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 In this section:

                Potential Contaminants in Cosmetics

Potential Contaminants in Cosmetics

                        1,4-Dioxane in Cosmetics: A Manufacturing Byproduct
          Bovine Spongiform Encephalopathy (BSE) and Cosmetics
          Lead in Cosmetics
          Microbiological Safety and Cosmetics Home
          Cosmetics
          Cosmetic Products & Ingredients
          Potential Contaminants in Cosmetics
          Microbiological Safety and CosmeticsPotential Contaminants in Cosmetics Microbiological Safety and Cosmetics
  
  	
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    PrintCosmetic products can become harmful to consumers if they are contaminated with harmful microorganisms, such as pathogenic bacteria and fungi. FDA is looking closely at the microbiological safety of cosmetic products.

What the Law Says About Cosmetic Product Safety
	How Microorganisms Get Into Cosmetic Products
	Questions FDA Is Asking, and Why
	How Consumers Can Help Protect Against Microbial Contamination
	How to Report a Problem
	FDA Resources on Microbiological Safety for Cosmetic Products
	Additional InformationWhat the Law Says About Cosmetic Product Safety

Under the law, cosmetic products and ingredients, except for color additives, do not require FDA approval before they go on the market. However, they must not be “adulterated” or “misbranded.”

This means they must be safe for consumers when used according to directions on the label, or in the customary or usual way, and they must be properly labeled. It also means they must not be prepared, packed, or stored in a way in which they may have become contaminated or harmful to health.

Companies and individuals who manufacture or distribute cosmetic products are responsible for the safety of their products. This includes, for example, making sure cosmetic products are free from harmful microorganisms.

While the law does not require cosmetic products to have FDA approval before they go on the market, we do monitor their safety, including microbiological safety. FDA can take action against cosmetic products on the market that don’t comply with the law. To learn more, see FDA Authority Over Cosmetics.

How Microorganisms Get Into Cosmetic Products

Remember, firms are responsible for making sure their cosmetic products are safe. Some of the ways cosmetic products may become contaminated with harmful bacteria or fungi are:

Contaminated raw materials, water, or other ingredients;
	Poor manufacturing conditions;
	Ineffective preservation system particularly for ingredients that encourage growth of microorganisms;
	Packaging that doesn’t adequately protect the product;
	Poor shipping or storage conditions; and
	Consumer use, such as dipping fingers into the product.Questions FDA Is Asking, and Why

At FDA, we must base our actions on reliable information. We want to make sure our knowledge and our actions reflect the current state of science, industry practice, and products on the market.

While injuries from contaminated cosmetic products are not common, they can be serious. For example, contaminated tattoo inks, eye-area cosmetic products, and lotions and mouthwashes used in hospitals all have caused serious infections.

Here are some of the questions FDA microbiologists are exploring:

What’s the best way to test cosmetic products for microbiological safety?
	What types of preservative systems are cosmetic companies using, and how effective are they?
	What kinds of microorganisms pose health risks in cosmetic products?
	How are people exposed to microorganisms in cosmetic products?
	What consumers are at greatest risk from certain types of contaminated cosmetic products?How Consumers Can Help Protect Against Microbial Contamination

Don’t share cosmetic products with anyone; you may be sharing germs.

Don’t add water or saliva to cosmetic products, such as mascara. You may be adding harmful  microorganisms. This also waters down preservatives that are intended to keep microorganisms from growing.
	Store cosmetic products as instructed by manufacturers. Some microorganisms may grow faster in warm or damp storage conditions, and preservatives in the product may break down.
	Keep containers clean.
	Wash your hands before applying cosmetic products, especially if you need to dip your fingers into the container.
	Pay attention to recalls and safety alerts. Microbial contamination is a common reason for recalls of cosmetic products. Here are two ways to stay informed:
	Sign up for Cosmetic News email updates.
		Follow Us on X@FDACosmetics (formerly Twitter).How to Report a Problem

If you have experienced a problem such as a rash or an infection, from the use of a cosmetic product, please inform FDA. You can even report something that did not cause a reaction but alerted you to a problem with the cosmetic product, such as a bad smell or other sign(s) of contamination.

You can report a problem with a cosmetic product to FDA by either of these ways:

Contact MedWatch, FDA’s problem-reporting program, at 1-800-332-1088, or file a MedWatch voluntary report online.
	Contact the consumer complaint coordinator in your area.To learn more, see How to Report a Cosmetic Related Complaint.

FDA Resources on Microbiological Safety for Cosmetic Products

Disposable Wipes
	Eye Cosmetic Safety
	Import Alert 53-17: Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination
	BAM Chapter 23: Methods for Cosmetics (Chapter 23 of FDA’s Bacteriological Analytical Manual)
	Good Manufacturing Practice (GMP)
	Draft Guidance for Industry: Good Manufacturing Practice for Cosmetics
	Cosmetic Recalls & Alerts
	Shelf Life and Expiration Dating of Cosmetics
	Insanitary Conditions at Tattoo Ink Manufacturing and Distribution Facilities; Draft Guidance for Industry
	Warning Letters and Untitled Letters Cite Microbial Contamination of CosmeticsAdditional Information

Modernization of Cosmetics Regulation Act of 2022 (MoCRA)
	FDA Authority Over Cosmetics
	FDA’s Field Science & Laboratories
	Product Testing
	Small Business & Homemade Cosmetics Fact Sheet

                                                                                  Content current as of:
      01/29/2024
              
              
Regulated Product(s)
		 CosmeticsPotential Contaminants in Cosmetics

          
                        1,4-Dioxane in Cosmetics: A Manufacturing Byproduct
          Bovine Spongiform Encephalopathy (BSE) and Cosmetics
          Lead in Cosmetics
          Microbiological Safety and Cosmetics
 
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