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