The Future of Cannabidiol Oil, Hemp and Other Cannabis-related Products

By: Richard M. Blau, Shareholder and Chair of GrayRobinson’s Food Law, Alcohol Law and Medical Marijuana practice groups

On January 10 and 11, 2017, the Senate Judiciary Committee held "confirmation" hearings on the anticipated nomination of Jefferson Sessions, III to become the nation’s next Attorney General. Many in the growing marijuana industry wondered about the impact this cabinet appointment would have on the relationship between federal and state cannabis laws. While this is an issue of vital importance for marijuana producers, as well as users, it also is important to note that the same concerns apply to collateral products, such as cannabidiol oil or "CBD oil."

Under current federal law, Congress defined marijuana to focus on those parts of the cannabis plant that are the source of tetrahydrocannabinols (THC), the hallucinogenic substance in marijuana that causes the psychoactive effect or "high." The marijuana portions of the cannabis plant include the flowering tops (buds), the leaves, and the resin of the cannabis plant.

However, the remaining components of the plant — stalks and sterilized seeds — are commonly referred to as "hemp." The federal Drug Enforcement Agency (DEA) has issued guidance that oils, as well as soaps, lotions and similar products, are legal if they are produced using sterilized cannabis seeds.

While most of the THC in cannabis plants is concentrated in the marijuana, all parts of the plant, including hemp, have been found to contain THC. The existence of THC in hemp is significant because THC, like marijuana, is a Schedule I controlled substance. Federal law prohibits human consumption and possession of Schedule I controlled substances. In addition, they are not approved by the Food and Drug Administration (FDA) for medical use.

In 2001, the DEA published rules explaining which hemp products are legal and which are not. Legality depends on whether the product causes THC to enter the human body. If the product does cause THC to enter the human body, it is an illegal substance that may not be manufactured, sold, or consumed in the United States. Prior to legalization of marijuana products by various states, outlawed products prohibited by the DEA included "hemp" foods and beverages that contain THC.

HOWEVER, if the product does not cause THC to enter the human body, it is a non-controlled substance that may be sold lawfully in the United States. Included in the category of lawful hemp products are textiles, such as clothing made using fiber produced from cannabis plant stalks. Also in the lawful category are personal care products that contain oil from sterilized cannabis seeds, such as soaps, lotions, and shampoos.

The DEA announced in late 2015 that the agency "eased some of the regulatory requirements imposed by the Controlled Substances Act (CSA) for those who are conducting FDA-approved clinical trials on cannabidiol (CBD), an extract of the marijuana plant. These modifications will streamline the research process regarding CBD’s possible medicinal value and help foster ongoing scientific studies. The DEA notified affected researchers by letter of the changes, which take effect immediately."  

That said, CBD currently remains a Schedule I controlled substance as defined under the CSA. Nor has the FDA ever approved marijuana as a safe and effective drug for any indication. The agency has approved two drugs containing a synthetic version of a substance that is present in the marijuana plant and one other drug containing a synthetic substance that acts similarly to compounds from marijuana but is not present in marijuana. However, in 2016 the FDA issued numerous warning letters to firms that market unapproved new drugs that allegedly contain cannabidiol. Specific details regarding the FDA’s warning letters are accessible online via the FDA’s Website at: http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm484109.htm

In the majority of states today, the relevant regulatory agency (usually the state Department of Health) has promulgated regulations that define "medical cannabis" to include CBD used as an herbal remedy or therapy to treat disease and alleviate symptoms. Whether those state laws remain effective could change depending on whether the incoming Trump Administration will change the current (albeit tenuous) policy of the Department of Justice not to enforce federal anti-drug laws against users of marijuana in states where that use has been authorized under state law.

THAT is a difficult question to answer at this time. Mr. Trump plans to nominate Senator Jefferson Sessions, III (R-AL), to become the nation’s next Attorney General. Historically, Senator Sessions has been very vocal in his opposition to legalization of marijuana. However, during his appearance this week before the Senate Judiciary Committee, he was indefinite in his answers on the tension between federal prohibitions and state legalizations of marijuana. Perhaps most telling, Mr. Sessions was clear that the Attorney General’s duty is to enforce the law, and that if Americans want marijuana legalized they should direct Congress to change the federal laws.

Senator Patrick Leahy (D-VT), the ranking Democrat on the Senate Judiciary Committee, questioned Senator Sessions on whether he felt that the current federal policies on marijuana, effectively deferring to the states, were appropriate and should be continued as a prudent allocation of limited federal resources? The putative nominee responded:

LEAHY:  . . . . WOULD YOU USE OUR FEDERAL RESOURCES TO INVESTIGATE AND PROSECUTE SICK PEOPLE WHO ARE USING MARIJUANA IN ACCORDANCE WITH THEIR STATE LAWS, EVEN THOUGH IT MIGHT VIOLATE FEDERAL LAW?

SESSIONS: WELL, I WON'T COMMIT TO NEVER ENFORCING FEDERAL LAW, SENATOR LEAHY. BUT ABSOLUTELY IT'S A PROBLEM OF RESOURCES FOR THE FEDERAL GOVERNMENT. THE DEPARTMENT OF JUSTICE UNDER LYNCH AND HOLDER SET FORTH SOME POLICIES THAT THEY THOUGHT WERE APPROPRIATE TO DEFINE WHAT CASES SHOULD BE PROSECUTED IN STATES THAT HAVE LEGALIZED AT LEAST IN SOME FASHION SOME PARTS OF MARIJUANA.

LEAHY: DO YOU AGREE WITH THOSE GUIDELINES?

SESSIONS: I THINK SOME OF THEM ARE TRULY VALUABLE IN EVALUATING CASES, BUT FUNDAMENTALLY THE CRITICISM I THINK THAT WAS LEGITIMATE IS THAT THEY MAY NOT HAVE BEEN FOLLOWED. USING GOOD JUDGMENT ABOUT HOW TO HANDLE THESE CASES WILL BE A RESPONSIBILITY OF MINE.  I KNOW IT WON’T BE AN EASY DECISION, BUT I WILL TRY TO DO MY DUTY IN A FAIR AND JUST WAY.

(Emphasis added).

Later in the same hearing, Senator Mike Lee (R-UT) raised the marijuana issue from a different vantage. After a long exegesis on the meaning of federalism, Senator Lee asked if the DOJ’s deferral policy created a constitutional Balance-of-Powers problem because the executive branch was declining to enforce laws expressly adopted by the legislative branch? Senator Sessions responded with a telling answer:

LEE:  . . .  ARE THERE SEPARATION OF POWERS CONCERNS ARISING OUT OF THE DEPARTMENT OF JUSTICE'S CURRENT APPROACH TO STATE MARIJUANA LAWS?

SESSIONS: WELL, I THINK ONE OBVIOUS CONCERN IS THAT THE UNITED STATES CONGRESS HAS MADE THE POSSESSION OF MARIJUANA IN EVERY STATE AND DISTRIBUTION OF IT AN ILLEGAL ACT. SO IF WE NEED TO -- IF THAT'S SOMETHING THAT’S NOT DESIRED ANY LONGER, CONGRESS SHOULD PASS A LAW TO CHANGE THE RULE. IT IS NOT SO MUCH THE ATTORNEY GENERAL'S JOB TO DECIDE WHAT LAWS TO ENFORCE. WE SHOULD DO OUR JOB AND ENFORCE LAWS EFFECTIVELY AS WE ARE ABLE.

A reasonable conclusion with the state of affairs to date is that Attorney General Sessions will do what President Trump tells him to do. Mr. Trump in the past has indicated that he is in favor of legalizing medical marijuana, but not recreational marijuana. Of course, as America already has seen, Mr. Trump’s presidential pronouncements can be somewhat mercurial, and certainly subject to change. 

Consequently, the future of CBD oil products in America, like marijuana products generally, remains unclear. Many cannabis industry members and advocates are taking solace in the fact that Senator Sessions did not vow to abandon current DOJ policies and vigorously prosecute existing federal laws criminalizing cannabis. However, objective observers believe it’s just too early to tell. Ultimately, American consumers of CBD oil and other cannabis products, including medical and recreational marijuana, must await the decision of President Trump – something that is nothing if not unpredictable.