The US Food and Drug Administration (FDA) aims to keep cannabis products safe for Americans.
In the CBD market, there are grey areas and loopholes in FDA rules, leaving the territory open to both legal businesses and “snake oil” salesmen in a billion-dollar sector. That, though, could change.
On Friday, May 31, the FDA held its FIRST public meeting to assess the CBD industry’s current and future directions.
“While there has been a surge in interest in CBD-infused products, there is still a lot we don’t know,” said FDA acting commissioner Dr. Ned Sharpless.
800 people registered for the FDA’s first CBD public meeting, which was broadcast live over the internet, and 500 people attended the meeting in Silver Spring, Maryland. Scientists, small company owners, medical professionals, and consumers were among those who took part. A total of 100 people gave their testimony. Key regulators, as well as the makers of Epidiolex, the first FDA-approved CBD medicine to treat a rare form of epilepsy, were in attendance.
The goal of this inaugural public hearing on cannabidiol (CBD) was to take the first step in former FDA Commissioner Scott Gottlieb’s strategy to create a framework for the legal distribution of suitable cannabis and cannabis-derived goods.
The Farm Bill has altered the landscape of CBD regulation.
Following the passage of the 2018 Farm Bill, the hearing was unavoidable. It introduced a new category of cannabis known as “hemp,” which is defined as “cannabis and cannabis-derived goods containing extremely low quantities of THC,” the psychoactive component commonly associated with cannabis. THC content of less than 0.3 percent on a dry weight basis was included to the definition of “low.”
Hemp was also removed from the Controlled Substances Act as part of the 2018 Farm Bill, making it no longer a federally controlled substance. Similarly, Congress upheld FDA’s power to regulate cannabis and cannabis-containing goods under the Food, Drug, and Cosmetic Act (section 351 of the Public Health Service Act), recognising FDA’s critical public health role in the products it oversees. The Food and Drug Administration was able to keep enforcement actions in place to safeguard patients and the public, while simultaneously establishing regulatory guidelines and paths for stakeholders.
CBD products have since grown into a multibillion-dollar business. Cannabis components are already present in a variety of foods, beverages, dietary supplements, animal products, confectionery, syrups, oils, skin patches, and other products.
CBD product sales are expected to reach $22 billion by 2022, according to estimates. Because of the surge in retail sales, the FDA must act rapidly to establish regulatory standards for stakeholders.
Identifying the Difference Between Snake Oil “Hype” and Evidence-Based Research
Ten hours of arduous testimony aimed at separating “snake-oil” hype from legitimate research yielded no answers to any of the FDA’s pressing challenges. Stakeholders, on the other hand, raised concerns about issues related to regulation and safety. Lead contamination was found in 34% of the CBD samples tested, inconsistent amounts on labels vs. what was in the product, a lack of evidence-based dosing guidelines, unfounded claims made by purveyors, and a lack of quality standards were all cited as obstacles to gathering the necessary information.
FDA received the message that the audience was not prepared to respond to the evidence-based questions FDA was seeking.
FDA sought clear evidence on outcomes, dosage guidelines, expiration dates, manufacturing standards, threshold limits, and safety concerns—data that stakeholders were not willing to supply since they appeared to be unfamiliar with the research landscape.
There were plenty of testimonials about observational data or personal anecdotes, but not the type of evidence-based data that the FDA was looking for. They argue that testimonials are frequently turned into “snake-oil” hype, with no evidentiary requirements and merely variable-infested personal anecdotes that may not effect others in the same way and are not repeatable in a research context.
The FDA is looking for a slew of credible research backed up by scientific data. While numerous exploratory studies have shown promise, they are insufficient to designate the molecule as an active ingredient at this time.
There were just as many proponents of the CBD craze as there were Reefer Madness-style doubters at the meeting, which left the FDA with plans for follow-up reviews. We compiled a quick summary of the hard 10 hours to help us make sense of it all.
6 Meeting Take-Home Messages EXPERIENCE THE PAIN RELIEF REVOLUTIONTM
After all was said and done, the public hearing yielded six messages:
1. There is a need for more credible studies.
We appear to be in the Wild West of CBD sales, with personal testimonies dominating the landscape. Some vendors are taking advantage of the absence of control to flood the market with questionable goods. Untrustworthy stakeholders fail to collect information on the quality or outcome of their products. The CBD landscape is a jumble of laws where everything goes. This strategy must alter in order to ensure that all consumers receive a safe and high-quality product with minimal adverse effects.
“Regulators are now pressing FDA to overcome the legislative difficulties and properly provide a legal road for CBD products to reach the marketplace,” according to the New York Times.
2. Consumers have no way of knowing what is a genuine product.
Consumers who are familiar with the sector still have difficulty deciding which CBD brands to trust. Consumers just have no way of knowing what “snake oil,” “vegetable oil,” or even cough syrup is. Stakeholders must provide greater leadership and data in this regard.
CBD MEDICTM is the first of a select group of CBD-blend products to get an OTC monograph. The items may be trusted since they are manufactured and audited in a Current Good Manufacturing Practice (cGMP) facility to assure high-quality control standards.
Unfortunately, this isn’t the case for many CBD-infused goods.
The FDA now intends to tighten its grip on consumer protection. While there are those who oppose tighter rules, it is undoubtedly in the best interests of a public that has become accustomed to being fooled.
3. Many people are still unaware of the benefits of CBD.
People don’t know what CBD is, which contributes to the widespread uncertainty in the marketplace. Cannabinoids are one of many natural substances found in cannabis plants. Along with THC, the psychotropic chemical, cannabidiol (CBD) is one of the cannabinoids. However, the public is unaware of the distinctions due to a nearly century-long ban.
Many people believe CBD is psychotropic, that it exclusively comes from the marijuana plant, that it might cause addiction issues, and that it is illegal. CBD, on the other hand, is the plant’s non-psychoactive ingredient, which is non-addictive and generally deemed harmless by most consumers.
CBD may be derived from both marijuana and hemp plants (Cannabis sativa L.). The distinction is that the marijuana plant includes THC, a psychotropic chemical that is federally regulated, whereas the hemp plant contains no THC or just trace levels of it.
4. Cannabidiol (CBD) Safety and Consumer Protection
The FDA’s conference came to a close with a request for further evidence on safety concerns. What are the safety standards for youngsters, what are the dosage thresholds, and what about women who are pregnant or breastfeeding? Epidiolex’s creators emphasised that they were unaware of the likelihood of liver involvement until they conducted their safety investigations. Former FDA Commissioner Scott Gottlieb also worries about the long-term effects of CBD that have yet to be addressed.
However, the World Health Organization (WHO) stated last year that CBD is generally well tolerated, has a favourable safety profile, and has no addictive properties. However, it did highlight the potential for medication interactions, which needs to be investigated further.
5. Side Effects Concerns and the Use of Anecdotal Evidence
Personal experiences have propelled CBD to the top of the sales rankings, but personal stories do not — and are not intended to — constitute evidence of linked negative effects. Hard data on potential negative effects from both short and long-term use is what the FDA wants and needs. Differences in outcomes/side effects of different modes of delivery, whether oral, inhaled, or swallowed, are another cause for concern. Routes of administration, according to some speakers, can alter dose guidelines, side-effect profiles, and outcome expectations.
Dietary supplements, medical claims, and cosmetics are all on the list.
CBD supplements are currently prohibited to sell. This product is not authorised to make any medicinal claims until it goes through the same drug review process as other derivatives like Epidiolex.
Non-pharmacological CBD products have yet to be recognised as having a therapeutic effect at the federal level, and none can be advertised because there is no proof to back up the claims. It’s not so much that CBD has no therapeutic impact as it is that we have yet to demonstrate that an effect exists in a therapeutic capacity in the dosages offered in a genuine series of trial designs.
The ability to supply this information to the FDA will distinguish “snake oil” sellers from those selling a high-quality CBD product with established efficacy and safety. The importance of clearly needed standardised guidelines in providing the data sought cannot be overstated.
Remarks at the End and the Future Agenda
The FDA’s main concern is the marketing of items that may endanger consumers’ health and safety, as well as the sale of unapproved drug products with unfounded claims.