The industry association said that a recent series of articles by The Sydney Morning Herald has made inaccurate statements and presented misconceptions on safety and quality of Australia-made vitamins and dietary supplements.
For instance, the articles referenced studies showing discrepancies between supplements and the product labeling - but the products listed in the studies were not Australian products, said CMA.
“The articles reference several overseas studies showing variable content compared to labels, including a 2022 study of 30 immune health supplements where 17 had inaccurate labels, and a 2023 study of melatonin gummies where 22 of 25 contained different amounts than listed.
“It is important to note these are not Australian products,” the CMA said in a statement.
The 2022 study on immune supplements was published in JAMA Network Open and the 2023 study on melatonin gummies in JAMA. The studies focused on products sold in the US market, including e-commerce platforms like Amazon.
The CMA added that the Australian regulator the Therapeutic Goods Administration (TGA) maintains rigorous oversight over product content, contamination controls and manufacturing that “extends far beyond what exists in many overseas countries referenced in the articles.”
In addition, it said that Australian products were subject to Good Manufacturing Practice (GMP) and Australian-specific manufacturing requirements, with the TGA conducting post-market surveillance and compliance reviews.
There are currently 82 TGA-licensed manufacturing facilities across Australia, and all have to comply with international standards including the medicinal GMP control Pharmaceutical Inspection Co-operation Scheme (PICS).
“Many of the concerns raised in the articles, while valid in the global context, are largely addressed by Australia’s stringent regulatory system,” said CMA.
As part of its targeted compliance reviews, the TGA recently removed four vitamin D products making bone strength claims from the Australian market, due to a lack of evidence.
On vitamin B6 supplementation and its links with adverse side effects such as peripheral neuropathy, the TGA also proposed to lower the recommended daily dosage (RDD) of vitamin B6 to 50mg or less.
It is also proposing vitamin B6 products with dosage of more than 50mg to be categorized as “pharmacist-only” or over-the-counter products.
Other regulatory reviews
Over the past year, the TGA has also reviewed regulations around the use of amygdalin, palmitoylethanolamide (PEA), and xanthium species in nutraceuticals, amongst others.
Amygdalin, for instance, has been scheduled for decades in Australia due to concerns over high dose and associated cancer claims. The compound can be found in naturally in foods such as almonds, apricot, and apple seeds.
Last year, the TGA proposed expanding the restrictions to a total ban on wild cherry bark which also contains amygdalin.
The regulator later confirmed it would set a new permissible threshold of 10mg/kg for amygdalin in therapeutic preparations.
“Following multiple rounds of consultation and sustained advocacy by CMA to permit a feasible testing threshold for complementary medicines, the TGA confirmed it would set a new permissible threshold of 10mg/kg for both amygdalin and hydrocyanic acid in therapeutic preparations,” the CMA said.
The CMA also highlighted a series of other achievements and ongoing advocacy work in Australia’s complementary medicines regulations in its Regulatory Outcomes Report 2025.
In the case of PEA, the TGA had initially consulted on proposed scheduling controls.
Subsequently, through stakeholder consultations, the TGA exempted PEA in therapeutic use and in dermal cosmetic preparations of up to 1% from scheduling controls since October last year.
“CMA supported the [PEA] applicant’s proposal and the interim decision to exempt PEA in therapeutic use from scheduling, highlighting its established safety profile.
“CMA also welcomed the proposed exemption for dermal cosmetic products containing 1% or less of PEA, in line with international practice and safety data.
“The outcome preserves market access and regulatory clarity for sponsors and manufacturers using PEA, preventing unnecessary disruption or reformulation,” said CMA in its report.
CMA’s ongoing advocacy works
CMA is also advocating for the TGA to review market exclusivity policy for Listed Medicines to ensure it is fit for purpose since its implementation seven years ago, amongst others.
At the moment, companies are granted two years market exclusivity for novel ingredients that they have come up with and have obtained TGA’s approval.
CMA is advocating for the market exclusivity period to be extended to five years, which it believes will significantly increase innovation in Australian ingredients.
“CMA advocated that extending the period will stimulate innovation, significantly increase new ingredients into Australia, and result in improved safety, quality and efficacy data packages to support Listed Medicine ingredients,” it said.
It added that market exclusivity should also apply to new routes of administration or an increase in approved daily dosages.
