尽管FDA监管框架的缺失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.
Like other product categories under FDA jurisdiction, there is an expectation that manufacturers and responsible persons have systems in place to effectively monitor the safety of their products. SafetyCall’s primary mission is to promote good product stewardship through our unmatched professional experience and expertise in adverse event surveillance. Our focus is on establishing a standardized system for documentation and assessment of adverse events involving CBD products SafeyCall’s approach allows for unbiased post-market surveillance which helps our clients identify expected or unexpected use patterns or conditions that may impact the safety of their product.
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!
|Regulatory Agencies||Applicable Federal Laws|
|Food and Drug Administration (FDA)||Not Applicable|
Principles of a Best Practice Post-Market Surveillance System
- Ensure that pre-market assessments or beliefs of inherent safety are realized during consumer use of the product.
- Ensure known safety concerns have been identified and considered, as well as stated on product warning labels.
- Ensure the post-market surveillance system is sufficiently sensitive, such that potential threats or safety concerns would likely be included in the monitored events.
- Ensure the system is sufficiently specific to allow detection, differentiation and ultimately determination of real vs. perceived threats.
- Identify intended and unintended patterns of use which may potentially contribute to unintended effects.
- Allow assessment of product performance by itself or in the presence of other products or substances.
- Help ensure that effects in unique populations are considered when monitoring safety.
- Further define, document and confirm a relative safety profile for the product during real life conditions of use.
Cannabidiol (CBD) manufacturers should also be aware of the following compliance obligations:
- Causality is not a prerequisite for tracking and reporting adverse events associated with the use of CBD products.
- Understand that consumers will most likely report adverse events directly to the manufacturer. This means that manufacturers need to implement additional processes for differentiating between those adverse effects which may represent a potential safety concern from those having nothing to do with the use of the product.
- Be aware of “background noise” involving adverse events not related to product use.