Not only is it effective for pain, it offers many clinical benefits, including seizure control. But if Big Pharma and our government have their way, you may not be able to purchase it legally in the future. Ditto for homeopathic remedies. Even though they've been used for many years
Posted April 4,2018 in Natural.
By Dr. Mercola
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.”
Cannabidiol (CBD) is the nonpsychoactive 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 nonpsychoactive. 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.”
Considering CBD is nonpsychoactive, 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.”
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…”
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.
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 homeopathycan 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.”
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.”
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.