Last Updated on September 29, 2022 by Ithos Global Regulatory Team
Cosmetic Companies Should Be Aware of FDA Regulatory Considerations for Microneedling Products
Despite its growing cosmetic popularity, the Food and Drug Administration’s current micro-needling guidance grants marketing authorization for a limited number of medical devices for specific uses in specified areas of the face and body. This means cosmetic companies may not be meeting the medical device requirements. Current FDA guidance only pertains to microneedling of the face and abdomen. Furthermore, if a microneedling instrument (manual or motorized) does not penetrate the living skin layers (epidermis and dermis) it would not be considered a medical device under current FDA definition. It is important that any cosmetic company considering microneedling accessories consult the full guidance titled, “Regulatory Considerations for Microneedling Products.”
How does microneedling improve the skin’s appearance?
Historically, micron-sized (extremely small) needles, made of a variety of materials and shapes, have been used in diagnostics, healthcare, and drug delivery. However, when arranged on a cylinder-like platform and rolled across the face or affixed to the point of a small pen for more precise targeting, microneedles have also become a new tool in exfoliating and improving the skin’s appearance. Because they penetrate the skin, microneedles deliver product directly to a target area, compared to topical application that takes time to soak through skin layers.
What is the FDA microneedling guidance?
The FDA defines microneedling devices as, “instruments with technological features, such as many small needles, tips, or pins on the surface, which are repeatedly inserted and removed into the skin.” These needles may be rolled across the skin with a small device, stamped on the skin, or arranged on the tip of a pen-shaped instrument. These devices create many small puncture holes in the skin by moving over the skin repeatedly. In addition to its narrow marketing authorization of microneedling, the FDA has only granted marketing authorization for a limited number of medical devices for specific use. By including potential risks and limits of microneedling on their website the FDA also aims to help consumers better understand microneedling if they are considering using these products.
Will the FDA approve more uses for microneedling?
Until new, more specific FDA guidance is provided, to ensure consumer safety in cosmetic microneedling, both companies and consumers should do adequate research before using or marketing microneedling products. Further, they should familiarize themselves with the potential risks and side effects of using devices incorrectly. Pre-existing medical or skin conditions should also be considered. Current FDA microneedling guidance was issued in 2020.
Fueled by endless video posts on YouTube, TikTok and Instagram, microneedling continues to gain popularity. The procedure, where tiny needles are inserted to rejuvenate skin, can be done at home or by a professional. Beauty brands considering adding microneedling tools or recovery lotions and serums to their product portfolio should be aware of current FDA guidance and limited approvals.
Ithos continues to monitor microneedling and other emerging cosmetic products, ingredients and procedures. With our continuously updated database of managed regulatory content from over 60 countries, sign up for our newsletter to get the latest updates.