FDA MedWatch - Crema Piel De Seda (Silky Skin Cream) by Viansilk: Consumer Warning - Risk of Mercury Poisoning

Crema Piel De Seda (Silky Skin Cream) by Viansilk: Consumer Warning - Risk of Mercury Poisoning

AUDIENCE: Consumer 

ISSUE: The Food and Drug Administration (FDA) is warning consumers not to purchase or use a skin whitening cream called “Crema Piel De Seda,” due to the risk of mercury poisoning.  FDA laboratory analysis identified mercury in the product.  Exposure to mercury can cause serious health problems, such as kidney and nervous system damage.  Mercury can also interfere with brain development in children. Signs and symptoms of mercury poisoning include, irritability, shyness, tremors, changes in vision or hearing, memory problems, depression, and numbness and tingling in hands, feet or around the mouth.

BACKGROUND: Crema Piel De Seda skin cream is labeled in Spanish and is sold primarily in Spanish-speaking communities in the U.S.  The product can be found in flea markets and local retail outlets, and is promoted to whiten skin, treat acne, and remove warts and various skin blemishes.  The product is manufactured in Mexico by Viansilk.

RECOMMENDATION: Consumers are urged to immediately discontinue using Viansilk’s Crema Piel De Seda.  Anyone who has used this product should thoroughly wash their hands and any other parts of the body that have come in contact with the product, and should contact their health care professional or medical care clinic for medical advice.  Consumers should seal the product in a plastic bag or leak-proof container and check with their local environmental, health, or solid waste agency for proper disposal.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressedform, or submit by fax to 1-800-FDA-0178.

Read the MedWatch Safety Alert, including links to the Consumer Warning, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm483842.htm