Latest Regulatory Affairs Newsletter

A collection of regulatory news from this month.

Primary sunscreens with SPF > 15 are regulated as medicines in Australia and as such, come under the jurisdiction of the TGA. In a controversial move, the TGA has ordered that the sponsors of “Invisible Zinc” stop advertising that their products are “nano-free” and implying that competitors products are potentially dangerous.

Two instant coffee products —‘Sexpresso’ and ‘Rock Hard’ — have been found to contain analogues of sildenafil (Viagra) not declared on the label.

“Biomarkers” such as cholesterol and blood glucose, may be referred to in claims for listed medicines only if they relate to maintaining healthy levels in normal people.

Parliament has announced that 8 synthetic cannabis-like substances will be classified as prohibited substances throughout Australia from 8 July.

The closing date for comments on the TGA’s compositional guideline is 30th July. (Source:


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