While you can’t blame them for trying, their application just didn’t pass muster with the U.S. Food and Drug Administration. CBD manufacturer Charlotte’s Web, based in Colorado, recently tried and failed to have one of its products marketed as a dietary supplement.
The FDA ruled that Charlotte’s Web could not market its “Full Spectrum Hemp Extract” as a dietary supplement because CBD is already the active ingredient in the company’s epilepsy treatment Epidiolex — to date the only FDA-approved drug derived from cannabis. In addition, the FDA was not satisfied with the safety studies that Charlotte’s Web provided:
• Two years of marketing for the product was submitted as evidence of history of use, which the FDA ruled was “insufficient to established the safety of your ingredient when used under the proposed conditions of use.”
• A study was submitted to show there were no observable adverse effects from using the product, however the FDA rejected the study as Charlotte’s Web did not provide the underlying data.
• None of the other studies provided by Charlotte’s Web addressed the issue of whether or not CBD affects the liver or the reproductive system.
While Charlotte’s Web is contesting the FDA’s decision, it does not affect the many other products they currently market. But it does illustrate the wish from manufacturers for more clarity from the FDA on marketing products as dietary supplements. And that’s drawn the attention of the Senate, where it’s been formally noted that the FDA is yet to issue long awaited final rules for hemp-derived CBD.
Earlier this year, Senators Ron Wyden (D-Oregon) Rand Paul (R-Kentucky) and Jeff Merkley (D-Oregon) introduced a bill that would allow for CBD to be marketed in dietary supplements as well as in foods and beverages. Called the Hemp Access and Consumer Safety Act (S.1968), the bill is currently in committee. A similar bill in the House, the Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act (H.R. 841) from Representative Kurt Schrader (D-Oregon) is currently in subcommittee.
The FDA’s CBD priorities appear to be enforcement of misleading and false health claims, such as claims CBD products can treat diseases like COVID-19, or provide pain relief — of which there is unfortunately no shortage. Unless they provide a clear regulatory framework soon, don’t be surprised if Congress decides to step in.