As an avid USER of the Product, I have to warn those who have taken my advice to please read the following!!!
The U.S. Food and Drug Administration (FDA) recently released a consumer advisory about certain Hydroxycut-branded products. According to the advisory, the FDA has received 23 reports over more than seven years about consumers having experienced serious liver-related problems coinciding with the time they were taking Hydroxycut-branded products. The advisory states that, “Although the liver damage appears to be relatively rare, FDA believes consumers should not be exposed to unnecessary risk.”
While this is a small number of reports relative to the many millions of people who have used Hydroxycut products over the years, out of an abundance of caution and because consumer safety is our top priority, we are voluntarily recalling these Hydroxycut-branded products.
The information below answers questions consumers may have about the advisory, the recall, and Hydroxycut-branded products.
What is Hydroxycut?
Hydroxycut is the brand name of some of America’s top-selling weight loss products which are taken by millions of consumers each year. Hydroxycut products are made by Iovate Health Sciences, which has over 750 items sold in more than 70 countries around the world.
What steps do you take to ensure the safety of Hydroxycut-branded products?
We conduct internal analyses of individual ingredients, and undertake extensive medical, scientific and toxicological literature reviews on the safety of the ingredients during the development stage of each product. Additionally, third-party experts from the leading independent scientific firm specializing in ingredient assessment, toxicology and product safety for the nutritional and pharmaceutical industry review the safety of Iovate’s ingredients and formulas before products are introduced in the marketplace. Only after this external review is completed does Iovate release a formula.
Why did Iovate voluntarily recall Hydroxycut-branded products?
Iovate initiated a voluntary recall when it became aware that the U.S. Food and Drug Administration’s assessment of 23 reports about consumers having experienced liver-related problems, as well as a small number of published case reports, was different from Iovate’s analysis. On May 1, 2009, the FDA issued an advisory which states that, “Although the liver damage appears to be relatively rare, FDA believes consumers should not be exposed to unnecessary risk.”
The number of adverse event reports described by the FDA is small relative to the many millions of people who have used Hydroxycut products over the 7 years referenced by the FDA. Iovate’s own assessment of the potential risk associated with the use of these products differs from that expressed by the Agency. Every product marketed by Iovate is evaluated during its development for the safety of its individual ingredients. Additionally, independent third-party experts from the leading independent scientific firm specializing in ingredient assessment, toxicology and product safety for the nutritional and pharmaceutical industry review the safety of Iovate’s ingredients and formulas before products are introduced in the marketplace. Only after this external review is completed does Iovate release a formula.
However, out of an abundance of caution and because consumer safety is Iovate’s top priority, Iovate is voluntarily recalling these Hydroxycut-branded products.
What is an adverse event?
The term “adverse event” refers to any unexpected or unintended event that happens while an individual is taking a dietary supplement, whether or not the supplement caused the event. Even minor events can be considered adverse if they are unexpected or unintended.
Which products are covered by this voluntary recall?
The following products are covered by this voluntary recall:
- Hydroxycut Regular Rapid Release Caplets
- Hydroxycut Caffeine-Free Rapid Release Caplets
- Hydroxycut Hardcore Liquid Capsules
- Hydroxycut Max Liquid Capsules
- Hydroxycut Regular Drink Packets
- Hydroxycut Caffeine-Free Drink Packets
- Hydroxycut Hardcore Drink Packets (Ignition Stix)
- Hydroxycut Max Drink Packets
- Hydroxycut Liquid Shots
- Hydroxycut Hardcore RTDs (Ready-to-Drink)
- Hydroxycut Max Aqua Shed
- Hydroxycut 24
- Hydroxycut Carb Control
- Hydroxycut Natural
Does the advisory say I should stop taking Hydroxycut-branded products?
Yes. The FDA’s advisory states that, “Consumers who have these products are urged to stop using them.”
What if I want to return my Hydroxycut product. How do I do that?
For product refunds, consumers are directed to return their product directly to the place of purchase.
