In the wake of FDA announcing its intent to hold a public hearing on May 31st, it is more important than ever to separate fact from fiction regarding CBD. While industry continues to state "trust the process" when it comes to CBD, a path forward is already available that does not require countless meetings and the drafting of position and policy papers. Section 301(ll) provides the legal means of moving forward with permitting the addition of CBD to foods. Specifically, 301(ll) authorizes FDA to specially permit the addition of any FDA-approved drug or a drug that was the subject to substantial clinical trials prior to the ingredient introduction into foods. In essence, FDA already has a mechanism in place to issue such regulation. It is called the food additive process.
Regardless, the law specifically allows FDA to contemplate approval of an ingredient for use in food. Obviously, there are requirements to be fulfilled.
- The company would need to establish the safety of the ingredient to be consumed on a daily basis
- The company should demonstrate that at the ingredient levels present in the food product would not have the same risks associated with it as the drug
How do we move forward? This is the time for compilation and filing of significant safety data for FDA approval rather than hiding behind legal theories, some merited and others that are simply pie in the sky.
Speaker
Todd Harrison, Partner, Venable LLP
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