There are additional considerations regarding the safety of commonly used vitamins and minerals.1 These include the addition of listed medicines to the Australian Register of Therapeutic Goods that style themselves as a multivitamin product but contain other ingredients. These may include chemicals (e.g. chromium picolinate, selenomethionine), other substances (e.g. concentrated fish omega-3 triglycerides) or various herbal substances (e.g. Panax ginseng, Ginkgo biloba). The consumer may not be alerted to the presence of these ingredients by the product name.
Changes to the Therapeutic Goods Act 1989 following the recommendations of a review2 have resulted in a cookbook list of ‘permissible ingredients’ in listed medicines. The Act requires that if the sponsor submits certain designated certifications, including that the product is safe for the purposes for which it is to be used, the relevant official in the Therapeutic Goods Administration (TGA) must list the medicine. The product may then be marketed in Australia.
It is only sometimes later, if at all, that the TGA will review those certifications, the product’s presentation (including name) and evidence supporting the inclusion of other substances in a multivitamin product. There is no requirement that the evidence includes an adequate study of clinical efficacy and safety of the exact formulation used in the product.
Australian consumers are being exposed to ‘multivitamin’ products with curious formulations and inadequate product names.
John McEwen PSM
Retired medical adviser, Therapeutic Goods Administration, Canberra
