Hormone supplement recalled over drug spiking
The FDA said the product contained contains 6-Etioallochol-1,4-Diene-3,17-Dione – or ATD – and must therefore be reformulated or withdrawn from sale in its current guise as it contravened the Food, Drug and Cosmetic Act.
“Though it disagrees with FDA, iForce Nutrition has agreed to the recall because it had already ceased selling the product,” the FDA wrote in a notice, acknowledging that iForce had ceased sales of the product on December 10, 2009.
“Although this product was discontinued nearly a year ago, it has come to the attention of iForce Nutrition that some online retailers may still have remaining inventory that they are offering for sale,” FDA wrote.
The agency noted that the recall did not include another iForce product, Reversitol V2.
“FDA has requested that iForce Nutrition inform consumers that adverse events associated with the use of aromatase inhibitors could include the following: decreased rate of bone maturation and growth, decreased sperm production, infertility, aggressive behavior, adrenal insufficiency, kidney failure, and liver dysfunction,” the agency wrote.
“Consumers with liver, kidney, adrenal, or prostate abnormalities are at higher risk for developing adverse events. iForce Nutrition has not received any adverse event reports nor are they aware of any adverse events associated with the use of these products.”
The voluntary recall follows four others in the past month for dietary supplements but FDA spokesperson Sebastian Cianci said it was not the result of any change in FDA policy or activity.
“When we issue a warning letter we are notifying the recipient that we believe some aspect of their product or operations is in violation of FDA regulations and we ask the recipient to reply to us explaining what they are doing to remedy the situation,” he told NutraIngredients-USA.com.
“We are interested in the resolution of all matters mentioned in a warning letter as quickly as possible. As far as recalls are concerned, they are virtually always voluntary as FDA has no authority mandate a recall for foods (the one exception is infant formula).”
