Cosmetics are a separate category under the Food and Drug Administration (FDA) different from medical devices or drugs. Despite this difference, though, product testing is still one of the major things manufacturers must do to ensure the safety of a cosmetic product. The FDA conducts testing of a cosmetic once they are investigating safety issues with the product or product part for research, this research is valuable to consumers and the industry alike1. Additionally, the FDA does not have the authority to approve cosmetic products and their ingredients before they reach the market.

Once they have reliable information to show a cosmetic does not meet legal safety requirements the FDA can act against the manufacturer. The FDA only regulates color additives before they are permitted for use in the cosmetic industry. Manufacturers tend to use safety data that is available for the ingredients in each product. The Cosmetic Ingredient Review (CIR) has information on the safety of the cosmetic ingredients that have been reviewed. The FDA participates in the CIR but does not vote or agree with conclusions, they tend to consider evaluations of ingredients during product testing1.

Depending on the product, toxicology testing is utilized to fill in the gaps on the safety of the ingredients and products. Cosmetics are not sterile but must not have any harmful microorganisms and minimal aerobic microorganisms. Many factors contribute to the contamination of cosmetics from user error to manufacturer expertise. Unfortunately, manufacturers use the terms natural and organic even though there is no safety guarantee.

The manufacturer is responsible for ensuring their products are safe, which includes completing additional testing. For clarification on the safety of your cosmetics products, EMMA International’s team of experts is available to assist with any regulatory or quality needs of your company. EMMA International provides Full Circle Consulting services, give us a call at 248-987-4497 or email us at info@emmainternational.com to get in touch with our team of experts today. 

[1] FDA (February 2022) Product Testing of Cosmetics, Retrieved 04/03/2022 from https://www.fda.gov/cosmetics/cosmetics-science-research/product-testing-cosmetics

Sarah Koehler

Sarah Koehler

Sarah is a Quality Engineer at EMMA International. She has experience in quality assurance, change management, laboratory controls, and process/equipment validation within the pharmaceutical and medical device industry. Sarah has earned a Bachelor of Science in Chemical Engineering from Western Michigan University.

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