Australia's Therapeutic Goods Administration (TGA), soon to be given new powers to regulate dietary supplements after a recent government report, last week ordered a recall of Vital brand Vitamin B complex capsules, after it was alerted by the manufacturer to problems with the folate content of the products.
Vital Health Foods Australia, a subsidiary of the South African company, advised the TGA in late October that they had found one batch of their vitamin B complex, which had been labelled as containing 400 micrograms of folic acid (folate), to only contain around 40 micrograms of folate. The company contacted all of its retail outlets and has advised the TGA that they have located and recalled all of the product except for 38 bottles which had been sold to consumers.
The TGA said it is very concerned about the breach because many women of child-bearing age and those who are pregnant often take the recommended dose of 400 micrograms or more of folate supplement a day to assist in the prevention of birth defects of the brain or spinal cord such as neural tube defects.
While the capsules in question are not specifically indicated for the prevention of neural tube defects, the label states supplementation is recommended 'whenever the body is low in nutrients and when bodily needs are increased such as during stress, pregnancy, dieting and exercise'.
The TGA has ordered the company to conduct an urgent consumer recall.
The TGA is set to gain new powers to regulate the Australian supplements industry after a government review of herbal and complementary medicines last month found that extensive reforms to the sector were needed to restore consumer confidence in natural medicines. The industry was badly damaged by the largest medicines recall in Australia's history earlier this year, involving leading natural products manufacturer Pan Pharmaceuticals. An expert committee called for the TGA, which regulates all medicines in Australia, to introduce more rigorous assessment of ingredients used in complementary medicines, and also require evidence to back claims for such products.