In the years since the 2018 farm bill legalized industrial hemp and hemp extracts such as cannabidiol (CBD), the CBD industry has grown into a behemoth. However, the U.S. Food and Drug Administration (FDA) has consistently failed to provide regulations for the industry, allowing it to become a barely regulated space that has been called the Wild West.
After years of relatively little action, regulators are finally taking a look into the cannabinoid market, specifically cannabinoid-infused dietary supplements. Last week, the FDA’s Science Board embarked on an all-day review to discuss specific, complex scientific and technical issues important to the agency and its mission.
Ideally, these discussions would pave the way for crafting suitable regulations for America’s billion-dollar CBD market. But after years of the agency dragging its feet, industry stakeholders have little hope that the review will lead to tangible CBD regulations that would allow businesses to sell CBD-infused dietary supplements.
Missouri-based CBD manufacturer and retailer Vince Sanders says it’s difficult to get excited about the review. He attended the FDA’s first cannabidiol hearing in 2019 in Maryland and has witnessed the agency’s inaction around CBD firsthand. Even more, the FDA’s hearing notice didn’t specifically mention CBD.
The meeting involved external drug safety and nutrition experts who had an informational discussion about the challenges faced in evaluating food ingredients that have some kind of pharmaceutical application, such as CBD, and used cannabinoids as a case study.
Cannabidiol is an active ingredient in an FDA-approved drug called epidiolex that is used to treat seizures in children suffering from Dravet syndrome and Lennox-Gastaut syndrome. Outside of approving the CBD-based drug for medical use, the FDA has done little else to regulate CBD, especially in the dietary and wellness segments. The agency has also stated that it cannot regulate CBD in a nonpharmaceutical setting since it is an active ingredient in an approved prescription drug.
Although the notice didn’t mention CB, some cannabidiol producers have submitted comments to the agency. They hope the FDA will finally acknowledge the fact that the CBD industry is growing exponentially and desperately needs standardized regulations.
The director of regulatory affairs and quality assurance at Vantage Hemp Laura Eder says that players in the cannabis industry either regulate themselves via Good Manufacturing Practices (GMPs) or operate with complete impunity. Studies have found that a significant percentage of CBD products are either mislabeled or contaminated with fungus, bacteria, pesticides and heavy metals.
Some companies have also taken to making absurd and untrue claims about the medical abilities of their products. In recent years, the FDA’s only action regarding the CBD market has been to send such companies warning letters instructing them to desist from making such claims.
The entire cannabis industry, including companies such as Cannabis Strategic Ventures Inc. (OTC: NUGS), would appreciate comprehensive regulatory guidance regarding CBD products so that proper decisions can be made as to how to proceed in this segment.
NOTE TO INVESTORS: The latest news and updates relating to Cannabis Strategic Ventures Inc. (OTC: NUGS) are available in the company’s newsroom at http://cnw.fm/NUGS
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