Complementary Medicine Labels : A Consumer’s Right To Know

January 31, 2014  |  Blog, Drug Intolerance

If you regularly use complementary medicines, and have an auto-immune condition, intolerances, or allergies, there is a thing or two you need to know about reading complementary medicine labels, and a consumers right to know about the ingredients. This information applies to Australia, where I live, but may also be of interest elsewhere.

Firstly, let me share a personal experience, to paint a picture as to the current state of affairs.

I am intolerant to many things. I know what those things are (having been at this for a while) and one of those things is synthetic colours. When I say intolerant I mean I need medical assistance.

I decided, on my doctors advice, to take a Vitamin D supplement during the winter months. I know that I am highly intolerant to synthetic colours, so I carefully checked the label, which in this instance at least included an allergy disclosure, but sadly no full ingredient listing. The disclosure clearly stated there were no synthetic colours in the product. I trusted the brand, so I trusted the allergy disclosure, and took the supplement.

Within minutes of taking the recommended dose I started having an allergic type reaction. I knew the reaction and knew it was synthetic colours. When I contacted the vitamin company (whom responded swiftly and professionally) I was provided with a full copy of the ingredients which included ‘Opacode black (PI)’ which is a synthetic colour. The allergy disclosure appeared to be incorrect.

I then called the Therapeutic Goods Administration to report the adverse reaction (who once again responded quickly and professionally) whom advised me that they responded to issues in order of risk.

Six months on it appears that the product is still mislabelled and on the shelves. It would seem to me that neither the manufacturer, nor the Therapeutic Goods Administration, perceive this incorrect allergy disclosure to be important.

Still, I believe it is important, to report adverse reactions.  If you have not done this, and had an adverse reaction, please do consider doing so. The form is here.

I was also advised by the Therapeutic Goods Administration that they are ‘obliged to release specific information to consumers under certain circumstances under the provisions of Regulation 46(2e)(vi). Should you have a question about a specific ingredient, you may wish to call the TGA on 1800 020 653, ask for the Office of Complementary Medicines, and quote this regulation number to ask your specific question, “Does <product name or number> contain <substance>?” You don’t get given or read the label.

I have subsequently used that service, which was helpful, but which is not practical for a variety of reasons, not least of which when you are intolerant to say amines, colourings, colours, and preservatives, they are not just one ingredient.

The point is that complementary medicine label laws do not provide enough information to evaluate the risk of allergy or intolerance.

Complementary medicines (including nutritional supplements) within Australia are regulated by the Therapeutic Goods Act 1989 and the Therapeutic Goods Advertising Code 2007, which is administered by the Therapeutic Goods Administration. The law requires complementary medicines only to list the active ingredients. There is no requirement to list all ingredients, and no requirement to provide an allergy disclosure.

This is not an issue that is personal to me.

Australia has one of the highest rates of allergies and intolerances in the world. In 2007, ASCIA-Access Economics Report estimated that between 4.1 million Australians (19.6% of the population) had at least one allergic disease. Other estimates, including NSW Health Department’s own public estimates, are significantly higher.

Australia’s laws are inconsistent with the World Health Organisation’s recommendations.

The World Allergy Organisation (of which the Australasian Society of Clinical Immunology and Allergy is a member) advocates the traceability of ingredients and label law reforms as critical to the health of persons with allergies and food intolerances.

Australia’s laws fall short of America’s.

American companies are required under the Dietary Supplement Health and Education Act of 1994 to provide a full ingredient listing and allergen disclosure. This means that Australians have to look to American brands, sold with online retailers such as Iherb, to obtain sufficient information. It also means they are not necessarily buying products under professional supervision.

Australians with allergies and intolerances may not have access to otherwise safe and effective complementary medicines.

Avoidance is the main recommendation for allergies and intolerances. This means that when ingredient listings and allergy disclosures are not provided otherwise safe and effective complementary medicines may not be used.

Ingredient listings and allergy disclosures are not even making it onto the agenda.

The Therapeutic Goods Administration has been undertaking a review of labelling and packaging since 2012. This review is aimed at reducing the risk of errors and enable consumers to make informed choices. Sadly, allergy disclosures and full ingredient listings are not part of the review, nor could I find any consideration in their labelling best practice guidelines.

This is easily doable.

In this example, the manufacturer rapidly produced the ingredients listing, so it is not like it does not already exist. When I enquired, I was told that some complementary medicines have a lot of ingredients, and it would not be practical. As a manufacturer of skincare (where ironically all ingredients are required to be listed) and which contained up to 30 ingredients, advances in labelling make this possible. Then there are ‘inserts’.

So what can consumers do? They can put it on the agenda.

When I look at the people that made submissions to the 2012 labelling and package review, by the Therapeutic Goods Administration, I realised that it is not on the agenda because we have not put it on the agenda. 

Will you sign a petition? I will then try and raise the profile of the issue and advocate for change.

I have therefore written a petition, which I am inviting you to sign. On signing a copy of your petition will be automatically emailed for you to the key political stakeholders (including the Prime Minister, Leader of the Opposition, Leader of the Greens, and the Therapeutic Goods Administration). You can also add to or delete the wording of the petition. 

Please join me in speaking up and sign the petition here

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