Latest Regulatory Affairs Newsletter

A collection of regulatory news from this month.

The promoters of Invisible Zinc sunscreen have been ordered to withdraw advertisements and representations and publish a retraction. 

Nice-Pak Products has been ordered to withdraw its advertisement for their product Hedrin and not make certain representations in any other advertising.

The TGA is writing to all sponsors with products containing Trigonella foenum-graecum (fenugreek) requesting information about the country of origin of the fenugreek.

The TGA plans to release for consultation in October a review of labelling and packaging requirements for all types of medicine – prescription, OTC and complementary medicines (Source: www.tga.gov.au).

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.

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