Australia and New Zealand have jointly issued a warning against pre-workout sports supplement OxyElite Pro following its links to an outbreak of acute non-viral hepatitis in Hawaii that killed one person and affected 29.
One case of acute non-viral hepatitis has been linked to the product in New Zealand, according to the country's government.
The US Food and Drug Administration (FDA) issued a similar warning this month and is engaged in an ongoing investigation of the matter, while US-based manufacturer USPLabs has defended its product, saying the hepatitis link, if proven, was not down to its products, but those produced by counterfeiters the company has long been fighting.
The Food Standards Australia New Zealand (FSANZ) warning follows similar actions taken this week by authorities in the UK, Spain and Denmark.
FSANZ alerted health authorities to look out for cases of acute non-viral hepatitis with symptoms including, “fever, fatigue, loss of appetite, nausea, vomiting, abdominal pain, dark urine, clay coloured bowel movements, joint pain, yellow eyes, and jaundice.”
FSANZ CEO Steve McCutcheon highlighted the typically online nature of the product sales and the increased potential for product fraud on the internet.
“Consumers need to exercise caution when using any dietary supplement and should do so under medical supervision,” he said.
“People also need to be particularly careful about purchasing products online. Online products can have unsafe ingredients and consumers can’t be certain they are getting legitimate products.”
“FSANZ will continue to liaise with health authorities and food regulatory agencies on the investigation and will update its advice to consumers as necessary.”
In New Zealand, the acting director general of the Minister for Primary Industries, Scott Gallacher, said the ministry, “is working with the FDA and FSANZ to obtain additional information.”
It added: “MPI is aware of one non-viral hepatitis case in New Zealand, with no current cause, arising in a consumer of OxyElite products.”
An investigation into that case is ongoing.
In its warning letter to USPLabs the FDA questioned the alleged botanical source of the active ingredient, aegeline, also referred to as N-[2-hydroxy-2(4-methoxyphenyl) ethyl]-3-phenyl-2-propenamide, which it said lacked approval in the US.
The UK Food Standards Agency (FSA) this week also increased attention via a consumer warning on the industrial chemical DNP, that is being used as a pre-workout aid. That action was welcomed by the European Specialist Sports Nutrition Alliance (ESSNA).
“The Food Standards Agency’s campaign against DNP is very welcome,” said ESSNA general secretary, Chris Whitehouse.
“DNP is a chemical, plain and simple. It has nothing to do with either sport or nutrition, and should not be available to the public in any form. It is unacceptable that products containing DNP are available over the internet, and we hope the FSA’s campaign will help crack down on sites that are peddling illegal products that could potentially put consumers’ lives at risk.”
“We urge all consumers to be very careful about the content of the products they are purchasing, to stick to legitimate sports nutrition products, and make sure they are buying from reputable retailers and manufacturers.”