Contents
1. What's Up, FDA?
2. What You Need to Know—According to the FDA
A) Only One Epilepsy Drug Approved
B) CBD and Restricted Marketing
C) Not Enough Clinical Evidence That CBD Is Safe
D) CBD Market Claims Are False
E) CBD is Potentially Harmful
F) Taking CBD Can Mess with Other Drugs
3. Conclusion
What's Up, FDA?
Admit it: everyone loves a good bashing every now and then. It's almost recreational, complaining about the powers that be. Like the case of "U.S. Food and Drug Administration (FDA) vs. cannabidiol (CBD)," a topic that has gained mega traction in the news of late.
Normally, we'd settle down with the popcorn and just enjoy the spat. However, right now, we're shaking our heads and wondering: "What the %$&^*, FDA?" ‘Cause the Agency's public statements about CBD are rather worrisome, aren't they?
So, we're packing away the popcorn and diving into the discourse ourselves, because really...this seems like a war an army tank is trying to launch against a bowl of Rice Krispies. (Wait, perhaps it should—Rice Krispies aren't that harmless at all, folks. But let's not digress just yet. We'll get back to FDA endorsement and the high fructose corn syrup fracas in a bit.)
So, we're wondering in all earnestness: what's the deal with CBD, FDA?! The Agency's statements of late have all the hallmarks of a concerted witch hunt—facts are distorted, studies referenced without context, and statements are alarmist and demonizing.
In short, the Agency just seems very defensive in general—about a substance millions of us have been using for yonks, with only good results to report. Also, there’s a plethora of good, solid research supporting our observations and personal experience.
What's going on?
RELATED: CBD is Everywhere! This is Why It's Popular
What You Need to Know—According to the FDA
Let's get real, then, and unpack one of the most recent FDA statements to the public about CBD (dated 11/25/2019). [1]
A) Only One Epilepsy Drug Approved
- The FDA has approved only one CBD product, a prescription drug product to treat two rare, severe forms of epilepsy.
In June 2018, the FDA approved Epidiolex®. The drug contains a highly purified cannabidiol extract for treatment-resistant epilepsy in children and adults. So far, so good.
This doesn't mean it is not a contentious issue, though. This epilepsy medicine is classified as a Schedule Five substance by the Drug Enforcement Administration (DEA), which is the safest designation possible for prescription medications. This also means that the product has been shown to have medical value (through rigorous medical research and testing) and has a low potential for abuse. [2]
Even as medicine for very serious epileptic conditions, CBD is classified as very safe.
Hemp-derived CBD is completely lawful now, and it has an anecdotal history of harmlessness even in high doses (Really, no death-by-CBD has ever been reported). Also, the bulk of scientific inquiry points to its very benevolent side effect and safety profile.
Yet the FDA proceeds to warn strongly against the wanton use of CBD, like it's a seriously underestimated monster we've been cradling for years now.
RELATED: The Greatest Victory for Hemp: The New Farm Bill Signed into Law!
B) CBD and Restricted Marketing
- It is currently illegal to market CBD by adding it to a food or labeling it as a dietary supplement.
Nationwide, hemp-CBD regulation is still somewhat of a mess, and the FDA seems to battle coping.
The Drug Enforcement Administration released a statement in August last year clearing up the confusion around hemp-CBD's Schedule I drug status: [3]
...as the result of a recent amendment to federal law, certain forms of cannabis no longer require DEA registration to grow or manufacture. The Agriculture Improvement Act of 2018, which was signed into law on Dec. 20, 2018, changed the definition of marijuana to exclude “hemp”—plant material that contains 0.3 percent or less delta-9 THC on a dry weight basis. Accordingly, hemp, including hemp plants and cannabidiol (CBD) preparations at or below the 0.3 percent delta-9 THC threshold, is not a controlled substance, and a DEA registration is not required to grow or research it.
We're sighing with thankful relief because the DEA's 2018 New Drug Code (7350) for Marijuana Extract was a minefield of innuendos. [8]
So, it seems that providing their CBD product is hemp-derived and contains less than a small amount of tetrahydrocannabinol (THC, which is the psychotropic compound of cannabis), Americans will very likely not be thrown in jail for possession.
But if it's not a controlled substance any longer, (meaning it doesn't have the potential for abuse and has been shown to have health benefits), why can't CBD be advertised as a supplement or when it's been added to food?
Amy Abernethy, MD, PhD., Principal Deputy Commissioner, Office of the Commissioner, Food and Drug Administration, explained in a congressional testimony dated July 2019: [4]
It is unlawful under the Federal Food, Drug, and Cosmetic Act (FD&C Act) to introduce into interstate commerce a food (including any animal food or feed) to which has been added a substance that is an active ingredient in an approved drug product or a substance for which substantial clinical investigations have been instituted, and the existence of such investigations has been made public.
And:
I think everyone on this Committee can understand why, in general, adding drugs like blood pressure medicines or chemotherapeutics to foods, or to products marketed as dietary supplements, may not be in the best interests of American consumers and patients.
Wait, what? CBD is a drug now, comparable to chemotherapy and beta blockers? Simply because the Agency approved a medicine with an already-legal CBD molecule? (CBD isolate was legal before Dec 2018, remember.) [5]
How did this happen? But wait, there's more.
According to the testimony, a federal law stipulates that if a substance was used and advertised as a supplement and/or a food additive BEFORE being approved as an active drug ingredient, the FDA cannot enforce any "Thou shalt not add it to food and advertise it as a supplement" regulations.
But apparently:
The Agency is not aware of any evidence that CBD was marketed in foods or dietary supplements prior to it being subject to substantial clinical investigation. Therefore, FDA has concluded this exception does not apply to CBD.
Huh? Where has the Agency has been all these years? ‘Cause prior to December 2018, mere months before this testimony, hemp-CBD was unlawful at worst, or in murky legal waters at best.
Maybe the Agency was not aware of any marketing because CBD was a mostly prohibited substance under federal and state laws? Or perhaps they weren't looking? This is starting to sound like sophistry and bollocks, to be frank.
The Agency concedes that "(t)he FD&C Act further allows for the Agency to make an exception through notice and comment rulemaking to one or both of the provisions that prohibit adding active drug ingredients to foods or marketing them as dietary supplements."
But this "notice and comment rulemaking" can take another five years or so, even if the process is expedited.
Also only if the Agency can "determine that products would be able to meet the other relevant safety standards in the FD&C Act, such as the food additive safety standards for human or animal foods, or the New Dietary Ingredient standards for dietary supplements."
Now, this statement opens up a can of worms, what with all the toxic substances currently on the Agency's list of harmless products. Or their Generally Recognized as Safe (GRAS) list, with its numerous untested substances. Think glyphosate, nitrates, and high fructose corn syrup (HFCS).
Double standards much? Research has shown HFCS to be extremely harmful, causing obesity and metabolic syndrome when consumed in large quantities. Also, according to a global study conducted in 2012, countries with higher availability of HFCS have a higher prevalence of type 2 diabetes independent of obesity. Yet it's found in many well-known cereal brands. [9]
With some other products, the FDA fails to meet its own objective but now wants to enforce it on hapless CBD?
But read on.
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C) Not Enough Clinical Evidence That CBD Is Safe
- The FDA has seen only limited data about CBD safety and these data point to real risks that need to be considered before taking CBD for any reason.
Really? Well, open Google and type in the question "Is cannabidiol safe?" Within 19 seconds, there's likely to be an excess of 8,000 studies at your fingers.
OK, the comment is somewhat facetious, but the point is: how much evidence is enough, then?
Even the World Health Organization (WHO)'s Expert Committee on Drug Dependence issued a pre-review report in 2017, boldly stating that:
They do state that not all potential effects have been explored, but this is mostly for CBD's therapeutic effects, which probably means taking medicinal doses. These quantities are typically very high. Not the quantities usually found in OTC cannabidiol products.
RELATED: CBD is Safe. Here’s the Data...
D) CBD Market Claims Are False
- Some CBD products are being marketed with unproven medical claims and are of unknown quality.
Finally, something that makes sense. In her testimony, Abernethy clarifies:
However, FDA’s biggest concern is the marketing of CBD products that make unsubstantiated therapeutic claims to prevent, diagnose, mitigate, treat, or cure serious diseases, but have not obtained new drug approvals. For example, FDA has seen various CBD products with claims of curing cancer or treating Alzheimer’s disease. The proliferation of such products may deter consumers from seeking proven, safe medical therapies for serious illnesses – potentially endangering their health or life.
Yet the proverbial baby and bathwater come to mind. Why punish the whole market when the offenders are but a few charlatans? Are there really no other ways to address this concern instead of releasing these alarmist, distorted statements posing as "information?"
Surely the FDA knows that the American public is not that stupid. After all, it OK-ed Rice Krispies on the hapless people of the land. So far, nobody's died of a Rice Krispies overdose that we know of. Maybe the FDA should take the same chance with CBD—especially considering that the main body of scientific evidence testifies that it's much less harmful that the cereal.
Unlawful and false advertising can present a danger, but that's true of every product on the market. And anyway, if the FDA is truly that concerned about this, a general public awareness campaign could sort that out, surely?
E) CBD Is Potentially Harmful
- CBD has the potential to harm you, and harm can happen even before you become aware of it. CBD can cause liver injury.
And further on, on this info page in question, the FDA states:
During its review of the marketing application for Epidiolex — a purified form of CBD that the FDA approved in 2018 for use in the treatment of two rare and severe seizure disorders — the FDA identified certain safety risks, including the potential for liver injury.
We are very, very puzzled by these bold alarmist claims because the latest scientific update on this specific topic is: [7]
Cannabidiol therapy is associated serum ALT and AST elevations that generally arise within the first 2 months of treatment and are mild-to-moderate in severity. The frequency of elevations is dose related and more frequent with concurrent use of valproate and clobazam. The elevations, however, are generally asymptomatic, self-limited in course and not associated with jaundice.
Also: There have been no convincing reports of clinically apparent liver injury with jaundice attributable to cannabidiol, but it has had very limited general use.
This article was published in the LiverTox: Clinical and Research Information on Drug-Induced Liver Injury, and the CBD drug under discussion: Epidiolex.
Also, a search with "liver toxicity of cannabidiol" as keywords produces thousands of tests that it is, in fact, liver protective.
Caution taking very high doses of any substance is advisable. But why single out and punish CBD, a compound with a remarkably clean track record?
F) Taking CBD Can Mess with Other Drugs
- CBD can affect the metabolism of other drugs, causing serious side effects.
Fair enough. So can alcohol—freely available most everywhere to anyone over a certain age. (And it's a known liver toxin in high quantities, btw.) As—theoretically—can glyphosate, food-preservative nitrates, sesame seeds, and grapefruit. Yet none of these are demonized by the Agency.
Again, clinical evidence of CBD's potential for drug interaction is sparse and inconclusive, and it seems to point to this only in exotic cases anyway. This means that the study samples in question do not represent the average American CBD user, nor do the study doses represent those they would normally take. A lot of medical research is still necessary in this regard.
And again, the double standards are shouting at us—so much scientific evidence is available regarding the harmfulness of some of the items on the FDA's GRAS list, including other approved substances. Yet based on this scant evidence, CBD is a potential liver toxin.
While caution taking any prescription drugs together with CBD and supplements is always prudent (especially for the very frail, the elderly, and the very young)—why single out and demonize CBD?
Conclusion
We feel that the FDA has launched a witch hunt of sorts on CBD and that the Agency's fear of CBD's "potential toxicity" is overblown. For what reason? Well, that's a whole discussion in itself right there.
Sources:
- https://www.fda.gov/consumers/consumer-updates/what-you-need-know-and-what-were-working-find-out-about-products-containing-cannabis-or-cannabis
- https://www.ecfr.gov/cgi-bin/text-idx?SID=41b038d23edcfc3b99051f9e56943bb6&pitd=20200101&node=se21.9.1308_115&rgn=div8
- https://www.dea.gov/press-releases/2019/08/26/dea-announces-steps-necessary-improve-access-marijuana-research
- https://www.fda.gov/news-events/congressional-testimony/hemp-production-and-2018-farm-bill-07252019
- https://www.deadiversion.usdoj.gov/fed_regs/rules/2016/fr1214.htm
- https://www.who.int/medicines/access/controlled-substances/5.2_CBD.pdf
- https://www.ncbi.nlm.nih.gov/books/NBK548890/
- https://www.deadiversion.usdoj.gov/schedules/marijuana/m_extract_7350.html
- https://www.tandfonline.com/doi/abs/10.1080/17441692.2012.736257
