FDA Discussion on Microbial Safety of Cosmetics_Industry News_FDA Certification_Jacob Star

FDA Discussion on Microbiological Safety of Cosmetics

2025-10-21

If cosmetics are contaminated with harmful microorganisms such as pathogenic bacteria and fungi, they may cause harm to consumers.FDA) is paying close attention to the microbial safety of cosmetics.

Legal provisions on cosmetic safety

By law, cosmetics and their ingredients (except dye additives) do not require approval from the U.S. Food and Drug Administration (FDA) before they are marketed.However, cosmetics may not be "adulterated" or "misbranded."

Important note: Please note that this article was published on2022Year02moon25Day, about“osmetic products and ingredients do not need FDA approval before they go on the market.”This information is no longer applicable due to2024 Year7 moon1 From now on,FDAStart executionMoCRASpecified cosmeticsFacility RegistrationandProduct ListingRequire.

This means that the product must be safe for consumers when used according to label instructions or in the customary or usual manner, and must be correctly labeled. It also means that the product must not be prepared, packaged, or stored in a way that could cause it to become adulterated or harmful to health.

Companies and individuals who produce or distribute cosmetics are responsible for the safety of their products. This includes, for example, ensuring that cosmetics are free from harmful microorganisms. Although the law does not require cosmetics to obtainFDA approves cosmetics, but we monitor their safety, including microbiological safety. FDA can take action against cosmetics on the market that do not meet legal requirements. For more information, see FDA's Regulatory Authority Over Cosmetics.

How microorganisms enter cosmetics

Remember, it is the responsibility of businesses to ensure the safety of their cosmetics. Some ways cosmetics can become contaminated with harmful bacteria or fungi include:

· contaminated raw materials, water, or other ingredients; 

· poor production conditions; 

· Ineffective preservative systems, especially for ingredients that promote microbial growth; 

· Packaging that does not adequately protect the product; 

· Adverse shipping or storage conditions; and

   · How consumers use the product, such as by dipping their fingers into the product.

Food and Drug Administration (FDA) and their reasons

At the FDA, we must base our actions on reliable information. We want to ensure that our knowledge and actions reflect current science, industry practices, and the status of products on the market.

While injuries from contaminated cosmetics are uncommon, they can be serious. For example, serious infections have been linked to contaminated tattoo ink, eye makeup, and lotions and mouthwashes used in hospitals.

How consumers can help prevent microbial contamination

Do not share cosmetics with anyone; this can spread germs.

   · Do not add water or saliva to cosmetics, such as mascara. You may introduce harmful microorganisms and this canDilutes the preservatives in the product, reducing their effectiveness in inhibiting microbial growth.

· Store cosmetics according to the manufacturer's instructions. Certain microorganisms may grow faster under warm or humid storage conditions, and preservatives in the product may become ineffective.

· Keep the container clean.

· Wash your hands before applying makeup, especially if you use your fingers to apply the product.

    · Be aware of recalls and safety alerts. Microbiological contamination is a common cause of cosmetic product recalls.







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