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Hemp and marijuana are two popular names for the cannabis plant.
1. Genetics
A 19th century illustration of Cannabis sativa (Photo: Wikimedia Commons)
Cannabis is believed to be one of the oldest domesticated crops. Throughout history, humans have grown different varieties of cannabis for industrial and medical uses.
Tall, sturdy plants were grown by early civilizations to make a variety of foods, oils and textiles, such as rope and fabrics. These plants were bred with other plants with the same characteristics, leading to the type of cannabis we now know as hemp.
Other plants were recognized for being psychoactive and were bred selectively for medical and religious purposes. This led to unique varieties of cannabis that we now know as marijuana.
According to Dan Sutton of Tantulus Labs, a Canadian company that specializes in cannabis cultivation technology, “the core agricultural differences between medical cannabis and hemp are largely in their genetic parentage and cultivation environment.”
In fact, scientists believe the early separation of the cannabis gene pool led to two distinct types of cannabis plants. The two species (or subspecies) of cannabis are known as Cannabis indica and Cannabis sativa.
2. THC Content
Cannabis plants contain unique compounds called cannabinoids. Current research has revealed over 60 different cannabinoids so far, but THC is the most well known. THC is credited with causing the marijuana high.
Hemp and marijuana plants contain another important cannabinoid: CBD. Hemp plants produce more CBD than THC, while marijuana produces more THC than CBD. Interestingly, research has shown that CBD acts to reduce the psychoactive effects of THC, separating hemp further from marijuana.
3. Cultivation
Hemp and marijuana are grown for different uses, and therefore require different growing conditions.
“Medical cannabis has been selectively bred over generations, and its characteristics are optimized in its cultivation environment to produce female flowering plants that yield budding flowers at the flowering stage of their life cycle,” explains Sutton.
In contrast, Sutton describes hemp plants as “primarily male, without representing flowering buds at any stage in their life cycle.” Instead, centuries of selective breeding have resulted in “relatively low concentrations of THC, and tall, fast growing plants optimized for higher stalk harvests.”
4. Legal Status
As you might already know, all cannabis is illegal to produce in the United States. Both hemp and marijuana are classified as Schedule I drugs under the Controlled Substances Act.
However, outside the U.S., hemp is grown in more than 30 countries. In 2011, the top hemp-producing country was China, followed by Chile and the European Union. Hemp production is also expanding in Canada, with the country’s annual crop reaching a record high of 66,700 acres in 2013.
Well Mystic....I really don't feel upset. You state old news. The Hemp CBD market has evovlved and this company has helped that market considerably. Since the material you quote comes direct from Project CBD you should also pay attention to the material that shows that they jointly tested the products from CV Sciences and they come out clean. I will agree with you that CBD oil with the psychoactive addition of THC is different but not what everyone wants. They are the same plant that are encouraged to grow differently. Your quote from project CBD is old news. You should be aware that Cannabis Marijuana can also be grown in soil that is contaminated just like every garden vegetable and fruit that we all consume today. CV Sciences had the professionalism to have joint tests conducted with Project CBD that gave a clean bill of health for contaminants.
I also have tried both versions of CBD oil Hemp and Cannabis and they both work for me. I just don't like the extra THC content that you get from Cannabis Marijuana. Just because it doesn't work for you doesn't mean others won't gain from these products.
If you are working on your short position it would explain your activity here, because you are clearly not up to date as shown by your posting of old news.
Even project CBD has stated that good organic hemp can be a viable source of CBD oil. Until more states become legal for marijuana and Hemp this company is supplying CBD to individuals in one of the only legal ways available.
And honestly....this board is a major league bust when it comes to bashing or pumping. I miss the good ole days when there would be thousands of posts a day....
Hemp and Marijuana both come from the same plant - Cannabis Sativa L. End of story.....The recreational crowd wants to paint any competitor with a negative outlook if it doesn't get you high. Their are benefits from both strains of Cannabis Sativa L. Whether it is classified as Hemp or Marijuana.
See link...
http://hempethics.weebly.com/industrial-hemp-vs-cannabis.html
The truth about the cananbidiol content of hemp: Industrial hemp has low THC levels compared to marijuana specifically cultivated for personal psychoactive use. Whereas marijuana that can be smoked usually contains between five and ten percent THC, industrial hemp contains about one-tenth of that. In order to get a psychoactive effect, one would need to smoke ten or twelve hemp cigarettes over a very short period of time.
The reason for the low THC content in hemp is that most THC is formed in resin glands on the buds and flowers of the female cannabis plant. Industrial hemp is not cultivated to produce buds, and therefore lacks the primary component that forms the marijuana high. Furthermore, industrial hemp has higher concentrations of a chemical called Cannabidiol (CBD) that has a negative effect on THC and lessens its psychoactive effects when smoked in conjunction.
This a quote from Project CBD: “We believe that industrial hemp is not an optimal source of CBD, but it can be a viable source of CBD if certain hemp cultivators are grown organically in good soil and safe extraction and refinement methods are employed,” wrote the authors of the Project CBD report. The problem is cost due to the large quantities of Hemp required to produce CBD.
Project CBD has reversed it's negative attitude on at least one company. CV sciences jointly tested their products under the scrutiny of Project CBD.
This is a joint effort to test CannaVest Products to prove the high quality that this company aspires to:
CannaVest Corp. (“CannaVest”) and Project CBD, a non-profit organization, jointly issue this statement:
Project CBD and CannaVest recently had samples of CannaVest’s hemp oil tested by an independent analytical lab as part of a collaborative effort to determine the absence or presence of heavy metals and industrial solvent residues in these products. The results of this independent testing showed only trace levels of solvents and heavy metals that are well below acceptable levels established by the U.S. Pharmacopeial Convention. Based on the results of this limited testing, Project CBD has concluded the CannaVest hemp oil tested is not contaminated with heavy metals or industrial solvent residues in amounts that pose a threat to human health, according to officially recognized safety standards.
Project CBD selected six samples from different batches of hemp oil that had been produced by CannaVest since mid-October 2014>. Project CBD selected three samples of CannaVest’s CBD Gold™ oil and three samples of CannaVest’s CBD Decarb™ oil for testing.
All samples were submitted to Exova, an independent testing facility based in Santa Fe Springs, California, for analysis. Exova tested the samples for 21 industrial solvents, including hexane, heptane, ethyl acetate, chloroform, toluene, and benzene. Exova also tested these samples to determine the presence or absence of four heavy metals—arsenic, cadmium, lead, and mercury.
On December 18, 2014, and December 23, 2014, Exova issued its findings in two reports to Project CBD and CannaVest. Exova found no significant levels of arsenic, cadmium, lead or mercury in the tested samples. Exova found no detectable levels of 21 industrial solvents in three CBD Gold™ samples. Three samples of CBD Decarb™ had trace of amounts of toluene that were well below acceptable levels, according to the U.S. Pharmacopeial Convention limit.
CV Sciences is in two states Nevada and California that have a high potential for legalizing Recreational Marijuana. The option to extract Cannabis derived CBD is achievable if they so choose. Watch for the November Vote.
Wrong "Into TheMystic" Get off the pipe and do you research. A lot of confusion over the CBD Oil from Hemp vs Cannabis. First of all, it’s important to note that marijuana and hemp are both cannabis plants. So they contain the same cannabinoids, just at different ratios and quantities. So, actually, when extracted correctly, the CBD derived from hemp can be equally as potent as that from the “marijuana” cannabis plant. The only problem is, it requires a significantly higher quantity of the raw product (hemp cannabis plant) to extract the same quantities of CBD. This results in a much higher cost for processing and product which results in higher costs for the consumer. In terms of purity though, there are significantly LESS traces of THC in hemp-derived CBD oil, because the ratio of CBD to THC in hemp is weighted significantly more towards the CBD side. This actually makes for a more pure form of CBD oil, than what is currently on the market from the marijuana derived products.
I have tried both....they both work. So, why come here to post if this is an inferior product why your interest. Are you trying to save people from making a bad mistake? Philanthropist maybe?
CBD: Just the Beginning
In many ways, the challenges CBD faces are the growing pains that
any ingredient relatively new to the supplements market would
face, including carving out a place in the regulatory domain. The
demand for this ingredient is very high, according to CV
Sciences, with Tomc adding that many of the more than 500 stores
carring CV Sciences’ CBD oil products complain they can’t keep up
with the demand.
CBD: Just the Beginning
In many ways, the challenges CBD faces are the growing pains that
any ingredient relatively new to the supplements market would
face, including carving out a place in the regulatory domain. The
demand for this ingredient is very high, according to CV
Sciences, with Tomc adding that many of the more than 500 stores
carring CV Sciences’ CBD oil products complain they can’t keep up
with the demand.
Well if you care to read this dry material, this document will show you how the initial players got together:
http://www.sec.gov/Archives/edgar/data/1510964/000101968715002817/cannavest_s1.htm
Cross and Company and everyone else.....
As far as Cross & Company is concerned, who knows? They still hold a nice little chunk. Might have needed the money.... I still worry about some of the holders like MJNA. Eventually they will all take their profit and move on....all weak holders will be shook out eventually. Its good for future share values to get them out while the stock is low.... Me personally? I am buying first thing in the am...
Tomorrows action is dependent on the attitude towards the product and the quarterly.
According to CV Sciences:
CBD: Just the Beginning
In many ways, the challenges CBD faces are the growing pains that
any ingredient relatively new to the supplements market would
face, including carving out a place in the regulatory domain. The
demand for this ingredient is very high, according to CV
Sciences, with Tomc adding that many of the more than 500 stores
carring CV Sciences’ CBD oil products complain they can’t keep up
with the demand.
So whats the story on these guys? They still hold a good size chunk of CV Sciences? Anybody know more? Alan?
Cross & Company Staff and Contact Information
Cross & Company, LLC
5301 Buckeystown Pike, Suite460
Frederick, MD 21704
Ph:
Tf:
Fx: 301-682-9015
800-336-2129
301-682-9016
For Commercial Property Management Emergencies and Service Requests,
please email: Service@CrossAndCompany.com and call: 301-682-9015, ext 10
Daniel C. Cross, CCIM, Broker, President
301-682-9015, ext 12
Daniel@CrossAndCompany.com
Lauren Potter, Property Manager
301-682-9015, ext 10
Lauren@CrossAndCompany.com
Ken Lawson, Facilities Manager
301-682-9015, ext 18
Ken@CrossAndCompany.com
Jeff Joy, Chief Operating Officer
301-682-9015, ext 13
Jeff@CrossAndCompany.com
Alan is one hundred percent correct in his assessment. I can only say that they didn't sell their entire position. Looks like profit taking.....happens.
Correction I meant 13g...
I now agree with Alan on the 13d. The latest 13d filed at Edgar does show that Cross & Co no longer have a position greater than 5% of the company shares. They still hold 1,651,231 shares...They may have taken profit. They have 10 days from the event that resulted in the reduction of their position. The event was recorded March 22 and the form filed as shown below. The good news? The stock has survived the selling an now is on the way back up. I am sure you all remember the activity around March 22.....
SC 13G CV SCIENCES, INC.(CROSS & CO) 03/25/16
Item 5. Ownership of Five Percent or Less of a Class.
If this statement is being filed to report the fact that as of the date hereof the reporting person has ceased to be the beneficial owner of more than five percent of the class of securities, check the following: [ ü ]
Alan had his facts straight....
This is a positive result.
Schedule 13G is an alternative SEC filing for the 13D which must be filed by anyone who acquires ownership in a public company of more than 5% of the outstanding stock. The 13G filing is considered a more passive version of the 13D and has fewer reporting requirements than the 13D. Activist practices are not permitted by 13G filers unless they refile a 13D.
The security holder of more than 5% but less than 10% must file within 45 days after the end of the calendar year in which the Exchange Act registration becomes effective. If the security holder holds more than 10%, then the holder must file within 10 business days once the threshold is met.[1]
I think the form filed the 13G. You may have misinterpreted the meaning of the form:
Schedule 13G is an alternative SEC filing for the 13D which must be filed by anyone who acquires ownership in a public company of more than 5% of the outstanding stock. The 13G filing is considered a more passive version of the 13D and has fewer reporting requirements than the 13D. Activist practices are not permitted by 13G filers unless they refile a 13D.
The security holder of more than 5% but less than 10% must file within 45 days after the end of the calendar year in which the Exchange Act registration becomes effective. If the security holder holds more than 10%, then the holder must file within 10 business days once the threshold is met.[1]
I am no expert....but doesn't form signal the current amount of shares held? After reading the form I see nothing that signals a specific reduction in position.
http://www.standardtrib.com/learn-why-cross-co-just-purchased-cv-sciences-inc-stake.html
Learn Why Cross & Co Just Purchased Cv Sciences, Inc Stake?
David Hannula | March 11, 2016
The New Cross & Co Holding in Cv Sciences, Inc
Cross & Co filed with the SEC SC 13G form for Cv Sciences, Inc. The form can be accessed here: 000114420416087594. As reported in Cross & Co’s form, the filler as of late owns 9.4% or 3,793,671 shares of the -company.
Cv Sciences, Inc stake is a new one for the and it was filed because of activity on July 21, 2015. We feel this shows Cross & Co’s positive view for the stock.
SEC Form 13G is required when the filer owns between (5% and 20%) of a company and plans to hold it only as a passive investor. In case the filler intend to exert control and the stake’s exceeds 20%, then 13D Form must be filed. These filings can NOT be a precursor to “change of control” events such as hostile takeovers, company breakups or others.
Where is proof of the dump you are referencing? Cross was buying as of early march and was holding 3.1 million shares. If the dump you are referencing is true.....the answer is simple. Stock gets sold for monetary gain. Happens all day long in every market world wide...no surprise. I am wondering when MJNA is going to dump some of there 4.9 million shares. If you need cash you sell...if the company is viable it will weather the storm.
Is Hemp CBD a Legitimate Ingredient of Dietary Supplements?
Is it time for the hemp CBD dietary supplements industry to
panic? Not at All, Say Insiders. This post from Nutritional
Outlook highlights the questions raised by FDA’s CBD warning
letters to some players of the dietary supplements industry.
When FDA sends a group of warning letters calling out a
particular dietary supplement ingredient, people tend to sit up
and take notice. But when that ingredient is as new, as trending,
and as controversial as hemp CBD, attention goes sky high.
On February 4, FDA issued warning letters to eight makers of
products being illegally sold as dietary supplements while making
disease-benefit claims. Some worry the agency is seeking to
exclude cannabidiol (CBD) from the definition of a legitimate
dietary supplement ingredient.
In a letter[1] to one of the companies, CBDy, FDA stated:
You should be aware that, based on available evidence, FDA has
concluded that CBD products are excluded from the dietary
supplement definition under section 201(ff)(3)(B)(ii) of the Act
[21 U.S.C. § 321(ff)(3)(B)(ii)]. Under that provision, if a
substance (such as CBD) 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. There is an exception if the substance was “marketed
as” a dietary supplement or 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 CBD.
This is the same language FDA used in a Q&A publication[2] the
agency first published on its website back in May 2015, titled
“FDA and Marijuana: Questions and Answers.” Buried within the
document’s information on marijuana was a short nod to questions
about CBD’s allowance as a dietary supplement ingredient.
FDA’s Issues with CBD Supplements
A recent spate of FDA warning letters does not mean the emerging
CBD dietary supplements market is in trouble, say insiders. But
it does raise some important questions about what’s fair in terms
of drugs versus supplements.
By stating it “has concluded that CBD products are excluded from
the dietary supplement definition,” FDA appears to clearly spell
out that, at this time, the agency does not consider CBD a
legitimate supplement ingredient. CBD holds neither Generally
Recognized as Safe (GRAS) status for use in food and beverages,
nor has anyone filed a notification with FDA for CBD as a new
dietary ingredient (NDI) for supplements.
For now, the crux of the agency’s CBD issue, based on FDA’s
statements, centers on two Investigational New Drug (IND)
applications that were filed by drug firm GW Pharmaceuticals for
its Sativex and Epidiolex CBD drug products. Per the Federal Food
Drug & Cosmetic Act (Section 201(ff)(3)(B)(ii)), if a drug
company, via an IND application, has said it is investigating an
ingredient as a drug, and if supplement marketers cannot prove
that the ingredient was sold as a dietary supplement prior to the
IND filing, then the ingredient is prohibited from being a
dietary supplement ingredient. FDA has said “the law is intended
to maintain incentives for companies to establish the clinical
safety and efficacy of drug products.” (The agency made this
statement following the 1997 case involving a red yeast rice
supplement, Cholestin, and a Merck drug, Mevicor, containing the
same active ingredient—a case that ultimately saw the Cholestin
supplement removed from the market.)
Supplement Ingredient Prior to IND?
The easy question to ask off the bat is whether there was ever a
CBD dietary supplement on the market before GW Pharmaceuticals
filed—and FDA accepted—its IND applications for Sativex and
Epidiolex. (The company was founded in 1998.) If proof exists, it
would seem simple enough for the supplement company selling the
product to step forward with the evidence. In its warning letter
to CBDy, FDA invited the company to “present the agency with any
evidence that has bearing on this issue” to show that CBD
supplements were on the market prior to the IND filing.
In a February 19 statement responding to FDA’s recent CBD warning
letters, the Hemp Industries Association (HIA) said, “It is the
position of the HIA that legal hemp products containing CBD were
marketed as foods and dietary supplements long before cannabidiol
formulations were submitted to FDA for testing as a ‘new drug.’”
Speaking to Nutritional Outlook, HIA’s executive director, Eric
Steenstra, says, “The FDA has not yet presented any evidence
regarding their claim [that CBD was not sold as a dietary
supplement or conventional food prior to GW Pharmaceuticals’ IND
applications]. We do believe that products containing CBD were
marketed and sold prior to any IND, and we intend to work with
industry members at the appropriate time to share the evidence.”
But finding the evidence is not as simple as it seems. For one
thing, FDA does not post publicly the date on which an IND
application was accepted. (A January 4, 2006, press release on GW
Pharmaceuticals’ own website announced that FDA had accepted the
IND application for Sativex.)[3] This makes determining an
official cut-off date to answer the “Which came first?” question
difficult.
Another controversy is whether GW Pharmaceuticals’ Sativex drug
can be considered comparable to any of the pure CBD oils sold by
the supplements industry because Sativex is a blend of both CBD
and another hemp cannabinoid, delta-9-tetrahydrocannabinol (THC).
CBD supplement companies selling purely CBD oils argue that these
products cannot be compared “apples to apples” with Sativex
because Sativex also contains THC. (GW Pharmaceuticals’ other
drug, Epidiolex, however, contains only CBD.)
“There are legitimate questions that can be raised,” says Michael
McGuffin, president of the American Herbal Products Association
(AHPA).
McGuffin acknowledges that GW Pharmaceuticals met the three
criteria it needed for an IND “that are described in the specific
provisions of the law: they had an IND, they had initiated
substantial clinical research, and they had said so publicly.”
But, he adds, “‘What was the article?’ has to be one question.”
(The Federal Food Drug & Cosmetic Act refers to an ingredient as
an “article.”)
“The provision of the law says that when [a drug company meets
all three criteria for the IND], then the drug industry, the drug
marketer, has exclusivity for that article,” McGuffin says. But
“what was Sativex? Sativex is a cannabis derivative that contains
a certain amount of THC and a certain amount of CBD.”
So, while supplement companies would not be able to sell this
combination of THC and CBD if the GW Pharmaceuticals IND holds
true, that doesn’t necessarily mean that supplement companies
wouldn’t be able to sell other cannabinoid products.
“What was the article that was protected by that provision?
What’s clear is supplement companies can’t sell that [Sativex]
article,” McGuffin says. But, he questions, “Is it also just as
clear that supplement companies can’t sell any of the
constituents contained in that article? If that is the case, or
if that’s FDA’s interpretation, then how well substantiated is
that interpretation?”
“I don’t think we can ignore it,” he says, continuing, “I don’t
have a contrary opinion as much as I think it’s a legitimate
question to ask whether FDA is correct in saying that because
Sativex and Epidiolex met the three IND criteria, that means that
[the dietary supplements industry] can’t market any of the
constituents in any of those drug products.”
One company raising these types of questions publicly is CBD oil
company CV Sciences Inc. (San Diego, CA), formerly known as
CannaVest Corp. The company has written a position paper
responding to the statements FDA made in the agency’s May 2015
marijuana Q&A posting. CV Sciences has been disseminating its
position response to its own contacts within the dietary
supplements industry. (The company says it has not, and does not
plan to, however, send the document directly to FDA.)
According to CV Sciences’ paper, “all requirements to consider
CBD under the IND preclusion regulations have not been adequately
conducted, thus furthering our opinion that CBD is not precluded
from the definition of a ‘dietary supplement.’” It continues, “it
is our opinion, which is broadly shared by the marketplace, that
CBD has been marketed as a dietary supplement prior to
commencement and public notice of any substantial clinical
investigations instituted on CBD, as the investigations that were
publicized were not substantial, due to being limited in number
and preliminary in nature, thereby rendering the IND preclusion
inapplicable.”
Speaking to Nutritional Outlook, Stuart Tomc, vice president,
human nutrition, for CV Sciences, says, “We’re going to argue the
idea of what is a substantial clinical investigation and when is
making it public. We’re going to take on the IND issue. If
someone’s going to have to lead this debate, it’s going to be us.”
At this point, it’s still worth noting that, to date, no CBD
supplement company has come forth with evidence showing that its
CBD supplement product was on the market prior to a CBD IND filed
by the drug industry. McGuffin says, “I’m not aware of anyone
having concluded that there either was or was not a CBD product
on the market prior to the GW date.”
Regardless, the fairness question raised by the IND provision
excluding supplements from the market troubles many.
“What the [FD&C Act] provision says, in summary, is that for any
article, if the drug industry gets there first, they get an
exclusivity,” McGuffin says. “And what they need to do to get
there is to say that they’re really interested in getting there.
They have to satisfy those three provisions. They don’t actually
have to be in the marketplace [selling product]. And if they
satisfy those three provisions, they get an exclusivity.”
He continues, “If the supplement industry gets to the marketplace
first, we can share the marketplace with the drug industry. So, a
basic fairness question arises: ‘Is that fair that the drug
industry gets exclusivity and we get a shared marketplace?’”
Consider, also, the long time it takes for a drug firm to get its
drug product to market. Merck, McGuffin says, took years,
possibly longer than a decade, to get to the marketplace with
Mevicor after the scientific publications on lovastatin, the
active ingredient in red yeast rice, appeared as far back as
1979. In the case of CBD, McGuffin points to a 1973 university-
researched article[4] on CBD for health benefits, titled “The
anticonvulsant activity of cannabidiol and cannabinol.”
Fast-forwarding to today, McGuffin says, “That’s 34 years of
publicly available information. Can one drug company now own
that? Is that okay?”
Instead, he says, “What if there was some kind of time
restriction? What if, for example, an additional criteria was
established that the drug industry has to establish those three
[IND] criteria within X years from the first publication of the
scientific research on that substance” in order to maintain its
market exclusivity?
“Let’s assume that we want rules that protect the research
interests of the drug industry,” he says. “But we also want rules
that protect consumer access to long-used ingredients. Do we want
to think about a revision to this provision in the law?”
Responsible Industry
Short of a revision to the law any time soon, CBD firms are
taking steps on their own to protect their industry—namely, by
ensuring they and their colleagues are marketing these products
lawfully and responsibly.
CV Sciences’ Tomc says he was “thrilled” to see FDA issue warning
letters to companies making illegal drug claims. “We were
thrilled that the warning letters went out, because these people
don’t understand the dietary supplement space [and] come from the
cannabis space or are entrepreneurs,” he says. “We actually think
these warning letters are great for the CBD market.”
“We implore, we beseech, all the other CBD companies to follow
the regulations of the FDA. We need to make sure that people
aren’t making medical claims because we’re not selling medicine,”
adds Sarah Syed, director of marketing, CV Sciences. “It’s a
challenge because the market is growing, but many people don’t
know what they’re doing wrong. They don’t know what they don’t
know, and they don’t know the regulations behind dietary
supplements and the health claims that you cannot make.” Syed and
Tomc point out the “variance” of companies in the market, which
includes larger, established firms like CV Sciences as well as
small start-ups and individuals growing their own cannabis.
Efforts are being made to bring the larger CBD market in line
with the regulations, including efforts by AHPA’s own Cannabis
Committee. The committee was formed five years ago when, McGuffin
says, “we saw this emerging marketplace and need of a forum and
community for the best companies to get together and discuss how
they could establish businesses with long-term marketplace
opportunity and not a short-term marketplace opportunity.”
Just last week, on February 19, the committee held a call with a
wide representation of CBD companies in the market. Tomc says,
“Here was the tone: Don’t make disease claims. If you are making
disease claims, hang up right now, fix it, and come back.” Tomc
says these types of calls “show the industry is being proactive.”
Industry Concern
Does the CBD industry at large worry that the recent FDA warning
letters threaten the future of the CBD supplements industry? Tomc
says no. He says that while FDA has “insinuated” that CBD may not
be a dietary supplement ingredient, he also points out that
warning letters only went to many of what he calls the “smaller
players” in the CBD market. “All the letters went to very small
players in the CBD space,” he says. “The larger players in this
space really have not received any warning letters.”
Does this mean only smaller companies have made disease claims?
Or does it mean that FDA, as a whole, has chosen not to actively
pursue the category unless companies are breaking the law? Has
the agency decided to leave the responsible CBD supplement market
alone until the case is settled as to whether or not CBD is a
legitimate supplement ingredient?
In the agency’s own words in its May 2015 Q&A piece, FDA did not
state that it is banning CBD. Instead, it said, “When a product
is in violation of the FD&C Act, FDA considers many factors in
deciding whether or not to initiate an enforcement action. Those
factors include, among other things, agency resources and the
threat to the public health. FDA also may consult with its
federal and state partners in making decisions about whether to
initiate a federal enforcement action.”
In terms of FDA pulling CBD supplements off shelves, Tomc says,
“We’re not there yet.” He adds, “There would have to be a trend
toward public harm. There is no trend toward public harm. The
amount of effort, the case that would have to be built—FDA is not
going into health food stores and telling people you cannot carry
these products. That’s not going to happen.”
He adds, “FDA did not say you can no longer sell this. There has
been no enforcement action. It’s all been Q&A posturing. Nothing
has happened yet. I think that’s important to remind everybody
about, because we still have the process of making the argument
to society in general and to regulators as to where this
ingredient is going to end up.”
In the meantime, Tomc says, CV Sciences’ goal is to continue
strengthening the science behind its ingredient. He says the
company has completed its own toxicological study that would be
the foundation of a GRAS self-affirmation. The data is now under
review.
Notably, Tomc says, it would be the first toxicological study
done “in the history of cannabis.” He says, “No one’s ever done
it for hemp, hemp protein, hemp meal, hemp seeds, hemp
oil—nothing cannabis-related has ever been tested to be safe.”
John Endres, ND, chief science officer for AIBMR Life Sciences
Inc. (Puyallup, WA), which specializes in GRAS services, says,
“As far as I know, there has been no GRAS self-determination
completed for any CBD-rich hemp oil.”
This would make CV Sciences’ data a landmark in the CBD
industry—and, indeed, the larger cannabis industry. Whether Tomc
thinks such data could cause FDA to see CBD in a new, positive
light, he says instead, “It could set a precedent that FDA may
adopt in deciding which suppliers they’ll allow on the market.”
“What we’re doing now is demonstrating that the ingredient we’re
bringing to market is safe and effective. And that’s our primary
responsibility,” he continues. “The indefensible position is the
lack of formal toxicological evidence of safety. I don’t blame
anybody for having questions about safety until you see the data.
That’s good, skeptical thinking.”
“Ingredients that are sold either for the addition to foods or as
dietary supplements need to demonstrate that they are safe for
consumption,” Endres says. “The CBD products that are on the
market are different in that some are much higher in CBD than
what is naturally occurring and therefore should be the subject
of rigorous toxicological assessments to determine what the safe
cumulative daily exposure is. The conclusions of such
toxicological studies are then used to support regulatory status
for the intended use of these products—GRAS for food ingredients
and NDI notifications for dietary ingredients/dietary
supplements.”
He concludes, “The completion and publication of safety studies
on a CBD-rich hemp oil product in a peer-reviewed academic
journal specializing in toxicology will be, to the best of my
knowledge, the first in recent times and a monumental step
forward in putting real science behind a product. I would have to
conclude that the public and the FDA should applaud this effort
as well as the time and expense it requires.”
CBD: Just the Beginning
In many ways, the challenges CBD faces are the growing pains that
any ingredient relatively new to the supplements market would
face, including carving out a place in the regulatory domain. The
demand for this ingredient is very high, according to CV
Sciences, with Tomc adding that many of the more than 500 stores
carring CV Sciences’ CBD oil products complain they can’t keep up
with the demand. As marijuana is increasingly legalized across
the country, the CBD industry is additionally challenged by
individuals and small companies wanting to participate in the
supplements market but not familiar with the regulations.
But, say individuals we spoke to, the bottom line is that there
are CBD companies looking to market products responsibly.
“Yes, I do believe there is a responsible center of the
cannabis/CBD/medical marijuana industry developing, and we’re
certainly working to keep them organized and informed,” AHPA’s
McGuffin says.
HIA’s Steenstra says, “HIA member companies are marketing CBD
responsibly, and none were sent letters. We believe that the vast
majority are in compliance with [the Dietary Supplement Health
and Education Act].”
As for CV Sciences, the company believes that one day, CBD
supplements and drugs will be able to live in harmony. In its
position letter, the company states, “Based on global demand for
hemp-derived CBD, a compromise will eventually be reached, with
artisanal hemp extracts sold in coexistence with pharmaceuticals,
as is the case with prescription omega-3 fish oils and
commercially available omega-3 offerings.”
“This isn’t the end of the CBD market,” Tomc says. “It’s just
getting started.”
It is the position of the HIA that legal hemp products containing CBD were marketed as foods and dietary supplements long before cannabidiol formulations were submitted to the FDA for testing as a ‘new drug.’ As such, CBD products are exempt from laws that preclude CBDs from product status as dietary supplements pending ‘new drug’ approval by the FDA. Though none of the companies in receipt of these warning letters are current or former HIA members, the HIA urges these CBD product manufacturers to revise their product labeling and marketing such that no medical claims are made.
“There is great potential for the CBD market to expand in the U.S., but we need to move forward as an industry on a path that defines cannabidiol products as dietary supplements, much like multi-vitamins and herbal products,” said Eric Steenstra, Executive Director of the Hemp Industries Association.
Unlike FDA approved pharmaceutical drugs, which are new compounds developed and patented by drug companies and go through rigorous clinical trials before reaching the market, and can only be administered with a prescription; cannabidiol is a botanically derived, floral extract that exists organically in nature. The Dietary Supplement Health and Education Act of 1994 explicitly defines ‘supplements’ as an extract of a botanical. As such, the HIA maintains that CBD products are indeed supplements, and that attempts by the FDA, or other agencies, to discourage lawful manufacturing and marketing of these products demonstrates unjust bias toward the hemp industry.
Much better article explaining the current legal status and battle between the FDA and the CBD Industry:
http://www.thecannabisadvisory.com/cbd_news/hemp-cbd-dietary-supplements/
MUST READ
Big pharma wants to sell their own and control the market.
The real drug dealers want a piece of the action!
The FDA has begun two promising trials of CBD formulations: GW Pharmaceuticals’ Sativex and Epidiolex. Both pharmaceutical tinctures contain CBD isolated from medical cannabis plants.
Interesting correlation: We know that CBD import into New Zealand was allowed (even though not 100% legal) for quite some time. It was helping many people. Suddenly, import of CBD product was getting seized by the customs. Some might say the protection agencies just caught on. But there is an interesting coincidence of GW Pharmaceutical CBD launching at this exact time.
Recently more letters were sent to companies selling CBD and making claims. While we respect that law, we find it absolutely absurd to be prevented from sharing REAL success stories.
It’s important to remember there is no cure all. This substance and all others work depending on your personal biological DNA. For some it will be a miracle, for others nothing will happen.
But this isn’t an article about effectiveness so I’ll digress.
Hemp Industries Association (HIA), the non-profit North American hemp trade association, has published its statement in response to recent warning letters sent by the FDA to manufacturers of CBD products, regarding mis-labeling of drug claims on said products. Available on the FDA website, the letters explain that per the Federal Food, Drug and Cosmetics Act, CBD products may not be marketed as drugs, meaning manufacturers cannot make claims regarding CBD products’ efficacy in the cure, mitigation, treatment or prevention of disease. Furthermore, the FDA asserts that cannabidiol products may not be marketed as supplements, because ‘new drug’ consideration is currently pending for CBD. To view these letters in their entirety, dated February 4, 2016, please visit: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/#browse.
It is the position of the HIA that legal hemp products containing CBD were marketed as foods and dietary supplements long before cannabidiol formulations were submitted to the FDA for testing as a ‘new drug.’ As such, CBD products are exempt from laws that preclude CBDs from product status as dietary supplements pending ‘new drug’ approval by the FDA.
Though none of the companies in receipt of these warning letters are current or former HIA members, the HIA urges these CBD product manufacturers to revise their product labeling and marketing such that no medical claims are made.
“There is great potential for the CBD market to expand in the U.S., but we need to move forward as an industry on a path that defines cannabidiol products as dietary supplements, much like multi-vitamins and herbal products,” said Eric Steenstra, Executive Director of the Hemp Industries Association.
Unlike FDA approved pharmaceutical drugs, which are new compounds developed and patented by drug companies and go through rigorous clinical trials before reaching the market, and can only be administered with a prescription; cannabidiol is a botanically derived, floral extract that exists organically in nature.
The Dietary Supplement Health and Education Act of 1994 explicitly defines ‘supplements’ as an extract of a botanical. As such, the HIA maintains that CBD products are indeed supplements, and that attempts by the FDA, or other agencies, to discourage lawful manufacturing and marketing of these products demonstrates unjust bias toward the hemp industry.
I have been amazed at the activity of CV Sciences. I have never seen a penney company defend against dilution ever.....I have traded hundreds of penney stocks over the last 20 years. Mostly they are pump and dump and dilute. I am in shock....this might actually be a real company that makes it to the NAS... I am using the PlusCBD oil for insomnia and back and joint pain. Fantastic stuff, I just ordered more today. I bought the first bottle from them which was the spray and was upset that the shipping was so high. I complained that you can't see the shipping cost before you pay. I wrote them about this issue and suggested they change immediately. By the next order I found the shipping automatically computed in the total cost before payment with a credit card. Packing was overkill to say the least. A little bottle in a good size box with lots of packing and quickly delivered within days. I bought 25000 shares at .11 .12 area. Long and strong....good luck all.