Strapit Surgi Mask - Therapeutic Goods Administration - Corrective Statement
Following an investigation by the Therapeutic Goods Administration, a delegate of the Secretary of the Department of Health and Aged Care formed the reasonable belief that Strapit Medical and Sports Supplies Pty Ltd contravened subsection 42DLB(1) of the Therapeutic Goods Act 1989 (Cth) (the Act) where subsection (6) applied, by advertising, or causing the advertising of therapeutic goods in circumstances where the advertisements contained statements suggesting or implying that the goods had been recommended or approved by the TGA. This was because in the TGA’s view the advertisements contained references which indicated a number of face masks and other personal protective equipment, while entered on the Australian Register of Therapeutic Goods (ARTG), had been ‘approved’ by the TGA without approval to make such claims. Strapit acknowledges that this conduct contravened the Act and has taken steps to rectify the advertising, and remedy the deficiencies in Strapit’s compliance systems by providing further training for its staff on therapeutic goods advertising, with a focus on correct representations and statements about products registered on the ARTG.