Regulator wants to avoid checking herbal pill claims

Regulator happy for supplements to go on shelves before checking them out.

herbal medicines to go unchecked

Consumers will have to use their own discretion about the benefits of over-the-counter health supplements if the watchdog that monitors ingredients in herbal medicines succeeds in quitting this role.

The Therapeutic Goods Administration (TGA) no longer wants to evaluate the validity of herbal component name (HCN) claims on supplement product labels before they are released to the market.

The TGA this week claimed this regulatory role was too burdensome and would likely lead to costs being passed on to consumers if supplement manufacturers were forced to comply.

Instead, it has suggested that it will do spot checks on hundreds of products after they go on sale to check if claims about herbal components are backed up by scientific evidence.

The regulator invited submissions on the role last November and received only seven responses. Four of the submissions supported an option for “industry and the TGA to work together to produce a workable mechanism that allows for discontinuing pre-market evaluation of HCN applications”, two supported the status quo and one did not express a preference.

The Australian Medical Association told YourLifeChoices it did not make a submission because its focus was on prescription medicines. However, it did say that “government agencies such as the TGA and educational bodies such as the National Prescribing Service should ensure information on the safety, quality, efficacy and cost effectiveness of complementary medicines is readily available to consumers and health practitioners”.

In one submission, an association that wished to remain anonymous supported the move to drop scrutiny of herbal compounds before they were marketed, but sounded a warning.

It raised concerns that unscrupulous manufacturers could make unsubstantiated claims about their products.

“Finally, we would like to highlight that clients are concerned that a small number of sponsors may take advantage of the removal of the pre-market evaluation process and make claims about components that are not present in an ingredient, exaggerate the truth, or make HCN claims without holding evidence,” the unnamed association said.

“This can negatively impact the industry by allowing products to compete on false pretences, and by reducing consumer confidence in the industry. We suggest that the listed medicines’ post-market review process should include an assessment of any claims made about HCNs.

“Such a regime would not increase the regulatory burden on sponsors who already hold evidence for the claims that are made,” the association said.

A separate “anonymous” organisation supported the status quo, saying that if the TGA drops oversight of herbal ingredients before they hit the shelves it could lead to consumers being deceived.

It said the TGA’s current role “prevents misleading consumers with respect to the herbal components contained within the products”.

“Additional concerns are held if the naming of non-mandatory HCNs is not controlled by the regulator, this could lead to the proliferation of a variety of names for the same herbal component dependent on the sponsor evaluation, causing confusion to consumers,” the organisation said.

In their submissions, the Australian Self-Medication Industry and Pathway International said they supported the TGA stepping away from its pre-market scrutiny in order to reduce red tape.

Pathway International is a privately owned Australian company that supplies ingredients to the complementary medicine, personal care, food and beverage, pharmaceutical and veterinary industries.

Complementary Medicines Australia (CMA) also called for reduced red tape, but did not commit to preferencing a change to the current regulations.

However, it did caution against changes to regulations that could leave herbal supplement manufacturers exposed to legal action or “become a negative focal point for media attention”.

“Whether pre- or post-market, it appears to us that the regulator will still need to play a role in the oversight of herbal component names, which are represented as components of active ingredients on product labels,” CMA said.

French listed company Naturex also made a submission to the TGA, however, it is not publicly available. The manufacturer of plant-based ingredients supplies compounds for the health, beauty and food sectors.

According to the TGA website, it regulates medicines and other therapeutic goods. “We assess higher risk medicines for safety, quality and efficacy before they can be legally supplied in Australia. Efficacy refers to whether a product does what it says it is going to do.

“We assess lower risk medicines for safety and quality only. However, the commercial sponsor of the medicine is required to hold evidence that their product works, and they must provide this evidence to the TGA if we conduct a formal compliance review of the product.

“The TGA's approach reduces the cost of approving low-risk medicines. If we reviewed all low-risk products for efficacy before they were permitted on the market, the additional costs would be passed on to consumers.

“The product must only contain ingredients from a pre-approved list that the TGA has already assessed for safety and quality.”

At the time of writing, requests for comments from the TGA and Medicines Australia, the peak body for pharmaceuticals, had not been answered.

Do you use herbal supplements and vitamins? Does it matter that some of these products are not regulated before going on sale given that the authorities consider them low-risk products?



    To make a comment, please register or login

    30th Aug 2018
    All medications should be regulated more because there is no such thing as low risk in anything especially when greed gets in the picture.
    30th Aug 2018
    I agree with you, Jackie. Although even with regulations the results can be slap dash. I’ve never been allergic to anything in my life but a prescription got me an ambulance ride to the hospital once.
    30th Aug 2018
    does this mean we can take pills with marijuana in it that's a 'herb' and no one to check it

    30th Aug 2018
    A rather frightening development. Manufacturers of herbal concoctions should be held accountable by the regulator and government. But what else would we expect under these incompetent Lieberal clowns.
    30th Aug 2018
    Get over yourself Know-a-lot! This is NOT a Government (of either persuasion) issue. The TGA is NOT the Government and exists and follows its own acts of law no matter who resides in The Lodge.
    30th Aug 2018
    Before you go further KSS check out the TGA website, it is at and comes under the Department of Health. TGA is part of government and has a minster responsible for it, same as Centrelink or Medicare or a host of other Federal government departments. Now if that ain't Government then what is it?
    30th Aug 2018
    TGA has always been part of the federal Health Department. They are all public servants. This lack of regulation will be due to the Government cutbacks and the focus on risk management - until something goes seriously wrong.
    31st Aug 2018
    The crazy Government idea of selling all the income producing assets, cutting taxes and passing laws so hardly anybody pays tax and bringing millions of new residents in must end up with us so poor we can't afford Government services. What did people think would be the consequences?
    30th Aug 2018
    Ensure that you choose supplements that are patented, are peer reviewed and show proof of effectiveness.
    30th Aug 2018
    Good advice.
    30th Aug 2018
    Given the potential for harm and even death from herbal supplements, someone somewhere must be responsible for checking them. Consumers should be able to rely on the fact that if an ingredient is claimed then that ingredient must be there AND in a therapeutic dose. If a health claim is made then those claims must be publicly verifiable. And far more important, any supplements from suspect countries (e.g. China) MUST be properly examined due to the high number that already are found to contain potentially deadly undeclared ingredients. There is also the potential for adverse drug-drug interactions between medications and supplements and such interactions can be fatal if the stated ingredients and dosage is not verifiable.

    It doesn't have to be the TGA who does this. In the USA for example supplements are classified not as medications but as foods (which is why it is cheaper to buy on the internet and including delivery still cheaper) nevertheless they need to be checked.
    30th Aug 2018
    You could also say the same about pharmaceuticals, they are causing a lot of harm and even death. And most of the ingredients come from China, that goes with illegal drugs too.
    30th Aug 2018
    I use mineral and vitamin supplements and have never worried as I make sure they are EU or USA or a known Australian product. Never had any troubles. The only time I ended up in hospital was from allergy to antibiotic prescription medicines.
    30th Aug 2018
    This proposal, to my mind, is akin to the Civil Aviation Safety Authority telling aircraft operators to make their own arrangements and they will only have a look when there is a crash or major incident. I expect for the taxes I have to pay that if I buy something to ingest that some government department has evaluated that product to ensure it is safe to consume and/or the labelling is not misleading. Similarly when I board an aircraft I expect CASA have ensured the pilot is qualified to fly it, the maintainers are qualified to maintain it and all practical measures are put in place to ensure I will be safe. If this costs me a few cents or dollars extra then it is money well spent.
    30th Aug 2018
    Most foods that comes into Australia is not tested, they cannot test every package.

    30th Aug 2018
    Herbal meds - biggest con ever. But if silly people want to throw their money down the drain , let them
    30th Aug 2018
    So are pharmaceuticals.
    30th Aug 2018
    Nope - they are scientifically proven to work

    Only air-heads believe in herbals and woo woo medicines
    30th Aug 2018
    I prefer to use wholefood as my medicine. Fresh and Australian grown. I do sometimes use complimentary medicines, and have tried many over the years. You need to buy from trusted sources, try it out and see if it makes a difference. Turmeric (or curcumin) has a lot of research done and with excellent results. It depends on your ailment, and do your research and find information that is genuine (yes I know hard to find but if you read enough you can weigh up what people say from experience).
    Vitamins are probably the biggest con, as many have too little to make any difference, most stronger quality complimentary medicines are only available via naturopaths who prescribe it.
    30th Aug 2018
    regardless of the origin of medications, herbal or otherwise it should be compulsory for ALL ingredients to be listed. Some even have grains in them which contain gluten which can make people will various bowel problems seriously ill.
    30th Aug 2018
    I try to remember that every pharmaceutical product that has been taken off the market by our government regulators for being unsafe- had already been passed by these same regulators.
    31st Aug 2018
    Health supplements have been exposed time and again as being less than honest about the active ingredients in them. As for the government checking them I highly doubt that. My understanding in this country is, as long as the manufacturer signs a form to verify what is in a supplement it gets passed. Does anyone really believe this will benefit the consumer.
    31st Aug 2018
    Buying anything from America is fraught with danger. I saw an interesting expose of their $30 billion a year industry. One manufacturer made some pills and sold them and women who were taking them started growing hair in all the wrong places and other side effects. When they tracked down the problem it turns out the manufacturer was making these pills in a vat that had not been cleaned out properly and had previously been making a batch of pills containing testostrone.
    And if you want to check out you omega 3 fish oil capsules, select one from the container, slice it open and smell it. If it's rancid you've just done your money. Omega 3 oil oxidises (and goes off) very quickly when exposed to air. It seems a large number of them are useless and probably doing you more harm than good.Try it for yourself.
    31st Aug 2018
    Most fish oil capsules are not good. Better getting it straight from a fresh fish or plant based omegas like walnuts, flax, chia and hemp. Or just eat less omega 6's to balance it out.

    31st Aug 2018
    Oh, goodie - so I can eat South American Flathead any time and not carp about it ..... as long as it's produce of Australia...
    4th Sep 2018
    Yet another Liberal government cave in, always complying with all big business demands.

    And instead we will get sick or die with untested herbal products.

    Way to go SCOMO. Help the Big end of town again, instead of us.
    9th Sep 2018
    There are far too many unscrupulous manufacturers in the world, regulation needs to be tightened not relaxed. Consumers are sick of being conned and slowly poisoned by chemicals.

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