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by Joseph Mercola
April 22,
2018
from
Mercola Website
Story at-a-glance
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CBD is the non-psychoactive component of cannabis and
hemp. Unlike the THC in cannabis, CBD does not
induce a high, but has many clinical benefits,
including the control of seizures and pain
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Federal drug laws stipulate cannabis is an illegal
Class 1 narcotic; in states where cannabis has been
legalized, buyers and sellers of cannabis rely on
federal authorities not enforcing federal drug law
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The U.S. Drug Enforcement Agency (DEA) considers CBD
to be cannabis and has scheduled it as a Class 1
narcotic. Hemp growers have sued DEA to deschedule
CBD. The case is currently pending before the Ninth
Circuit of Appeals
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There's a limited time left for CBD companies to
petition FDA to market CBD as a dietary ingredient.
Once FDA approves
GW Pharmaceuticals' CBD medicine
as a new drug, CBD can no longer be legally sold or
marketed as a supplement
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FDA has issued a draft document in which they state
they intend to exercise enforcement discretion on
homeopathic products, but made it clear they believe
homeopathic medicines are unapproved new drugs
Todd Harrison is a partner in the legal firm, Venable LLP -
one of the "white hat" legal firms that helps defend us and many
other companies against overreaches by federal regulatory agencies
such as the U.S. Food and Drug Administration (FDA) and Federal
Trade Commission (FTC).
In this interview, he
discusses the latest legal developments involving
cannabidiol (CBD)
and
homeopathy, both of which have come under recent serious attack.
Venable is a full-service law firm founded in Baltimore City in the
1800s. In the 1980s, the firm decided to develop a regulatory
practice, which led to the opening of a Washington D.C. office.
In the 2000s, offices
were added in Los Angeles, New York and San Francisco. "We do
everything from intellectual property work to contracts and
distribution agreements, to general corporate work," Harrison says.
Harrison's expertise is Food and Drug Law and advertising law, and
many of his clients are companies that market nutritional
supplements and cosmetics.
Venable also has a number
of lawyers who used to work for federal regulatory agencies and have
had an inside view of their workings.
"For instance, in our
New York office, we have Leonard Gordon [who] came out of the
FTC.
He was an East Coast
regional director of the FTC. We recently brought in Michael
Bloom, who was at the U.S. Department of Justice (DOJ).
While at DOJ, he
oversaw not only FDA cases but also the FTC cases."
Legal Update
on CBD Oil
Cannabidiol (CBD) is the non-psychoactive component of cannabis.
Unlike
tetrahydrocannabinol (THC), it doesn't induce a "high," but has many
clinical benefits, including the control of seizures and pain. With
projections suggesting somewhere between 50,000 and 60,000 Americans
will die from
opioid overdoses this year, we are
in dire need of nontoxic pain relief.
CBD oil is one of them. Unfortunately, cannabis is classified as a
Class 1 narcotic, which makes the legalities surrounding CBD a bit
more complex.
Harrison explains:
"What people should
realize is that cannabis and hemp are the same plant.
It's just
the amount of THC that's in that plant. The status of cannabis
is quite clear. Under federal law, it's a controlled substance.
It cannot be marketed. It cannot be sold. That's regardless of
what the states have done...
[T]he federal government [could]
clamp down on the states that have legalized cannabis and take
action against individuals in those states.
In states where they've legalized [cannabis], it really depends
upon the good will of the federal government not to enforce the
U.S. drug laws. CBD is a different issue.
It's kind of a complex
issue. CBD is part of the hemp plant. It could also be part of
the marijuana plant. It generally comes from the resin of the
plant. CBD is considered... by the Drug Enforcement
Administration (DEA), to be a controlled substance. It's
considered to be marijuana.
There is a case now pending before the Ninth Circuit of Appeals.
Oral hearings were... on whether DEA's scheduling of [CBD] is
appropriate. We will have a decision of the Ninth Circuit from a
DEA perspective probably sometime midsummer.
I would think no
later than September...
I truly believe the Ninth Circuit will rule against the DEA. I
think the DEA has overstepped [with] a non-psychoactive. You
can't sit there and classify everything under marijuana to be a
controlled substance. I think, in the end, it's a fight that DEA
is losing.
The lawsuit was brought by several hemp growers against the DEA.
It's been going on for a while. We're at the Court of Appeals
stage. We expect a decision. I think the arguments are very
strong that the DEA has overstepped its bounds.
From a
controlled substance point of view, that decision of the Ninth
Circuit will either be a game changer, or it will be the
industry's worst nightmare."
Drug Industry May
Ultimately Push for Descheduling of CBD
Considering CBD is non-psychoactive, there's really nothing for the
DEA to be concerned about.
You cannot get high from
it and it's not addictive. From these facts alone, it makes
absolutely no sense to regulate CBD as a Class 1 narcotic. One
possible ulterior motive might involve collusion with the drug
industry.
By eliminating CBD, drug companies stand to make more money from
drug sales. However, the drug industry may ultimately want CBD to be
descheduled as well, as companies have started developing CBD-based
drugs.
"They're not going to
want it to be a controlled substance," Harrison says.
"In the end, I think
that even if the Ninth Circuit case goes badly, my prediction
would be that once the FDA approves [GW Pharmaceuticals'] new
drug, there's going to be a recommendation to deschedule [CBD]
from the FDA."
CBD Industry
Has Failed to Take Necessary Action
Unfortunately, even if the FDA calls for the descheduling of CBD to
pave the way for CBD drugs, it won't help manufacturers of CBD
supplements.
GW Pharmaceuticals
have
already been granted a patent for its CBD product and are pursuing
classification as a drug. Once that drug application goes through,
it becomes a crime to sell CBD oil unless you've gone through the
FDA drug approval process.
Harrison explains:
"In 2006, GW Pharma
filed an investigational new drug (IND) application with the FDA
to conduct clinical trials on CBD, because it held a lot of
promise for patients with certain seizure disorders.
To be able
to make that type of claim, you'd have no choice but to go
through clinical trials. And then they instituted clinical
trials immediately after that.
Those dates are important because under the Dietary Supplement
Health and Education Act, if an ingredient is a subject of an
IND and significant clinical trials prior to its use as a
dietary ingredient, you'd have to get authorization from FDA to
market that ingredient.
Nobody paid attention to this...
The CBD industry just went hog-wild and decided they were going
to get into it and ignored that part of the law. There's still
actually a limited time [for action]. Somebody could petition
FDA to market CBD as a dietary ingredient.
The only way it ever becomes a preclusion is if somebody does an
act prior to FDA approving CBD as a new drug. Once they approve
it as a new drug, it would be precluded, unless FDA actually
went ahead and permitted its use before that.
That's the rub
here. It's that there is a small window of time that a company
could go forward with FDA.
There's a good chance that the FDA may reject it. You may very
well have a very good case to bring it to a court, because
there's no reason that CBD shouldn't be able to be marketed as a
dietary ingredient. But nobody is doing that right now.
Because of that, the industry risks that FDA - once it approves
that [CBD] drug approval - there's no way of being able to use
CBD as a single moiety marketed as a dietary supplement.
CBD
companies, in many ways, act like the cannabis crowd, [saying]
'If everybody is selling it, then we're not going to have any
problems. We're going to force the law to change that way.'
There's one big difference here.
Most pharmaceutical companies don't have clinical trials on
smoking weed. Here is a company that does very good work.
Actually, if you talk to even some of the natural botanists out
there, they've done extremely good work on CBD, THC and
marijuana.
They're going to want to... protect their interests.
They may very well - and this is my speculation - tell FDA, 'You
need to do something at that point.' Or they may try to do it
themselves by bringing their own actions. That's the risk that
CBD industry takes...
I once argued,
'Are you better off having the fight now or
later?'
If the fight's going to happen, should you just go ahead
and do it now, or should you go ahead and do it later? From that
perspective, maybe it's better to have that fight now, while
it's not an approved drug.
Because having the fight after it's
an approved drug is going to make it significantly more
difficult…"
Hemp Products
Are Legal, Even if They Contain CBD - At Least For Now
Considering the risks of not petitioning the FDA to have CBD
approved as a dietary supplement, why hasn't anyone done it already?
Barring poor legal
advice, the most likely reason is cost.
As noted by Harrison,
"To file a good
petition with the FDA, with all the safety data and everything
that you would need, you're probably talking about $50,000 to
$80,000.
But if you lose to
the FDA, the litigation costs could easily reach the mid-six
figures to low-seven figures. I think that's why people don't do
it."
Now, as mentioned, CBD
can come from either cannabis or hemp.
Again, the distinction
between these two plants hinges on the THC content. Hemp has very
little if any THC, whereas cannabis will have varying amounts of THC
depending on the species. Hemp products such as hemp oil and hemp
extract are legal.
Even though they may have small amounts of CBD, hemp products can be
lawfully marketed. This is a potential loophole the CBD industry
could use.
The drawback is hemp
products may not have much CBD in them, and they may not be
clinically effective.
"My hope is that
there is a resolution to be had, and that CBD will be made
available, but we'll have to see.
It's a shame to have
something that has potential health benefits outside what we
call a drug claim not available to individuals," Harrison says.
"I think the idea
that… it helps alleviate daily stress and things along that
line… is appropriate for a dietary supplement."
There are many instances
where people have moved simply to avail themselves of legal medical
cannabis. It's truly sad that it's not available across the nation.
CBD products are
currently available in all states, but that may soon change,
depending on how this pending litigation plays out.
Legal Update
on Homeopathics
The second topic Harrison addresses in this interview is the legal
status of
homeopathic medicines.
The FDA has issued a
draft document in which they state they intend to exercise
enforcement discretion on homeopathic products, but made it clear
they believe homeopathic medicines are unapproved new drugs.
"I believe they're
just wrong on the law. Homeopathy goes back a long time,"
Harrison says.
"It goes back to the
original Federal Food, Drug and Cosmetic Act. It is recognized
as a drug in the Federal Food, Drug and Cosmetic Act…
Why are we vilifying
a whole medicinal paradigm just because it doesn't fit our ideas
of Western medicine?"
Indeed, the FDA's stance
comes across as both irrational and inconsistent.
On one hand, they're
saying there's no way homeopathy can work since there's no active
ingredient. It's just a "vibrational essence" or energy of an active
ingredient left due to extreme dilution. On the other hand, they
want to treat homeopathics as new drugs.
The legality that allows for this inconsistency is the fact that
it's the disease claim that makes a product a drug. In other words,
if the product claims to treat a disease, it's a drug.
If it makes no claim to
treat disease, it's not a drug.
"It's more about the
intent of the product," Harrison explains.
"One of the problems
I have... [is] we've decided that everything is a disease in
this country. There's nothing that's not a disease. We don't
worry about maintaining health.
But even if I wanted
to say that FDA was right... why do we care if somebody is using
a homeopathic medication for the alleviation of cold symptoms,
cough or a rash on your body?
That's just a waste of money. You don't have to believe it
works. Even if I wanted to assume it's a placebo effect on
individuals, those individuals believe it's working. The placebo
effect's a real effect.
It's just that the
whole rationale makes no sense. FDA admits that homeopathic
drugs are safe. They are not going to cause harm.
Whether you believe
they're effective or not is irrelevant, because the people who
take them [believe it].
Regardless of the prescription products, that should be between
the physician and his patients. They should discuss the pros and
cons of whether a homeopathic product will work or not.
Now, homeopathic
products that treat serious conditions should not be made
available over the counter, because we don't even like
conventional drug products that are intended to treat serious
conditions over the counter.
But you can't all of a sudden say,
'Well, no. Not
even a practitioner in his practice of medicine [can]
recommend a homeopathic.'
I think that FDA is
overstepping.
But I also think that
in many ways, the homeopathic industry is being lazy about it.
[They say] 'Well,
FDA has decided that they're going to exercise their
enforcement discretion and not do anything'...
But what do you do
when FDA decides to do something?
On top of it all, then you have plaintiff attorneys out there
that are going to argue that FDA is on the record saying these
products aren't approved new drugs. That makes you illegal.
Therefore, that's a reason to be sued.
I'm hoping that the
industry wakes up and pushes back hard.
Not everything needs to be established by double-blind,
placebo-controlled studies... People should be allowed to have
their homeopathic products. If they believe in it, they should
allow it.
If you don't believe
in it, you don't have to buy it."
Future of
Homeopathics Remains Uncertain
As for the future of homeopathic remedies in the U.S., Harrison
believes they'll remain under continual assault.
That said, he doubts the
FDA will ever finalize its draft guidance document because it,
"knows that when you
finalize things, it has other repercussions."
Unfortunately,
homeopathic companies will likely continue to be sued until or
unless the FDA admits that homeopathic remedies are appropriate and
legal.
Companies must also take
care to be consistent with the materia medica to ensure their
claims are not misleading.
"To boil down
homeopathy simply, it's that like cures like.
If you have a poison
ivy blister, you put poison ivy on yourself. But it's a
highly-diluted poison ivy. I think that in many ways, vaccines,
like the smallpox vaccines and things like that, actually kind
of grew out of that idea - that we give people minute quantities
that will help their immune system respond...
My hope is that FDA will withdraw and just admit that
homeopathic products may be lawfully marketed, as long as they
are part of the materia medica, and that the FTC, on the
other hand, doesn't try to say,
'The only way you
can make a product for homeopathy is if you actually do a
double-blind placebo-controlled study.'
I think that would be
a huge mistake."
Why Aren't
Homeopathics Grandfathered In?
A reasonable question to ask would be, why homeopathic remedies
aren't grandfathered in.
Drugs in use prior to
1938 are not required to have clinical studies to back up their
claims, yet can still be used as drugs. Homeopathic remedies have
been used far longer than that, so why are they being penalized?
Harrison explains:
"Grandfather drugs
are a very narrow category of drugs. Everything has to be
identical, all your claims, all your warnings, your labels, your
labeling has to be identical to that pre-1938 product.
If you can't show
that it's not absolutely identical to that product that was
marketed prior to that, then you're not grandfathered.
There are very few products FDA would ever admit that are
grandfathered. But it's not a bad argument to make, especially
if you can go back and show this homeopathic remedy was marketed
back in 1938.
But part of the
problem is that back in the old days, the homeopathic products
tended to be single-ingredient products.
Almost all of the homeopathic products today are
multi-ingredient. That will take you out of the grandfather. It
complicates the issue.
If I were to find a
1938 one and I copy that label identically... I would have a
good argument that [it] is [grandfathered]."
Using single-ingredient
remedies is a legal loophole that makers of homeopathics could
resort to if push comes to shove in the years ahead.
That said, it makes
little sense to vilify something that is completely harmless and
that many feel works. No one has ever died from taking a homeopathic
preparation. It's hard to imagine a medicine that could be safer.
While many simply don't
believe homeopathic remedies work, this really should not be cause
for their discontinuation.
It's really about freedom of choice...
If you feel a homeopathic
is helping, you should be allowed to use it, especially when you
consider all the other things you're allowed to use that come with
significant if not extreme risks, be it cigarettes, alcohol or
over-the-counter medications.
The FDA's public comment
period expired on March 30, so at this point, all we can do is wait
and watch for further developments.
Video
Dr. Mercola Interviews Todd Harrison
...about CBD Oil and Homeopathy
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