There is never a dull moment in the hemp industry these days. First, there are the daily changes and clarifications in hemp policy and law on state and national levels. Then there is an increasing amount of research promising to expand our knowledge of hemp uses and benefits.
Understandably, there has been a struggle for politicians and agencies to keep up with the CBD industry. However, many voices are calling for them to pick up the pace.
One such voice in Senate Majority Leader Mitch McConnel. Last month, according to a US Hemp Roundtable article, he submitted a proposal to the US Senate Appropriations Subcommittee on Agriculture. The proposal would require the FDA to issue formal enforcement discretion policy on the sale of CBD products within 120 days. If passed, this will clear the way for CBD related products to be produced and lawfully distributed.
The US Hemp Roundtable is a coalition of over dozens of hemp companies – representing every link of the product chain, from seed to sale. It additionally includes all of the industry’s major national grassroots organizations.
If Senator McConnel’s policy is adopted, the FDA will be required to follow specific timelines relative to adopting an enforcement discretion policy.
What is an Enforcement Discretion Policy?
Over the last several years, the FDA has been using enforcement discretion policy. This policy is exactly what it sounds like—a tool that defines in guidance and regulations what will be enforced and what won’t. Formalizing the FDA’s enforcement discretion policy around CBD buys the agency time to work out its final regulatory process.
If adopted, the US Senate Appropriations Subcommittee on Agriculture would require the FDA to:
- Provide congressional committees a report of the agency’s progress in developing an enforcement discretion policy on CBD within 90 days;
- Issue a formal enforcement discretion policy on products containing hemp CBD within 120 days;
- Keep the enforcement discretion policy in effect until the agency has implemented its final regulatory process; and
- Establish a process for CBD manufacturers to share safety data through existing FDA notification procedures.
FDA Policy Relative to CBD Isolate vs Full Spectrum CBD Oil
It’s important to differentiate between CBD isolate and full-spectrum CBD in the current discussion on the FDA’s stance on regulating CBD.
The Food and Drug Administration is responsible for regulating the following areas:
- Biologics like vaccines and blood products
- Medical Devices
- Veterinary Products
- Tobacco Products
- Foods, water, and supplements
- Prescription and over-the-counter pharmaceutical drugs
Right now, the FDA is not differentiating between CBD isolate and full-spectrum CBD.
CBD isolate is pure cannabidiol. To produce this isolate, CBD is refined to strip out any additional cannabinoids, terpenes, and plant components found in the hemp plant. At the end of the process, one has a fine white powder that contains around 99% cannabidiol.
Full-spectrum CBD is just that—hemp oil that contains the full spectrum of cannabinoids and terpenes contained in the hemp plant. In addition to CBD, full-spectrum oil contains hundreds of additional cannabinoids and terpenes.
CBD as a Drug
CBD isolate is a key component in the recently FDA approved medication Epidiolex. Epidiolex is a brand-name prescription drug. It treats seizures caused by two types of epilepsy: Lennox-Gastaut syndrome and Dravet syndrome. These rare but serious conditions usually appear in early childhood or infancy. Epidiolex comes as a liquid solution that’s taken by mouth. It is approved for use in adults and children ages 2 and older.
Epidiolex was approved by the FDA in June of 2018. It is the first drug that contains a component of the cannabis plant.
Organizationally, the Food and Drug Administration is broken up into Offices and Centers. All drugs whether over-the-counter or prescribed like Epidiolex, are monitored by the Center for Drug Evaluation and Research (CDER). Located in Silver Springs MD, the CDER is a consumer watchdog in America’s healthcare system. CDER’s best-known job is to evaluate new drugs before they can be sold.
There is no argument that the CBD isolate as found in the seizure medication Epidiolex falls into the last category—prescription drugs.
Should Full Spectrum CBD be regarded as a Food/Supplement?
Full-spectrum CBD is a whole plant extract. One could make the case that full-spectrum CBD should fall into the categories of dietary supplements or food. If used externally, full-spectrum CBD oil falls into the cosmetics category.
Classified in this way, full-spectrum CBD would fall under the purview of a different FDA Center—the Center for Food Safety and Applied Nutrition (CFAN) located in College Park, MD.
CFAN works to ensure that the nations’ food supply is safe, sanitary, wholesome, and honestly labeled and that dietary supplements and cosmetic products are safe and properly labeled.
This FDA Center regulates all foods and food ingredients introduced into or offered for sale in interstate commerce, except for meat, poultry, and certain processed egg products regulated by the U.S. Department of Agriculture (USDA).
Unlike the Center for Drug Evaluation and Research, the Center for Food Safety and Applied Nutrition does not approve food, supplements, and cosmetics before them being sold.
How CBD Could be Classified in More Than One Way
To understand better why CBD isolate can be classified as a drug and full-spectrum CBD could be otherwise, we will use an analogy. Our analogy will be one that many of us are familiar with—caffeine.
Caffeine is classified as both a food additive and a drug by the FDA.
Excedrin, an over-the-counter drug, contains 65 milligrams of caffeine. Caffeine is listed as one of its three active ingredients on Excedrin’s label. Excedrin is regulated by the Center for Drug Evaluation and Research.
Coffee also contains caffeine. Coffee, however, is considered food so falls under the purview of the Center for Food Safety and Applied Nutrition.
In our analogy:
- CBD = caffeine
- CBD in the prescription drug Epidiolex = Caffeine in Excedrin
- CBD in full-spectrum CBD oil and products = Caffeine in coffee
The view of the FDA on Classification
“From the perspective of the FDA, the most important distinction between requiring that a substance be classified as a drug or not is how it is used,” said FDA representative Nathan Arnold. “As soon as claims are made that it will cure or prevent a disease, then generally it will meet the definition of a drug.”
A concrete example can be given with a jelly bean. Let’s say someone sells you a jelly bean and claims it will cure your cancer or relieve your pain. That jelly bean is a drug, and it’s subject to FDA’s drug authorities. But if the jelly bean is intended just as a tasty snack, and it’s not marketed with any drug claims, and there’s no other evidence that it’s intended for drug use, then it’s not a drug.
Following that logic, two different companies could sell full-spectrum hemp CBD oil from the same field. Everything could be the same about the products they sell. However, if one company makes claims about the product and the other does not, one is subject to the regulation of the FDA drug authorities and the other would be subject to the FDA Center for Food Safety and Applied Nutrition.
Why This is Important
Consumers of the past worked to ensure that vitamins and essential oils were not classified as drugs requiring FDA approval. Essential oils and vitamins aren’t drugs or miracle cures. Like full-spectrum CBD oil, they are organic compounds that participate in various metabolic functions. Many people have found their use helpful in sustaining balance and health.
Getting FDA approval as a drug is incredibly costly and time-consuming. While guidelines on labeling, advertising, and making claims are welcome, requiring that every product containing CBD receive approval from the FDA as a drug before being sold, is not. This would greatly limit the availability of full-spectrum CBD products to the general public.
Senator Mitch McConnell’s full report language to the FDA
“As previously mentioned, the Committee provides $2,000,000 for research, policy evaluation, market surveillance, issuance of an enforcement discretion policy, and appropriate regulatory activities with respect to products under the jurisdiction of the Food and Drug Administration which contain cannabidiol (CBD) and meet the definition of hemp, as set forth in section 297A of the Agricultural Marketing Act of 1946 (7 U.S.C. 1639o).
“Within 90 days, FDA shall provide the Committee with a report regarding the Agency’s progress toward obtaining and analyzing data to help determine a policy of enforcement discretion, and the process in which CBD meeting the definition of hemp will be evaluated for use in products.
“Within 120 days, FDA shall issue a policy of enforcement discretion with regard to certain products containing CBD meeting the definition of hemp as defined by section 297A of the Agricultural Marketing Act of 1964 (7 U.S.C. 1639).
“Such enforcement discretion shall be in effect until FDA establishes a process for stakeholders to notify FDA for use of CBD in products that include safety studies for intended use per product, and makes a determination about such product.
“FDA is encouraged to consider existing and ongoing medical research related to CBD that is being undertaken pursuant to an Investigation New Drug (IND) application in the development of a regulatory pathway for CBD in products under the jurisdiction of FDA and to ensure that any future regulatory activity does not discourage the development of new drugs.”
The Future is Bright for Hemp CBD Products
With all of the challenges surrounding the hemp and CBD industries, the great news is that the people’s voices are being heard.
“The Agency is committed to science-based decision making when it comes to CBD, while also taking steps to consider if there are appropriate regulatory pathways for the lawful marketing of CBD, outside of the drug setting,” said FDA representative Nathan Arnold.
With continued education and discourse between all stakeholders–consumers, producers, health care providers, and government, we are sure to reach an equilibrium soon.
To try full-spectrum CBD oil products for yourself, visit our online store.