Each country has its own regulatory body that controls what supplements and drug are or are not approved for use and what a company can or can’t say about its product.In Australia we have the Therepeutic Goods Adminstration (TGA) whilst the US has the FDA. The TGA has very strict guidelines compared to other countries, which has its good and bad sides.
The downside of having a regulatory body such as the TGA is that for businesses who want to bring a therapeutic product to the market, it can create huge expense in terms of time and money.What we need to understand however, is that the TGA is essentially there to protect the public. To get a product either registered or listed, the minimum cost is around $10,000 per product. When an application is put to the TGA a huge amount of research must be supplied about each ingredient, to back up the companies claim.
The TGA regulates all products that make a claim about health or changes to the body including creams, oral products and machinery. So what is a “claim”? An example is where a company has a skin care product and their promotion states something like “helps relieve the pain or minor burns” or “the relief of the symptoms of eczema”.This is a low level claim meaning that the product will need to be licenced. If the product states “for the prevention of eczema”, it is considered a high level claim and the product (usually a drug) must be registered and is usually only available with a prescription.
A listed product can be purchased at a supermarket, health food store or over the counter products in a chemist. They will have the letter L followed by a number, printed on the label. You can see an example of this on the essential oil bottle above.
With the great cost involved in getting a product registered or listed with the TGA it is not surprising that many great products don’t make it to the market place. Occasionally however, company’s disregard TGA requirements and take the risk that they won’t get caught. Financially this could be a disaster for the company with fines in the $100’s of thousands of dollars. Often products suddenly disappear from the market – frequently because TGA has given them the option to withdraw the product or cop the fine. Company’s with unapproved products are also taking a huge gamble when it comes to protecting themselves legally. For example if a customer has some type of reaction to a product that does not have the proper approval, the company is unlikely to be covered by their product liability insurance and this could cost them thousands or even millions of dollars.
You will see in the diagram above the specific things that you need to look for to ensure your product is approved for sale. In the example above, the company has made a claim that their Lavender essential oil can relieve headaches, insomnia and anxiety. TheTGA has subsequently allowed this claim by the company.
The TGA stipulates exactly what can and cannot be put on the label. This company is permitted to put in its advertising such as pamphlets, information sheets or on the internet, that it can relieve headaches, insomnia and anxiety. Take a look at the Directions. It is approved for use as a massage oil, in a vaporizer or a bath. The allergies and alerts inform the public of how it should not be used. Essential oils are not recommended for oral use in Australia and therefore the alert says NOT FOR INTERNAL USE.
Remember that whenever a company refers to their product as therapeutic, it means that they are saying that it brings about changes in the body and it is subject to TGA approval.
Why should you as a consumer, check to see that your product is listed?
TGA approval basically means that a product has been checked to see that it does what it says it does. It also means that the product has been tested to ensure it contains what it says it contains. For example, tablets purchased overseas that have claimed to be fish oil tablets, when tested, have been found to contain only olive oil. These days it is easy to buy a non-TGA approved products and put a label on the product. Many of these products are coming from China. An internet search for “private label supplements” brings up many such products, that anybody, trained or otherwise can stick their label on. Homeopathics and other liquid products such as essential oils are particularly susceptible to this misleading practice.
Not only can these products not contain what you think they do, but they can also contain dubious ingredients that TGA approved facilities would reject.The use of approved substances even extends to specific species of plants. For example the essential oil Frankincense comes from several species of boswellia. Boswellia Boswellia carterii, Boswellia serrata , Boswellia thurifera are approved for use but Boswellia frereana is not.
For the consumer, purchasing a non TGA approved products means that they cannot guarantee that they are getting what they think they are. They cannot be sure of the real dose inside the container or that they are not buying expensive fillers. If a product is being purchased to treat a specific disorder, money may well be wasted on something that is not going to make any difference to their health problem.
Of more concern is the fact that non TGA approved products can be recommended for use in a manner that is considered dangerous. Natural products are often presumed to be safe – unfortunately this is far from the truth. For example a large number of essential oils are abortifacient agents, meaning that they should not be used even in small amounts such as in a cream or massage oil in pregnant women. How strong are essential oils? Very strong – in fact some can be 70 times stronger than herbal extracts. Long term toxicity is a major concern with oral essential oils and the consumer will not be aware that toxicity is taking place for some time.
To do your own research on natural substances (non-drug) go to http://www.tga.gov.au/pdf/cm-listed-substances.pdf. This is a changeable document that lists the substances approved for use by the TGA. Products are added to it as they are approved. Substances are only added when a person or company has paid for a product to be added. As this is very expensive and time consuming, new substances are not added often. This pdf document is therefore up to date even though it was last updated in 2007.
Whatever products you purchase, be sure to look on the label for the letters L or R followed by some numbers, to ensure that are deemed safe by the TGA for use in Australia.
Written by Darwin Naturopath, Vivienne Savill