Australian pharmacies selling contaminated supplements

A study has found nearly 50% of CAM products tested had contamination issues, with some showing the presence of animal ingredients, nuts, wheat, pharmaceuticals and toxins

Researchers have discovered safety concerns after testing complementary and alternative medicine (CAM) products purchased from pharmacies, health food stores, traditional herbal retailers and online in Australian capital cities.

Samples came in various forms including tablets, capsules, gel capsules, tea, chewable tablets and gummies, honey, liquids and powders, and included Western herbal medicines and supplements, traditional Chinese medicines and Ayurvedic products.

The researchers from Murdoch University and Curtin University in WA, and the University of Adelaide in SA, were able to confirm at least one of the listed ingredients for only 21% (n = 29) of the 137 samples.

Meanwhile 40% (n = 55) of the samples were found to contain no detectable DNA.

Of those samples that did contain DNA (n = 82), 51% had additional plant DNA while 30% contained commonly used ‘filler’ ingredients such as soybean, rice, oat, wheat or grasses.

DNA from cashews and walnuts were detected in three samples, presenting possible nut allergy concerns.

A fifth (21%, n = 17) had animal contamination, revealing DNA from domestic species such as dog, pig, rat, mouse or cow, which “may speak to poor manufacturing processes,” the researchers said.

A further four percent (n = 3) had DNA from non-domestic animals not listed or related to ingredients, including reindeer, frog and shrew.

One sample contained undeclared Neem oil, which has previously been the cause of poisonings, mostly in children.

Of the products listed on the Australian Register of Therapeutic Goods (ARTG) for which DNA data could be generated, only 44% had stated ingredients confirmed while 31% had animal contamination.

Of the products not listed on the ARTG, 24% had stated ingredients confirmed and 6% contained animal contaminants.

Twenty-six percent of samples contained pharmaceuticals—20% of these were declared on the label or explained by the ingredient list, for example caffeine from green tea.

However 5% (n = 7) of the samples contained additional unexplained pharmaceuticals, such as caffeine, synephrine, ephedrine and related alkaloids, paracetamol, chlorpheniramine, and trace amounts of mycophenolic acid and buclizine (a drug no longer in use in Australia).

Of these seven samples, six were listed on the ARTG.

The data highlights a number of concerns with herbal CAM products, say the researchers the Journal of Pharmaceutical and Biomedical Analysis.

“As found in our previous study and elsewhere, the ingredient list for a product does not always reflect what is actually contained within that products,” they write.

“The presence of undeclared fillers is of particular concern to people with allergies.

“Unknown ingredients and inaccurate labels increase the potential for adverse and allergic reactions because consumers cannot make informed choices.

“This study demonstrates that, despite current monitoring approaches, contaminated and adulterated products are still reaching the consumer,” they say.

Brands, country of manufacture and pharmacies were not specified in the study.

However the authors said that the products were being “sold in some of the biggest health food stores and pharmacies in Australia.”

The researchers suggest stronger pre-market evaluation would be superior to post-marketing surveillance.

Friends of Science in Medicine (FSM) told AJP it has written to Health Minister Greg Hunt to “point out that this is yet another example of the failure of the TGA’s trust-based regulatory system for listed products that has no pre-market evaluation and trusts sponsors to obey the rules.

“This research amplifies the TGA’s own limited findings on post-market surveillance, their recent consumer survey and the high level of upheld advertising complaints,” said FSM president Dr Ken Harvey.

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