Proposed Section 7 Declaration: that products in capsule, tablet or pill form are therapeutic goods

[occidentalis]

http://www.tga.health.gov.au/cm/consult/co...ation.htm#notes

The TGA are proposing to declare (under Section 7 of the Therapeutic Goods Act 1989) that goods presented for oral consumption in tablet, capsule or pill form are therapeutic goods, to "clarify regulatory requirements for industry". Should this initial consultation indicate that the Section 7 Declaration is warranted, a full regulatory impact statement would be prepared.

This means that any health supplement, such as herbal preparations or even spirulina in capsule form would be considered a therapeutic good and the TGA will have the power to say how and from where you are allowed to purchase and use it.

While this may not necessarily result in massive changes for many products, personally I feel that the TGA is not an organisation to be trusted to do the right thing for those of us who use, manufacture, or have other interests in alternative or herbal medicines. The less control they have the better. Feel free to disagree with me on this point - perhaps allowing them to control everything will solve the following grave problem

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.

but personally I sense that this will just give them more chances to fuck us over and further the move towards complete corporate control of health care.

You are invited to provide comment on the proposed Section 7 Declaration: that products in capsule, tablet or pill form are therapeutic goods by close of business on Monday 30 November 2009.

Read the page linked at the top of this post for info on how to present your submission.

Edited October 27, 2009 by occidentalis

[Smiling Cloud]

What about those darrel lea musk lolllies? Or lifesavers/fruit tingles/breath mints/tic tacs etc? Will all these lollies be covered?

[faustus]

does that mean that their therapeutic benefits need to be demonstrated?

[Alice]

So I guess the smaller herbals suppliers will just have to supply as loose herb or powder, and chuck in a couple of empty gel caps so the consumer can cap them themselves. A bit of a pain, but hey, maybe there will be a small saving on price since the capping time/effort is removed

It's a bit of a worry. The TGA should mind their own business, not ours.

Edited October 28, 2009 by Alice

[Torsten]

Alice, the TGA IS minding their own business. It is controlled by big pharma business and the medical industry [just look at the make up of the board], so any move to squeeze out small operators is definitely the big boys looking after their slice of the pie.

As far as this section 7 goes, the TGA has been prosecuting manufacturers of capsulated and tabletted products for years with the claim that all such products are classed as therapeutics. Maybe they recently lost a court case so need to tighten the law with a blanket definition.

[ethnodude]

Those in the know have been warning about this for about as long as the word paranoid has been popular with medics.

From what I gather anything labelled for consumption or in pill form will be deemed a therapeutical product. In this case it will need to be approved by the TGA by way of an $100,000 instalment (bribe). Even then there's no guarantee of approval.

What this means is that less information will be permitted to be provided to the consumer. Manufacturers will not be allowed to put information about consumption methods and precautions if not approved. Its a harm minimising approach to protect us from ourselves. I imagine there will be a lot of plant feeders on the market next year.

Liquids will remain permitted, as it would be pretty hard for the TGA to justify the therapeutic values of most consumable liquid products which they pedal (Alcohol, caffeine drinks ect).

What absurdity.

Edited October 28, 2009 by ethnodude

[Xenodimensional]

Don't forget to get your submission in by COB today! I'm working on mine progressively throughout the day. If the TGA has its way things like Flaxseed oil will be regulated as a theraputic good (and any other substance that can currently be classified as a food or a theraputic good). By their definition of "Theraputic Good" I have a feeling that almost anything we put into ur bodies will end up under their jurisdiction:

therapeutic use means use in or in connection with:

( a ) preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury in persons or animals; or

( b ) influencing, inhibiting or modifying a physiological process in persons or animals; or

( c ) testing the susceptibility of persons or animals to a disease or ailment; or

( d ) influencing, controlling or preventing conception in persons; or

( e ) testing for pregnancy in persons; or

( f ) the replacement or modification of parts of the anatomy in persons or animals.

I wish to see this legislative body dumped and something far more transparent put into its place. Something that actually has a fair regulatory system in place where public consultation is a major factor in the decision making process instead of a small blip on the radar that in almost no way has any bearing on the decisions they make. :evil: :twisted: :evil: :twisted: :bunnycake: