Latest Regulatory Affairs Newsletter

A collection of regulatory news from this month.

The closing date for comments on the TGA’s compositional guideline is 30thJune. However, the TGA’s compositional guidelines are not legally enforceable. (Source:

Significant changes include simpler labelling, with clarification on SPF numbers, and “water resistance” and “broad spectrum” claims.

"Pink Lady for Women" has been found to contain tadalafil (the active ingredient in Eli Lilly's product Cialis, which is for male erectile dysfunction) and "St Nirvana herbal slimming capsules" contains the prescription medicine sibutramine (no longer available in Australia due to safety concerns), and also dangerous levels of phenolphthalein (Source:

At a meeting today of Australia’s Prime Minister Julia Gillard and New Zealand’s Prime Minister John Key it was announced that the governments have decided to set up a joint medicine and medical device agency. This resurrects discussions held in the early 2000s which did not come to fruition. The proposed new agency will at first exclude complementary medicines and dietary supplements until a mutually acceptable regulatory framework is  agreed on.

In 2006, the Nutrient Reference Values replaced the 1991 Recommended Dietary Intakes for Use in Australia (RDIs). The FSANZ website states that NRVs "indicate the daily amount of nutrients required for good health, as well as a safe intake of nutrients".


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