2. ââŚThe data surrounding its (CBD) efficacy,
particularly indications such as pain relief, traumatic
brain injury, suppression of seizures among others
auger well for its future in the market if the
molecule were derived from almost any other
plant. If CBD has been found in another plant, it
would be considered a miracle cure, a miracle
functional food, or a miracle drugâŚâ
Mark Blumenthal
American Botanical Council
6. Getting to Retail:
Understanding the Supply Chains
âIndustrial Hempâ vs. âMarijuanaâ
⢠Different Legal Definitions, Regulators, Licensors
⢠Industrial Hemp: Section 7606 of 2014 Federal Farm Bill (State Departments of Agriculture and
Institutions of Higher Learning)
⢠Marijuana: State Laws and Enforcement/Regulatory Divisions
⢠DEA and FDA concerns and risks apply to both, but in different ways through different
interpretations of the law.
⢠âCBDâ as an ingredient best understood in context of âHemp Derived Sourceâ vs. âMarijuana
Derived Source.â Does the product being sold come from a marijuana grower or a hemp grower?
⢠Products containing CBD are processed in both supply chains but ultimately sold into different
retail channels.
⢠Natural, Specialty and Traditional Channels vs. Dispensary Channel. Hemp derived products can
crossover into Dispensaries, but Dispensary products can not cross into mainstream channels.
⢠Pharmaceutical (CBD Isolate) vs. Natural Products (Hemp Extract) = A clash weâve all seen before
⢠Ultimately, products in all channels contain âCBDâ but are regulated by different bodies, grown
under different licenses, sold through different channels, and come in different forms (isolates
vs. oil/extracts). Therein lies the complexity of the emerging CBD ingredient industry.
7. $93mm $80mm
2015 2016 2020 (e)
Grown and Sold through a Marijuana Supply Chain
vs.
Grown and Sold through a Hemp Supply Chain
Total CBD Sales
$132mm $130mm
$417mm $395mm
Pharmaceutical
Marijuana Marijuana Marijuana
Hemp Hemp
Hemp
$350mm
Source: Hemp Business Journal estimates (consumer sales), BDS Analytics and New Frontier Data
8.
9. Several top âcannabis brandsâ
are targeting both distribution channels
but in different ways.
Hemp Channels
âHemp Extractâ or âCBDâ
Marijuana Channel
Dispensaries
Channel Specific Branding
Totally Different Branding
Same Branding, Different Packaging
11. Methodology Used to Analyze CBD Dispensary Sales
2. Medical vs. Recreational
3. Branded Product vs. Flower
1. State Where Dispensary is Located
Continue to next slideâŚ
12. CBD : THC Ratio
Negligible THC High CBD High THC Variable
> 4:1 < 1:2 Between
4:1 and 1:2
<.3% THC
Consumer Buying Intent
16. Marijuana Channel Advantages
(vs. Hemp Channel)
⢠Products can contain THC
⢠Can more aggressively market âCBDâ and
other Cannabinoids (CBN, CBG, THC-A,
etc.) on the label.
⢠More knowledgeable consumer
⢠Higher and more difficult barrier to entry for
competition
⢠Hip, New, Cool, Innovative
26. Feb. 2015 â FDA sends 6 Warning Letters
âYour products are not generally recognized as safe and effective for the above
referenced uses and, therefore, these products are ânew drugs,'â the FDA wrote to
CBD Life Holdings in Arizona. âNew drugs may not be legally introduced or delivered
for introduction into interstate commerce without prior approval from the FDAâŚYou
should take prompt action to correct the violations cited in this letter.â
Feb. 2016 â FDA sends 8 Warning Letters
(From FDA Website) âFDA has tested these products, and many were found to not
contain the levels of CBD they claimed to contain. It is important to note that these
products are not approved by FDA for the diagnosis, cure, mitigation, treatment, or
prevention of any disease. Consumers should beware purchasing and using any
such products.â
27. Consider.
⢠The FDA has sent a total of 14 letters the last three and half years while
there are 100+ companies (that we are aware of) selling CBD based
products.
⢠The letters were sent to companies making clear medical claims and are
considered by those in the industry to be less than legitimate companies
with less then legitimate products. None of the major players/brands
received a letter.
⢠The FDA didnât specify what types of enforcement actions it may take
against companies that continue to market CBD as a dietary supplement.
The FDA website says that the FDA âconsiders many factorsâ in such
decisions, including input from other federal agencies and state officials,
and whether such products constitute a threat to public health.
⢠The FDA acknowledged this point, and wrote that it will continue to work
with companies that are âinterested in appropriately bringing safe,
effective, and quality products to market, including scientifically-based
research concerning the medicinal uses of marijuana.â
28. In December 2016, the DEA issued a three-
page âclarifyingâ document on cannabis oil
products, including CBD-rich extracts, entitled
âEstablishment of a New Drug Code for
Marihuana Extract.â
The document asserts: âThe DEA has
previously established separate code numbers
for marihuana and for tetrahydrocannabinols,
but not for marihuana extract. To better track
these materials and comply with treaty
provisions, DEA is creating a separate code
number for marihuana extract with the
following definition: âMeaning an extract
containing one or more cannabinoids that has
been derived from any plant of the genus
Cannabis, other than the separated resin
(whether crude or purified) obtained from the
plant.ââ
In essence then, the DEA is saying that under
the Controlled Substance Act CBD is a Schedule
I Drug and is called âMarijuana Extract.â
29.
30. Whatâs really going on.
⢠The DEA is applying its âinterpretationâ of Federal Law (the Controlled
Substance Act). Under their interpretation a Schedule I Drug, by definition,
has âno medical benefit.â
⢠Industrial Hemp is legal under Federal Law (Sec. 7606 of the 2014 Federal
Farm Bill (also Federal Law). The Hemp Industryâs interpretation of the law
is it has full legal ground to implement research and commercial pilot
projects involving all constituents of hemp (defined as anything anything
with <.3% THC)
⢠There is a chorus of companies the marijuana industry that wants to see
hemp producers not allowed to produce CBD, and thus allow marijuana
producers o corner the market through the dispensary channel. The hemp
industry is pushing back with its sights to expand in the natural products
channel and break into big box retailers the next 1-3 years.
⢠HBJ is waiting to see what happens with the Hoban Law Group lawsuit.
Until then, business and commerce is thriving and many people are
receiving tremendous benefit from CBD.
31. While thereâs a sense to some a chill is in the
industry regulatory air, a top selling hemp CBD
product is in 1000+ stores (and counting).
32. Private Labeling
Pure Hemp
Botanicalâs tincture
under the generic
product name
âHemp Extractâ
Market leader with
10+ branded Hemp
CBD products in their
âlocked caseâ
âFlying off the
shelves.â
-Alfalfaâs Buyer
34. 2017 Forecasted Total
U.S. CBD Sales
2016 End of Year Cash
on GWâs Balance Sheet
Consider.
$358mm
$483mm
35. Why There is Even More Looming
Big Pharma Opposition
36.
37.
38.
39.
40.
41.
42.
43. Want more on CBD?
⢠Data Charts
⢠Market & Product Analysis
⢠Top Company Profiles
⢠State Rankings
⢠M&A Activity
⢠FDA & DEA Intel
44. The CBD Report | $399
HempBizJournal.com
Special Promo
CBD2020% off
Editor's Notes
DEA/FDA regulatory stance
rate of growth
 Â
And thanks
Â
Please ensure there is a good promotional piece at the end so that I can give you a big plus and maybe a discount code for attendees?
Roy,
Here is a few good links on the FDA from the Hoban Law Group:
CBD and FDA - Is there a chill in the air (marketplace)
FDAâs stance on CBD - Q&A with Bob Hoban
From the FDA websiteâŚ.
https://www.fda.gov/NewsEvents/PublicHealthFocus/ucm421168#dietary_supplements
Can products that contain cannabidiol be sold as dietary supplements?
No. Based on available evidence, FDA has concluded that cannabidiol products are excluded from the dietary supplement definition under section 201(ff)(3)(B)(ii) of the FD&C Act. Under that provision, if a substance (such as cannabidiol) has been authorized for investigation as a new drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, then products containing that substance are outside the definition of a dietary supplement. FDA considers a substance to be âauthorized for investigation as a new drugâ if it is the subject of an Investigational New Drug application (IND) that has gone into effect. Under FDAâs regulations (21 CFR 312.2), unless a clinical investigation meets the limited criteria in that regulation, an IND is required for all clinical investigations of products that are subject to section 505 of the FD&C Act.
There is an exception to section 201(ff)(3)(B)(ii) if the substance was âmarketed asâ a dietary supplement or as a conventional food before the new drug investigations were authorized. However, based on available evidence, FDA has concluded that this is not the case for cannabidiol. For more information on this provision, including an explanation of the phrase âmarketed as,â see Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues.
The FDA is not aware of any evidence that would call into question its current conclusion that cannabidiol products are excluded from the dietary supplement definition under section 201(ff)(3)(B)(ii) of the FD&C Act. Interested parties may present the agency with any evidence that they think has bearing on this issue.
Is it legal, in interstate commerce, to sell a food to which cannabidiol has been added?
No. Under section 301(ll) of the FD&C Act, it is prohibited to introduce or deliver for introduction into interstate commerce any food (including any animal food or feed) to which has been added a drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public. There are exceptions, including when the drug was marketed in food before any substantial clinical investigations involving the drug had been instituted or, in the case of animal feed, that the drug is a new animal drug approved for use in feed and used according to the approved labeling. However, based on available evidence, FDA has concluded that none of these is the case for cannabidiol. FDA has therefore concluded that it is a prohibited act to introduce or deliver for introduction into interstate commerce any food (including any animal food or feed) to which cannabidiol has been added. FDA is not aware of any evidence that would call into question this conclusion. Interested parties may present the agency with any evidence that they think has bearing on this issue.