Export Corporation Penalised $3.1 Million for Illegal Supply

On the 3rd of February 2012 the Federal Court ruled that Export Corporation (Australia) Pty Ltd should pay civil penalties of just over $3.1 million for importing and supplying a number of products that were not on the Australian Register for Therapeutic Goods (ARTG). This comes as stern reminder for all therapeutic goods manufacturers and suppliers that regulatory requirements should be a key component of business practice in Australia.

The decision shows that the Federal Court can and will impose significant penalties on therapeutic goods manufacturers and suppliers who import or supply therapeutic goods without completing the required regulatory actions.

The TGA report that in the period from 2006 to 2009 Export Corporation imported and supplied over 35 products that were not certified by the TGA as required.  These included nutritional and weight loss products as well as body building, muscle growth and vitamin products.

In deciding the applicable penalty, the Federal Court took into account the following:

• The large number of contraventions (numbering in the thousands)
• The lack of appreciation by the company of the seriousness of the regulatory requirements
• The deficiencies in the company’s compliance culture
• The need for the level of penalty to act as a deterrent to others who might be tempted to “make the same mistake” and to serve as a particular message to those involved in importing and distributing sports supplements in Australia

The best advice we can give is if you are unsure of regulatory requirements applicable to your organisation, don’t risk it. Contact KD&A for guidance and assistance.