Is it a Drug, Medical Device, Cosmetic, Soap or Both?


FDA regulations can be daunting. The first step in meeting regulatory requirements for a new or in-development product is to property categorize it. Many clients have come to us with miscategorized products and misconceptions about the regulatory environment. It can be confusing. Product ingredients, intended use, and the way its marketed can define the product's categorization and thus the way its regulated. A good place to start is the FDA's website for regulatory basics.

Give us a call or email and we can walk you through the basics to get you started, however, we recommend regulatory advice be verified with 3rd party regulatory consulting services.