updated: 8-01-2019
The Food and Drug Administration is in charge of regulating the drug and supplement industry in the United States.
Their decisions have wide reaching implications for the heath of the public and also for the financial solvency of companies that bring beneficial drugs and supplements to market.
Let me begin by saying I have tremendous respect for the FDA based on the scope of the organization, the difficulty of their work and the paucity of their budget.
As of 2018, the FDA regulates more than $2.5 trillion in consumer products. The image below illustrates how many human consumed items are under their purview.
The FDA manages all of these products for a very low cost to the US taxpayer. In 2018, the total FDA budget cost taxpayers $9.11 for the year, about the cost of two fancy coffees.
Currently, the FDA is deciding how to best manage the CBD industry.
Fortunately, as the FDA weighs this issue, they are considering the interests of both the pharmaceutical and the supplement sectors of the CBD industry.
On May 31, 2019 the FDA held a public hearing for all cannabis and CBD stakeholders. The FDA genuinely wanted to hear from different voices in the CBD world. Here, you can see the diversity of stakeholders that presented to the FDA.
Before I get any further, here’s a very brief background on CBD.
CBD is a non-psychoactive chemical component of the cannabis plant.
THC is the chemical in cannabis that makes you high. The CBD molecule can be easily separated from the THC in the cannabis plant.
Scientific research into the CBD compound has revealed that this molecule can deliver health benefits to humans.
Pharmaceutical companies are already conducting human, clinical trials with CBD as a means to convince the FDA to approve their isolated CBD product as a drug. In fact, CBD has already been FDA approved to treat childhood epilepsy. In addition, pharmaceutical companies are currently attempting to get CBD approved as a drug for other indications (i.e. Rett Syndrome, neuropathic pain and multiple sclerosis spasticity).
On the other side of the industry, supplement companies would also like to manufacture and sell CBD. Supplement companies generally don’t conduct clinical trials, and as a consequence, they can’t use health claims in their marketing and advertising. Alternatively, since supplement companies aren’t spending millions on clinical testing, they can afford to sell a CBD product at an affordable price.
The current cost for a year of Epidiolex is approximately 32K. The supplement equivalent of a similar quantity of purified CBD is considerably less.
CBD supplements exist as topical creams, oil extract, edibles or capsules.
The FDA has taken the position that CBD cannot be legally sold as a dietary supplement because this compound has already been approved as a drug.
The FDA explains that, because CBD is now being marketed as an epilepsy drug with GW Pharma, this molecule cannot be added to food or beverages as a dietary supplement. Interestingly, the FDA also stated that, if this drug approval issue were somehow mitigated then CBD could be subject to FDA oversight as a new dietary ingredient. So, the FDA has opened the door to the possibility of allowing the CBD molecule to simultaneously exist as both a drug and a dietary supplement.
Interestingly, the FDA is currently fine with CBD being used in a cosmetic context. A cosmetic is basically defined as some substance that is put on the body as opposed to inside the body.
Under the FD&C Act, cosmetic products and ingredients are not subject to premarket approval by FDA, except for most color additives. Certain cosmetic ingredients are prohibited or restricted by regulation, but currently that is not the case for any cannabis or cannabis-derived ingredients.
But wait…curve-ball! The FDA position against selling CBD as a dietary supplement stands at odds with the 2018 Farm Bill.
Congress approved this bill, which removes hemp (with THC levels below 0.3%) from the list of controlled substances.
The 2018 Farm Bill means U.S. farmers can replace their corn and soybean fields with hemp plants that are enriched with CBD.
Ok, that’s good news…but under federal law CBD manufacturers can’t legally sell CBD as a dietary supplement.
Huh? Then why are store shelves everywhere filled with CBD gummy bears, CBD oil and capsules? Surely those aren’t approved drugs? No, they are not. As far as I know, GW Pharma doesn’t sell Epidiolex gummy bears.
All of those CBD dietary supplements are sold because manufacturers and local officials are disregarding federal law.
This is nothing new.
Our states and federal government have been at odds with each other since the 1790s, back when Hamilton and Jefferson squared up. In 2019, many states have already passed state laws allowing CBD or recreational cannabis use, regardless of the opposing federal law.
Where does your state stand on the issue? Who knows??…it’s hard to keep up. But, here you go, this is a reference, check out where your state currently sits on the issue.
Ok, are you confused yet?
No, not confused??
Ok, let me throw one more variable at you!
What does the DEA have to say about all this?
The U.S. Drug Enforcement Administration is in charge of regulating illegal drugs.
Even though many states have legalized all forms of cannabis…the DEA continues to classify CBD as a Schedule I drug. Schedule I drugs are “drugs with no currently accepted medical use and a high potential for abuse.” Heroin, LSD and ecstasy are also Schedule 1 drugs.
I know what you’re thinking….How can that be?? Purified CBD has been approved as a safe and effective therapeutic drug with the FDA.
Well…when the FDA approved Epidiolex (pure CBD) as a treatment for epilepsy, the DEA decided to classify Epidiolex as a Schedule 5 drug. This is their most lenient classification and indicates the lowest potential for addiction and abuse. Lyrica and Robitussin are examples of Schedule 5 drugs.
So in summary… the CBD compound is naturally produced by a legal plant and… in the hands of a pharmaceutical company, the chemical is an FDA approved medical drug and is Schedule 5 with the DEA.
But, when the exact same compound is sold as a dietary supplement, then this molecule becomes a Schedule I drug with the DEA and the transaction breaks federal law with the FDA.
Does that seem reasonable?
I don’t think it passes for reasonable.
I think the most generous assessment of this regulatory scenario would be to say, we are currently in a transitional phase.
How can this confusing mess be resolved?
Short answer….I don’t know.
I’m a biologist not a magician!
That said, I do think it makes sense for the FDA to allow both pharmaceutical and dietary supplement companies to sell CBD.
I do think the FDA, the DEA and congress can put their collective heads together and find a copacetic solution.
Here is my why I think CBD should be available as a dietary supplement.
- CBD is a naturally occurring chemical. If GW Pharma had altered the chemistry of CBD while they were developing Epidiolex, then it would make sense to prohibit the sale of their altered CBD as a supplement. GW Pharma could claim patent protection on their proprietary form of CBD. But GW Pharma didn’t do that…they plowed forward with a naturally occurring chemical structure. Therefore, they have no IP claim on the chemical.
- It is patently unjust to deny the public a beneficial compound that is easily available in a plant, simply because one pharmaceutical company included this chemical in their product pipeline. By the same logic, a pharma company could include naturally occurring vitamins and minerals in their product pipeline, then restrict their usage when supplement companies attempt to manufacture multi-vitamins.
- As pointed out above, GW Pharma is charging $32,000.00 for one year of treatment for their CBD product. Private or government insurance will pick up the tab for much of that…but ultimately, we all pick up the tab for expensive drugs via higher deductibles or more taxes going towards medicare/medicaid. This is nothing unique to CBD, this is standard business in our broken healthcare system. But….finally, we have a beneficial compound that is easily isolated from a plant. Not just any plant, a plant that can be legally grown in the U.S. Let’s let U.S. farmers grow our CBD enriched cannabis, allow manufacturers to extract and purify the CBD and then let’s make this CBD available as an affordable dietary supplement.
Here’s the catch. If we are going to do this, it better be done right!
In my ideal future, the FDA steps in to place strict growing and manufacturing guidelines across the CBD dietary supplement industry.
Every state operates 3rd party testing of CBD to ensure potency and purity. The product is tested for toxins and for CBD concentration. If a dietary supplement company fails to comply with the standards, they lose their ability to operate.
The FDA can also determine an appropriate upper limit CBD concentration to allow in a supplement context. This should be based on the best safety and tolerability data available.
GW Pharma should be rewarded for their investment and their clinical testing. They should have the exclusive right to deliver CBD in a higher concentration if that is appropriate and safe for epilepsy. GW Pharma can develop a dosage and administration protocol that is specific for their approved indications. They are free to carve out their niche in the appropriate medical context.
In closing, I greatly respect science and I am grateful for the safety and efficacy work performed by GW Pharma. However, I don’t think their clinical work warrants exclusive ownership of a naturally occurring plant compound.
If that was their intention, they should have tweaked with the chemical bonds to make a proprietary compound…. But, I imagine they didn’t want to do that…. cause the natural structure did the trick.
I will keep this page updated as the new developments unfold with the FDA ruling on CBD.
EthnoHerbalist Guide to Quality CBD products
A cloud of confusion swirls around the CBD industry. Does this molecule do anything?
How do you distinguish between a crappy CBD brand and a quality brand. To address these questions, we put together this guide. We hope it helps!
Updates on the federal regulation of CBD
July 22, 2019
The FDA sent a warning letter to a fairly large and established CBD company called Curaleaf. Curaleaf is a supplier of CBD products for CVS. In fact, Curaleaf is available in over 800 CVS stores.
Apparently, Curaleaf has been stepping over the bounds when it comes to the health benefits of CBD. As stated above, the FDA can and will crack down on companies that advertise a supplement with statements normally used for an approved drug.
This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your [Curaleaf] website in April and June 2019 and has determined that you take orders there for the products “CBD Lotion,” “CBD Pain-Relief Patch,” “CBD Tincture” (5 versions), “CBD Disposable Vape Pen” (5 versions) and “Bido CBD for Pets” (3 versions), all of which you promote as products containing cannabidiol (CBD).
Here is an example of some of the marketing/health claims made by Curaleaf that caught the eye of the FDA.
On your webpage titled “How to Use CBD Oil for Anxiety”
• “CBD can successfully reduce anxiety symptoms, both alone and in conjunction with other treatments.”
• “CBD oil can be used in a variety of ways to help with chronic anxiety.”
May 31, 2019
FDA held a public hearing on the use of CBD in the United States. FDA representatives stated that they wanted feedback on how the agency might regulate CBD. The agency also asked for data on how safe and effective this cannabis compound is for human consumption.
People from the supplement and pharmaceutical industry were invited to speak directly with the FDA. Some groups in the supplement side of the industry are hoping that CBD will be regulated similar to Vitamin C. The Consumer Healthcare Products Association is lobbying the FDA to regulate CBD similar to Vitamin C, possibly establishing guidelines like dosage levels that are deemed safe for over-the-counter use.
Amy Abernethy, M.D., Ph.D., is the Principal Deputy Commissioner at the FDA. Amy is one of the key members of the FDA looking into the CBD regulatory landscape. You can read Amy’s thoughts on the CBD public hearing here.