Do cosmetics contain harmful contaminants, such as lead? What does FDA do to guard against them?
Under the Federal Food, Drug, and Cosmetic Act, cosmetics must be safe for consumers when used as intended. If a cosmetic is harmful to consumers, it is adulterated under the law, and it is against the law to market adulterated cosmetics in interstate commerce. It doesn't matter whether the safety problem is caused by ingredients or contaminants. Companies and individuals who market cosmetics have a legal responsibility for the safety of their products.
FDA monitors cosmetics on the market to watch for potential safety problems, including potential contaminants. We also stay abreast of scientific research, so that we can be aware of potential problems. We take action against products that do not comply with the law, and against companies and individuals who market them.
These are some of the ways FDA watches out for cosmetics that may contain harmful contaminants:
One way that FDA guards against contaminated cosmetics is by working with U.S. Customs and Border Protection staff to inspect imported products. Because we cannot inspect every shipment, FDA issues Import Alerts to help inspection staff look out for products that are most likely to pose a safety hazard. A number of our Import Alerts for cosmetics warn about products that may contain harmful contaminants. Cosmetics that are found to be unsafe are refused entry into this country.
FDA has issued guidance to manufacturers on how to keep two kinds of contaminants, nitrosamines and 1,4-dioxane, from forming during the manufacturing process. FDA inspectors check to make sure manufacturers are following the proper procedures.
Except for those intended as coal tar hair dyes, each color additive used in cosmetics must be approved by FDA and listed in a regulation that states its permitted use, as well as all specifications and restrictions. These regulations set strict limits on contaminants. FDA sets these limits based on how much of the color additive a person is likely to be exposed to and the routes of exposure under the intended conditions of use. To learn more, see Color Additives and Cosmetics.
To learn more about how FDA evaluates the safety of cosmetics, including potential contaminants, see How FDA Evaluates Regulated Products.
To learn more about potential contaminants and what FDA has done about them, see
- Bovine Spongiform Encephalopathy (BSE)
- Cosmetic Imports and Import Surveillance
- FDA's Cosmetics main page
- Ingredients Prohibited and Restricted by FDA Regulations (includes information on mercury both as an ingredient and as a contaminant)
- Inspection of Cosmetics: An Overview
- Lipstick and Lead: Questions and Answers
- Microbiological Methods for Cosmetics
- Potential Contaminants
- Recalls & Alerts
- Warning Letters Cite Cosmetics as Adulterated Due to Microbial Contamination