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|Federal Authorities Seize Xiadafil VIP Tablets After
Company Refuses to Recall Product July 24, 2008
At the request of the U.S. Food and Drug Administration, U.S.
Marshals seized nearly $74,000 worth of Xiadafil VIP tablets,
Lots 6K029 and 6K209-SEI, distributed by SEI
Pharmaceuticals, Inc. of Miami, Fla. Although marketed as a
dietary supplement to treat erectile dysfunction (ED) and for
sexual enhancement, these lots represent an illegally
marketed drug containing an undeclared ingredient.
Today's action follows a formal FDA request to SEI
Pharmaceuticals (SEI) on May 27, 2008, to recall the lots of
Xiadafil VIP tablets. The products were given away at trade
shows and sold in eight tablet bottles (Lot # 6K029) and blister
cards of two tablets (Lot # 6K029-SEI) bearing an expiration
date of September 2009 (09/09). The company, however,
refused to recall these products, making the seizure action
necessary to prevent additional, illegal Xiadafil VIP products
from entering the marketplace.
The FDA's chemical analysis of Xiadafil VIP tablets Lots #
6K029/6K029-SEI found that the product contains
hydroxyhomosildenafil, which is chemically similar to sildenafil.
Sildenafil is the active ingredient in Viagra, an FDA-approved
prescription drug for ED. The FDA has not approved Xiadafil
VIP for ED or any other drug use, and the safety and
effectiveness of this product is unknown. Although offered for
sale as dietary supplements, the seized articles are new drugs
that may not be introduced into interstate commerce without
an approved new drug application filed with FDA.
"Today's seizure action shows that FDA will take enforcement
action to protect the public from dietary supplements that
contain prescription drug ingredients that are potentially
harmful to consumers," said Margaret O'K Glavin, associate
commissioner of the FDA's Office of Regulatory Affairs. "FDA
will not tolerate a company's failure to take voluntary action to
protect the public health after being given the opportunity by
FDA to do so," she added.
On April 22, 2008, the FDA initiated an inspection at SEI
Pharmaceuticals following its analysis of the Xiadafil VIP
tablets. The company was advised of the FDA's findings and
informed of the potential adverse health risks the product
posed to unsuspecting consumers. The FDA also warned the
company of possible legal actions, including seizure and/or
injunction if corrective and preventive actions were not
implemented. Although the company committed to halting
distribution of the product and deactivated its Internet site, it
refused to recall the product already in the market.
On May 13, 2008, Florida state officials issued a "stop sale"
action at SEI's distribution facility to keep the illegal product
out of the marketplace. This action required SEI to hold, intact,
violative Xiadafil VIP tablets found at the facility.
ED is a common problem in men who have diabetes, high
blood pressure, high cholesterol, or heart disease. Because
they may have been advised against taking ED drugs, men
with these conditions may seek alternative products like
Xiadafil VIP tablets because they are marketed as "all natural"
or as not containing the active ingredients in approved,
prescribed ED drugs. Furthermore, because the
manufacturing source of the active ingredients in many of
these alternative products is unknown, consumers should also
be aware that the safety, efficacy, and purity of these
ingredients have not been verified by the FDA.
Consumers should discontinue the use of Xiadafil VIP tablets
immediately and consult their health care professional if they
have experienced adverse events that they believe may be
related to the use of this product.