As evidenced by the FDA’s landmark public hearing, products containing cannabis or cannabis-derived compounds – such as CBD pain relief rubs – exhibit an economic and medical potential that can no longer be ignored by lawmakers in the U.S.
Unlike the typical tedious FDA hearings that are usually held in the nation’s capital, this public hearing was one of the more well-attended and sought-after events in Washington in May.
And it’s not hard to understand why: As more individuals turn to CBD oil for pain management, the CBD industry boom that is currently going on in the United States has thrust cannabis-based medicines and other cbd-infused products into the spotlight.
Because of this, users and producers are calling for regulation within the industry that will ensure the production of high-quality and safe products. These regulations will enforce industry standards that will keep users safe and allow the industry to reach its economic growth potential.
Why the push for an FDA hearing?
According to the Brightfield Group, a lead cannabis industry analyst company, on its own, the CBD product market is predicted to reach $22 billion in the United States by the year 2022.
The numbers for CBD’s expected growth exceed those of the cannabis industry as a whole by nearly $2 billion, and it is only expected to continue to increase beyond expectations, making it one of the biggest medical industries in the United States to this point.
With this in mind, it probably comes as a shock to most that such a vast health and wellness industry has, for the most part, remained largely unregulated by the Food and Drug Administration. After all, as the country’s lead authority concerning all things to do with human and veterinary drugs, biological products, medical devices, it is the FDA’s responsibility to ensure public safety and protect public health.
Despite the country’s notorious history with the restriction of cannabis products, the tremendous growth that has taken place, particularly in the CBD product industry, finally prompted the FDA to take action with a public hearing.
The hearing was intended to give those affected by the industry the opportunity to take the floor and help the regulatory body determine the best path forward for everyone involved.
Who was there?
The hearing took place on May 31st of 2019 on the Food and Drug Administration campus in Washington DC.
Before the hearing even began, the number and diversity of attendees present made it readily apparent that the issue at hand was one of public interest. More than 400 applicants had applied to the FDA for the chance to speak at the landmark hearing, which resulted in the development of a complex lottery system that would allow for 120 speakers to take to the floor with concerns and testimonies.
Each of the stakeholders who were given a chance to speak took between two and five minutes to address a panel of top FDA officials.
One of the most interesting aspects of the hearing concerning the speakers was the incredible diversity of backgrounds that took to the floor: Hemp business owners, farmers, lawyers, doctors, researchers, industry associations, healthcare professionals, and consumer advocates all offered their testimony to the panel.
In his opening remarks at the hearing, entitled “Scientific Data and Information About Products Containing Cannabis or Cannabis-Derived Compounds” Dr. Norman E. Sharpless – the commissioner of the Food and Drug Administration – said of the attendance:
“I am pleased to see that there is such interest in this topic. We have over 500 people registered to attend in person, over 800 people registered to join us remotely, and over 100 speakers on today’s agenda presenting on this topic.”
The viewpoint and information offered by the speakers varied, but one thing was made more startlingly apparent with each individual that spoke: The FDA can no longer maintain a non-regulatory stance on products such as CBD pain relief rubs. Doing so not only brings down industry standards but also mitigates the industry’s growth and the accessibility of the product for individuals who rely on CBD oil for pain relief.
The following are our top 5 takeaways from the testimonies that were heard at the FDA’s landmark public hearing concerning the future of the cannabis industry in the United States.
1. The FDA and “scheduling” drugs in the United States
The FDA follows the restrictions set out by the HHS – the U.S. Department of Health and Human Services – in their “scheduling” of drugs in the United States, which is outlined in the Controlled Substances Act (CSA) of 1970.
Scheduling, according to the FDA, is the “classification of drugs based on their abuse potential, medical use, and physical or psychological dependence.” This classification is determined through an eight-factor authentication process, also outlined in the CSA, and requires that the HHS consider the following factors in determining which schedule a drug belongs in:
- Actual/relative potential for abuse.
- Scientific evidence of the drug’s pharmacological effects (if any).
- State of current scientific knowledge regarding the substance in question.
- Current and historical patterns of use.
- Scope, duration, and significance of abuse.
- Potential public health risks.
- Psychic and physiological dependence liability.
- Immediate precursor of a substance already controlled.
Based on these criteria, the HHS will then determine which of the five possible schedules of control a drug belongs to; either CI, CII, CIII, CIV, or CV, with CI (schedule 1) drugs being the most restrictive and CV (schedule 5) being the least. The substances in each schedule are relegated to different manufacturing, distribution, and prescription controls that are set in order to allow the substances to enjoy medical availability while prohibiting abuse.[table id=1 /]
According to the restrictions put forward in the CSA in 1970, and as shown above, marijuana is currently classified as a Schedule 1 substance.
2. Cannabis advocates are calling on the DEA to reconsider cannabis scheduling
The hearing was called in part because there have been calls to the DEA – the U.S. Drug Enforcement Administration – to reconsider the current schedule 1 classification of cannabis and cannabis-derived compounds.
This is because, since its classification in the 1970s, multiple studies have been conducted concerning the potential of cannabis-based medical solutions and their possible benefits.
This includes studies that show the potential benefit of utilizing CBD oil for pain relief as an alternative to traditional opioid-based pain relief medications, which have proven addictive.
In December of 2018, the call for reclassification by advocates (including the Governors of the states of Rhode Island and Washington) was answered by the Agriculture Improvement Act of 2018, also known as the Farm Bill. Though marijuana remains restricted as a schedule 1 drug, the bill removed cannabis plants that do not contain high levels of the psychoactive chemical compound THC from the list of substances that are controlled by the Federal government.
This means that hemp plants, which contain less than 0.3% THC among their chemical compound composition, are no longer federally regulated, which contributed to the flood of CBD products that have entered the medical market in the past couple of years.
3. The FDA will support scientific research concerning new marijuana-based drugs for medical use
One of the major takeaways to come out of the hearing was the FDA’s indication that it would fully support the development of scientific research concerning the new marijuana-based drugs that are being used in the professional sports industry, by doctors, and in homes across the country.
The FDA’s statements also indicated a willingness to return to the topic of marijuana’s classification, which does not allow for federally funded research to be conducted on the substance, pending the review of current data concerning its safety of use.
This means that, if enough scientific data showing CBD’s widespread and safe use is collected, we may see even some larger changes to the restrictions placed on using CBD oil for pain management in the coming years than we did in prior years.
4, There are three different agencies involved in researching marijuana products in the U.S.
When it comes to collecting the data that is necessary for changing the restrictions that are placed on CBD use, three different agencies have been tasked with researching marijuana-derived products in the U.S.
The first is the National Institute on Drug Abuse, typically shortened to its acronym – NIDA. The NIDA is responsible for obtaining the marijuana used in medical research. Through a contract that was drawn up between the agency and the University of Mississippi, it oversees the plant’s cultivation process and approves release applications that are submitted by researchers.
The second is the DEA. Because marijuana remains a schedule 1 substance, any researchers who are looking to study the effects of it must register themselves with and apply to the DEA for the necessary licensure.
Finally, the third agency involved is none other than the FDA itself. In developing a new drug that contains marijuana or marijuana-derived products, a drug developer must first submit an IND or an investigational new drug application. This allows the FDA to oversee the process of the drug’s development and ensure quality control.
5. The FDA has already approved the use of various medical products containing cannabis or cannabis-derived compounds
Because of its relatively vague stance up until this point on the changes that were brought about by the Farm Bill in 2018, you may be surprised to earn the FDA has already approved the use of one cannabis-derived and three cannabis-related products.
The first cannabis-derived medicine to be approved by the FDA in June of 2018 was the drug Epidiolex. Used to treat the seizures that individuals who suffer from Lennox-Gastaut syndrome experience, Edidiolex contains the cannabis-derived chemical compound CBD or Cannabidiol.
Its approval by the FDA indicates the drug is considered both safe and effective for use in children who are at least two years of age and up.
6. The FDA took a stance to support the development of cannabis-based drugs
At the conclusion of the hearing, the FDA indicated they would continue to support the developments of new cannabis-based drugs that are safe, effective, and manufactured according to strict quality standards.
The administration also put forth its commitment to conducting the necessary scientific and market research efficiently due to the already apparent popularity of the products among American consumers.
This support for continuing scientific research concerning the therapeutic value of cannabis-based products at an accelerated rate underlines just how current and pressing the matter of market regulation in the CBD industry remains.
After nearly a century’s worth of strict regulations in the United States concerning the use of cannabis-based products, we seem to have finally reached a turning point.
However, unlike mobilization efforts that take place in other industries, where the regulations that exist seem to be in place simply to the benefit of big pharma and agricultural giants, the call for more accessible CBD products stems from grassroots and consumer advocates.
These advocates are individuals who understand the potential wellness benefits of CBD products and are demanding that their concerns about regulating the industry for the good of its consumers be heard.
When regulating bodies like the FDA can no longer ignore the popularity and potential benefits of certain products, and everyday consumers and producers come together to advocate for the safe, regulated use of a product, the outcome has the potential to change the way that we medicate in the U.S. every day.