In product manufacturing, cosmetic products are classified differently than drug, also known as over-the-counter (OTC) products. Cosmetic products are face and body products that enhance appearance, including makeup, body lotion, fragrance, and shampoo/conditioner. However, some cosmetic products make therapeutic marketing claims. Thus, in the eyes of the Food and Drug Administration (FDA), are classified also as OTC. OTC products have a rigorous set of regulatory requirements. Moreover, they are subject to a formal FDA approval process before being brought to market. For this reason, it’s crucial salon owners and beauty brands work with a reputable product manufacturer that can navigate this complex process. In this blog, we’ll share how to get FDA approval for cosmetics when they overlap as OTC products.
According to the FDA, cosmetic and OTC products overlap when the product makes a therapeutic claim. For example, a leave-in hair product that claims to treat dandruff is considered both a cosmetic and an OTC product. In contrast, a “clarifying” shampoo that regulates scalp sebum production is only considered a cosmetic product.
Other therapeutic claims for beauty and personal care products might include treatments for acne, dry skin conditions, and sun protection. These types of products are heavily regulated and must pass a strict FDA approval process. FDA requirements for OTC products include specifications for labeling, active ingredients, and testing. These specifications ensure safety and efficacy standards are met to endorse marketing claims.
Bringing your OTC cosmetic products to market involves a complex regulatory process that advises consumers on using them safely. Now that we know the difference between cosmetic and OTC classifications and when the two overlap, let’s review the FDA’s requirements for overlapping products.
There are two pathways to FDA approval for cosmetic products that overlap with OTC requirements. The first is through OTC Drug Monographs, which are existing “recipes” the FDA provides. These recipes include pre-approved ingredients, concentration dosages, and labeling specifications. Monographs are the faster option of the two approval processes. No further FDA approval is needed as long as your product meets the relevant monograph’s requirements.
The monograph approval process consists of three simple steps:
If your product doesn’t fit into an existing monograph, you must submit a new drug application (NDA). You’ll need to gather extensive quality control and quality assurance data to support your submission. Here’s a brief overview of what the NDA approval process looks like:
As you can see, the monograph approval process can bring your cosmetic OTC product to market much faster than the NDA process for new drug products. However, there are also a few other requirements the FDA calls for, regardless of which process ensues.
Navigating the FDA’s complex regulatory process is a tall and daunting task. As stated above, it’s essential to work with a reputable, GMP-certified product manufacturer that can lead you through this multifaceted process. When it comes to how to get FDA approval for cosmetics, especially when your cosmetic products make therapeutic claims and overlap with OTC requirements, trust Allure to show you the ropes the way they have successfully done for over seven hundred satisfied brands. Allure’s success in product development and manufacturing is showcased by its collection of top-selling beauty and personal care products dominating the industry today. To inquire about the best way to approach your product idea, submit a Product Request Form on our website today and we’ll be in touch.
