The Hemp Industries Association (HIA), an organization focused on hemp standardization and legalization, blasted the FDA’s recent decision to pass on regulating cannabidiol (CBD).
“The FDA has been presented with reams of evidence that CBD is safe for consumption, yet they stubbornly cling to a few pharmaceutical studies that only show a risk if people ingest massive doses. All the hemp industry needs is for CBD to get a fair shake: let cannabidiol products be brought to market through existing dietary supplement and food pathways, which would amply ensure that consumer safety is protected,” the HIA said in a statement. “Unfortunately, they seem stuck in a Pharma-first mindset, which stifles innovation and chokes off end markets for hemp products. The notion that a whole new regulatory framework needs to be established for CBD—which has been safely sold to consumers for the better part of a decade—would be laughable, if the stakes weren’t so high for businesses, farmers, and consumers alike.”
The National Cannabis Industry Association also shared its disappointment with the decision after the FDA’s “protracted study” and expressed the need for Congress to step in.
“A vibrant state-regulated industry has formed to safely provide cannabinoid products and medicines to millions of Americans, which has the support of the vast majority of U.S. voters. Moving forward with bi-partisan federal cannabis reform this year would be both good public health policy and good politics,” said NCIA CEO and Co-Founder Aaron Smith.
Last week, after a multi-year study, the FDA determined that its existing foods and dietary supplement authorities are too limited to properly regulate CBD, which it said “raises various safety concerns, especially with long-term use.”
"The working group, which I chair, has closely examined studies related to the CBD-based drug Epidiolex, published scientific literature, information submitted to a public docket, as well as studies both conducted and commissioned by the agency. Given the available evidence, it is not apparent how CBD products could meet safety standards for dietary supplements or food additives," said FDA Principal Deputy Commissioner Janet Woodcock, M.D. "For example, we have not found adequate evidence to determine how much CBD can be consumed, and for how long, before causing harm. Therefore, we do not intend to pursue rulemaking allowing the use of CBD in dietary supplements or conventional foods."
While the federal government continues to slowly consider nationwide cannabis legalization, new laws are seemingly drawing increased public support. As the NCIA points out, a November 2022 Gallup survey found that 68% of Americans support making cannabis legal for adults and a recent Pew Research Center poll found that fewer than 10% of Americans still support cannabis prohibition.
In 2019, the NCIA outlined recommendations for four “regulatory lanes” for cannabis products, including CBD and other non-psychoactive cannabinoids.
The four lanes are: Pharmaceutical drugs; Ingested, inhaled or topically applied products with more than 0.3 percent THC; Ingested and inhaled products with 0.3 percent or less THC; and Topically applied products with 0.3 percent or less THC.