Spanish authorities have issued a warning about a food supplement from the United States after it was linked to a death in Spain.

The Spanish Agency for Food Safety and Nutrition (AESAN) reported the withdrawal of Hydroxycut Hardcore Next Gen for possible serious adverse reactions. The supplement is a MuscleTech brand, which is owned by Iovate Health Sciences International.

Iovate said it believes the product does not pose a risk to consumers as there have been no reports of adverse events relating to liver toxicity or death with almost half a million units sold.

Spanish authorities reported commercialization in the country is not allowed. However, the company said it confirmed with a local distributor that the product was notified and registered in Spain.

Death in Madrid
AESAN was informed by the Coordinated System for the Rapid Exchange of Information (SCIRI) of an alert by health authorities in Madrid. Officials at Madrid’s Pharmacovigilance Center suspect acute liver failure resulting in the death of a patient who had been taking the food supplement, marketed as a weight loss product.

Authorities believe the product was purchased through a Canadian-based website but it is marketed through numerous sites that sell food supplements, as well as on online platforms and some physical stores dedicated to selling supplements.

Kelly Albert, chief operating officer of Iovate, said it has not been given any details about the incident from Spanish authorities.

“Immediately after learning of the incident, Iovate reached out to the Spanish authorities to attempt to obtain details and are still awaiting a response after almost a week. We have not received any information that any of our products caused or contributed to the patient’s unfortunate condition,” she told Food Safety News.

“Our distributor in Spain did inform us that during their discussions with Spanish authorities, a regulatory officer verbally informed them the patient in question was consuming other supplement products which may have contributed to the unfortunate fatality; we are still in the process of verifying this information.”

Premature conclusions
Albert said based on information to date and the firm’s ongoing investigation, it believes the product does not pose safety risks to consumers.

“If the Spanish authorities had reached out to us beforehand they would have known we have sold nearly half a million bottles of this exact formula with absolutely zero reported cases alleging liver toxicity or fatality, with the exception of this unconfirmed event.

“Iovate is absolutely committed to the safety of its products and would not knowingly sell any product that is harmful. Iovate monitors adverse event reports on a daily basis in order to identify and analyze any trends in adverse events with the assistance of a third party pharmacovigilance company.”

Albert said given the lack of complete information surrounding the situation and potential influence of other ingestible products used simultaneously by the consumer, it is reasonable to assume the report may have formed erroneous conclusions too early.

“Iovate takes such matters seriously and we will continue to thoroughly investigate this matter, including proactively engaging with the relevant authorities, until we have a full understanding of the facts. We look forward to collaborating fully with the Spanish authorities to determine the true cause behind the patient’s unfortunate fatality,” according to the statement.

Previous problems
Hydroxycut Hardcore Next Gen is made in the United States from international ingredients.

Manufacturers and distributors of products labeled as dietary supplements are responsible for evaluating safety and labeling of their products before marketing to ensure they meet regulations, but they do not need approval from the U.S. Food and Drug Administration (FDA) before introducing them to the market.

An FDA spokesman told Food Safety News that the agency was unable to comment on whether it was investigating a product or company.

“The FDA advises consumers to talk to their doctor, pharmacist, or other health care professional before deciding to purchase or use any dietary supplement. Also, if claims sound too good to be true, they probably are. And finally, if a consumer thinks that a dietary supplement might have caused a reaction or illness, they should immediately stop using the product, contact their health care provider, and submit a complaint to the FDA,” he said.

However, the spokesman confirmed there had been previous related Class II recalls, the second level of health hazard. A total of 23 Hydroxycut-associated liver toxicity reports were identified between 2002 and 2009 before it was reformulated.

“FDA had monitored recalls conducted by firms involving Hydroxycut and MuscleTech products around 2009 and 2014 respectively. The Hydroxycut product was associated with a number of serious liver-related illnesses and other health problems while the MuscleTech amino build fruit punch was recalled due to potential cross contamination with egg protein.”

AESAN has passed on the alert to the Spanish Agency for Medicines and Health Products (AEMPS), the Coordination Center for Health alerts and Emergencies, and European Commission through the Rapid alert System for Food and Feed (RASFF). A RASFF alert shows the product was also sent to Andorra, Brazil, France, Netherlands, Portugal and Slovakia.