Aek
New member
Sign the Stop the TGA categorising our Foods as Medicine Petition!
(
Australian residents only)
Put simply, this petition is trying to stop the Australian Therapeutic Goods Administration from legislating regulation which will term all food in a capsule or tablet as a drug or a Therapeutic Good (its still regulated as a drug).This petition will be sent to the federal minister of health (Nicola Roxon) and the Assistant Minister of Health (Mark Butler). Your petition email will also be sent to the TGA's submission email address.
Nicola.Roxon.MP@aph.gov.au
Mark.Butler.MP@aph.gov.au
The Project Officer
Section 7 Consultation 2009
Regulatory Compliance Unit
Therapeutic Goods Administration
PO Box 100 WODEN ACT AUSTRALIA
Section7consultation@tga.gov.au
The TGA explanation is below:
In Australia, it has long been recognised that there is a legislative ‘interface’, or overlap, between foods and medicines for human oral consumption. As the food and complementary medicine sectors have evolved over recent years, a ‘grey area’ has unintentionally developed at this food-medicine interface. The confusion is due to certain areas of food legislation and therapeutic goods legislation overlapping in such a way that makes it difficult to determine which legislation should be applied in many
Health Petitions
SO WHY ARE WE AGAINST THIS PRPOSAL.
Hippocrates said "let food be thy medicine". This did not mean that our food should be regulated as dangerous drugs that need to be treated as potentially life threatening!
Hundreds of years later the observation of Hippocrates still stands, yet the Australian Therapeutic Goods Administration (TGA) want to go one step further and class our food as a hazardous medicine similar to dangerous synthetic pharmaceutical drugs? The TGA wants to do this by changing legislation that makes our food in capsule or tablet form a drug!
Section 7 declarations - food or therapeutic good?
http://www.tga.gov.au/cm/consult/cons-s7declaration.pdf
Does this mean that Kellogg's Special-K in a capsule could soon be a drug or shredded wheat cereals?
The TGA states:
"In Australia, it has long been recognised that there is a legislative ‘interface’, or overlap, between foods and medicines for human oral consumption. As the food and complementary medicine sectors have evolved over recent years, a ‘grey area’ has unintentionally developed at this food-medicine interface. The confusion is due to certain areas of food legislation and therapeutic goods legislation overlapping in such a way that makes it difficult to determine which legislation should be applied in many cases."
The real reason for this over lap is that the TGA regulates health supplements as medicines. Health supplements should be regulated in a third category of their own, just as they are now or soon to be in New Zealand. If this happened then foods would not be regulated as drugs or medicines. This "confusion" is the fault of the TGA's regulation and not the fault of the health supplement industry!
We use natural health products as foods and not medicine. Yes good food keeps us healthy but it is not a drug! We do not find the existing laws misleading or confusing as the TGA has insisted .
In fact, changing the law as the TGA is suggesting makes the new laws even more confusing.
We as consumers understand the difference between foods and medicines and we do not need the TGA to define this for us. We are intelligent human beings, we read the labels, we educate ourselves. It may be confusing to the TGA but it is not confusing to the public!
This law benefits the bigger health companies of which are mostly owned or majority controlled by drug companies. This proposal by the TGA will raise the costs of entry point into the health food market for small business, leaving a monopoly for larger companies.
Turning such food products into medicines is misleading on the TGA's behalf and serves also the financial interests of the TGA, as it generates more income with regards to annual audits and listing on the TGA Therapeutic Register of a health product. These costs will then be passed on to consumers.
For example, such products as Chlorella, Wheat grass, Barley grass and Spirulina, under the TGA's proposed plans, will become a drug and a medicine. These products will then become more expensive to purchase. This is outrageous!
People prefer these foods in a capsule form during travel, or because the taste may not be desirable to the palate, or just simply as it is easier to monitor how much of the food they have ingested, this does not make them a therapeutic good (drug).
Does this mean that the TGA will also categorise products, available from food retail, such as sodium saccharin tablets as a drug? This is the same sodium saccharin which has been linked to cancer (but still available to the public). Or will the TGA make exemptions for dangerous products like sodium saccharin to be freely available as a food?
Over the years the TGA and its officers seem to have forgotten about their original charter, and now we are seeing what is commonly called "regulatory creep".
The whole primary raison d'être for the TGA is to keep us safe from dangerous drugs, which the TGA is not doing such a good job of. Remember Vioxx? The TGA did nothing! Merck Sharp & Dohme eventually pulled the Vioxx off the market voluntarily after it had already killed 50,000 people (Authorities ignored Vioxx warning - Breaking News - http://www.theage.com.au)
The TGA should keep its hands off our foods! Food is a food and drugs are potentially dangerous products produced by drug companies! There is a large difference and we do not find the definition confusing, nor should the TGA!
The amendments to Section 7 of the Therapeutics Goods Act should not be implemented in any form.
Health Petitions
