FDA issues warnings to companies claiming to cure H1N1 virus
ROCKVILLE, Md. The Food and Drug Administration last month issued 35 warning letters to companies promoting a product for the treatment or prevention of the novel H1N1 influenza virus, suggesting that the agency is paying close attention to Internet marketers who may be hoping to capitalize on consumer fears of the “swine flu.”
Marketers were given 48 hours to respond to the warning letters.
“Firms that fail to take corrective action may also be referred to FDA’s Office of Criminal Investigations for possible criminal prosecution for violations of the FFDC Act and other federal laws,” the agency warned.
For those companies located outside the United States, the agency promised to intercept and refuse entry of their products at the border.
“This is to advise you that the United States Food and Drug Administration reviewed your web site at the Internet address http://www.fitura.com/ on May 15, 2009,” the agency stated in its most recent letter emailed to Fitura. “The FDA has determined that your web site offers a product for sale [Power Immune] that is intended to diagnose, mitigate, prevent, treat or cure the H1N1 Flu Virus in people. This product has not been approved, cleared, or otherwise authorized by FDA.”
The agency noted it is paying close attention to the marketing and sale of unapproved H1N1-related products partly on the request of the Centers for Disease Control and Prevention. However, the agency also noted that these products are “a potentially significant threat to the public health.”
Garden of Life teams up with WomenHeart
WEST PALM BEACH, Fla. Garden of Life on Tuesday announced it is teaming up with WomenHeart, the National Coalition for Women with Heart Disease, to improve the health and quality of life of women living with or at risk of heart disease.
“We are privileged to work with WomenHeart to help provide education, support and hope to millions of women at risk or suffering from heart disease,” stated Brian Ray, president.
As part of the partnership, Garden of Life will feature a WomenHeart logo on the packaging of its recently-launched Oceans 3 Healthy Hormones dietary supplement, a percentage of sales from will be donated to WomenHeart, the company stated.
Vitamin Shoppe, Twinlab Co. team up to create new weight gainer
NEW YORK The Vitamin Shoppe and Twinlab Co. joined forces to develop Mass Fuel Xtreme, a unique weight gainer said to help athletes increase muscle mass.
Twinlab Co. has been creating and developing within the sports nutrition field for 40 years. In conjunction with leading national health retailer, Vitamin Shoppe, the companies have developed a weight gainer said to help maximize lean muscle growth, enhance protein synthesis, and speed post-workout recovery period.
“We wanted to develop a product that would help athletes gain the ‘right’ type of mass — muscle versus simply weight. Mass Fuel Xtreme is uniquely designed to deliver the results athletes are looking for,” said Bruce Renick, VP sales for Twinlab.
Mass Fuel Xtreme is now available at Vitamin Shoppe locations and its e-commerce site. Suggested retail price is $62.99 for a 5.95 lb. container.