top of page

What Skincare Brands need to Know About FDA Guidelines

Skincare product claims that are substantiated through clinical research are becoming the norm, and this trend is supported by the Food and Drug Administration (FDA) guidelines for skincare research.

The FDA provides general guidelines for the clinical testing of skincare products to ensure that formulas are safe and effective before they reach consumers. Skincare brands must conduct clinical studies to support their product claims before they can be marketed to the public. Here's a closer look at the FDA's guidance for skincare clinical testing:

Starting with Study Design

To meet the FDA's guidelines, skincare brands must design clinical trials which answer specific questions about their products. The study should have a well-defined population and specific endpoints, as well as standardized protocols for measuring outcomes. This includes objective measures, such as digital imaging or skin biopsies, to assess the product's effects on the skin.

For further guidance on outcome reporting and the kinds of primary endpoints that may be suitable for clinical research, read more via. The national library of medicine.

A Contract Research Organization (CRO) can be a great choice for smaller brands or those seeking out their first clinical studies, as these companies will be familiar with the ins and outs of study designs that are suitable for the FDA.

Collecting Safety Data

In addition to measuring the product's efficacy, skincare brands must also collect data on product safety, including information on adverse events such as irritation and any other participant complaints. The FDA requires that these reports are submitted to them, and the skincare brand must also have an ethical and informed consent procedure in place to protect study participants and ensure their anonymity in the event of adverse effects.

Structured Study Conduct

The FDA outlines a specific series of steps that skincare brands must adhere to when conducting clinical trials. They must first obtain approval from an Institutional Review Board (IRB) to ensure the study follows ethical standards. The study should be conducted with every effort to minimize any risk to participants and ensure the study is as unbiased as possible. Finally, skincare brands should document the results of the study in a clinical study report that follows the FDA's guidelines.

Concluding FDA Review

Once a skincare brand has completed the clinical study, they may submit their results to the FDA for review. The FDA will evaluate the data to determine if the product is safe and effective for its intended use. If the product meets the FDA's requirements, it can then be marketed to the public with the product claims attained in the clinical study.

Why Are These Guidelines Important for Skincare Brands?

Brands understanding the FDA guidance for skincare clinical research is vital in obtaining scientific support for product claims. This simple breakdown of the guidelines is a great place to start, but brands should always default to the information provided to them by the FDA or any CRO they may be working with.

Successful clinical research is an effective way to establish your brand as an authority in the skincare space and is crucial to promoting transparency and trust in your brand. Read more about why skincare product claims are so important.

Wrapping Up

The FDA guidance for skincare clinical testing is designed to ensure that skincare products are safe and effective. By following these guidelines, skincare brands can ensure that their products are supported by rigorous clinical studies that provide accurate information to consumers. The FDA's guidance helps to protect consumers while also encouraging innovation in the skincare industry.

Want to create your own clinical trial?

Citruslabs provides a simple and affordable way to prove that your cosmetic products actually work. At Citruslabs, we design a clinical trial that is right for you and your budget, so you can start sharing research-backed product claims without spending a fortune. We offer the cohesive planning and management required to conduct successful clinical trials, from start to finish. Ready to get started? Let's talk! You can contact us here.


bottom of page