NPA supports draft CBD legislation on “long overdue” US safety levels

16 Jul 2021 --- The Natural Products Association (NPA) is welcoming new draft legislation from the US Senate that directs the Food and Drug Administration (FDA) to set an upper limit for a safe daily consumption level of CBD products.

“This is excellent news for the industry. Setting a safe level of consumption for CBD products is long overdue,” Kyle Turk, NPA’s director of government affairs, tells NutritionInsight.

“It is the best path forward to ensure consumers’ safety and provide the industry with the regulatory clarity it desires. We are excited to continue working with the FDA and Congress to ensure the market has safety standards for CBD products.”

Clearing the regulatory fog
In the US, cannabis regulations and CBD legality vary from state to state. Crucially, the FDA affirms it is currently illegal to sell CBD by adding it to a food or labeling it as a dietary supplement. 

CBD has only been approved so far in one drug, not as a dietary supplement. The approved drug, Epidiolex from GW Pharmaceuticals, is used to treat two severe forms of epilepsy in children.

Introduced in May, the Hemp Access and Consumer Safety Act aims to ensure hemp-derived CBD products are regulated by the FDA like other legal products used in F&B and dietary supplements.

Introduced by Senator Chuck Schumer (D-NY), the bill’s CBD safety level provision would decriminalize cannabis at the federal level.However, the new provision is part of a broader bill called the Cannabis Administration and Opportunity Act, which builds on the aforementioned, but goes further by requiring a threshold for the level of CBD used in a dietary supplement. 

“While we still believe dietary supplements and foods should be under one piece of legislation. This is a positive development for consumers who use these products every day,” comments Dr. Daniel Fabricant, president and CEO of NPA. 

Estimates for safe consumption levels
Turk looks to Europe for regulation inspiration. In the UK, the Food Standards Agency (FSA) advises healthy adults to take no more than 70 mg of daily CBD. 

“Here in the US, the NDI process specifies that data has to be provided to the FDA on the safety of a new dietary ingredient 75 days prior to market [entry]. So the FDA will need to rely on presently available data to determine what an upper limit would look like,” Turk explains.

He calls out “entirely false” criticism that once the FSA decides on a safety level, it will not have the flexibility to amend the upper limit.

“The [FSA] is absolutely able to establish and then amend an upper and lower limit as data becomes more readily available to them. If foreign agencies like the FSA can make a determination, then so can the FDA.” 

Moreover, the FSA clarified criteria for safety certifications in novel foods last November. Overall, the UK CBD sector is estimated to be worth US$1 billion, where sales exceeded 2021 expectations this year.

Will it pass?
When asked how likely it is the Cannabis Administration and Opportunity Act will pass, Turk responds: 

“Regardless of whether this bill passes in its current form, it is clear that our approach to regulating the CBD industry – setting a safe level of daily consumption – shows the most promise.”  

“This will allow Congress the opportunity to amend other pieces of legislation that attempt to address CBD regulation. We believe these provisions will continue the conversation that the best path forward for consumers and the industry is setting a safe level of daily consumption.”

By Anni Schleicher