The new product - Thermogenic Hydroxycut Advanced – is a completely new blend of ingredients, and contains only one of the ingredients present in the previous formulation, confirmed the United Stated Food and Drug Administration (FDA).
On May 1, 2009, 14 different products in the Hydroxycut line were recalled by their manufacturer Iovate Health Sciences after 23 adverse event reports found that they could be linked to serious liver damage. One death was reported, as well as six patients diagnosed with serious liver disease and two requiring liver transplant.
Caffeine is safe
At the time of recall, FDA said it had not identified any particular ingredient or ingredients that may have caused the liver toxicity.
In response to a recent inquiry from NutraIngredients-USA.com, FDA said it has still not identified the potentially problematic components, but said that the product’s manufacturer has “removed most of the ingredients that were in the original formula”.
“The only ingredient left in from the original formulation is caffeine. We do not have any evidence that caffeine causes liver toxicity,” an FDA spokesperson told NutraIngredients-USA.com.
Iovate confirmed that “all of the product’s herbal ingredients and extracts have been replaced”, and that the reformulated product was on the market. However, the firm declined to answer any further questions.
Back on shelves
Some of the nation’s largest supplement retailers – including Vitamin Shoppe and GNC – have also confirmed that they have placed Hydroxycut back on their shelves.
GNC said Iovate provided “all required certificates of analyses” to confirm the products’ safety. The retailer now stocks Hydroxycut Advanced, Hydroxycut Hardcore X and Hydroxycut Max Advanced.
Vitamin Shoppe confirmed that it began carrying the reformulated product on June 3, 2009. This is just one month after the recall was announced, and two months after FDA first informed Iovate of liver toxicity concerns associated with the Hydroxycut products.
To read a letter recording FDA’s first meeting with Iovate on March 31 click here .
Hydroxycut is one of the most popular weight-loss supplement brands in the US. In 2008 alone, over nine million units of the product were sold.