business
The Confusion Over Legal Drugs VS Legal Products
This fight is ongoing. Are all cannabinoids that have to do with hemp, legal? Are hemp-derived cannabinoids that are completely or partially synthetic, legal? Are the cannabinoids that show up in nature, but are only used for production as synthetics, legal? And what about the products that are made from these compounds? Are they legal? There’s a mass amount of confusion on this, and on one end, a pretty discreet answer. So here we ago, when it comes to the DEA and FDA, what’s the difference between legal drugs, and legal products?
DEA, FDA, and USDA: what do these government agencies do?
For the most part, we have a generally good idea about this, but just to be clear, let’s quickly go over on a broad scale, the purpose (and power) of these government agencies. We’ll start with the DEA.
According to the agency, “The mission of the Drug Enforcement Administration (DEA) is to enforce the controlled substances laws and regulations of the United States and bring to the criminal and civil justice system of the United States, or any other competent jurisdiction, those organizations and principal members of organizations, involved in the growing, manufacture, or distribution of controlled substances appearing in or destined for illicit traffic in the United States.”
On another hand, according to the FDA, “The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation.”
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It goes on, “FDA also has responsibility for regulating the manufacturing, marketing, and distribution of tobacco products to protect the public health and to reduce tobacco use by minors.” And, “is responsible for advancing the public health by helping to speed innovations that make medical products more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medical products and foods to maintain and improve their health.”
As the FDA controls the regulation of all tobacco products, as stated, this includes vapes. Vapes are currently regulated under tobacco law, meaning all usage of vapes (e-cigarettes) falls under FDA regulation as electronic nicotine delivery systems (ENDS).
As far as the USDA, “We provide leadership on food, agriculture, natural resources, rural development, nutrition, and related issues based on public policy, the best available science, and effective management. We have a vision to provide economic opportunity through innovation, helping rural America to thrive; to promote agriculture production that better nourishes Americans while also helping feed others throughout the world; and to preserve our Nation’s natural resources through conservation, restored forests, improved watersheds, and healthy private working lands.”
These three agencies all play a role with cannabis in some way. The USDA regulates industrial hemp cultivation; the DEA regulates the legality of drug compounds; and the FDA regulates cannabis in products like foods, cosmetics, medicines, and supplements. These designations are important when looking at the controversy over the cannabinoid industry (and the cannabis industry as a whole), and the idea of legal drugs vs legal products.
The part of the USDA
There is a huge argument right now over which cannabis compounds are legal, and which products are legal; and these two questions are fundamentally different, because they’re governed by different agencies. So, to get an idea how it works with cannabis, let’s go over the breakdown between the legality of one vs the other.
To start with, the USDA’s 2018 Farm Bill legalized the cultivation of industrial hemp. And set a definition for ‘hemp’, which is the basis for a huge, and ongoing, argument, over exactly what this refers to; particularly in the case of wholly synthetic, or partially synthetic compounds. The ambiguity is partly related to the US not having a general definition for ‘natural’, meaning, there are no definitions for other thing like ‘naturally-derived’ either. Such a term is often used to greenwash products (make them sound more natural than they are), which has led to multiple lawsuits.
There is more specific regulation on this front in terms of food, however, with organic laws setting particular standards. And with organizations like the ISO (International Organization for Standardization) which set standards for cosmetics and food. Apart from offering the hemp definition that causes so many problems (on one front), the USDA is less involved in the rest of the argument.
Legal cannabis drugs vs legal cannabis products, which is DEA and which is FDA?
USDA aside, the DEA regulates drugs on behalf of the Department of Justice. It holds drug scheduling lists that determine the legality and uses of a drug on a federal level. Schedule I is for 100% illegal drugs with no accepted medical use, a high risk of danger, and a high risk of addiction. These drugs are illegal for any resident to possess, use, cultivate, sell, transport, traffic, or do anything else with. Cannabis is one of these drugs. However, recently, plants with no more than .3% THC were legalized by the most recent farm bill, for industrial use; by moving regulation for cultivation and production (only) to the USDA.
When we want to know if a drug is legal in general, we look to the DEA. And that’s why the agency has fielded inquires, like from the Alabama Board of Pharmacy about delta-8, and more recently, by attorney Rod Kight in terms of two synthetic cannabinoids: Delta-9-THCO and delta-8-THCO. In both cases, it stipulated they’re illegal. These questions are about overall legality, like, can I have it at all as a legal compound, or will simply having it be a federal offense. But that’s where DEA control ends.
The problem with the current debate, is that its essentially over products, rather than standard legality. Whether the DEA says the compounds are legal or not, has 100% no bearing on whether they’re legal to use in products. And that’s because the FDA (NOT the DEA) overseas all uses of cannabis in anything related to medical, supplements, cosmetics, smoking, and food products.
This means anything dealing with cannabis in vapes, is illegal. As is every other kind of cannabis product: oils and tinctures (both supplements, or food), creams, patches, and makeup (cosmetics, or medicine), pills, and treatments of any kind (medicine or supplements). They’re all uniformly illegal; because the FDA never made them legal.
What does the FDA permit? “With the exception of Epidiolex, Marinol, and Syndros, no product containing cannabis or cannabis-derived compounds (either plant-based or synthetic) has been approved as safe and effective for use in any patient population, whether pediatric or adult.”
If it needs to be stated more clearly, this ends the question of whether any cannabis product is legal on a federal level. And the answer is no. Once again, this is unrelated to whether the DEA classifies something as illegal or not. In fact, it should be remembered that the DEA has cannabis in Schedule I, yet the FDA approved Epidiolex, Marinol, and Syndros. Which means an illegal drug can still be used in legal products, should the FDA pass them. And a legal drug, is still illegal in products, if the FDA doesn’t make an allowance.
Why do people try to use DEA answers to promote product legality?
Hard for me to say, but I have my theories. One of them is simply confusion. I fully admit I, myself, was quite entangled in the ‘synthetic or not’ aspect of the argument for a long time. And that still matters in terms of legal drugs, but it doesn’t affect legal products. At least not in current circumstances. When an industry has regulation through different government bodies for the same topic, it can get confusing. And for many, it might seem like the DEA holds the answers to issues of product legality.
The other possibility is more a manipulation issue. The ideas generally focused on when speaking of the debate on hemp-derived cannabinoids, are whether they cross the .3% THC level at any point in processing, and whether they’re synthetic to some degree and what that means. That’s because these things can be argued. What is less arguable, is that the agency that allows legal products, never changed its stance. If industry promoters and vendors had the public focus on this, their products would be seen as illegal with no recourse. If response letters from the FDA were published, there wouldn’t be a question.
This is similar to how I believe the government uses methods of subterfuge to keep American attention off certain topics. Whether the cannabinoid industry is dirty or not, it simply doesn’t come with any real death toll that can be attributed to anything but additives. As in, not any of the cannabinoids, synthetic or not, have caused an issue to any real degree. On the other hand, while the government talks of them like they’re a massive threat to humanity, it continues to push opioids through regulation, as they now kill close to 100 thousand people a year.
Same concept. By focusing on the DEA, and whether a drug is legal overall, takes attention away from the fact that the FDA regulates products, and the DEA has nothing to do with this. The cannabinoid products industry isn’t going to focus on the legal aspect that renders it completely illegal. It’s going to focus on the debatable part, and sell it products based on the argument therein.
Final thoughts
I really don’t care if the products market continues. I mean, it’s a bit gross, with trademark violations, fake labs, mislabeled products, and no way to know what’s added in. But legal markets tend to have these issues too. And realistically, they ain’t killing anyone. My argument is simply about understanding the legal landscape, and not falling victim to subterfuge marketing moves when it comes to this understanding. But am I parading around for the end of cannabinoids? No. And realistically, illegal or not, there seem to be few, if any, repercussions involved; likely because the US can’t fight another losing drug war.
I’d sure love if everyone had access to the real plant (which seems to lower use of synthetics anyway), but I also know people like to get high and will try what’s available. And if its not going to cause damage, or at least, not in remotely the same ballpark as other drugs like medically approved opioids and benzodiazepines, and illegal ones like meth; it kind of seems like the FDA should suck it up, and allow it to happen. Although, in the world of reality, the market continues regardless.
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Related
A move by the Biden Administration to change how marijuana is treated by federal authorities was met with cautious approval by Massachusetts state regulators, cannabis sellers, and national marijuana advocates alike.
The Drug Enforcement Agency will drop marijuana from the list of banned substances found under Schedule I of the Controlled Substances Act, where it currently sits alongside heroin and LSD. It will instead move it to Schedule III, among the likes of Tylenol with codeine and anabolic steroids. This follows the recommendation of the Department of Health and Human Services
“Rescheduling cannabis is a monumental step forward for the federal government, one that can open new avenues to research, medical use, and banking for the regulated industries states like Massachusetts have built across the country,” said Ava Callender Concepcion, the acting chair of the Bay State’s Cannabis Control Commission.
Cannabis advocates in Colorado cheered the Biden Administration’s reported move to reclassify marijuana and said the decision likely would reduce businesses’ tax burden significantly.
Industry leaders cautioned that such a move — if finalized — would not resolve some major challenges facing the industry, such as limited access to banking. But they pointed to the symbolic importance of preparations by the U.S. Drug Enforcement Administration to downgrade the substance’s drug classification.
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