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Questions and Answers on the Cosmetic Microbiological Safety Public Meeting (November 2011)

December 8, 2011

Why was the public meeting called, and what did FDA hope to accomplish from it? 

The purpose of this public meeting was to provide stakeholders an opportunity to present information regarding cosmetic microbiological safety.

FDA is seeking information about a variety of cosmetic microbiological safety issues, including microbiological testing of cosmetics; types of preservative systems and how to test their effectiveness; the identity and prevalence of microorganisms that pose specific health risks in finished products; routes of exposure to microorganisms and the corresponding infective doses; product and packaging characteristics that affect microbial growth and risk of infection; consumer subpopulations that may be at greater risk of infection from cosmetic products; adverse events associated with microbial contamination of cosmetics; and other issues relevant to cosmetic microbiological safety. FDA is also looking for suggestions on areas where FDA guidance may be useful.

Does FDA intend to issue guidance or publish regulations on this subject?

As we learn more, from material presented at this meeting and from other sources, we will consider our options, based on factors such as our legal authority and public health priorities. 

Why is FDA concerned about microbiological contamination of cosmetics? 

Although the law does not give FDA pre-market approval authority over cosmetics, we do monitor the safety of cosmetics on the market. Potential contaminants, including microorganisms, are one aspect we look at, because there is a potential for serious adverse events. For example, eye-area cosmetics that contain pathogenic microorganisms have the potential to cause serious eye infections which can, in some cases, result in partial or total loss of vision. In addition, the legal definition of cosmetics includes many products other than makeup. Among them are lotions and mouthwashes, some of which are used by vulnerable populations, such as hospital patients. Some of these products have been associated with infections, both in this country and elsewhere.

Why now? 

We want to make sure our knowledge and our actions reflect the current state of science, industry practice, and products on the market.

Have there been recent cases of microbially contaminated cosmetics? 

Microbially contaminated cosmetics are the subject of an FDA Import Alert, and microbial contamination is a common reason for refusing entry of cosmetics offered for import into this country.

Although the law does not give FDA the authority to order a cosmetic recall and does not require cosmetic firms to share their recall information with FDA, we have data suggesting that microbial contamination is the most frequent reason for cosmetic recalls. A variety of factors may trigger a recall, from consumer complaints to a company's own quality assurance system. Notice of a recall of contaminated eye cosmetics, announced in October 2011, is posted on our website. 

What can FDA do to keep unsafe cosmetics off the market? 

FDA does not have the legal authority to approve cosmetic products or ingredients before they go on the market, other than most color additives. The law does, however, require cosmetics to be safe for consumers when used as intended. Companies and individuals who manufacture or market cosmetics have a legal responsibility for the safety of their products. FDA's authority is post-market: We can take action against products on the market that do not comply with the law and against the firms and individuals who market them.

We also can inspect imported cosmetics to determine whether they should be permitted entry into this country, although we do not have the resources to inspect every shipment. An FDA Import Alert addressing cosmetics with microbial contamination helps inspectors focus on products that are likely to be a problem. 

Has FDA ever published guidance or regulations related to microbial contamination in cosmetics? 

The Federal Food, Drug, and Cosmetic Act itself addresses not only the safety of cosmetics, but the conditions under which they are prepared, packed, and held. 

Although we have not published regulations or in-depth guidance on microbiological safety, we have published the FDA Bacteriological Analytical Manual, a collection of microbiological test methods and procedures, which includes a chapter on cosmetics. 

What kinds of microorganisms might occur in cosmetics? 

That depends on a variety of factors, such as how a cosmetic is formulated, manufactured, stored, and used. Some microorganisms pose little to no risk of illness or injury to consumers. Other microorganisms can pose significant risks; such microorganisms are characterized as “pathogenic.”  

What precautions can consumers take? 

Consumers can take a number of steps to help keep cosmetics clean and safe. Wash your hands before applying cosmetics. Do not allow cosmetics to become contaminated with dust and dirt. Keep containers clean and discard old products (see Shelf Life/Expiration Date). Do not add liquid--such as saliva or even water--to mascara, because that can introduce germs and dilute the preservative. Use cosmetics as they are intended to be used. For example, do not use a lip liner as an eye liner. You may be exposing your eyes to contamination from your mouth. Lastly, do not store cosmetics at temperatures above 85 degrees Fahrenheit. Cosmetics held for long periods in hot cars, for example, are more susceptible to their preservatives not working.

Consumers are also an important source of cosmetic safety information. If you experience a problem that may be associated with a cosmetic, or if you notice that a product has a bad smell or unusual color, tell FDA. You can contact MedWatch, FDA’s problem-reporting program, on the Web at http://www.fda.gov/Safety/MedWatch or at 1-800-332-1088, or you can contact the consumer complaint coordinator in your area, listed at http://www.fda.gov/Safety/ReportaProblem/ConsumerComplaintCoordinators

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