TGA allays CM concerns
February 26, 2014
Following reports from the
University of Adelaide stating that
18% of complementary medicines
sold in supermarkets are not
registered with the Australian
Register of Therapeutic Goods
(ARTG) in spite of the fact that this
is a legal requirement for their
sale (PD 20 Feb), the Therapeutic
Goods Administration (TGA) has
responded to allay consumer fears.
A spokesperson for the TGA said
the writers of the manuscript did
not appear to fully understand the
operation of the Therapeutic Goods
Act and how the regulation of
therapeutic goods occurred.
“As a result we believe they
have made some wrong findings
with regard to compliance with
labelling,” the TGA said.
The discrepancies related to
labelling and product content
were noted last year by the TGA
and have now been rectified,
the TGA added, saying that the
Administration ensures compliance
with regulatory requirements on a
case by case basis and cancellation
of a product is an option.
The Consumer Health Council
(CHC) has also commented
emphasising “caution with any
study drawing results from such a
very small sample size.”
Carl Gibson, ceo of the CHC, said
that the sampling of 121 of the
11604 listed medicines registered
on the ARTG did not give a true
reflection of the compliance of the
industry.
Moreover, many of the regulatory
reforms, which the CHC had been
proactively involved in, were still
to be rolled out to the industry
and would continue to increase
consumer confidence in low risk
listed medicines, he said.
The CHC emphasised the
regulatory vigour of the
complementary medicines
industry in Australia which is
recognised as having one of the
highest regarded and most tightly
regulated systems in the world,
with products manufactured under
Good Manufacturing Practice, and
the industry operating under strict
safety and quality regulations set
by the TGA.
The public did need to be aware
that products purchased online
from overseas were not subject
to the same regulations as those
enforced in Australia, and therefore
these purchases of complementary
medicines should only be made on
the recommendation of a qualified
healthcare professional or from a
reputable retailer, the CHC said.
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