Cosmetic companies often find they are making drug claims on their product mainly due to two parts of the definition of a drug. First, a drug claim is any claim that the product has an intended use in the “diagnosis, cure, mitigation, treatment, or prevention of disease”. The next section of defining a drug says “articles (other than food) intended to affect the structure or any function of the body”. Foods (including dietary supplements) get an exemption when it comes to making a claim of affecting the structure or function, but cosmetics are not given this leeway. What then is a cosmetic?

A cosmetic must have a main purpose of “cleansing, beautifying, promoting attractiveness, or altering the appearance”. Okay, easy enough. Your new makeup setting spray does just that and even has SPF too! Not so fast. Any SPF claim or sunscreen claim falls under the definition of a drug. So your brand new product with SPF protection? This is actually a drug.

Having an OTC Drug Is Not the End of the World

Just because your product is considered a drug does not mean you should shy away from the main features of the product. The FDA has published a variety of blueprints for OTC drugs called monographs. A monograph pertains to a certain class of products (such as sunscreens, topical pain relievers, etc) and contains specific information the product must contain, like active ingredients, claims, testing parameters, and other labeling requirements.

So long as you follow the monograph for the class of product you have, you may market the product without an in-depth FDA review. This means no long, drawn-out (and expensive) clinical trials or drug approvals. All OTC drug products are, however, required to be listed with the FDA.

So don’t be so quick to ditch your claims of sun protection or relieving pain. Maybe an OTC is right for you.

Whether you need help in determining whether your claims cause your product to be a drug or you are ready to look into OTC drugs, call, text, or email and we are happy to help out.