1. Are cosmetics currently regulated in the US?
The Food and Drug Administration (FDA) is a government agency put in place to enforce the laws regarding cosmetics, such as the Federal Food Drug and Cosmetics Act (FFDCA). Under the FFDCA, cosmetics manufacturers are responsible for verifying the safety of their products through various testing methods; however, they are not required to perform particular safety tests or gain approval from the FDA prior to marketing their products.
2. How do I know what ingredients are not allowed in my products?
“In general, except for color additives and those ingredients which are prohibited or restricted from use in cosmetics by regulation, a manufacturer may use any ingredient in the formulation of a cosmetic provided that the ingredient and the finished cosmetic are safe, the product is properly labeled, and the use of the ingredient does not otherwise cause the cosmetic to be adulterated or misbranded under the laws that FDA enforces.” See the links below for the list of ingredients that are either restricted or prohibited in cosmetics. “Although not prohibited by law or regulation, in addition, the manufacturers of cosmetic fragrance products have voluntarily agreed to not use or to limit maximum use levels of certain selected ingredients which have been found to cause depigmentation, irritation, neurotoxicity, phototoxicity or other allergic reactions.”
3. Why are preservatives necessary in cosmetics?
Preservatives are ingredients used to protect a product from deterioration and help it perform as intended for the lifetime of the product. From the time a cosmetic or personal care product is opened to the time it is discarded, it is subject to constant contamination from the environment and consumers’ hands and body. Consumer products are required to be safe and therefore, inhibit microbial growth within the intended period of use of the product. Without preservatives, cosmetics and personal care products are likley to become contaminated with various microorganisms, leading to product spoilage and possibly irritation or infections caused by harmful microorganisms.
4. How much testing is required before a product is deemed safe for the market?
“The FD&C Act prohibits the distribution of cosmetics which are adulterated or misbranded. A cosmetic is considered adulterated if it contains a substance which may make the product harmful to consumers under customary conditions of use; if it contains a filthy, putrid, or decomposed substance; if its container is composed of a harmful substance; if it is manufactured or held under insanitary conditions whereby it may have become contaminated with filth, or may have become harmful to consumers; or if it is not a hair dye that contains a non-permitted color additive. Although the FD&C Act does not require that cosmetic manufacturers or marketers test their products for safety, the FDA strongly urges cosmetic manufacturers to conduct whatever toxicological or other tests are appropriate to substantiate the safety of their cosmetics. If the safety of a cosmetic is not adequately substantiated, the product may be considered misbranded and may be subject to regulatory action unless the label bears the following statement: ‘Warning – The safety of this product has not been determined’.”
The European Union regulates cosmetics to be marketed in the EU. See here for more information.
5. Do cosmetics have to be safety tested on animals?
“The Federal Food, Drug, and Cosmetic Act does not specifically require the use of animals in testing cosmetics for safety, nor does it subject cosmetics to FDA premarket approval. However, FDA has consistently advised cosmetic manufacturers to employ whatever testing is appropriate and effective for substantiating the safety of their products. It remains the responsibility of the manufacturer to substantiate the safety of both ingredients and finished cosmetic products prior to marketing. FDA supports the development and use of alternatives to whole-animal testing as well as adherence to the most humane methods available within the limits of scientific capability when animals are used for testing the safety of cosmetic products.”
“The Cosmetics Directive, issued by the European Union, provides the regulatory framework for the phasing out animal testing for cosmetics. It establishes a ban on testing finished cosmetic products and cosmetic ingredients on animals, and a prohibition to market, in the European Union, any finished cosmetic products and ingredients in cosmetic products that were tested on animals. The same provisions are contained in the Cosmetics Regulation, which replaces the Cosmetics Directive as of 11 July 2013.”