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FDA Advises Consumers Not to Use Imported Viagra

FDA Assesses Irregularities Involving the Handling of Certain Unapproved Imported Viagra Products

May 20, 2003

The Food and Drug Administration (FDA) is taking steps to respond to irregularities related to its handling of a large import shipment of unapproved "Viagra," apparently from Belize. Through a series of procedural irregularities, foreign versions of Viagra that were examined by FDA upon importation, were released to individuals who had ordered them.

In order to detain illegally imported products that may present a risk to the public health, FDA issues import alerts that assist the Bureau of Customs and Border Protection and FDA border personnel in identifying certain high-risk commercial import shipments.

The number of imports has jumped in the past 20 years. Over 8 million products-regulated and unregulated -- were presented for import last year. The Port of Miami mail facility in Florida alone receives over 100,000 packages a day. This large increase in imports has meant an increased need for surveillance--a need FDA has met by doubling its import operations. FDA monitors all imports, and physically inspects and analyzes thousands of imported products, far more than ever before.

To detain illegal and potentially unsafe products, the product must be identified among all imports coming into the United States, FDA must issue a Notice of Detention and then must notify each and every individual recipient of the product of FDA's action. Through this process, FDA successfully detains several thousand unapproved drug imports annually that appear to be of particularly high-risk to the public.

FDA is sending a letter to each of the consumers who may have received these Viagra products alerting them that the agency cannot vouch for the quality, safety or effectiveness of these unapproved products. The agency advises these consumers not to use these products.

FDA is thoroughly assessing this matter in order to prevent these mistakes from being repeated. This situation highlights the enormous challenges that the agency faces in dealing with the rising number of unapproved and potentially risky foreign versions of U.S. products imported into the country in large quantities.

http://www.seniors.gov/articles/0603/fdarecalls.htm

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