During a recent webinar conducted by officials from the FDA, comments regarding the legal future of CBD indicated that the path forward might be lengthy and arduous.
Since its introduction into the mainstream market for alternative health and wellness offerings, CBD or Cannabidiol has generated equal parts lucrative sales, a loyal consumer base and controversy. Derived from the hemp plant, which Congress delisted from the Controlled Substances List as part of the 2018 Farm Bill, CBD has gone from a fringe elixir and topical treatment for maladies including anxiety, chronic pain, and crippling epilepsy to a multi-billion dollar industry in a matter of five years.
That rapid explosion in growth has translated into big business for farmers, manufacturers, and retailers in the hemp industry. According to an analysis conducted by Precedence Research, the global CBD market generated $15.88 billion in revenue in 2022. Furthermore, researchers anticipate that number to exceed $62 billion by 2032.
However, those enticing projections depend on several regulatory and compliance initiatives that industry stakeholders hope will take CBD from a largely unregulated hemp-derived novelty item to an FDA-approved food and dietary supplement. During a recent webinar conducted by the FDA regarding the future of CBD in America, agency officials indicated that resolving safety issues and setting a legal path forward for the enigmatic cannabinoid, if it occurs at all, could be a long and difficult one.
As first reported by HempToday, the comments shared by senior advisors from the FDA left many invested industry advocates and stakeholders in the webinar somewhat discouraged.
One of those agency representatives, Norman Birenbaum, a senior advisor and the FDA's cannabis expert, noted that the process of resolving all of the outstanding issues concerning CBD rest first and foremost with Congress.
His sentiments reinforce a familiar party line from the regulatory body, which sent a letter to Congress in January, effectively passing the regulatory buck for CBD to Capitol Hill.
The agency said there needed to be more information about the safety of CBD products to properly regulate them as foods or supplements under the FDA's current structure.
In a separate statement, FDA Deputy Commissioner Janet Woodcock said, "A new regulatory pathway would benefit consumers by providing safeguards and oversight to manage and minimize risks related to CBD products."
"A new regulatory pathway would benefit consumers by providing safeguards and oversight to manage and minimize risks related to CBD products."
- FDA Deputy Commissioner Janet Woodcock
Birenbaum's comments were almost identical to those of Deputy Commissioner Woodcock. Keen to tow the overriding agency strategy and philosophy, Birenbaum hammered the point that Congressional leaders must determine if CBD and other hemp-derived cannabinoids are inherently legal before the agency can begin formulating a regulatory framework for establishing safety and compliance protocols.
He said, "We understand the urgency of establishing a regulatory framework for these products and providing regulatory certainty to consumers and industry. Historically there's been bi-partisan interest in addressing this issue, particularly as the market has evolved."
"We understand the urgency of establishing a regulatory framework for these products and providing regulatory certainty to consumers and industry. Historically there's been bi-partisan interest in addressing this issue, particularly as the market has evolved."
- Norman Birenbaum, Senior FDA Advisor and cannabis expert
However, if and when Congress acts to establish legality parameters for CBD and other hemp products, the necessary FDA rulemaking to follow in creating that regulation infrastructure could be a rather lengthy process.
According to another FDA official in attendance, Patrick Cournoyer, a Senior Science Advisor who leads the agency's Cannabis Product Committee, the FDA wants to promote a "harm reduction" approach to hemp-derived cannabinoids, ensuring the type of safety controls consumers have come to expect from the regulatory body.
There are still many concerns over the potential health impacts presented by CBD. For its part, the agency began researching the effects of CBD on consumers in 2019 by conducting some internal toxicology studies while reviewing the existing research and monitoring "adverse event" reports by consumers.
That due diligence on the part of the FDA generated significant alarm internally regarding the potential safety of CBD, especially concerning its potential harm to the liver and male reproductive system, adverse interactions with certain medications, and effects on vulnerable population groups and pregnant women.
Officials like Cournoyer envision a new pathway to establish a separate category for CBD and other hemp-based cannabinoids. This grouping would exist outside the current ones of drugs, food, and food supplements for which the FDA sets rules.
Under this cannabinoid-specific regime, Cournoyer said the agency could set guidelines for content limits, truth in labeling, full disclosure of ingredients in product offerings, assurances of zero contaminants, and measures to keep children from accidentally ingesting items.
Assuming Congress takes the initiative to address the concerns outlined by the FDA and passes legislation clearly defining what is and what is not legal regarding CBD and other hemp-derived cannabinoids, the actual creation of rules to monitor their safety will take some time to implement, according to Cournoyer and his colleagues.
Cournoyer concluded by saying, "These types of safety red flags are . . . not what we normally see for typical food ingredients like sweeteners or preservatives or emulsifiers. The safety concerns we're seeing set CBD apart from some of the more run-of-the-mill types of food ingredients."
"These types of safety red flags are . . . not what we normally see for typical food ingredients like sweeteners or preservatives or emulsifiers. The safety concerns we're seeing set CBD apart from some of the more run-of-the-mill types of food ingredients."
- Patrick Cournoyer, Senior FDA Science Advisor
Because of those red flags and the growing evidence of potential safety hazards, the FDA is committed to taking it slow to ensure the prioritization of consumer health above the economic pressure applied by industry stakeholders. Unfortunately, the waiting game will continue for those in the hemp/CBD sector stuck in regulatory and legal limbo.
Hopefully, with the Farm Bill coming up for renewal later this year, lawmakers can address the legality issues put forth by the FDA. If not, the CBD hot potato will continue bouncing from one governmental body to another while small business owners and consumers foot the financial and safety bill.
