the Dance #3 Distribution Kicking into Gear 58 SKUs (1 Pet)
  26. #4. Pet/Animal Market Breaks Out
  27. #5. Synergistic Blending
  28. Innovative? Inefficient?
  29. Organic – Not really happening… yet. 2017 3% 2016 5% Natural and Specialty Channel 5% $320,000$124,000
  30. Support H.R. 3530 !
  31. Things to Watch – 2018 & early 2019 1. Introduction of Senate Bill: Leadership Support 2. Epidiolex® Go to Market: FDA/GW actions 3. HIA (Hoban Law) vs. DEA: Response By the Court 4. Farm Bill 2018: Sec. 7606 Update/Amendment? 5. Clarification on Statement of Principles: TBD
  32. Keep an eye on “The Big Four”
  33. Stated Position + Notice + More Warning Letters = Moving ducks in a row to regulate CBD as a drug Statement of Principles + Not stepping out of regulatory line = Will follow FDA and DEA on CBD
  34. New Drug Code (7350) for Marijuana Extract
  35. Seizures, Apologies, Schedule IV’ing… oh my!
  36. Epidiolex Timeline The New Drug Application (NDA) submitted End of December, 2017: The FDA accepts the Epidiolex NDA The Prescription Drug User Action (PDUFA) outlines the timeline and protocol by which drug companies submit fees and the FDA approves drug applications. PDUFA is typically a one year timeline unless the drug is “fast tracked,” and then it’s 6 months. Epidiolex was fast tracked. June 27, 2018 PDUFA Date. Upon the FDA’s approval under PDUFA, the DEA has up to 90 days to reschedule a drug. HBJ anticipates Epidiolex will be re- scheduled on the CSA as a Schedule IV drug in September or October 2018. The Greenwhich Biosciences sales team will take Epidiolex to market. HBJ estimates an initial wave of pent up demand at the end of 2018. End of 2018 or beginning of 2019. The hemp industry should watch for increased FDA action or regulation to enforce CBD as a drug given Epidiolex commercialization. Epidiolex sales ramp-up. Continued regulatory clashes between FDA, DEA and cannabis companies (hemp and marijuana) concerning labeling, marketing and scheduling. Note: If the DEA reschedules (to Schedule II) or de-schedules marijuana from the Controlled Substances Act, it will have an impact on this timeline. HBJ estimates no such scheduling action will occur – until at the earliest - Epidiolex becomes a scheduled drug and pharmaceutical financial interests are ‘in play’ across regulatory agencies and financial markets. Application Submitted and Accepted for Review by the European Medicines Authority (EMA) 2018 2019 Management anticipates approval decision in the first quarter of 2019
  37. 2017 Total U.S. CBD Sales (hemp and marijuana) 2018 End of Q1 Cash Balance $367mm $560mm
  38. $52,600,000,000
  39. • “Current information does not justify scheduling CBD” • “CBD could have therapeutic value for seizures due to epilepsy and related conditions” • Postponed full review of CBD until May 2018
  40. • Oversees World Anti-Doping Code: Used by 600+ sports organizations including International Olympic Committee and the U.S. Anti-Doping Agency. • “Cannabidiol is no longer prohibited” • THC remains banned
  41. Researchers bought 84 CBD products online and had them tested in Colorado labs. • 43% contained more CBD than the label claimed. • 26% contained less CBD than promised. • 31% were within 10 percentage points of the promise.
  42. Labeling: “CBD” vs. Hemp Extract, Oil and Complex
  43. Chuck “DESHEA” Norris
  44. Hemp- Derived CBD Consumer Education!
  45. Available on
  46. $299 $249 Pre-Order Today! Go to and save.

Hinweis der Redaktion

  1. Greeting Some sort of audience pump up Poll the Audience, (owners, entrepreneurs, work for an NPI company?, practioneer? Attorney? Regulator? Pharmacuetical Company? FDA or DEA? Story time - begin with a short story that brought us to where we are today…
  2. How many people remember this advertisement?
  3. My story begins about this time….
  4. Compound fracture foot, never felt better. Take a moment and think about what brought you into this industry. Mine is just a boring story about a sick kid, but there are some amazing stories—some miraculous stories.
  5. How many people know what DSHEA is? DSHEA defines the term "dietary supplement" to mean a product (other than tobacco) intended to supplement the diet that bears or contains one or more dietary ingredients, including a vitamin, a mineral, an herb or other botanical, an amino acid, a dietary substance for use by man to supplement the diet by increasing the total dietary intake, or a concentrate, metabolite, constituent, extract, or combination of any of the aforementioned ingredients.[6] Furthermore, a dietary supplement must be labeled as a dietary supplement and be intended for ingestion and must not be represented for use as conventional food or as a sole item of a meal or of the diet.[6] In addition, a dietary supplement cannot be approved or authorized for investigation as a new drug, antibiotic, or biologic, unless it was marketed as a food or a dietary supplement before such approval or authorization.[6] Under DSHEA, dietary supplements are deemed to be food, except for purposes of the drug definition
  6. To Protect Investors
  7. Introduction: About HBJ, Pedigree
  8. Overused term, I know. I’m going to use it a bunch of times today, and then never use it again. But there’s also another good word to describe the CBD market….
  9. The date the disruption and eruption started…
  11. Canada grew about 120,000 acres of hemp this year, 10 times the acreage of hemp in the United States. “We can be in an excellent position to get a whole lot more CBD out of this product,” said Jordan Sinclair of Canopy Growth. Canadian hemp farmers will be able to sell flower and leaves for CBD extraction – but only to the few dozen entities licensed to process and sell CBD. That’s because U.S. hemp guidelines are expected to get an update in the 2018 Farm Bill. In addition, Canada’s hemp changes could spark more interest in a languishing proposal to remove hemp from the list of controlled substances in the United States. Canopy Growth is moving farther into the Canadian hemp market with the acquisition of hemp land in Saskatchewan that could scale to over 2,000 acres. The medical marijuana producer, which trades on the Toronto Stock Exchange as WEED, on Monday announced the acquisition of Green Hemp Industries. As of January 25, 2018, Green Hemp Industries Ltd., Certain Assets And Intellectual Property was acquired by Canopy Growth Corporation. Green Hemp Industries Ltd., Certain Assets And Intellectual Property comprises hemp farming operations and associated assets, equipment, and genetic stock. The operations are located in Canada. Canada’s global cannabis-buying spree is moving to Uruguay. Vancouver, British Columbia-based Cannabis Wheaton announced Tuesday that it plans to spend up to $15 million to acquire 80% of Inverell shares. Based in Uruguaya’s capital, Montevideo, Inverell produces high-CBD hemp and low-THC marijuana. While Canadian marijuana companies have expanded their international reach by purchasing businesses in countries such as the United States, Australia and Germany, the Inverell deal is the first venture into Latin America for Cannabis Wheaton, which plans to produce CBD products for export. The transaction includes $2 million in cash, plus an additional $3.5 million worth of shares in Cannabis Wheaton, according to a news release. Cannabis Wheaton will give Inverell an additional $9.5 million worth of stock once the Uruguayan company registers its cannabis genetics and successfully exports CBD. Inverell holds a license in Uruguay – the first nation to legalize recreational marijuana – to grow three strains of hemp, plus a marijuana strain that contains about 0.5% THC. The company is currently growing the strains on about 40 acres (16 hectares) and has an additional 1,420 acres (574 hectares) available for additional production. Raul Urbina will stay on as CEO of Inverell. Wheaton CEO Chuck Rifici said in the release that the Inverell acquisition gives his company “a diversified source of low-cost CBD production for our international distribution channels.”
  12. The BIG… Tobacco, Alcohol, Outside of NPI, Scopia 3,455,054 of GW Capital Group 3,375,000 of GW John Kapoor 42,430,310 of Insys OrbiMed 5,406,844 of Insys
  13. Lucky’s 17 Stores, product classes, like a diversified portfolio, mention Kroger “significant stake” Target Who will be next?
  14. Tumeric, Mannuka Honey, Ashwanganda, and others
  17. At the end of December, GW achieved the important milestone of FDA acceptance of its Epidiolex NDA submission. Also at the end of December, we submitted a regulatory application to the European Medicines Authority and I'm pleased to announce today that this application has been accepted for review by the EMA. These achievements position us for a midyear NDA approval and an anticipated U.S. launch in the second half of the year. This timeline reflects an expedited review by the FDA. In Europe, we anticipate an approval decision in the first quarter of 2019.
  18. WHO: “Recent evidence from animal and human studies shows that its use could have some therapeutic value for seizures due to epilepsy and related conditions. Current evidence also shows that cannabidiol is not likely to be abused or create dependence as for other cannabinoids (such as Tetra Hydro Cannabinol (THC), for instance). The ECDD therefore concluded that current information does not justify scheduling of cannabidiol and postponed a fuller review of cannabidiol preparations to May 2018, when the committee will undertake a comprehensive review of cannabis and cannabis related substances. which is used by more than 600 sports organizations, including the International Olympic Committee and the U.S. Anti-Doping Agency (USADA).
  19. They may take our “CBD on the Label” but they will take take our “Hemp”!