The Hydroxycut products, which sold over nine million units in 2008 alone, were voluntarily recalled on Friday by their manufacturer Iovate Health Sciences.
FDA issued an advisory on Friday morning, warning consumers to immediately stop using the products, which are sold nationwide under the Iovate and MuscleTech brand names. The 14 products included in the recall are marketed for weight-loss, as fat burners, as energy-enhancers, as low carb diet aids, and for water loss.
The agency said it was taking this action after receiving 23 reports of serious health problems related to liver damage. One death was reported, as well as six patients diagnosed with serious liver disease and two requiring liver transplant. Other health problems reported included seizures; cardiovascular disorders; and rhabdomyolysis, a type of muscle damage that can lead to other serious health problems such as kidney failure.
FDA said it has not as yet determined which specific ingredients are associated with the adverse events.
However, Dr Vasilios Frankos, director of the Division of Dietary Supplement Programs at FDA’s CFSAN, said that as part of the agency’s investigations into the ingredients at fault, it could be looking at other products on the market that contain the same ingredients.
“We’re investigating and that’s really all we can say at this point,” he told journalists in a press conference.
AERs
The safety issue was identified by an adverse event reporting (AER) system, which is designed to allow FDA to monitor for signals of safety concerns related to dietary supplement products.
AERs have been subject to much tighter regulations since the end of 2007, when the Dietary Supplement and Nonprescription Drug Consumer Protection Act came into effect. This stipulates that any serious adverse events reported to a manufacturer must be sent on to FDA within 15 days. FDA can inspect both serious and non serious adverse event reports for six years after receiving them.
In the current case, the agency said it had first started receiving adverse event reports around 2000, when the products originally contained the weight loss ingredient ephedra, which was later banned. More adverse event reports came through after the products’ reformulation in 2004.
The death associated with the products, which occurred in 2007 and involved a 19 year old man, was not reported to the agency until the end of March 2009. FDA said this time lag was “not really that unusual” as the incident had occurred before the mandatory reporting requirements were implemented.
Ingredients?
The 14 products in question contain a variety of ingredients and herbal extracts, and FDA said it has not yet determined which ingredients or dosages are related to the risks reported.
“It’s actually not accurate to say ‘ingredients’ because what we have are propriety blends of ingredients and the amount of each component of that blend varies from product to product (…) It’s very hard to draw a specific individual ingredient determination when you have a product like that,” said Dr Frankos.
Linda Katz, interim chief medical officer at FDA’s CFSAN added: “What we do know is that the reaction is idiosyncratic, which is part of the concern that we have and why we want to get the information out rather quickly to make sure that we do not expose consumers to undue risk.”
Idiosyncratic reactions are ones that do not appear to have a dose-response relationship, or ones for which there are no specific risk factors, she explained. “Most of the individuals in which we’ve had AERs had normal liver functions and were otherwise healthy individuals.”
Susan Cruzan from FDA’s Office of Public Affairs told NutraIngredients-USA.com that the agency “is looking at the ingredients and will continue to review and evaluate them”.
She added that there was no evidence that unacceptably high levels of an ingredient were present in the product due to a manufacturing error, a risk factor that is specifically addressed by new supplement GMP regulations.
Weight loss
The dietary supplement weight loss category is one of the industry’s most vulnerable areas. As well as being a major focus for regulators due to an abundance of misleadingly marketed products, or products containing undeclared drugs, the sector is also suffering from internal inconsistency.
Its strongest ingredient, ephedra, was banned in 2004 after it was found to be associated with severe health risks, including death. Since then, there have been no undisputed category leaders.
“If we were to be asked ‘what are you best players in the weight loss game’, we wouldn’t have an answer. In the past we would have said ephedra, or hoodia, but now we simply don’t have a unified response. That is tactically and commercially unacceptable. For a category this size, it’s astonishing. Our strategy must be to get a unified response,” said Loren Israelsen, executive director of trade group United Natural Products Alliance (UNPA) at an industry seminar last year.
Ingredients currently used in weight loss supplements include: bitter orange, chromium, guar gum, hoodia, garcinia, Conjugated Linolenic Acid (CLA), pyruvate and chitosan.
Nutrition Business Journal, values the US weight loss supplements market at $1.7bn.