Skin Products Containing Mercury and/or Hydroquinone
In the past few years, FDA and state health officials have discovered numerous products marketed as skin lighteners that contain ingredients like mercury and/or hydroquinone. FDA does not allow mercury in drugs or in cosmetics, except under very specific conditions where there are no other safe and effective preservatives available – conditions that these products do not meet. Over-the-counter (OTC) skin lightening products containing the active drug ingredient hydroquinone are unapproved drugs and are not generally recognized as safe and effective (not GRASE). Skin lightening products are generally marketed to be applied topically but may also be injected.
Often, mercury or hydroquinone is not declared on the product label. There have been cases in which people exposed to such products have had mercury poisoning or elevated levels of mercury in their bodies. Additionally, FDA has received reports of serious side effects including skin rashes, facial swelling, and ochronosis (discoloration of skin) from the use of skin lightening products containing hydroquinone.
The table below provides the mercury and/or hydroquinone content of skin lighteners tested by FDA laboratories. Consumers should beware purchasing and using any such products. If you have questions, call your health care professional or the Poison Center at 1-800-222-1222; it is open 24 hours a day.
-
FDA works to protect consumers from potentially harmful OTC skin lightening products
-
Reporting Unlawful Sales of Medical Products on the Internet
-
MedWatch: The FDA Safety Information and Adverse Event Reporting Program
-
Dial 1-888-INFO-FDA (1-888-463-6332) or call the FDA Consumer Complaint Coordinator for your state or region