From: Subject: Federal Authorities Seize Xiadafil VIP Tablets After Company Refuses to Recall Product Date: Fri, 25 Jul 2008 09:50:39 -0400 MIME-Version: 1.0 Content-Type: multipart/related; type="text/html"; boundary="----=_NextPart_000_008A_01C8EE3B.E54D03D0" X-MimeOLE: Produced By Microsoft MimeOLE V6.00.2900.3198 This is a multi-part message in MIME format. ------=_NextPart_000_008A_01C8EE3B.E54D03D0 Content-Type: text/html; charset="iso-8859-1" Content-Transfer-Encoding: quoted-printable Content-Location: http://www.fda.gov/bbs/topics/NEWS/2008/NEW01864.html Federal = Authorities Seize Xiadafil VIP Tablets After Company Refuses to Recall = Product
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FOR IMMEDIATE RELEASE
July 24, 2008 =

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Rita = Chappelle,=20 301-827-6242
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Federal Authorities Seize = Xiadafil=20 VIP Tablets After Company Refuses to Recall Product
Product contains undeclared ingredient that could = harm=20 consumers

At the request of the U.S. Food and Drug Administration, U.S. = Marshals seized=20 nearly $74,000 worth of Xiadafil VIP tablets, Lots 6K029 and 6K209-SEI,=20 distributed by SEI Pharmaceuticals, Inc. of Miami, Fla. Although = marketed as a=20 dietary supplement to treat erectile dysfunction (ED) and for sexual=20 enhancement, these lots represent an illegally marketed drug containing = an=20 undeclared ingredient.

Today's action follows a formal FDA request to SEI Pharmaceuticals = (SEI) on=20 May 27, 2008, to recall the lots of Xiadafil VIP tablets. The products = were=20 given away at trade shows and sold in eight tablet bottles (Lot # 6K029) = and=20 blister cards of two tablets (Lot # 6K029-SEI) bearing an expiration = date of=20 September 2009 (09/09). The company, however, refused to recall these = products,=20 making the seizure action necessary to prevent additional, illegal = Xiadafil VIP=20 products from entering the marketplace.

The FDA's chemical analysis of Xiadafil VIP tablets Lots # = 6K029/6K029-SEI=20 found that the product contains hydroxyhomosildenafil, which is = chemically=20 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=20 ED or any other drug use, and the safety and effectiveness of this = product is=20 unknown. Although offered for sale as dietary supplements, the seized = articles=20 are new drugs that may not be introduced into interstate commerce = without an=20 approved new drug application filed with FDA.

"Today's seizure action shows that FDA will take enforcement action = to=20 protect the public from dietary supplements that contain prescription = drug=20 ingredients that are potentially harmful to consumers," said Margaret = O'K=20 Glavin, associate commissioner of the FDA's Office of Regulatory = Affairs. "FDA=20 will not tolerate a company's failure to take voluntary action to = protect the=20 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=20 following its analysis of the Xiadafil VIP tablets. The company was = advised of=20 the FDA's findings and informed of the potential adverse health risks = the=20 product posed to unsuspecting consumers. The FDA also warned the company = of=20 possible legal actions, including seizure and/or injunction if = corrective and=20 preventive actions were not implemented. Although the company committed = to=20 halting distribution of the product and deactivated its Internet site, = it=20 refused to recall the product already in the market.

On May 13, 2008, Florida state officials issued a "stop sale" action = at SEI's=20 distribution facility to keep the illegal product out of the = marketplace. This=20 action required SEI to hold, intact, violative Xiadafil VIP tablets = found at the=20 facility.

ED is a common problem in men who have diabetes, high blood pressure, = high=20 cholesterol, or heart disease. Because they may have been advised = against taking=20 ED drugs, men with these conditions may seek alternative products like = Xiadafil=20 VIP tablets because they are marketed as "all natural" or as not = containing the=20 active ingredients in approved, prescribed ED drugs. Furthermore, = because the=20 manufacturing source of the active ingredients in many of these = alternative=20 products is unknown, consumers should also be aware that the safety, = efficacy,=20 and purity of these ingredients have not been verified by the FDA.

Consumers should discontinue the use of Xiadafil VIP tablets = immediately and=20 consult their health care professional if they have experienced adverse = events=20 that they believe may be related to the use of this product.

Consumers and health care professionals can report adverse events to = the=20 FDA's MedWatch program at 800-FDA-1088, by mail at MedWatch, HF-2, FDA, = 5600=20 Fishers Lane, Rockville, Md 20852-9787, or online at www.fda.gov/medwatch/repo= rt.htm.

For more information, visit:
www.fda.gov/consumer/updates/erectiledysfunction010408.html.=20

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persistent cookies if 1 triggerParms["rw"] =3D 129600; // resample wait (value in minutes) triggerParms["pu"] =3D 0; // pop-under control triggerParms["olpu"] =3D 1; // On Load pop-under control triggerParms["lfcookie"] =3D "ForeseeLoyalty_MID_oFU8oht9h8"; triggerParms["ascookie"] =3D "ForeseeSurveyShown_oFU8oht9h8"; triggerParms["width"] =3D 420; // survey width triggerParms["height"] =3D 500; // survey height triggerParms["domain"] =3D ".fda.gov"; // domain name triggerParms["omb"] =3D "1505-0186"; // OMB number //triggerParms["cmetrics"] =3D "90010257"; // coremetrics client id triggerParms["cpp_1"] =3D "userURL:" + cppUrlPatch = (window.location.href); triggerParms["capturePageView"] =3D 1; //excludeList[0] =3D "/exclude/"; //trigger script will not work under = this path //triggerParms["dcUniqueId"] =3D "TEST04JloZZN0k9cI1Ep5d"; // (22 chars = unique Id for double cookie I/II) //triggerParms["midexp"] =3D 129600; // model instance expiry value triggerParms["rso"]=3D 0; //user has chosen to use Retry Survey Option triggerParms["aro"]=3D 0; //user has chosen to use Auto Retry Option, = with SP=3D100 //triggerParms["rct"]=3D 1; //The maximum number of times allowed to = serve a survey to a user //triggerParms["rds"]=3D 1; //The minimum number of days to wait to = serve a survey repeatedly //triggerParms["mrd"]=3D 1; //The total number of days that a user can = be re-served a survey triggerParms["compliant508"] =3D 1; //508 compliant if 1 //DHTML Parameter triggerParms["dhtml"]=3D 1;// disable dhtml trigger if dhtml=3D0 triggerParms["dhtmlWidth"] =3D 400; // welcome page width triggerParms["dhtmlHeight"] =3D 290; // welcome page height triggerParms["dhtmlURL"]=3D "/fsrscripts/FSRInvite.html"; ------=_NextPart_000_008A_01C8EE3B.E54D03D0 Content-Type: application/octet-stream Content-Transfer-Encoding: quoted-printable Content-Location: http://www.fda.gov/fsrscripts/stdLauncher.js // Customer:U.S. Food and Drug Administration // Version : DHTML Trigger 3.0.1 // ************ don't modify below this line ************* var popUpURL =3D "//www.foreseeresults.com/survey/display"; // base URL = to the survey=20 var FSRImgURL =3D "//www.foreseeresults.com/survey/FSRImg"; var OTCImgURL =3D "//controller.foreseeresults.com/fsrSurvey/OTCImg"; var ckAlreadyShown =3D triggerParms["ascookie"]; // name of the = persistent/session cookie var ckLoyaltyCount =3D triggerParms["lfcookie"]; // name of the loyalty = count cookie var fullURL=3Dnull; var oldURL=3Dnull; var myPopUp=3Dnull; var fsr_aol=3Dnull; var dcQString=3D""; var cpp_3 =3D ""; var winOptions =3D "width=3D 1,height=3D 1,top=3D 4000,left=3D = 4000,resizable=3Dyes,scrollbars=3Dyes"; var persistentExpires =3D new Date(); //persistent cookie expiration=20 persistentExpires.setTime(persistentExpires.getTime() + = (triggerParms["rw"]*60*1000)); function ForeCStdGetCookie (name) { var arg =3D name + "=3D"; var alen =3D arg.length; var clen =3D document.cookie.length; var i =3D 0; while (i < clen) { var j =3D i + alen; if (document.cookie.substring(i, j) =3D=3D arg) { return ForeCStdGetCookieVal (j); } i =3D document.cookie.indexOf(" ", i) + 1; if (i =3D=3D 0) { break; } } return null; } function fsr_showWindow() { =20 if(myPopUp !=3D null && !myPopUp.closed && fsr_aol=3D=3Dfalse) = {return;} =20 var cpp3Str =3D "";=20 cpp_3 =3D "Browser:"+ cppUrlPatch (navigator.userAgent)=20 cpp_3+=3D";dhtml";=09 var pos1 =3D fullURL.indexOf("&cpp_3=3D"); var pos2 =3D fullURL.indexOf("&",pos1+1); if (pos2=3D=3D-1){ fullURL =3D fullURL.substring(0,pos1); }else{ cpp3Str =3D fullURL.substring(pos2,fullURL.length); fullURL =3D fullURL.substring(0,pos1); } =20 fullURL+=3D"&cpp_3=3D"+cpp_3 + cpp3Str; =20 if(document.all && document.all.fsr_window.filters) { eval("document.all.fsr_window").filters.revealTrans.transition =3D 23 = ; eval("document.all.fsr_window").filters.revealTrans.Apply(); eval("document.all.fsr_window").style.visibility =3D 'visible'; eval("document.all.fsr_window").filters.revealTrans.Play(); } else if(document.all) {document.all.fsr_window.style.visibility =3D = 'visible';}=09 else if(document.getElementById) = {document.getElementById("fsr_window").style.visibility =3D 'visible';}=09 } function fsr_hideWindow() { if(document.all && document.all.fsr_window.filters) { eval("document.all.fsr_window").filters.revealTrans.transition =3D 23; eval("document.all.fsr_window").filters.revealTrans.Apply(); eval("document.all.fsr_window").style.visibility =3D 'hidden'; eval("document.all.fsr_window").filters.revealTrans.Play(); } else if(document.all) {document.all.fsr_window.style.visibility =3D = 'hidden';}=09 else if(document.getElementById) = {document.getElementById("fsr_window").style.visibility =3D 'hidden';} } function ForeCStdSetCookie (name, value) { var argv =3D ForeCStdSetCookie.arguments; var argc =3D ForeCStdSetCookie.arguments.length; var expires =3D (argc > 2) ? argv[2] : null; var path =3D (argc > 3) ? argv[3] : null; var domain =3D (argc > 4) ? argv[4] : null; var secure =3D (argc > 5) ? argv[5] : false; document.cookie =3D name + "=3D" + escape (value) + ((expires =3D=3D null) ? "" : ("; expires=3D" + expires.toGMTString())) = + ((path =3D=3D null) ? "" : ("; path=3D" + path)) + ((domain =3D=3D null) ? "" : ("; domain=3D" + domain)) + ((secure =3D=3D true) ? "; secure" : ""); } function ForeCStdGetCookieVal(offset) { var endstr =3D document.cookie.indexOf (";", offset); if (endstr =3D=3D -1) { endstr =3D document.cookie.length; } return unescape(document.cookie.substring(offset, endstr)); } function specialEscape(str) { var translated =3D ""; var i;=20 var found =3D 0; for(i =3D 0; (found =3D str.indexOf('+', found)) !=3D -1; ) { translated +=3D str.substring(i, found) + "%2B"; i =3D found + 1; found++; } translated +=3D str.substring(i, str.length); return translated; } function Pop(){ myPopUp =3D window.open(fullURL, 'survey',winOptions); if ( myPopUp!=3Dnull && !myPopUp.closed) { if (triggerParms["pu"] =3D=3D 1){ self.focus(); } else { myPopUp.focus(); =09 } } } function checkMAC(){ if(navigator.platform.indexOf("Win32") >=3D 0){ return false; } else { return true; }=09 } var detect =3D navigator.userAgent.toLowerCase(); function checkAOL(){ if (detect.indexOf("aol") >=3D0){ return true; } return false; } function currentLocationExcluded() {=09 var parentURLPath =3D window.location.pathname;//location path for(key in excludeList) { if(parentURLPath.indexOf(excludeList[key]) !=3D -1) { return true; } } return false; } var newDt; var currTime; // in millisecs var OTCImg; var FSRImg; var surveyProcessCont =3D 1; function stdImgProc() { if(triggerParms["compliant508"] =3D=3D 1) { fsr_showWindow();} else { setTimeout ( "fsr_showWindow();", 1000, "JavaScript" ); } } function fsrShowSurvey(){ if(dcQString =3D=3D "") { stdImgProc(); } else { newDt =3D new Date(); currTime=3D newDt.getTime(); // in millisecs FSRImg =3D new Image(); FSRImg.src =3D null; FSRImg.onerror =3D imgErrorProc; FSRImg.onload =3D imgOnloadProc; FSRImg.src =3D FSRImgURL + "?" + dcQString + "&uid=3D"+ currTime; = //for NE/FF Cache Fix } } function imgOnloadProc() { if(surveyProcessCont =3D=3D 1 && FSRImg.width =3D=3D 3) { stdImgProc(); = } return true; } function imgErrorProc() { surveyProcessCont =3D 0; return true; } function otcOnloadProc() { =20 if(surveyProcessCont =3D=3D 1 && OTCImg.width =3D=3D 3) { = fsrShowSurvey(); } else { surveyProcessCont =3D 0; } return true; } function otcErrorProc() { fsrShowSurvey(); return true; } function Poll() {=20 if(triggerParms["dt"] =3D=3D 1) { return; } if(currentLocationExcluded()) { return; } var stickyCounter =3D ForeCStdGetCookie(ckLoyaltyCount); // check = counter cookie var alreadyShown =3D ForeCStdGetCookie(ckAlreadyShown); // check if we = already have shown survey var pageCount; var randNum =3D Math.random(); randNum *=3D 100; if (stickyCounter =3D=3D null) { pageCount =3D 1;=20 ForeCStdSetCookie(ckLoyaltyCount, pageCount, = null,'/',triggerParms["domain"]); stickyCounter =3D ForeCStdGetCookie(ckLoyaltyCount); } if (stickyCounter !=3D null) { pageCount =3D stickyCounter; if(pageCount >=3D triggerParms["lf"]) { if(alreadyShown =3D=3D null) { if (triggerParms["rso"] =3D=3D 1 && triggerParms["aro"] =3D=3D 1) { triggerParms["sp"] =3D 100.0; // Update Ssample percentage } if(randNum <=3D triggerParms["sp"]) { fsr_aol=3D checkAOL(); var fsr_mac=3D checkMAC(); =09 var fsr_browser=3D"fsr_nn6"; if(document.all || document.getElementById){=20 fsr_browser =3D "fsr_ie"; } if(document.layers) { fsr_browser =3D "fsr_nn"; } fullURL =3D popUpURL + "?" + "width=3D" + triggerParms["width"] + "&height=3D" + triggerParms["height"] + "&cid=3D" + specialEscape(escape(triggerParms["cid"])) + "&mid=3D" = + specialEscape(escape(triggerParms["mid"])); if ((triggerParms["omb"] ) !=3D null) { fullURL +=3D "&omb=3D" + escape(triggerParms["omb"]); } if ((triggerParms["cmetrics"] ) !=3D null) { fullURL +=3D "&cmetrics=3D" + escape(triggerParms["cmetrics"]); } if (triggerParms["olpu"] =3D=3D 1) { fullURL +=3D "&olpu=3D1"; } if ((triggerParms["dcUniqueId"]) !=3D null) { fullURL +=3D "&dcUniqueId=3D" + = escape(triggerParms["dcUniqueId"]); } if (triggerParms["rso"] =3D=3D 1) { fullURL +=3D "&rso=3D1&rct=3D" + triggerParms["rct"] + "&rds=3D" + = triggerParms["rds"] + "&mrd=3D" + triggerParms["mrd"] + "&rws=3D" + = triggerParms["rw"]; } if (triggerParms["capturePageView"] =3D=3D 1) { triggerParms["cpp_2"] =3D "PageView:"+ pageCount; // customer = parameter 2 - Page View } if ((triggerParms["midexp"] ) !=3D null) { fullURL +=3D "&ndc=3D1&fsexp=3D5256000&midexp=3D" + = triggerParms["midexp"]; } triggerParms["cpp_3"] =3D "Browser:"+ cppUrlPatch = (navigator.userAgent) + ";normal"; =09 var customerParams =3D ""; =09 for(paramKey in triggerParms) { if(paramKey.substring(0,3) =3D=3D "cpp"){ fullURL +=3D "&" + paramKey + "=3D" + = escape(triggerParms[paramKey]); } }=09 oldURL=3DfullURL; if (triggerParms["rso"] !=3D 1) { if(triggerParms["npc"] =3D=3D 1) { ForeCStdSetCookie(ckAlreadyShown, = 'true',null,'/',triggerParms["domain"]); } else { ForeCStdSetCookie(ckAlreadyShown, 'true', = persistentExpires,'/',triggerParms["domain"]); } } // for AOL users - show DHTML (by default) if (fsr_aol=3D=3Dfalse) { myPopUp =3D window.open(fullURL, 'survey',winOptions); } if (fsr_mac=3D=3Dfalse && (fsr_browser !=3D "fsr_nn") && = (triggerParms["dhtml"] =3D=3D 1)) { fullURL=3DoldURL; fsr_left =3D (screen.width - triggerParms["dhtmlWidth"])/2; fsr_top =3D Math.min((screen.height - = triggerParms["dhtmlHeight"])/2,150); =09 document.write("
" + "
"); =09 //DC I/II verification if (triggerParms["rso"] =3D=3D 1) { dcQString =3D "rso=3D1&rct=3D" + triggerParms["rct"] + "&rds=3D" = + triggerParms["rds"] + "&mrd=3D" + triggerParms["mrd"] + "&rws=3D" + = triggerParms["rw"]; if(triggerParms["dcUniqueId"]!=3Dnull) { dcQString +=3D = "&dcUniqueId=3D" + specialEscape(escape(triggerParms["dcUniqueId"])); } } if ((triggerParms["midexp"] ) !=3D null) { dcQString =3D "ndc=3D1&midexp=3D" + triggerParms["midexp"] + = "&mid=3D" + specialEscape(escape(triggerParms["mid"])); if(triggerParms["dcUniqueId"]!=3Dnull) { dcQString +=3D = "&dcUniqueId=3D" + specialEscape(escape(triggerParms["dcUniqueId"])); } } =09 =09 //Failover Check surveyProcessCont =3D 1; =09 newDt =3D new Date(); currTime=3D newDt.getTime(); // in millisecs OTCImg =3D new Image(); OTCImg.src =3D null; OTCImg.onerror =3D otcErrorProc; OTCImg.onload =3D otcOnloadProc; OTCImg.src =3D OTCImgURL + "?protocol=3D" + = window.location.protocol + "&uid=3D"+ currTime; //for NE/FF Cache Fix } =09 if(myPopUp !=3D null && !myPopUp.closed) { if (triggerParms["pu"] =3D=3D 1){ self.focus(); } else { myPopUp.focus(); } } } } } =09 pageCount++; ForeCStdSetCookie(ckLoyaltyCount, pageCount, = null,'/',triggerParms["domain"]); =09 } } ------=_NextPart_000_008A_01C8EE3B.E54D03D0--