Clinical Testing in Skincare: Understanding FDA Approval and Required Clinical Testing

Clinical Testing in Skincare: Understanding FDA Approval and Required Clinical Testing

Clinical testing is a cornerstone in deciphering the efficacy and safety of skincare formulations, especially when sorting through the huge array of products promising radiant, healthy skin. However, most skincare products do not require formal clinical testing. This article explores the importance of clinical testing in skincare while shedding light on which skincare products require FDA approval and rigorous clinicals.

Clinical Testing vs. Consumer Testing

Clinical testing in skincare involves systematic and scientifically controlled studies to assess the efficacy, safety, and overall performance of skincare products. These tests, often conducted through randomized controlled trials (RCTs), blinded studies, and placebo-controlled experiments, play a pivotal role in substantiating the claims made by skincare brands. Through objective measurements and assessments, clinical trials provide valuable data that empowers consumers to make informed decisions about their skincare choices.

Consumer perception testing involves gathering feedback directly from consumers who use skincare products in their daily routines. This testing method is focused on subjective experiences and individual opinions regarding the product's performance, usability, and overall satisfaction. Both methodologies serve essential roles in understanding and improving skincare products, but only clinicals provide objective, scientific validation.

How does clinical testing prove a product "works"?

Clinical testing evaluates the effectiveness of skincare products in addressing various skin concerns such as acne, hyperpigmentation, aging, and hydration. These studies measure specific parameters such as wrinkle reduction, skin tone improvement, moisture retention, and acne reduction, among others. They provide quantitative and qualitative data to validate the product's claimed benefits.

Where does "safety" fit into skincare testing?

In addition to efficacy, clinical testing is vital in assessing the safety profile of skincare products. It helps identify potential adverse effects, allergens, irritants, and compatibility issues through patch testing, dermatologist-supervised trials, and long-term studies. Ensuring a product is not only effective but also safe for consumer use is a crucial aspect of clinical testing.

Which skincare products require FDA approval?

Skincare products fall under two main categories regulated by the FDA: cosmetics and drugs. Cosmetics -- items like moisturizers, cleansers, and certain treatments like some AHA serums and anti-aging products -- do not require FDA approval before being marketed. However, they still need to comply with FDA regulations regarding ingredient safety, labeling, and manufacturing practices. Conversely, skincare products classified as drugs, including acne treatments and sunscreens with specific SPF claims, must undergo FDA approval through rigorous clinical testing to demonstrate both efficacy and safety before reaching the market.

Which skincare products require clinical testing?

It may shock you that non-FDA regulated products -- again, items like moisturizers, cleansers, and certain treatments like some AHA serums and anti-aging products -- do not mandate clinical testing is complete before products get to market. But conducting clinical trials and tests help brands establish credibility, substantiate claims, and ensure product effectiveness and safety. Therefore, brands may voluntarily undertake clinical or consumer perception testing to demonstrate their commitment to delivering reliable and beneficial skincare solutions. But remember, only clinical testing provides objective, scientific validation. 

Is clinical testing required to be done across diverse skin tones?

As we deciphered, clinical testing is not required for most skincare products sold in retail stores. Therefore, it is safe to assume majority of products are also not tested across diverse skin tones. Even for those products that require FDA approval, the FDA does not require products be tested on all skin tones. They "encourage" brands to be inclusive in their testing, but have no method for deciphering which brands have taken that extra step.

Clinical testing in skincare is vastly under-regulated, and yet super important in determining what products to use for your skin type and tone. As the end of the day, it is up to you as a consumer to scrutinize brands and choose products that have been rigorously tested in third party facilities, utilizing an inclusive participant testing pool, and showing statistically significant results.  


Baumann L. (2007). Cosmetic Dermatology: Principles and Practice.
U.S. Food and Drug Administration. "FDA Authority Over Cosmetics: How Cosmetics Are Not FDA-Approved, but Are FDA-Regulated."