03.Product regulation
All the products we looked at are available over the counter in pharmacies, yet only three... are listed with the TGA.
The Therapeutic Goods Administration
(TGA) is the government body
responsible for regulation of medicinal
products. Products listed with the
TGA are divided into two categories:
registered goods and listed goods.
All
registered medicines, deemed to be of
higher risk – such as prescription drugs
– are individually assessed for efficacy
and safety before they reach the shelf,
while listed goods, considered to be of
lesser risk, usually reach the shelf
without any regulatory examination.
Only about 20% of new listings in
this category are randomly assessed
each year for compliance with
TGA requirements.
All the products we looked at
are available over the counter in
pharmacies, yet only three – the
Bioglan Intense Cleanse, Blackmores
Kickstart Detox and the Skinny Mini
– are listed with the TGA.
Dr Ken Harvey, adjunct
associate professor at La
Trobe University’s School
of Public Health, wrote in
a recent article published
in the Medical Journal of
Australia that the TGA fails
when it comes to protecting
consumers in the purpose it
was established to achieve:
to provide for a national
system of controls relating
to the quality, safety and
efficacy of therapeutic goods.
Harvey recently succeeded in
bringing a complaint before the
Complaints Resolution Panel of the
TGA’s Advertising Code Council for
misleading claims attached to a detox
product. The claims made about
Slimright 123 Detox n Burn that it
would detoxify the body, reduce
bloating and cleanse toxin build up
were found to be misleading and likely
to raise unwarranted expectations.
Similar claims are attached to all these
products, however only the products
listed with the TGA can be regulated
under the code.
The remaining seven products,
formulated as liquids or powders, escape
the ambit of regulation. Such products
fall within the realm of Food Standards
Australia and New Zealand (FSANZ).
FSANZ’s Health Claims Standard,
currently being updated, regulates
high-level health claims attached to
food products, including powder sachets
and oral liquids clearly intended to be
sold as diet detox products.
Our experts say that, in lieu of
adequate regulation, the onus is on
consumers to look out for words
used in conjunction with claims on
these products, such as “aids” and
“assists”, effectively buying leeway
for the manufacturers.