Eczema & Psoriasis
Eczema and psoriasis are skin conditions that cause itchiness, redness, rash, and/or scaly patches. They are considered physical diseases, and any product that is intended to treat, mitigate, prevent, alleviate, or reduce them is a drug. Even claiming to reduce the redness associated with them causes the product to become a drug.
OTC External Analgesic Products
There are non-prescription products on the market to treat or relieve eczema (skin protectants) or psoriasis. They often look like cosmetics but are, in fact, over-the-counter drugs. To be legally made and marketed, they must comply with the applicable OTC Monographs (M016 and NM900, respectively).
Reality vs. Regulation
The truth is that there are formulations based on natural substances that have traditionally been used to treat or alleviate – or at least not worsen – eczema or psoriasis outbreaks. However, fairly or unfairly, the regulations only allow a product to be marketed to treat eczema or psoriasis if it has been proven by direct clinical tests and drug approval or by meeting the requirements of the applicable OTC Monograph.
Remember, it is what the consumer thinks the product's intended use is. As soon as you use the words “eczema” or “psoriasis” in relation to what your product could do or why someone should buy it, you have left the world of cosmetics and entered the world of drugs.
It's also important to note that any drug 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.
