EmpireLabz Australia fined for unlawful advertising and supply of unauthorized sports supplements

28 Aug 2023 --- The Therapeutic Goods Administration (TGA) issued seven infringement notices for a total of AUD$115,500 (around US$74,085) to EmpireLabz Australia for the alleged unlawful advertising and supply of sport supplement products not included in the Australian Register of Therapeutic Goods. 

Laboratory testing on the products allegedly advertised and supplied by EmpireLabz Australia identified the banned substances 1,4-Dimethylpentylamine (DMAA) and 1,5-Dimethylhexylamine (DMHA). The sale, supply and use of products containing these substances is prohibited in Australia due to their dangers to human health. 

The TGA notes that potential adverse effects of these substances include cardiac, nervous and psychiatric disorders. 

DMAA is an amphetamine derivative marketed in sports performance and weight loss products, including supplements. Both the TGA and FDA have banned it. DMHA was used initially as a drug for nasal congestion and is included in some supplements to boost workout performance, burn fat or increase weight loss. 

Product testing 
In addition, all tested products also contained prescription-only ingredients, including Deanol, Yohimbine and Levadopa. Advertising prescription-only medicines is not allowed in Australia. 

The Australian Register of Therapeutic Goods is a public database of therapeutic goods that can be legally supplied in the region. Listings in the register include the product name, formulation details, sponsor (company) and manufacturer details. Unless exempt, companies cannot supply unregistered therapeutic goods. 

The TGA found prohibited substances in EmpireLabz Australia’s food supplements.Sports supplement products are considered therapeutic goods when they make therapeutic claims and contain scheduled substances or substances prohibited for sports by the World Anti-Doping Authority. Supplements that contain undeclared or potentially harmful ingredients can cause serious health problems. 

The TGA will continue to take decisive enforcement action in compliance issues in the unlawful import, manufacture, advertising and supply of unapproved medicines used in the wellness industry, including sports supplements.

Safety and advertising issues in supplements 
Research has revealed that supplements sold online are difficult to regulate, and most lack correct labeling. For example, earlier this year, studies on multivitamins and resveratrol sold online revealed that most products contained insufficient or too high vitamin levels or had inaccurate labels. 

In the US, research has deemed the FDA’s attempt to remove dangerous supplements from the market ineffective. The regulatory agency issues warning letters, which often go unheeded by manufacturers. 

Last year, the FDA issued warning letters to seven companies said to have been selling illegal supplements claiming to cure, mitigate, treat and prevent cardiovascular diseases. After receiving such letters, companies have 15 working days to respond and need to explain how the issues will be addressed. Companies failing to do so may face legal action, product injunctions and seizures. 

The Council for Responsible Nutrition has also expressed concerns over how supplements are presented by the FDA, noting that the agency downplays the benefits of taking supplements while exaggerating the potential hazards. 

In 2022, the UK-based Advertising Standards Authority found three vitamin supplement companies used misleading or fake claims in their Google search advertising. The paid-for Google search ads had some variation of “UK’s Top 5 Vitamin D Ranked” or “Best Ashwagandha of 2021 Ranked.” For each site, the product to be ranked was specific to each company’s products and listed each company’s product as number one.

By Jolanda van Hal

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