Reduces Redness
An externally applied product intended to reduce redness is considered a drug. To actually reduce redness, the product must alter the function or structure of the body, which is the intended result of a drug.
On the other hand, a product that is intended to cover up redness is classified as a cosmetic. It’s important to understand that this product is not altering the body's function or structure, but rather changing its appearance. This distinction is key in the classification process.
Reality vs. Regulation
Remember that it is what the consumer thinks the product's intended use is. It’s entirely possible that the product could do something more or different than the intended use. There are formulations based on natural substances which have traditionally been used to soothe reddened skin. However, none of them are approved as a cosmetic treatment for redness.
Rightly or wrongly, only products approved as drugs for treating redness can claim that they will or can reduce redness.
It's important to note that even if a product meets the requirements, it must be manufactured in a facility registered as a drug manufacturer with the FDA. This facility must adhere to the good manufacturing practices detailed in federal drug manufacturing regulations. Additionally, there are likely state-level drug manufacturing registration and licensing requirements. Compliance with these regulations is crucial for the legal marketing of a product.
