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


Authors' response

Geraldine Moses AM, author of the article, comments:

It is a very valid point that many ‘vitamin and mineral’ products sold in Australia contain ingredients that are neither vitamins nor minerals. Given that the product names invariably give no hint that substances such as fish oil and Ginkgo biloba are co-formulated, it is possible that consumers are taking them unknowingly. The potential for adverse effects and drug interactions from these additional substances is likely be underestimated.

Although a comprehensive list of all ingredients is usually included on the labelling of medicines listed by the TGA, consumers may still be unaware that these substances are not vitamins or minerals. It would be preferable if the TGA required that multivitamin and mineral products stated clearly, in the brand name area of the labelling, that the product contains such substances in addition to the vitamins and minerals.


John McEwen

John McEwen, Retired medical adviser, Therapeutic Goods Administration, Canberra

Geraldine Moses

Consultant clinical pharmacist, Mater Health Services, Brisbane

Adjunct associate professor, School of Pharmacy, University of Queensland, Brisbane