FDA Sends Cannabis Guidance to the White House

CBD and the FDA: Regulatory Update

In the past few months, coronavirus has fully captured the FDA’s attention. The tall task of managing a pandemic across the country has postponed any movement on cannabis regulation, or so we thought. That all changed last week. The Food and Drug Administration submitted draft guidance on marijuana and CBD research last week to the White House Office of Management and Budget (OMB). Details about the document — titled “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research” — are sparse. But an FDA spokesperson indicated that it’s related to the agency’s ongoing work to develop broader CBD regulations that could eventually allow for the marketing of cannabis products as dietary supplements or food items.

“We recognize that there is substantial public interest in marketing and accessing CBD for a variety of products. We are working toward a goal of providing additional guidance, and have made substantial progress,” the FDA said in a statement. “There are many questions to explore regarding the science, safety, effectiveness and quality of products containing CBD, and we need to do our due diligence.” The statement continues, “As part of our work, the FDA continues to explore potential pathways for various types of CBD products to be lawfully marketed.” 

It’s not clear how long the OMB review will take or when the document will be finalized for public release. In the meantime, the FDA is maintaining enforcement discretion when it comes to action against companies that sell CBD products regardless of the lack of regulations and has said it is currently targeting sellers that make especially outlandish or unsanctioned claims about the therapeutic value of their products.

Navigating The Current State

As we continue to talk to brands throughout the industry, we have noticed a few successful marketing tactics to avoid FDA scrutiny. Most brands are guided by the FDA’s previous statements stating that brands can market CBD as the active ingredient, however, cannot promote the health benefits. A number of these brands are acting on the forefront of regulation by communicating with the FDA directly through dedicated representatives. Another avenue some brands are taking is to entirely remove the term “CBD” from their marketing. Instead, their products are labeled “Hemp Extract”.

As more large retailers, like Whole Foods and CVS, are stocking CBD products on their shelves, the writing is on the wall for the FDA to open the market. Hopefully, we will hear from them soon with a defined CBD classification and clearly established regulations. With that, confusion in the market will clear up, allowing uninhibited growth.

BDX Update: Supercritical CO2 Extraction

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