FDA calls for recall of supplement marketed for ED
ROCKVILLE, Md. The Food and Drug Administration today requested that SEI Pharmaceuticals, of Miami, Fla., recall all Xiadafil VIP Tabs sold in 8 tablet bottles (Lot # 6K029) or blister cards of 2 tablets (Lot # 6K029-SEI) because these products contain a potentially harmful, undeclared ingredient that may dangerously affect a person’s blood pressure and can cause other life-threatening side effects.
These lots of Xiadafil VIP Tabs bear an expiration date of September 2009 and are marketed as a dietary supplement for sexual enhancement and able to treat erectile dysfunction.
Today’s formal request follows an action by the state of Florida to prevent the further distribution of this product into consumer channels. FDA is advising consumers not to buy or use this product. The agency may take further regulatory action to protect consumers from this illegal product.
Although labeled as a dietary supplement and touted as “all-natural,” Xiadafil VIP Tabs are an illegally marketed drug that contains a potentially harmful undeclared ingredient, the FDA stated. FDA chemical analysis revealed that Xiadafil VIP Tabs contains hydroxyhomosildenafil, which is an analog of sildenafil, the active ingredient in Viagra, an FDA-approved prescription drug for ED.
“Because these products are labeled as ‘all natural dietary supplements,’ consumers may assume that they are harmless and pose no health risk,” stated Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research. “But an unsuspecting consumer with underlying medical issues may take these products without knowing that they can cause serious side effects and interact in dangerous ways with drugs that a consumer is already taking.”
On May 13 Florida officials issued a “stop sale” action at SEI’s distribution facility in Miami, Fla. This action required the firm to hold, intact, violative Xiadafil VIP Tabs found on-hand at the facility. The state of Florida’s action to control the supply of the product, coupled with today’s formal request by FDA to recall this product from the marketplace, will further reduce the likelihood that this potentially dangerous product is used by unsuspecting consumers.
Kmart awards weight-loss contest winner
HOFFMAN ESTATES, Ill. Kmart on Wednesday awarded Diana Tollerud from Gurnee, Ill., as the grand prize winner of its annual “New Day Your Way” contest, a program designed to help Kmart customers shed pounds and achieve their fitness goals in 2008.
“Kmart is committed to helping customers work their way to a healthier, happier lifestyle, and we’re thrilled to be honoring such dedicated individuals for their hard-earned fitness achievements while on the New Day Your Way program,” stated Bill Stewart, senior vice president and chief marketing officer, Kmart.
During the 12-week contest, Kmart provided more than 24,000 customers across the United States with the tools necessary to work towards weight loss and a healthier lifestyle. The top 5 winners were chosen by the following criteria: weight lost during the contest, dramatic physical transformation in before and after photos and most inspirational essay.
After being found pinned between two vehicles from a car accident in 2003, Tollerud underwent knee surgery, which prohibited her from the running she used to enjoy and allowing extra weight to add on. However, through the guidance and motivation of the New Day Your Way program, this 44 year-old mother of three shed 38 pounds and is enjoying running again, along with the fresh, new benefits of a healthy body and mind, Kmart stated.
As the grand prize winner, Tollerud was awarded $10,000, a $1,000 Kmart gift card and gifts from contest sponsors, including a Weslo 60CT Treadmill, a makeover at John Frieda Salon provided by KAO Brands, a Bally’s Mini-Stepper, a Slim-Fast gift basket, and a $250 gift basket from L’Oreal among other prizes.
“I’m so excited about all of the weight that I’ve lost and the new sense of confidence that I’ve gained,” Tollerud stated. “I found it so easy to stick to my workout regimen with the support of other contest participants on the New Day Your Way social networking and online discussion boards and look forward to showing off the new me this summer!”
Winners Trelana Nance from Florissant, Mo., David Murphy from Galt, Calif., Billie Smith from Thomasville, N.C., and Cynthia Krusza from Lansing, Ill. also were chosen by Kmart judges as runners up for the “New Day Your Way” contest. These winners participated in bi-weekly weigh-ins at their local Kmart and submitted inspirational essays on the theme “How Kmart Has Helped To Bring Out A New You.”
The winners will receive a combined total of more than $30,000 in cash and prizes, including a trip to New York, the Fit Body Elliptical Bundle, John Frieda Brands Gift Basket and an Active Series 20 by Schwinn Recumbent Bike.
All winners will appear in future Kmart advertising, the retailer noted.
FDA to hold meeting on contact lens products
ROCKVILLE, Md. The Food and Drug Administration last week announced that its Ophthalmic Devices Panel of the Medical Devices Advisory Committee has scheduled a June 10 meeting to discuss general issues concerning the post-market experience with various contact lens care products.
According to the notice, the discussion will include recommendations on contact lens care product development topics such as preclinical testing and clinical performance measures, and labeling for contact lenses and lens care products.
On the agenda will be the recalled lens cleaning solutions that were linked to potentially blinding infections from both Advanced Medical Optics and Bausch & Lomb in the past three years. An estimated 35 million Americans wear contact lenses.