Despite the absence of a FDA regulatory framework for CBD containing products, it is clear that regulatory oversight of the category is coming. In the meantime, SafetyCall is supporting manufacturers that are currently in the market with a suite of product safety related services to help them document and confirm the safety profile of their products and to ensure that they are safe for their intended use.
SafetyCall is closely monitoring the potential passage of federal legislation and/or regulatory rulemaking regarding CBD containing products and we are anticipating that post-market surveillance requirements including mandatory reporting of serious adverse events will be a prominent component of FDA oversight. We also expect that adverse event monitoring requirements will likely be similar to those in place for OTC drugs and dietary supplements. Independent of a company’s product stewardship responsibilities, having a robust post market surveillance system in place will ensure immediate compliance once FDA takes action to regulate this market. To that end, SafetyCall clients will be compliant day one!
