U. S. Food and Drug Administration
FDA Statement
July 23, 1996


FDA WARNS CONSUMERS NOT TO USE CREMA DE BELLEZA


The Food and Drug Administration is warning consumers not to purchase or use a Mexican facial skin cream called "Crema de Belleza -- Manning" because the product contains mercury and poses significant health risks.

Anyone using the product should discontinue use at once, contact their local health authority, and see a doctor for a medical evaluation.

The cream is manufactured in Mexico by Laboratories Vide Natural SA de CV., Tampico, Tamaulipas, and is distributed primarily in Mexico but also has been distributed in the United States along the U.S.-Mexican border in Arizona, California, New Mexico and Texas.

The product's label, printed in Spanish, claims the cream reduces facial oil and removes pimples and blackheads. The cream is used primarily in Hispanic communities. FDA is taking steps to warn Spanish-speaking consumers in the border states not to use the product.

The label lists the ingredient calomel, which is mercurous chloride (a salt of mercury). Product samples have been found to contain 6 percent to 10 percent mercury by weight.

Chronic exposure to mercury salts can result in a variety of symptoms and adverse reactions including nervousness, irritability, tremors, weakness, fatigue, memory loss, changes in hearing, vision and taste, nausea, vomiting, diarrhea, kidney damage, and death. The product is sold in semi-opaque plastic bottles about six inches high, marked as containing 160 milliliters. The bottles have beige plastic caps and bear labeling in red and blue. If a bottle is left undisturbed, the contents separate into an upper layer of clear liquid and a lower layer of white solids. The U.S. Centers for Disease Control and Prevention has identified about 200 consumers in the four border states who have used the product. CDC tests showed elevated mercury levels in more than 80 of these individuals. At least three people have been diagnosed with mercury poisoning.

FDA continues to cooperate with CDC and state and local authorities to remove the product from the U.S. market. In Mexico, authorities have issued health alerts to all northern Mexican states, and report that efforts are underway to withdraw the product from that country's market.


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