Aussie Mega Supplements operator fined and undertakes to comply with rules for supply and advertising of therapeutic goods

The Therapeutic Goods Administration (TGA) has accepted a court enforceable undertaking from Yossef Wahib, operator of the online store Aussie Mega Supplements, in relation to alleged illegal manufacture, supply and advertising of unregistered therapeutic goods.

It is alleged that Mr Wahib manufactured, supplied, and advertised “EVA B17” products, which were found to contain amygdalin, a substance which is listed under Schedule 10 of the Poisons Standard.

In Australia, medicines and chemicals are classified into schedules according to the level of regulatory control required to protect public health and safety. Schedule 10 lists substances of such danger to public health as to warrant their prohibition from supply and use.

Amygdalin is broken down within the body into hydrogen cyanide, a highly poisonous substance which could cause death at higher doses or for people with lower bodyweight, such as children.

The undertaking is enforceable for a period of three years, and requires Mr Wahib to:

• educate current and former suppliers of the TGA’s action
• recall unregistered therapeutic goods
• inform the TGA within 7 days of recommencing operations of his business or commencing a new business dealing with therapeutic goods
• engage an externally qualified compliance professional to advise regarding regulatory procedures.

In addition to the enforceable undertaking, Mr Wahib was also issued an infringement notice for $3,756.00

The TGA reminds individuals and businesses that serious penalties can apply for breaches of the Therapeutic Goods Act 1989, including fines and civil or criminal court action.

If you suspect non-compliance in relation to therapeutic goods, you can report illegal or questionable practices online to the TGA.

Contact for members of the media:

• Email: news@health.gov.au
• Phone: 02 6289 7400