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The Therapeutic Goods Administration (TGA) is aware of a product referred to as ‘Haytox’ that is being promoted as a treatment for nasal allergies, such as hayfever.
‘Haytox’ has not been approved by the TGA or included in the Australian Register of Therapeutic Goods (ARTG).
The TGA has not evaluated this product and therefore warns consumers that it cannot guarantee the quality, safety or efficacy of this product. Consumers should also be aware of the risk of serious side effects when accessing medicines for an unapproved use.
The TGA reminds prescribers that they must not mislead patients as to a product’s safety or efficacy. It appears that 'Haytox’ may contain the botulinum toxin (botox). While the TGA has approved certain products containing botox, ‘Haytox’ is not approved and has not been evaluated for the purpose of treating hayfever.
It is unlawful to advertise therapeutic goods that are not on the ARTG to the public, or in a way that is inconsistent with the entry of the product in the register, such as for a different medical purpose. It is also generally unlawful to advertise prescription-only substances or goods, including in relation to a compounded medicine.
Warning to businesses supplying ‘Haytox’
These products are not approved for marketing or sale in Australia.
There are legal implications for advertising and supplying these products. Importing, exporting, manufacturing or supplying these products is illegal and can lead to prosecution.
For clinics who may be using Haytox products or advertising them to their clients, the TGA encourages them to familiarise themselves with the legal requirements of the advertising code, and also the legal requirements around supply of prescription medicines.
The TGA can and does act in relation to illegal advertising of health products, including in relation to online advertising. Unlawful advertising of a prescription medicine in Australia can result in jail time and penalties of up to $1.565 million for individuals and $15.65 million for corporations.