The Future of CBD Oil after DEA and FDA Move to Enforce more Stringent Regulation

The United States Department of Health and Human services has owned the patent to use cannabinoids as nueroprotectants and antioxidants since October 2003. Scientists from the National Institute for Mental Health (NIMH), a smaller division of The National Institute of Health (NIH) applied for the patent 4 years prior for the purpose of awarding exclusive rights to create a new class of antioxidants significant for the role cannabinoids serve as nueroprotectants. 

Patent #6,630,507 excludesTetrahydrocannabidiol (THC) as a qualifying cannabinoid citing the medicinal benefits of Cannabidiol (CBD) with no psychotropic effects allowing patients to ingest high doses with "no toxicity or side effects."  It is important to consider this patent when analyzing recent actions taken by the FDA and DEA with regards to clarifying CBD Oil extracts being introduced in emerging medical and recreational markets.  

The two Federal Regulatory agencies working to regulate Hemp and Marijuana are the Food and Drug Agency (FDA) and the Drug Enforcement Administration (DEA). The purpose of the FDA is to promote public health by regulating food, dietary supplements,  over the counter medications not prescribed by a doctor and vaccines among others. The purpose of the DEA is to classify and enforce laws for substances considered to have a potential for abuse,  medical or pharmaceutical benefit or pose risk to the general public in accordance with the Controlled Substances Act of 1970. Both agencies are extensions of the US Department of Health and Human Services.  

Agricultural Hemp Foods and Extracts containing only trace amounts of THC are regulated by the FDA after a concerted effort on the part of the Hemp Industries Association (HIA),  the Organic Consumers Association (OCA) and several Hemp food and body product companies who spent more than $200,000 fighting the DEA to exempt these products from definition in the Controlled Substances Act and won in 2004. Hemp CBD Oil was not an issue during this time as these products were marketed as food items and were not tested for the cannabinoid, only for THC.  Hemp producers wouldn't realize their products contained high amounts of CBD until many years later when analytical testing became available in emerging State regulated Medical Marijuana Markets.  

Currently Marijuana is considered a Schedule 1 substance in the DEA's Drug Diversion Program considered harmful to society and highly addictive with no medicinal benefit in spite of scientific research depicting the opposite.  Extracts from the marijuana plant, like Charlottes Web falls under the regulation of the DEA. The Controlled Substance Act of 1970 defines Marijuana as, "all parts of the plant Cannabis Sativa L., whether growing or not; the seeds thereof; the resin extracted from any part of such plant; and every compound,  manufacture,  salt, derivative,  mixture,  or preparation of such plant, its seeds or resin. Such term does not include the mature stalks of such plant,  fiber produced from such stalks, oil or cake made from the seeds of such plant,  any other compound,  manufacture,  salt,  derivative,  mixture or preparation of such mature stalks (except the resin extracted therefrom), fiber, oil, cake, or the sterilized seed of such a plant which is incapable of germination." Resins and oils from the Marijuana plant had always been included in the definition of Marijuana in the Drug Diversion Program if they were derived from the flowers of a mature plant.   

In 2017 the DEA created a new drug code for Marijuana extracts to better comply with the United Nations Convention on Narcotic Drugs enacted in 1961. Drug Code 7350 Marihuana Extract defines oil extracts as such: "Meaning an extract containing one or more of the cannabinoids that has been from derived from any plant of the genus Cannabis, other than the separated resin (whether crude or purified) obtained from the plant." This new drug code goes into effect January 13, 2018. The intent behind this action is for the DEA to better track extracts derived from the Marijuana plant,  however,  this same action caused confusion and misunderstanding with leaders in both medical marijuana and agricultural hemp communities. 

Back in 2004, the technical act achieved by HIA allowing for Agricultural Hemp Foods and body products to be sold in stores was exempting Agricultural Hemp Products with only trace amounts of THC from the definition of Marijuana in the Controlled Substance Act. That was before Hemp Processors understood their products contain high levels of CBD and therefore could be used as medicine just like oils and resins extracted from the Marijuana plant.  Very quickly, CBD Hemp Oils began flooding National Markets with online sales and appeared on the shelves of several health food stores claiming the oil helps alleviate medical problems,  not just provide nutritional benefits.  

This began the concerted effort on the parts of both agencies to quickly clarify. As the DEA's new drug code goes into effect,  the FDA is sending warning letters to online distributors of CBD Hemp Oil Companies who claim their products are medicinal for the nueroprotectant and antioxidant qualities of the CBD's contained.  Meanwhile,  the DEA issued a clarifying statement ensuring Hemp food and body products are still exempt from inclusion in the definition of Marijuana in the Controlled Substance Act. 

One such letter was sent to That's Natural! Marketing and Consulting in Pueblo, CO. Specific products referenced in the letter were CBD All Natural Hemp Oil, Bosom Lotion Potion and CBD Rich Healing Creme sold on the Company's website www.cbdoil.life. The letter informed the Company the aforementioned products are classified as a drug and not a dietary supplement according to the Federal Food, Drug and Cosmetics Act because product claims on the website show intent for use in the diagnosis, cure, mitigation, treatment or prevention of disease.  Referenced from the Company's Website, the FDA listed claims the products "kill cancer cells" and "provide a protective coating around our brain cells" among others as violations. The Company Website also made claims the products are anti-tumor, effective against MRSA (antibiotic- resistant bug), lowers blood sugar,  regulates blood pressure and heart rate and alleviates cancer related pain, among others.  The FDA gave the Company 15 days to respond to the letter with actions taken to correct violations. 

In spite of the DEA's actions to move CBD Oil into classification with Marijuana CBD Oil,  grocery stores and independent health food stores are pushing the conversation by stocking CBD Oil products on their shelves.  Kroger backed Lucky's Market announced plans in October 2017 to offer these products to their customers, the first National brand to do so.  Independent health food stores like Corner Store Apothocary in Grand Rapids, IA, know they are operating in a legal gray area,  but are willing to assume the risk.  Without clarification in the Federal Laws, these businesses are most certainly assuming great risk. 

In December of 2017, The United States Patent and Trademark Office revised its stance announcing patent and trademark applications involving CBD products would no longer be accepted and pending applications would be rejected based on the Office's Lawful Use Rule.  This rule applies after the DEA'S new drug code categorizes CBD Oil derived from the tops of flowering plants as a schedule 1 drug and therefore its use considered unlawful.  Prominent attorneys in the industry are advising their clients they can no longer expect protection from the trademark office,  at least not while the DEA's new drug code remains in place.  Theories on the purpose and status of patent #6,630,507 for the use of Cannabinoids as antioxidants and nueroprotectants owned by the US Department of Health and Human Services are speculative.  

The Hemp Industries Association (HIA), along with two other parties responded in January of 2017 moving to block implementation of the DEA's Drug Code filing a lawsuit in the 9th District Court questioning the legality of the code. Attorneys involved in the case claim products derived from Hemp lawfully under section 7606 of the Agricultural Act of 2014 (farm bill) remain exempt from the definition of Marijuana in the Controlled Substances Act.

"The DEA's attempt to regulate hemp-derived products containing cannabinoids lawfully sourced under the CSA, and farmed and produced under the Farm Bill in States like Kentucky and Colorado,  is not only outside the scope of their power,  it's an attempt to rob us of hemp' s economic opportunity, " said Colleen Keahy,  executive director of HIA, in a statement.  Oral arguments in the case are scheduled to be heard in February of 2018. The DEA's Drug Code went into effect mid January,  2018. 

Attorneys, Activist Organizations and Industry Business Leaders make up the think tank around all of these issues. Course of action proposals vary greatly and often cause discourse in the grassroots movement to regulate Cannabis in all forms.  Most agree the fundamentals of the laws are intricately integrated in the language used to market products vs. the language in the law,  whether it's food or medicine.  Below are listed some of the more prominent theories.  

Rescheduling

Currently,  Marijuana is classified as a Schedule 1 substance, considered to have no medicinal value, a high potential for abuse and harmful to society along with heroin, LSD, ecstasy, methaqualone and peyote. Some believe placing Marijuana in a less stringent category would open the doors for research and development of Cannabinoids as medicine.  Opinions on which category Marijuana should be placed vary greatly in the community.  It is important to note the drugs falling into these categories must be obtained by a prescription from a doctor or are illegal under Federal Law. Anything outside of these schedules but still considered medicinal are regulated by the FDA as an over the counter drug.  

Schedule ll drugs have a high potential for abuse and are considered dangerous,  but also have applied medical applications.  Drugs in this category include Vicodin, Dilauded, oxycodone (Oxicotin), Fentanyl, Adderall and Ritalin, to name a few.  More illicit drugs in this category are cocaine and methamphetamine.  Most of the groups pushing for this category are connected to pharmaceutical companies with patents pending for use of cannabinoids as medicine.  Opposing groups believe this move will push out the small business farmer considered to be the very backbone of the medical cannabis movement.  

Schedule lll contains drugs with a moderate to low potential of abuse.  Drugs in this category include Tylenol with Codeine, steroids, testosterone, ketamine and anabolic steroids. 

Schedule lV drugs are considered to have a lower potential for abuse or risk of dependence than Schedule lll and include Xanax, Soma, Darvon, Valium and Ambien to name a few.  

Schedule V drugs have low potential for abuse,  but also contain limited amounts of narcotics and are generally used for antidiarrheal, antitusive and analgesic purposes like cough medicine with Codeine. Lyrica and Motofen are also included in this category.  

The conversation surrounding scheduling is controversial to say the least.  Some activists believe Schedule lll to be destructive to local medical cannabis markets and would like to see Marijuana fall into Schedule lV or V believing small farmers could exist in a competitive environment with pharmaceutical companies.  Many take the whole plant approach believing all of the cannabinoids in the plant work together to produce medicinal effects and isolating cannabinoids while adding terpenes back in makes the plant less effective.  They believe allowing patents for these procedures to be issued would also be devastating to everyone involved,  grower to patient. 

Descheduling

Removing Marijuana from the Controlled Substance Act, thereby descheduling it altogether is another proposal for Federal clarification.  These activists believe Marijuana to be a plant, not a drug and would like products derived from the plant to be considered a nuetracuetical.  Nuetracueticals are loosely regulated by the FDA which doesn't interfere in research and production,  however products must be labeled as not intended for medicinal use.  Nuetracueticals exist because there is currently no official definition in current law unlike Marijuana, defined by the Controlled Substance Act,  however as recent as January 2018, the FDA launched an effort to impose more stringent regulations for homeopathic products.  

Announcing a new "risk based enforcement approach" the FDA declared any and all homeopathic medicines currently on the market as being sold illegally and any drug which has not been considered "generally recognized as safe and effective" to be classified as a "new drug" and go through the FDA Approval Process. Products intended to be used for the prevention or treatment of serious life threatening illnesses were specifically listed, which makes CBD Oil as a target for enforcement.  

No matter where one falls on the spectrum of belief,  everyone having the conversation agrees action to counteract the US Department of Health and Human Services must be well thought out and presented as a United Front.  Attorneys and organizations are preparing themselves for an extensive, very expensive legal battle to protect well established businesses and communities.  Anyone inspired to join the conversation can find activist groups representing all aspects of the spectrum who desperately need time and financial support from volunteers and businesses. It's time to advance to conversation if the movement wants to maintain their voice in the legal and political battles ahead.