Latest Regulatory Affairs Newsletter

A collection of regulatory news from this month.

An application has been received seeking permission for food derived from soybean genetically modified to contain stearidonic acid (SDA), an alternate source of omega-3 fatty acid.

FSANZ is considering a proposal submitted by the Winemakers Federation of Australia (WFA) to reduce the minimum alcohol content for wine and sparkling wine from 8% to 4.5% alc/vol.

A discussion within the ACCM (Advisory Committee on Complementary Medicines) used krill oil as an example. The compositional guideline was drawn up by the TGA in conjunction with the applicant to reflect the nature of their substance. However other suppliers (not the original applicants on the "new substance application") provide krill oil substances which vary from these guidelines.

The 3rd meeting of the ACCM discussed the difference between these two substances, which both have therapeutic benefits. Issues arise as to the correct nomenclature and labelling of products for the consumer.

This warning was issued 29th April after TGA laboratory tests revealed the product, promoted as being "100% herbal", actually contains sildenafil, the active ingredient in the prescription medicine Viagra.


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