Browsed by
Category: Medical Marijuana and CBD

The Feds Send Some Love Letters to CBD Companies

The Feds Send Some Love Letters to CBD Companies

CBD is the new gold rush in complementary and integrative health. It’s everywhere. But while CBD based products may be legal federally, they are obviously not approved drugs, and are at best regarded as dietary supplements. As such, no medical claims can be made. But legal technicalities have not stopped the CBD companies from marketing their products as miracle cures for all things pain related and more.

And therein lies the problem according to the feds.

Two days ago there was a joint FDA and FTC announcement of warning letters being issued to four CBD manufacturers who made disease or cure claims. Here is the press release.

One of the companies was selling a CBD based product for dogs. Lucky them.

Here is the warning letter to that company which lays out the standard FDA/FTC litany of violations for false and unsubstantiated advertising and the unapproved new drug mantra.

The warning letter is instructive for companies to see what’s not allowed to be claimed (and not much is allowed).

CBD is now on the fed’s radar screen for medical and disease claims, so CBD manufacturers should be careful.

Rick Jaffe, Esq.

Do you have ED? (not the guy thing, but rather endocannabinoid deficiency)

Do you have ED? (not the guy thing, but rather endocannabinoid deficiency)

The absolute best part of my job is that I get to work on really interesting medico legal issues, interact with very smart experts who know their stuff.
In July, I tried a California medical board case for a doctor who recommended medical marijuana to five-year-old who was having severe mood disorder problems at home and school. The doc saw the patient back in 2012, before the CBD oil explosion, and it was also back when the closest diagnosis for this kind of behavior was ADHD/bipolar, even though bipolar wasn’t normally diagnosed in children that young. In part based on the recognition of this diagnositic conundrum, and other similar problems, in 2015 the American Psychiatric Association in the DSM-V made up a new label for kids who had chronic or episodic mood disorder, and named it disruptive mood dysfunction disorder (DMDD). But that’s not the interesting part.

One of our experts was a leading practitioner/expert on medical marijuana, Jeff Hergenrather, who is the head of the California medical marijuana physician group, a researcher, extremely knowledgeable on the subject, and an all-around good guy.

The Board’s experts testified about all the harm that marijuana could cause children. In many of my cases, I use what I call a fractal defense, meaning, I go a quantum level deeper than the other side, like a different fractal level of magnification. I felt this would be a good case to go deep, so I had Jeff explain to the judge the endocannabinoid system and how it functions. I thought it was incredibly interesting, important, and it’s something which most layman and even most conventional physicians don’t know anything about. So I thought it was worthy of a post.

I can’t put it any better than Jeff did in his testimony, so for all those wondering whether they have any ED (endocannabinoid deficiency) disorder, here’s what it is:

Q Doctor, in your opinion, based on your years of experience using cannabis, is it generally a safe medication?
A Yes. It is remarkably safe.
Q What kind of information or explanation would you need to give to the Court in order to explain your opinion that cannabis is a generally safe medication? What type of explanation, I’m asking.
A I would want the Court to understand that this is a — cannabis works in our bodies in a system in the body, augmenting a natural system that’s already there.
Q What’s that system called?
A That system is called the endocannabinoid system.
Q What is the function of the endocannabinoid system? And you’re saying in humans?
A Well, it’s not only in humans. The endocannabinoid system is seen throughout the animal kingdom, so it’s seen — probably excluding insects, but it’s seen all the way into the oceans, in primitive creatures, hydra, sea squirts, and when you look at the genes of these animals, you can see that they have an endocannabinoid system. The system is there to bring the body into balance, to modulate the body, to help it to come into balance. So it’s really what fits the word homeostasis. The endocannabinoid system brings us into homeostasis.

Q What are the components of that system, physiologically?
A It’s based on a receptor, which is like a socket, and molecules that fit in that socket called the endocannabinoids. So these are small molecules that fit into the protein receptors. These receptors reside in two areas of the body. One is in the brain and in the nervous system and the other is in the immune system. So wherever they are in the body and in the — in the brain and in the immune system, they modulate the way that these systems work.
Q “Systems” meaning what system?
A The nervous system and the immune system. They modulate the way these systems work in the bodies, so they bring them into balance. Otherwise, the body would tend to go haywire, literally, overactivated if you get nervous, and the nerves can’t turn off again. Then you burn up nerves. You literally damage the nerves. So the endocannabinoid system is there to protect the body, to protect the brain, and to protect and modulate the way the immune system works as well.
So it’s a very key system. It’s been evolving along for — it’s thought to be for 600 million years along with the evolution of all these sea creatures through the animal kingdom, the amphibians, and the reptiles and the mammals. We see this system in these animals and we know that the natural cannabinoids are responsible for bringing that system, that body, back into balance.
So its main roles are to help us eat and to sleep and to relax, which is both mental and physically relaxing, and to forget in a helpful kind of a way, but it does have a role in helping forget or — I’ll talk more about that — and to protect, and the protective role is very interesting because there are mobile endocannabinoids in this immune system that are circulating cells and they are going around the body looking for problems, either abnormal cells or cells that are cancerous, and when they come upon them, they program the cell death of those cells and rid them from the body. So they’re key to the health of an organism of a human, to have a healthy endocannabinoid system working in the body.

Q And from your answer, just to be clear, because this is like a physiology thing, the body — you’re implying that the body produces these endocannabinoids?
A That’s correct. These are molecules that are mimicked by the cannabis molecules, so we know of THC and CBD. There’s some molecules we hear about in the press. There are actually over a hundred cannabinoids in the cannabis plant and these cannabinoids are uniquely similar, almost identical, in shape to the natural endocannabinoids.
Q Produced by the body?
A Produced by the body. They’re produced on demand as a response to a stress, as a response to something needing correcting. And so the natural cannabinoids are produced, they activate the receptors, they bring the body back into balance, and then they’re broken down again.
So here’s cannabis that comes along. The same shape molecule from the cannabis plant fits into these receptors and in being there, in activating these receptors, we’re augmenting the natural cannabinoid tone of the body and in this way we’re helping the body to come back into balance.
Q What you call homeostasis?
A What I would call homeostasis.
Q Why — if the body produces these natural cannabinoids that fit these receptors, why would you ever need to what you call augment the system?
A Perfect question. The reason is that not all receptors are the same. The cannabinoids are the same we think between all animals and humans, but these receptors are a little bit different. The ones in the brain are 472 amino acids long. It clumps into a socket. The ones in the circulating cells are 360 amino acids long, a little shorter, but they’re the mobile ones and they go floating around the body in the bloodstream.
So these receptors, with one change of an amino acid, you can measure that this endocannabinoid system isn’t working as well. So many human conditions are now being recognized as endocannabinoid deficiency syndromes.
Q Really? Like what? What kind of conditions now do you think are —
A Migraine, fibromyalgia, M.S., mood disorders.

Q How are they recognized? Because that’s relevant to our case. Talk about how mood disorders are now becoming recognized as an endocannabinoid —
A Deficiency.
Q — deficiency.
A This is simply because we can see in the genes that these are not the same from person to person. There was a clever test done by a Japanese researcher called Matsunaga a few years ago and he looked at — he tested people for happiness and he gave them a questionnaire and those that tested very happy in their outlook on life, he looked at their genes and they all have the same endocannabinoid genes, a similar polymorphism, a similar shape of their cannabinoid receptor.
Similarly, we’re able to look at the genes with people with depression or other mood disorders and these other diseases that I’ve spoken of and many, many others and we can see schizophrenia as well is one of those conditions considered to be an endocannabinoid deficiency.
So by augmenting the natural system, we’re basically helping the body to bring itself back into homeostasis where it’s having a hard time doing it with its natural receptor and cannabinoids.

Q Okay. So let’s tie this in. How does that explanation of our endocannabinoid system and the lock and key, how does that help the Court understand your testimony about why cannabis is a relatively safe drug? So tie it up and then we’ll move on, because I’m sure the judge is going to want to move on.
A Sure. Well, we’re looking at — we have a situation here where the body is in need of coming in to balance and so in mood disorders and anxiety disorder, it just — a person tends to be anxious. In PTSD, you tend to dwell on aversive memories; in depression and so forth, there’s a tendency in various mood disorders to not be able to really recover very well and so we see family histories of mood disorders. The same family will have depressive disorders. The same family will have anxiety disorders or bipolar disorders and so forth.
We see that in the families and now we’re actually able to look at the genes of these people and understand this in a different way, in a better way. So these molecules and cannabis mimicking the natural cannabinoids are, in fact, bringing us into balance and helping to cure these — not cure, but to pharmacologically improve the situation for these — for these individuals, and we really — the clinicians doing cannabis medicine see this every day and it’s very impressive to be able to use cannabinoids and modulate these diseases and bring them into control with an herb.
So it’s rather remarkable. These aren’t synthetic molecules which have proven to be dangerous. They’re plant cannabinoids. They’ve evolved along for -¬the cannabis plant has supposedly been on earth for 60 million years. It’s been around and been used by human beings for probably 100,000 years, maybe 5,000 where we actually have evidence of it in the literature, but this plant has been used for many, many years, eons as far as a plant that seems to have gained a great deal of use and a degree of safety that is rather remarkable.
It’s only in the synthetic molecules that are manufactured that we actually see problems where people get into trouble and even have died with synthetic molecules.

Q Does this explanation shed any — do you have an opinion as to whether medical marijuana cannabis is safer than psychoactive drugs or is that a reasonable question?
A It is a reasonable question and, quite honestly, I have people coming to me because they have tried conventional drugs and the side effects have just been horrible and they don’t want to continue use of those drugs.
Q Okay. I’m going to ask a more refined question now, is there something in the explanation in terms of the biochemistry that you just explained that would lead you to conclude why cannabinoids natural would be inherently safer than antipsychotics or stimulants or Ritalin? I mean, what about your explanation might help explain the fact that — I don’t know — an earlier witness said that it’s a safer drug than some of the other antipsychotics, because now we can get to the biochemistry as you explained and tie it in all together, briefly, very briefly.
THE COURT: Can you do that?
THE WITNESS: I think I can do that.
THE COURT: All right.
THE WITNESS: Well, from the side of the question of
pharmacologic drugs that are very commonly used, many of them, especially in the antipsychotic division of these drugs, have boxed warnings on the drugs.
Q Black box, you mean?
A Black box warnings. They are in some cases dangerous drugs that may result in deaths and that’s why the black box warning is there. These are drugs that commonly have fairly significant side effects. They’re not tolerated by people very well and at least in my patient population, which is to some degree self-selected because they want to come and see if cannabis will work, they’ve tried conventional drugs and they’re not working. They are looking to cannabis to see if this herbal medicine can modulate their mood disorder, their mental disorder, and keep them from needing conventional drugs.
And quite honestly, this is a mix in my practice. Some people use cannabis only, quite successfully, and other people rely on both cannabis and conventional drugs to be able to maintain a good mental health. So it’s not necessarily going to work in everybody. Some people don’t like the feeling of using cannabis as a medicine, so they’ll move along and try something else.

Q Okay. And unless there’s some other thing I missed about the biochemistry in all this stuff, I’m going to move on. Do you think I’m —
A Briefly, we all hear about neurotransmitters such as dopamine and serotonin and adrenalin. These are common neurotransmitters in the brain. What the cannabinoids are doing is they’re modulating all of the neurotransmitter systems in the brain. They’re there as a retrograde messenger in the synapses of the brain to calm the system down.
So if in — let’s say in an anxiety, for example, if the nerve impulses are firing away and you’re very anxious, cannabinoids have an ability to turn this neurotransmitter down or off to where it relieves the anxiety or whatever the problem is. It can be a movement disorder where dopamine is involved. It can be a mood disorder where serotonin is involved. It can be an anxiety neurotransmitter where adrenalin might be involved. In any of these neurotransmitters, the cannabinoids are there to modulate the way the brain works and so it’s good across the spectrum of many diseases as an effective and safe medicine.
Q And does that, what you’re talking about, have anything — make it more or less likely that the cannabis would alter the brain chemistry or the personality of the patient? Is that a relevant — is that related in any way?
A Well, it is related but in a way that I think I should make a comment about because since we know that these cannabinoids in the plant can turn the brain down a notch to bring it into balance to down-regulate it to reduce the neurotransmission, it has an effect on the brain.
Q Okay.
A There’s no question about that. It does alter the brain while those molecules are active in the system and once they’re metabolized — in the case of most of these molecules, they’re largely metabolized when they’re inhaled over the course of three hours and when they’re ingested, they’re metabolized over the period of about eight to ten hours — and then the effects may linger for a few more hours or even a few more days before they’ve finally worn off, but then the brain goes back to its natural state, unaltered, by having had these plant cannabinoids.

Q Okay. Let’s zoom in now on that issue but on kids because the patient in this case was a child and there’s been discussion about how this cannabis can harm the patient. Let’s continue just on the biochem- — the physiology and biology and the receptors. What effect -¬how does — is there increased risk of harm in cannabis in light of the fact that it’s a child and, if so, what’s the harm or what’s the reason there is no harm? Because that’s really what we’re talking about in this case, because there’s been testimony about some of these issues.
A I see. Well, in a word, it is not a harmful substance. Just in a one phrase, it is not a harmful substance. Granted, it’s not for everybody, but it does not harm the brain. It alters the brain while the active molecules are there, but it doesn’t harm anything.
Q How about in kids? What’s the basis, a biological basis, of you’re thinking it wouldn’t harm kids? Doesn’t it kill receptors or something like that?
A No, it actually doesn’t. It does articulate with the receptor. It activates the receptor. It increases the natural cannabinoids to work better for the
Q Do children have as many of these receptors, these ethno — endocannabinoids?
A They’re born with fewer —
Q Do children have as many of these receptors, endocannabinoids receptors?
A They’re born with fewer and through the earlier years of life, these cannabinoid receptors in the brain increase in population. When we use cannabis as medicine, this population of receptors diminishes in response to having this added load of natural — of plant cannabinoid.
Q Isn’t that a bad thing?
A No, because the cannabinoids that are there as plant cannabinoids and natural cannabinoids are providing a better ability to respond to whatever the stress is.”

I think this is pretty interesting stuff, especially considering all the kids who are being diagnosed with hyperactivity and more serious emotional/behavioral problems. I hope the explosive growth in the CBD field leads to research or at least publication of case studies of kids successfully treated with CBD or cannabis for their serious behavioral issues. Imagine a world without having millions of kids on Ritalin and other similar drugs.

Rick Jaffe, Esq.

Ohio Takes Action against the CBD Industry

Ohio Takes Action against the CBD Industry

The Ohio Board of Pharmacy has just passed a regulation that CBD products can only be sold in state licensed dispensaries.
Here is the new regulation.

Although around 50 licenses have been issued, currently there are no dispensaries in operation and it is estimated that it will take many months before the dispensaries pass the necessary inspections to operate. So what happens until the dispensaries open? Here’s what the board says:

“Until dispensaries are operational, no one, including board licensees, may possess or sell CBD oil or other marijuana related products. Violation of Ohio Revised Code or Ohio Administrative Code can subject a licensee (person or entity) to administrative or criminal action.” Gulp!

And just to remind you. CBD is still illegal under federal law and can’t be sold as a dietary supplement in interstate commerce. My earlier post on CBD discussed the federal status. Here it is:

Still not convinced? here are two Q&A’s from the FDA’s website page on marijuana:

“2. Can products that contain THC or cannabidiol (CBD) be sold as dietary supplements?
A. No. Based on available evidence, FDA has concluded that THC and CBD products are excluded from the dietary supplement definition under sections 201(ff)(3)(B)(i) and (ii) of the FD&C Act, respectively. Under those provisions, if a substance (such as THC or CBD) is an active ingredient in a drug product that has been approved under 21 U.S.C. § 355 (section 505 of the FD&C Act), or 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 “authorized for investigation as a new drug” if it is the subject of an Investigational New Drug application (IND) that has gone into effect. Under FDA’s 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 sections 201(ff)(3)(B)(i) and (ii) if the substance was “marketed as” a dietary supplement or as a conventional food before the drug was approved or before the new drug investigations were authorized, as applicable. However, based on available evidence, FDA has concluded that this is not the case for THC or CBD. For more information on this provision, including an explanation of the phrase “marketed as,” see Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues.
FDA is not aware of any evidence that would call into question its current conclusions that THC and CBD products are excluded from the dietary supplement definition under sections 201(ff)(3)(B)(i) and (ii) of the FD&C Act. Interested parties may present the agency with any evidence that they think has bearing on this issue. Our continuing review of information that has been submitted thus far has not called our conclusions into question.

13. Is it legal, in interstate commerce, to sell a food to which THC or CBD has been added?
A. 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 substance which is an active ingredient in a drug product that has been approved under 21 U.S.C. § 355 (section 505 of the Act) or 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 the drug was approved or before the 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 THC or CBD. 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 THC or CBD has been added. FDA is not aware of any evidence that would call into question these conclusions. Interested parties may present the agency with any evidence that they think has bearing on this issue. Our continuing review of information that has been submitted thus far has not called our conclusions into question.”

Translation: CBD is not a dietary supplement, it’s a schedule I drug. And that’s regardless of the oft asserted but incorrect safe harbor of less than .3 percent THC.

I’m sure you’ve noted that the FDA treats THC and CBD as the same, at least from a regulatory point of view, them both being illegal.
That’s what I’ve been telling people in my post and verbally, that the THC content is irrelevant in determining whether the product is legal. It’s just about what part of the plant is used as I explained in my prior post.

The good news: Neither the DEA nor the FDA seem to be in a particular hurry to stop companies from selling CBD oil or people using it.
One partial reason for this might be that the FDA has just approved a purified CBD oil product called, Epidiolex, for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients 2 years of age and older.

In the short term, I don’t think much will change, and the companies will still push out huge quanities of CBD products, but maybe not so much in Ohio. It will be interesting to see what kind of enforcement action is taken. I suspect the Ohio Board of Pharmacy has limited resources, so if anything will be done, I would expect it would come from the AG’s office, as it has a bigger stick and more resources.

Rick Jaffe, Esq.

Can a doctor recommend medical marijuana for a five-year-old in California?

Can a doctor recommend medical marijuana for a five-year-old in California?

That’s the question that will be answered in a California medical board case I am trying this week in downtown Los Angeles.

Back in 1996, California became the first state to allow for a doctor to recommend medical marijuana for patients with serious medical conditions. There was a lot of confusion initially as to what was required to issue the recommendation without getting into board trouble. The California law (called prop 215) by its terms granted physicians immunity from prosecution or even investigation based on their writing a medical marijuana recommendations. (Because it is a schedule I drug, it can’t be technically “prescribed.”).

Notwithstanding the immunity, doctors were prosecuted by the board for writing these recommendations. The administrative law judges, the medical board and the courts allowed for these prosecutions on the theory that if a doctor doesn’t follow standard medical procedure in making the recommendation, he or she is subject to discipline. To some it’s a very subtle distinction, but it does reflect the state of the law in California. Basically a physician has to go through the same kind of analysis and procedure to make the recommendation as he/she would for any other therapeutic recommendation. That means, a history and physical appropriate to the mental condition, informed consent, a treatment plan, follow up, and adequate medical records. Presumably, if the doctor does all that, then theoretically he or she shouldn’t be prosecuted or investigated, just because the treatment recommendation was medical marijuana.

Here are the facts of the case being tried this week

A father brings his son to see the physician. The father is a long-standing patient and has a prop 215 medical marijuana letter from the physician. He explains that the school has told him that his child is so disruptive they’re not going to let him back unless he’s put on medication. He is also disruptive at home. The physician examines the child, obtains history from the father, and observes the child for around 20 minutes, and then agrees to write the recommendation. The father signs a detailed informed consent, and the physician has typed medical record evidencing the history and exam, and states as the diagnosis probable bipolar/ADHD. (back in 2012 they didn’t have any better diagnostics possibilities)

The parents give the kid a small cookie with some marijuana in it before school each day.

miracle of miracles, the child is no longer disruptive in class and he becomes a model student. But it wears off towards the end of the day, so the school requests that the child receive a second dose after lunch.

The rub

The school doesn’t know the kid is on MM. The father naively goes to school and gives the teacher a MM cookie and asks that it be given to his child.

You guessed it!

The school freaks out, call the sheriff’s department, which opens up a criminal investigation of the father. It also calls CPS (child protection service) which obtains a temporary removal order for all four kids. The mother then takes the kids out of state, and the sheriff’s office pursues criminal charges against the father. The father sues back. Eventually, the family returns, the CPS order is dropped, and the father settles with his prosecutors. But there was a lot of collateral damage. The parents get divorced. The child has to be involuntarily committed for a few days because of rage and aggression (he hasn’t been on MM since it was originally given to him several years before his commitment), and he’s diagnosed with a newly established medical condition. All the kids and the father now live with his parents. The father is now being prosecuted for cultivation. The child is still on bad shape because the parents are refusing Ritalin or other drug therapy, and the doctor won’t write another MM recommendation.
(And by the way, the cops file a complaint against the doctor with the medical board.)

Those are some tough facts. Our experts think that all this harm was caused by the overreaction of the authorities. The Board of course blames the doctor. Neither of the Board’s experts appear to have any experience with small children (they are family practitioners) and neither think MM should be used for anything, because of insufficient peer review literature support.

We one of the country’s leading MM experts, Jeff Hergenrather, M.D. and a physician who ran the UC PACE program for physician training and rehabilitation. Doesn’t seem like a close case expert-wise.

There’s also the little matter that the case may have been filed 8 days after the statute of limitations expired. In fairness, I did spend some time resisting providing medical records (like over two years), but the statute of limitations is a harsh mistress.

Anyway, it should be an interesting case. If any of my friends happen to be in downtown LA this week, stop by: Office of Administrative Hearings, 320 West Fourth Street, Suite 630; Tomorrow (Wednesday) through Friday.

I’ll bring the popcorn!

Rick Jaffe, Esq.

Is CBD Oil Legal?

Is CBD Oil Legal?

The CBD oil business has exploded in the last couple of years. I was at an integrative medical conference in New York City back in February and I asked a few CBD oil vendors whether their product was legal. They all assured me that their product was legal, some claiming that it was legal because it contained less than 0.3 percent THC, while others said it was legal because it contained no THC. That didn’t sound right to me. I have a friend who distributes CBD oil and I recall looking into the legality a year or two ago, and I recall the feds did something or other which got the CBD oil and hemp industry up in-arms, and I also recalled that two California counties shut down prominent CBD oil manufacturers. At the conference several of my practitioner friends asked my opinion about using it in their practices and/or distributing it. So I decided to take a harder look at it.

Note that there is some biological confusion in the regulatory field because both legal hemp and illegal marijuana carry the same plant nomenclature, (Cannabis sativa L.) As I understand it, the difference between the two is a result of breeding and the use the male, non-flowering plants (for hemp) and female flowering plants for marijuana.

The Regulators

The DEA (drug enforcement agency) regulates narcotic drugs and other dangerous or addictive drugs. The primary statute is the Controlled Substances Act (“CSA”). The CSA and its implementing regulations create five categories or schedules of drugs, roughly corresponding to the level of addiction potential. Drugs available for prescription are listed in schedules 2 through 5. (the statute uses roman numeral designations) Schedule 1 is reserved for drugs with supposedly no medical value whatsoever, like heroin, LSD and marijuana. Schedule 1 drugs are illegal to sell or use, at least under federal law.

As you know, many states have laws on marijuana and some also specifically regulate CBD oil. However, technically, federal law preempts state law on these drug issues, though there have been few or no recent federal enforcement actions challenging state marijuana laws.

So what is Marijuana under the CSA?

According to Section 802 (16) of the CSA:

“The term “marihuana” means all parts of the plant Cannabis sativa L., whether growing or not; the seeds thereof; the resin extracted from any part of such plant; and every compound, manufacture, salt, derivative, mixture, or preparation of such plant, its seeds or resin.

Such term does not include the mature stalks of such plant, fiber produced from such stalks, oil or cake made from the seeds of such plant, any other compound, manufacture, salt, derivative, mixture, or preparation of such mature stalks (except the resin extracted therefrom), fiber, oil, or cake, or the sterilized seed of such plant which is incapable of germination.”

Marihuana is a schedule 1 drug. However, if the cannabis product is made from the mature stalks, fiber, oil or cake made the seeds of such plant … then it’s not marihuana and is not an illegal schedule 1 drug.

The DEA has issued several clarifications basically saying that CBD oil which is made from the flowering and other parts of the Cannabis sativa L plant is included in the definition of Marihuana, so it is a schedule 1 drug.

So what’s all this talk about .3% or no THC?

Some countries use the amount of THC to distinguish between legal hemp and illegal marijuana.

In the U.S., the .03 percent THC cut-off is only used in a recent farm bill for hemp. The bill basically defines hemp as a cannabis product which has less than .3% THC.

However, the bill and its hemp definition doesn’t overrule or modify the definition of marihuana in the CSA, and the bill only applies to agriculture research into what is called hemp in the bill.

Here is the law.

So anyone who is telling you that their CBD oil is legal because it contains less than .3% THC or no THC, is confused or misleading you.

As shown above, it’s not how much THC is in the product, it’s the source of the product; i.e. the part of the plant used which determines whether the product is illegal marijuana or a legal hemp based product.

What about some federal lawsuit by the Hemp Association? Didn’t that make it legal?

Short answer no. The Hemp Association, filed a federal lawsuit last year, Hemp Industries Association, et al, vs DEA, et al, challenging some abstruse classification issues creating a marijuana extract classification for international reporting purposes. The Hemp group claimed that it effected a reclassification of things like CBD oil from legal to illegal. The DEA argued that CBD oil has always been illegal, as evidenced by its recent clarifications to the public. I read the briefs and even listened to the oral arguments. I thought the case was a loser. The 9th Circuit recently denied the Hemp group’s petition.

So federally it’s simple, isn’t it?

If the product you’re selling or using is coming from the stalks, oils . . . it’s legal, otherwise it’s not. At least according to the DEA and under federal law, which the federal government believes supercedes or preempts state law to the contrary.

What can change things?

The good news is that the CBD oil proponents haven’t been sitting on their thumbs. In late April 2018, a new hemp farming bill was introduced in Congress. Here it is:

It would do what the old farm bill didn’t actually do, namely set the threshold of legality of cannabis products at the .3% of THC. Meaning, irrespective of the part of the plant being used, if the product has less than .3% THC, it’s not a schedule 1 drug and is legal.
We’ll see how far the bill goes.

What else is in the horizon?

Pres. Trump is making noises about legalizing marijuana. That might make the farm bill moot, since if marijuana isn’t a schedule 1 drug, well that would make a lot of people happy and should resolve the CBD oil legal problem.

(Complicating things is the fact that CDB oil is illegal in some states, so you’ve got the whole federal vs. state thing in reverse if the feds make marijuana legal.)

So what does that all mean to the practitioners and resellers of CBD oil?

Good question; see the sequel to this post anon.

Rick Jaffe, Esq.