MoCRA Pitfalls! Optional Requests Edition

In preparation for listing your products with the FDA, it is important to understand what is required and what is optional.

Cosmetics Direct, the product listing portal, is based on the OTC drug portal. Product labels are required to be submitted as part of an OTC drug registration, but to date are considered an optional document for a cosmetic product notification.

If you choose to submit your labels as part of your product notification, you should conduct a regulatory review of your product label to ensure that it complies with the FDA's cosmetic labeling and doesn't make any claims that would cause your product to be misbranded. IRI-Sys can help.