CBD policy proposal: One Hemp urges Congress to classify CBD as dietary supplement

08 Dec 2023 --- The One Hemp coalition advised the US Congress and the FDA this week on a policy solution to create a regulatory framework for CBD or hemp-derived products as dietary supplements. The congressional session was followed by a stakeholder briefing in Washington, DC, to inform the broader public about the outcome.

“What the proposed policy solution suggests is definitionally regulating non-intoxicating hemp-derived products, including those that have no concentration or synthesis of any cannabinoid in the product and are ingestible and marketed as dietary supplements,” Kelly Fair, strategic advisor of One Hemp and US Cannabis and Hemp Group Partner, Dentons, tells Nutrition Insight, and briefing attendees.

The proposition does not prohibit anything that falls outside the definition. Inhalable products and intoxicating hemp-derived products would not be included in the regulation and will fall under other applicable regulations.

“The second piece, which is critical and addresses our key stakeholder, the FDA’s concerns, is a requirement that these products are labeled with warning disclosures for known and unknown risks identified. The FDA has done a fantastic job over decades of regulating dietary supplement products with warning statements and consumer disclosures,” Fair says.

“The third component is meeting the market where it is today, five years later from legalization and relying on the science. The proposal is to allow products with a 100 mg of hemp-derived cannabinoids, including CBD, or less to remain on the market and be sold without any further FDA scrutiny, recognizing that those products with appropriate labels are safe to be sold as dietary supplements.”

CBD power
The coalition, composed of the Coalition for Access Now, US Pain Foundation, Balanced Veterans Network, ToxStrategies and Dentons, was formed in September to push the FDA to further regulate hemp-derived CBD products as dietary supplements.

According to Fair, the coalition was able to simplify CBD supply chain fracturing to Congress because of the lack of regulation in the segment. Manufacturers have provided the FDA with data on reproductive toxicity, liver toxicity, drug interaction, minor exposure and vulnerable population exposure to assist with enacting the necessary regulation.The One Hemp coalition feels positive that an agreement will be reached with Congress and the FDA that will lead to the formation of a regulatory framework for the production and sale of CBD.

“The USDA did a great job of stepping in early after the farm bill legalized the commodity to regulate the crop. The states have piecemeal, along the way, tried to regulate the finished goods through manufacturing standards, among others. But where the supply chain breaks entirely is by lack of federal regulation,” Fair explains.

“It bottlenecks at the traditional retail point of distribution for non-intoxicating hemp-derived products, including CBD. Without federal regulation, traditional retail, large grocery and traditional pharmaceuticals won’t sell the products.” 

“They want to sell the products — the consumers are demanding the products. But until the FDA blesses these products as dietary supplements or otherwise, that point of distribution is constrained,” says Fair.

Farmers, especially those who invested in diversifying their portfolios in 2019 — when the market took off — are disempowered because they do not have a market to sell their inputs. At the other end of the spectrum, consumers who use CBD products for wellness and health are not getting the best in market solutions.

The coalition has proposed a standalone bill to address all stakeholder concerns and that of the FDA. “It creates a clear distinction between what would be CBD dosing or hemp-derived dosing at a dietary supplement level versus a pharmaceutical,” says Fair.

“That becomes critical and it doesn’t create this back door for then legalizing all cannabis products because it doesn’t allow for the concentration or synthesization of a cannabinoid.” 

The case from chronic pain
The briefing is part of a broader effort to urge the committees of jurisdiction in Congress — House Energy and Commerce and Senate HELP — to move ahead with marking up legislation on CBD regulation.

Earlier this year, the FDA received criticism for its lack of regulatory action on CBD, as organizations sent testimonies questioning how there could be a lack of CBD laws when dietary supplements became part of the administration’s regulation three decades ago. 

“I’m a veteran of the US Air Force, where I served as a Security Forces member for a little more than 14 years before a series of unfortunate surgical events led to my medical retirement in late 2012,” says Jennifer Baxter, executive director of the Balanced Veterans Network.

“I am here to be the voice of all veterans who rely on alternative therapies as a vital tool for their healing and wellness. Many veterans have found relief in healing through the use of CBD. The over-prescription of pharmaceutical medication has led many veterans to seek alternative therapies to reduce or eliminate toxic pharmaceuticals. They’re finding actual relief and healing through the use of alternative therapies such as CBD.”

“It is no secret that we face a severe epidemic of opioid addiction and veteran suicides with the daily number of veteran suicide, actually closer to 44 veterans a day as determined through an intensive substantial study deemed Operation Deep Dive. The regulation of CBD is essential for the safety and protection of veterans who have incorporated this into their lives.”A dosage recommendation of 70–100 mg has been scientifically reached within the coalition and presented to Congress.

The current lack of regulation presents significant safety and reliability concerns for chronic pain sufferers, such as veterans, among others. 

“Myself nor the veteran community did not transition from toxic pharmaceutical medications to a natural approach where I must worry about harmful and dangerous substances including heavy metals, toxins and pesticides,” Baxter emphasizes.

Descheduled and still in limbo
Hemp was descheduled by Congress in 2018, but nearly five years later, a broad range of hemp-derived CBD products are sequestered to a regulatory “no man’s land.” 

Scientific consulting firm ToxStrategies presented the findings of its latest analysis to Congress and set a recommended dose of 100 mg to include in the regulatory framework. 

Dr. Rayetta Henderson, foods and consumer products, senior managing scientist at ToxStrategies says: “I want to highlight that we not only use a comprehensive approach — meaning that we assessed all publicly available data across human clinical trials. We also did so across studies available in animal models.”

“We use a systematic approach to do this review of the data. Systematic has a very specific connotation and meaning in the world of evidence-based science and toxicology. It means that we systematically reviewed the data and did that according to established criteria.”

“Dietary supplements enable us to assess safety and derive limits for special populations because supplements can and should have adequate and proper labeling for their product, including warning statements. This enables us to look more specifically at the intended use of the products,” Henderson says.

The researchers used guidelines from the FDA, the World Health Organization and the European Food Safety Authority. The main parameters were determined for liver and reproductive effects and they arrived at a recommendation of between 70 and 100 mg.

By Inga de Jong