MoCRA Pitfalls! OTC Drug Actives Edition

In preparation for listing your products with the FDA, it is important to double-check the use of any OTC ingredients in your products. While Titanium Dioxide, Dimethicone, and Salicylic Acid have multiple potential functions in a formula, there are others that *do not* such as Benzoyl Peroxide or Fluoride.

If you are notifying a face wash with Benzoyl Peroxide, regardless if you are making acne claims, or if you are notifying a cosmetic toothpaste with Fluoride, you may face heightened scrutiny from the FDA if they review the data submitted in the portal for non-compliance.

The best way to avoid this situation is to conduct a regulatory review of your formulas. IRI-Sys can help.