What happens when the United States Food And Drug Administration invites over 100 witnesses to an FDA hearing on CBD products? As it turns out, not much….yet. While the guest list was certainly long, no new regulation came from it, nor was it expected. While no immediate, practical changes may have occurred, the meeting did accomplish its goal: the process of regulating CBD under the FDA has begun.
Cannabidiol: Healthy or Hokum
Cannabidiol, or CBD, is one of the active compounds found in Cannabis sativa L. plants. Along with over 100 other active compounds, proponents choose CBD with the intent of using it to support their endocannabinoid system in hopes of receiving health and wellness benefits. While rigorous, peer-reviewed studies and trials have been few and far between, existing studies and a wealth of anecdotal evidence points to CBD’s potential to improve users’ physical, mental, and emotional well-being. It is these attributed properties that prompted an FDA hearing on CBD in the first place.
Part of the reason for the lack of good data is that until recently, no distinction was made between industrial hemp, which CBD Oil is derived from, and marijuana. Thanks to a decades-long smear campaign, the Controlled Substances Act of 1970 effectively classified hemp as a Schedule 1 controlled substance with no therapeutic value. Controlled substances are harder to research due to increased cost and regulatory requirements. It was only with a test program included in the 2014 Farm Bill that was subsequently expanded and made permanent by the 2018 Farm Bill that industrial hemp was reclassified as separate from its psychoactive relative and allowed to re-enter polite society as a (mostly) federally-legal substance.
To get CBD oil, the leaves, stems, and flowers of the industrial hemp plant are harvested. These areas of the plant contain hemp oil that is rich in CBD and other terpenes. Unlike marijuana, industrial hemp contains less than 0.3% THC, so it is safe to use and won’t get you high. Once the oil is extracted, it is often formulated into other products for use. The range and availability of CBD products have exploded in recent years, and in a recent Consumer Reports study cited at the FDA hearing on CBD, indicated more than 1-in-4 respondents had tried CBD.
The job of the FDA is to protect consumers from not only unsafe products but also from wild therapeutic claims that have not been approved, and that safety responsibility is at the heart of the FDA hearing on CBD. It is meant to help avoid so-called “Snake Oil”–type scams where a substance is touted as a cure when it is ineffective and worthless. The lack of quality research into CBD’s efficacy at over-the-counter levels combined with claims by manufacturers based on the strong anecdotal reports has caused a loggerhead the FDA feels is dangerous for consumers.
In addition, the 2018 Farm Bill gave authority to regulate CBD and hemp products to the FDA, which has no regulatory framework in effect. The result has been chaos when it comes to accepted manufacturing practices and standards among growers, processors, and distributors. In this area, a regulatory framework is not only needed but overdue. The lucrative niche industry is attracting entrepreneurs and not all of them have the consumers’ best interests ahead of profits as their priority.
Takeaways From the Hearing
- The FDA Is Concerned About The Lack Of Research—While it was noted by one witness that much of the lack of research they decry can be partially laid at their own feet for the restrictive nature of research while listed as a controlled substance, the FDA hearing on CBD made it clear the time for limited research is past.
- The FDA Is Not Comfortable With the Unfettered Growth of CBD—How could they be? In an area where consumer safety is their responsibility, users and sales are skyrocketing without any roadmap to keeping the industry safe. While reputable manufacturers have been able to “police themselves,” the scale of the industry is already far too vast to allow market pressures to keep producers in line on all fronts.
- They Intend to Move Fast to Begin Regulation—The one solid action to come out of the FDA hearing on CBD was the creation of a working group to chart a path forward led by Amy Abernethy, M.D., Ph.D. A veteran of the FDA’s bureaucratic system, it is clear she is intended to roll up her proverbial sleeves and get right to the task at hand.
- But No One Knows What That Will Be—Right now the only consensus seems that something needs to be done about the Wild West environment surrounding CBD. Precisely what that something is, however, is unclear. While some favor limited oversight, other entities are seeking stricter regulation beyond that which is given to most dietary supplements. Under such a plan, CBD would enter a gray area that is neither prescription nor readily available.
What This Means Right Now
For our customers, you can continue to trust us to provide the highest quality CBD at reasonable prices. We feel confident our naturally grown industrial hemp, pharmaceutical-grade facility, and clean-room environments put us in the elite of CBD manufacturers. Right now we are doing business the same way today as we did before the FDA hearing on CBD. We do have one favor to ask.
The FDA is currently accepting public comments on CBD. Visit their public docket and take the opportunity to make your voice heard. They have indicated that much of their regulatory discussion will be directed by the will of consumers. Your comments could have a hand in crafting public policy about access to, manufacture of, and the legality of CBD.
We’re proud of our work making sure you have access to the top CBD products on the market. If you need additional information, you can always call and talk to one of our experts at (888) 506-1501. Stay informed on the issues affecting your CBD products by keeping an eye on the CoreCBD blog regularly.