FDA on the Microbiological Safety of Cosmetics

If cosmetics are contaminated with harmful microorganisms such as pathogenic bacteria and fungi, they can harm consumers. The U.S. Food and Drug Administration (FDA) is closely monitoring the microbiological safety of cosmetics. The law on cosmetic safety Under the law, cosmetics and their ingredients (other than color additives) do not require approval from the FDA before they go on the market. However, cosmetics must not be “adulterated” or “misbranded.” Important note: This article was published on 25 February 2022. The statement that “cosmetic products and ingredients do not need FDA approval before they go on the market” no longer applies, because since 1 July 2024 the FDA has begun enforcing the cosmetic “facility registration” and “product listing” requirements under MoCRA. This means that, when used according to the label directions or in the customary or usual way, a product must be safe for consumers and must be correctly labeled. It also means that a product must not be prepared, packed or stored in a way that could cause it to become contaminated or harmful to health. Companies and individuals who manufacture or distribute cosmetics are responsible for the safety of their products. This includes, for example, ensuring that cosmetics do not contain harmful microorganisms. Although the law does not require cosmetics to be approved by the FDA before they go on the market, the FDA does monitor their safety, including microbiological safety, and can take action against cosmetics on the market that do not meet legal requirements. For more information, see the FDA's regulatory authority over cosmetics. How microorganisms get into cosmetics Remember that businesses are responsible for ensuring the safety of their cosmetics. Some of the ways cosmetics may become contaminated with harmful bacteria or fungi include: • contaminated raw materials, water or other ingredients; • poor manufacturing conditions; • an ineffective preservative system, especially for ingredients that promote microbial growth; • packaging that does not adequately protect the product; • poor transport or storage conditions; and • the way consumers use the product, such as dipping into it with their fingers. The questions the FDA raises, and why At the FDA, we must act on the basis of reliable information. We want to ensure that our knowledge and actions reflect current science, industry practice and the reality of products on the market. Although harm from contaminated cosmetics is not common, it can be very serious. For example, contaminated tattoo ink, eye cosmetics, and lotions and mouthwashes used in hospitals have all caused serious infections. How consumers can help prevent microbial contamination • Do not share cosmetics with anyone; this can spread pathogens. • Do not add water or saliva to cosmetics, such as mascara. You may introduce harmful microorganisms, and this dilutes the product's preservatives, weakening their ability to inhibit microbial growth. • Store cosmetics according to the manufacturer's instructions. Some microorganisms can grow faster in warm or humid storage conditions, and the product's preservatives may fail. • Keep containers clean. • Wash your hands before using cosmetics, especially when you need to dip into the product with your fingers. • Pay attention to recalls and safety alerts. Microbial contamination is a common reason for cosmetic recalls.