The Truth About CBD Regulations

Is CBD a DEA Controlled Substance?

In the United States, the Drug Enforcement Administration, or DEA, is a division of the Department of Justice. The DEA is in charge of overseeing Federal laws governing the manufacture, distribution and use of narcotics. The agency’s long-time position has been that cannabis (and by-products) is incredibly dangerous, equivalent to heroin, methamphetamines and other hard drugs. However, in recent years, states and advocates have slowly been chipping away at these long standing beliefs. Finally, we’re seeing some real progress.

Each of the 50 states have their own laws regarding drug classifications and controlled substances. This is why some states have legalized the use of marijuana (commonly referred to as cannabis), medical marijuana and/or recreational marijuana products and established laws governing growing, manufacturing, dispensaries, taxes, and other regulations.

But even though marijuana has been legalized on a state by state case, it remains classed as a Schedule 1 drug at a Federal level. According to the DEA website:

The abuse rate is a determinate factor in the scheduling of the drug; for example, Schedule I drugs have a high potential for abuse and the potential to create severe psychological and/or physical dependence. As the drug schedule changes– Schedule II, Schedule III, etc., so does the abuse potential– Schedule V drugs represents the least potential for abuse.

So no matter what the laws were at state level, up until recently, the DEA officially considered the cannabis plant, along with parts of the cannabis plant, and all CBD products derived from cannabis sources to be in violation of federal law. Within states with some level of legalized marijuana, cannabis-derived CBD oil and other cannabis-based CBD products can only be sold through licensed dispensaries.

A Direct Contradiction in CBD Regulations

Earlier this year, the DEA created a massive amount of confusion among businesses and consumers in the cannabis community. The confusion stemmed from the approval of the first non-synthetic cannabis-based drug by another Federal division. In Spring of 2018, the FDA approved Epidiolex, a cannabis-based oral drug created by GW Pharmaceuticals.

Epidiolex is a promising drug designed to treat Lennox-Gastaut syndrome and Dravet syndrome, two rare and severe early-onset, drug-resistant epilepsy syndromes. The drug is approved for use in children from age 2 and up.

Epidiolex an oral formulation of purified cannabidiol (CBD), where the CBD has been extracted from cannabis plants. It does NOT contain THC, which is the psychoactive component in cannabis that causes the feeling of being ‘high’.

The general confusion about CBD products and drugs sprang from the DEA’s decision to class Epidiolex as a Schedule V controlled substance. While many believed that this ruling meant all cannabidiol products were now legal, nothing could be further from the truth. The federal government still considers all other cannabis-derived CBD products as illegal and a violation of federal law.

Clearly, the CBD based drug could not be legally prescribed or sold if cannabis it was made from was listed as a Schedule 1 controlled substance. The DEA had 90 days to reclassify the drug, otherwise, it would not be available for those who needed it most – children with epilepsy.

The DEA’s official statement indicates “this order places FDA-approved drugs that contain CBD derived from cannabis and no more than 0.1 percent tetrahydrocannabinols in Schedule V.”

Now that we’ve seen FDA approval of a pure cannabis based drug, we’re sure to see others up for approvals. In the meantime, the cannabis plant, cannabis-derived CBD, cannabidiol, marijuana extracts and other CBD-based products remain saddled with a Schedule 1 classification. Well, almost all of them.

In September 2018, the DEA reclassified some CBD medications from Schedule 1 to Schedule V, which is a limited expansion to cannabis access. It’s also the first time the agency has admitted that the cannabis plant has actual medical value. Baby steps.

What the CBD Ruling by the DEA Really Means For Legality

So how can the federal government classify cannabis and CBDs as Schedule 1 and consider them to have a high potential for abuse in one case, and then turn around and name a cannabis-based CBD drug to Schedule V (the least potential for abuse)?

Well, that’s the government for you. But the legalities are all in contradiction with one another, which is why we’re seeing so many clarifications and statements coming out of the DEA and other regulatory bodies.

In reality, CBD derived from hemp CANNOT and SHOULD NOT be classed as a Schedule 1 controlled substance. A 2004 decision by the Ninth Circuit Court of Appeals specifically excluded non-psychoactive cannabinoids from the federal government’s definition of marijuana. In addition, The Farm Bill of 2014 made products derived from industrial hemp, including CBD, legal to sell and use.

However, in keeping with the somewhat fuzzy ‘is it legal or not’ aspects of CBD, The Farm Bill also requires that industrial hemp be cultivated under a state agricultural pilot program. A state will usually issue a license or some other form of authorization that permits cultivation of industrial hemp. Some also require a license to process industrial hemp into CBD oil or to create other products.

While hemp and marijuana are both members of the cannabis family, they are different plants, most notably in their levels of THC – or lack of them. The fact that cannabis and practically anything related to it is still classed as a Schedule I drug simply creates unnecessary confusion for everyone. In September of 2018, the DEA issued a ruling and statement to help clear up the confusion centered around their classification schedules:

From the DEA’s recent decision: “Products and materials that are made from the cannabis plant and which fall outside the CSA definition of marijuana (such as sterilized seeds, oil or cake made from the seeds, and mature stalks) are not controlled under the CSA. Such products may accordingly be sold and otherwise distributed throughout the United States without restriction under the CSA or its implementing regulations. The mere presence of cannabinoids is not itself dispositive as to whether a substance is within the scope of the CSA; the dispositive question is whether the substance falls within the CSA definition of marijuana.”

The DEA now defines approved CBD drugs as follows:

Approved cannabidiol drugs. A drug product in finished dosage formulation that has been approved by the U.S. Food and Drug Administration that contains cannabidiol . . . derived from cannabis and no more than 0.1 percent (w/w) residual tetrahydrocannabinols.

The DEA creates three conditions for a product to become an approved CBD drug. It must be FDA approved; be derived from cannabis; and have less than .1% THC.

Currently, the only CBD approved drug is Epidiolex. So what about CBD products like CBD oils, tinctures, topicals, edibles, and other products? These products are not FDA approved, nor will they achieve approval because they are NOT drugs. The products exist because of the not-so-gray-area surrounding industrial hemp. That’s why CBD products are saturating the marketplace nationally, without much objection or oversight. Hemp is legal, therefore, products derived from hemp are legal.

CBD Products – Why the Source Matters

As previously established, CBD products derived from the cannabis plant are only legal in states where marijuana has been legalized in some form. These products are heavily regulated from seed to final sale, and may contain higher levels of THC than that deemed allowable by federal law. CBD products derived from hemp are legal, although in 2016, the DEA, FDA and other federal agencies stated that The Farm Bill of 2014 does NOT permit interstate transfers or commercial sales of industrial hemp.

The DEA does not have the time, funds or bandwidth to pursue distributors and manufacturers of CBD products derived from hemp, and they’d have a hard time pursuing it in court as they’d have to overturn an abundance of legislation and prove that CBD is somehow harmful, and that it requires oversight through the Controlled Substances Act.

For now, there will be some risk of regulatory or enforcement action hovering over CBD distributors and manufacturers. A congressional budgetary restriction specifically prohibited use of DEA funds to prosecute industrial hemp producers and distributors expired in September 2018. While the FDA could take action to regulate and limit distribution of CBD products, it’s unlikely to happen, simply because industrial hemp is NOT prohibited under the Controlled Substances Act.

HOT OFF THE PRESSES: CBD LEGALIZED AT FEDERAL LEVEL

Great news! The passage of the 2018 Farm Bill in December of 2018 has clarified the legal status of CBD and allows U.S. farmers grow hemp. By redefining ‘marijuana’ within the Controlled Substances Act, CBD derived from hemp will no longer be on the controlled substances list. In addition, companies will be able to legally transport CBD products across state lines, allowing for greater product selection and availability.