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Legal ambiguities on CBD status survive 'legalization'

Posted on March 13th, 2019 by Global Ganja Report and tagged , , , , , , .

CBDThe conventional wisdom—and certainly the impression made by much media and advertising—is that CBD is legal pursuant to the federal Farm Bill enacted late last year. As is often the case, however, there are some devils in the details.

Cannabidiol, or CBD, is all the rage among the health faddists now, and clearly does have legitimate medical applications even amid much unsubstantiated hype about its salubrious properties. And it is unburdened of the stigma that attaches to its psychoactive sibling cannabinoid, THC. A CBD industry that has been hampered by technicalities of federal law is now preparing to spread its wings and soar.

When Donald Trump signed the US Farm Bill into law in late December, it was supposed to clear up the situation—and, to an extent, it did.

But in addition to the widespread oversimplification that CBD is simply "legal," we are also getting misleading headlines like that in Rolling Stone on March 5, "Why Isn’t CBD Legal Yet?"

In fact, CBD is sometimes legal and sometimes not. To make sense of the situation, there are two key questions to keep in mind.

First question: hemp-derived or marijuana-derived? 
While the Farm Bill (partially) legalized CBD, the actual text of the law does not mention the cannabinoid by name. But it includes “any… cannabinoids” excluding THC in its definition of hemp products the law removes from Schedule I of the Controlled Substances Act. This implicitly covers CBD.  

There is, however, a catch. Because THC and the THC-laden buds of the cannabis plant remain illegal, CBD’s legality is contingent on whether it is derived from such flowers, or the plants that produce them. Although chemically identical, CBD derived from low-THC strains (under 0.3%, in dried flower samples) is now legal while that derived from high-THC strains is not.

This speaks to the stigma that continues to surround THC and its much-maligned "high," which persists as a kind of cultural hangover from the days of Reefer Madness even amid the recent progress toward normalization of cannabis. It also speaks the distinction between "marijuana" and "hemp," which is often derided as a semantic question (as if clear language were not critical to communication).

Many in the cannabis industry are seeking to phase out the word "marijuana" due to the stigma that attaches to it, and have it universally replaced with the scientific name cannabis. But this erases the distinction between high-THC strains of cannabis ("marijuana") and low-THC strains ("hemp"). Where the current legal status of CBD is concerned, this distinction is critical. 

Adding to the confusion, in its state regulations, California last year essentially did the opposite of what the federal Farm Bill would do just a few months later: made CBD permissible only when derived from the high-THC strains covered in the state medical marijuana program. This places California's regs squarely at odds with federal law on the question.

As WebMD medical website notes, "CBD oil" was state-legal even before passage of the Farm Bill in the 30 states that have passed medical marijuana laws, as well as 17 additional states with "CBD-specific" laws (meaning no THC). Following passage of the Farm Bill, these laws are no longer quite so relevant.

But note that we said "CBD oil." This brings us to the next question. After considering how the CBD was extracted, we must look at what form it is being marketed in...

Second question: CBD-infused or CBD isolate?
The 1971 Controlled Substances Act, which was tweaked by the Farm Bill, is not the only law that has something to say on the matter of CBD. The 1938 Food, Drug & Cosmetic Act gives the Food & Drug Administration responsibility for regulating food ingredients and additives, as well as those in drugs and cosmetics. The the FDA has not approved any cannabinoids for such uses. This may be an anachronism from the days (just three months ago!) when it was precluded from doing so by the CSA. But this still makes any such uses of CBD illegal.

Upon passage of the Farm Bill, the FDA issued a statement that poured cold water on the euphoria. It emphasized "what the law didn’t change"—the FDA's regulatory powers over food, drug and cosmetic ingredients under the FD&C Act. The statement did leave open a window of hope, saying that the FD&CA "allows the FDA to continue enforcing the law to protect patients and the public while also providing potential regulatory pathways for products containing cannabis and cannabis-derived compounds." 

It is the absence of FDA approval that has led health authorities in New York City and some other jurisdictions around the country to unleash a crackdown on CBD-infused edibles last month. This prompted a group of Capitol Hill lawmakers to send an urgent letter to the FDA demanding clarity on CBD's status. But the matter was still unresolved when FDA chief Scott Gottlieb unexpectedly announced his resignation earlier this month. The FDA's Marijuana Questions and Answers page continues to state that CBD as a food additive or dietary supplement is not legal.

The one exception to the illegality of CBD as a drug ingredient is Epidiolex, the anti-seizure medication that was approved by the FDA last June. This essentially forced the Drug Enforcement Administration to re-examine CBD's status as a controlled substance. In September, the DEA issued a hair-splitting decision that removed Epidiolex from Schedule I, but not CBD itself. Now that the Farm Bill has basically gone over the head of the DEA on the question of CBD's status under CSA, the FDA is the last barrier to its free use other than as a pure extract.

Which leads us to a final ambiguity. Even a pure extract or "isolate" is usually suspended in a "carrier" substance to help preserve potency and deliver the desired concentration per dose. This is usually hemp or coconut oil. And this could theoretically provide a legal window for an FDA crackdown even on the "pure" product. Thus far, however, this window has not been exploited, and maybe we shouldn't give the FDA any ideas.

In any case, the legal risks of purchasing CBD products are slim, and even before passage of the Farm Bill there was a vigorous mail-order and over-the-counter trade in hemp-derived CBD. Manufacturers made the argument that it was legal by provisions of the 2014 Farm Bill that allowed "research" in hemp-derived cannabinoids. The federal government did not accept this argument when the matter went before the courts in litigation brought by the Hemp Industries Association—but neither did it move against the trade.

Following passage of the 2018 Farm Bill, the industry's argument has been formally honored by the law. But a degree of confusion persists even now. And, even amid all the CBD hype, consumers should be aware of it.

Cross-post to Cannabis Now
 

Image: World of Molecules

 
 

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