Earlier this week the UK Medicines and Healthcare products Regulatory Agency (MHRA) told the UK online retailer, Predator Nutrition, that Dexaprine was an unlicensed medicine and to remove it from sale.
But the regulator has since backtracked after discussions with Predator Nutrition revealed iForce Nutrition, the Californian manufacturer had developed the UK-specific formulation.
“The owner of Predator Nutrition advised us that the manufacturers produced a formulation specifically for the UK market, which does not include any of the medicinal ingredients,” MHRA press officer Matthew Niizeki told us in an email today.
“He produced a product label which would bear this out and is going to provide me with new evidence and contact details for the manufacturers.”
“I have consequently suspended the 'Urgent Notice' pending further enquiries.”
Testimonials on body building net boards and the Predator and iForce Nutrition websites swear by Dexaprine's efficacy to safely burn fat.
Predator Nutrition sells a 60 tablet box of Dexaprine for £34.99 (€40.93).
Dutch ban
The UK action followed a ban by Dutch authorities who last week told 10 online retailers to cease selling the product after 11 adverse events were reported over about six months including severe heart problems and nausea.
The Dutch Food and Consumer Products Safety Authority (NVWA) said the products remained under lab analysis.
Dexaprine contains a proprietary blend as well as green tea, acacia and citrus extracts and caffeine.
Both the Dutch supplements association, NPN, and the European Specialist Sports Nutrition Alliance (ESSNA) welcomed action against products found to be dangerous.
“ESSNA is working with the responsible sector of the industry and with enforcement authorities to bring cowboy operators within the law and welcomes the action taken on this occasion,” said ESSNA director, Chris Whitehouse.
“The reputation of the whole sector is damaged by those who flout the law and put consumer safety in jeopardy.”
iForce Nutrition was not available for comment at the time of publication.
DNP alert
On Wednesday, the UK Food Standards Agency (FSA) today issued a warning, particularly to bodybuilders, about fat burners, “following the deaths of two people believed to have taken a ‘fat-burner’ substance in tablet or powder form.”
The agency did not name the people or the products in question but said they contained DNP (2, 4 dinitrophenol), “an industrial chemical known to have serious short-term and long-term effects, which can be extremely dangerous to human health.”
Symptoms of high DNP consumption included, “nausea, vomiting, restlessness, flushed skin, sweating, dizziness, headaches, rapid respiration and irregular heart-beat, possibly leading to coma and death.”
“Consuming lower amounts over longer periods could lead to cataracts and skin lesions and effects on the heart, blood and nervous system.”
Dr Mark J. Tallon, LLM, PhD, MD of Legal Foods, a UK-based regulatory affairs company specialising in EU food law, said DNP was likely to cause more problems, and called for greater enforcement.
"DNP is a well known dieting aid from back in the 1930s but its risks of use have been well reported in the scientific literature. There are both acute and chronic risks associated with its consumption even at relatively low dosages," Dr Tallon said.
"However, DNP and many other ingredients presented as, and delivering pharmacological effects are freely for sale across the EU and UK. Chemicals such as DNP are in breach of both medicines and food law and increased surveillance and prosecution are required to curb this problem."
"The authorities in the UK such as the FSA and MHRA are ware of the sale of such ingredients and I foresee action under both food legislation and the Misuse of Drugs Act following for those distributors that continue to put at risk human health."