Microbiological Safety and Cosmetics
Cosmetics can become harmful to consumers if they’re contaminated with harmful microorganisms, such as certain bacteria and fungi. FDA is looking closely at the microbiological safety of cosmetics.
- What the Law Says About Cosmetic Safety
- How Microorganisms Get Into Cosmetics
- Questions FDA Is Asking, and Why
- How Consumers Can Help Protect Against Microbial Contamination
- How to Report a Problem
- FDA Resources on Cosmetics and Microbiological Safety
- Additional Information
What the Law Says About Cosmetic Safety
Under the law, cosmetic products and ingredients, except for color additives, do not need 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 expected 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 cosmetics are legally responsible for the safety of their products. This includes, for example, making sure cosmetics are free of harmful microorganisms.
While the law does not require cosmetics to have FDA approval before they go on the market, we do monitor the safety of cosmetics, including their microbiological safety, and FDA can take action against cosmetics on the market that don’t comply with the law. To learn more, see “FDA Authority Over Cosmetics.”
How Microorganisms Get into Cosmetics
Remember, cosmetic firms are legally responsible for making sure their products are safe. Some of the ways cosmetics may become contaminated with bacteria or fungi are—
- Contaminated raw materials, water or other ingredients
- Poor manufacturing conditions
- Ingredients that encourage growth of microorganisms, without an effective preservative system
- Packaging that doesn’t protect a product adequately
- Poor shipping or storage conditions
- Consumer use, such as the need to dip 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.
Even if injuries from contaminated cosmetics are not common, they can be serious. For example, contaminated tattoo inks, eye-area cosmetics, 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 cosmetics 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 cosmetics?
- How are people exposed to microorganisms in cosmetics?
- What consumers are at greatest risk from certain types of contaminated cosmetics?
For example, in November 2011 FDA held a public meeting, requesting information on the microbiological safety of cosmetics from industry and consumer advocacy organizations.
How Consumers Can Help Protect Against Microbial Contamination
Don’t share cosmetics, with anyone. You may be sharing germs.
- Don’t add water or saliva to cosmetics, such as mascara. You may be adding bacteria or other microorganisms. You’ll also be watering down a preservative that’s intended to keep bacteria from growing.
- Store cosmetics carefully. If cosmetics get too warm, some microorganisms may grow faster and preservatives may break down.
- Keep containers clean.
- Wash your hands before applying cosmetics, 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 cosmetics. Here are two ways to stay informed:
How to Report a Problem
If you’ve experienced a problem with a cosmetic, from a minor rash or headache to an illness that put you in the hospital, please tell FDA. You can even report something that didn’t cause a reaction, but alerted you to a problem with the product, such as a bad smell or other sign of contamination.
You can report a problem with a cosmetic to FDA in 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 “Adverse Event Reporting: How to Report a Cosmetic-related Problem to FDA.”
FDA Resources on Microbiological Safety for Cosmetics
- Disposable Wipes
- Eye Cosmetic Safety
- Import Alert 53-17: Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination
- Microbiological Methods for Cosmetics (Chapter 23 of FDA’s Bacterological Analytical Manual)
- Good Manufacturing Practice (GMP)
- Public Meeting - Cosmetic Microbiological Safety, November 30, 2011
- Cosmetic Recalls & Alerts
- Shelf Life and Expiration Dating of Cosmetics
- Tattoo Inks Pose Health Risks: Consumer Update (on contaminated tattoo inks)
- Warning Letters and Untitled Letters Cite Microbial Contamination of Cosmetics