The manufacturers allegedly omitted milk products as an allergen on the ingredient warning in advertising two products targeted at children
The TGA has issued 13 infringement notices totalling $164,520 to Sydney-based company PharmaCare Laboratories for alleged breaches of the Therapeutic Goods Act in relation to the advertising of two listed complementary medicines.
Milk products were allegedly omitted from the ingredient warning present on the label applied to 10 batches of Nature’s Way Kids Smart Vita Gummies Omega 3 DHA Fish Oil (AUST L 313445), as well as on the web pages for both the 60 and 120 pastille pack size for Nature’s Way Kids Smart Vita Gummies Omega 3 DHA Fish Oil (AUST L 313445), and the web page for the 60 pastille pack size for Kids Smart Vita Gummies Omega 3 DHA Fish Oil (AUST L 335573).
The TGA said it is aware of three allergic reactions occurring in children with a known milk allergy who consumed Nature’s Way Kids Smart Vita Gummies Omega 3 DHA Fish Oil. Two were severe anaphylactic reactions that required medical intervention.
“The TGA requires all advertisements for medicines, including labels, to be accurate. Omitting important information, such as life-threatening allergens, from medicine information and advertisements puts consumer’s health at risk,” said Adjunct Professor John Skerritt, Deputy Secretary of the Department of Health.
Both Kids Smart Vita Gummies Omega 3 DHA Fish Oil products include the milk protein casein as an inactive ingredient.
An ingredient warning was present on the label and web pages identifying the presence of gluten, fish, sugars, soya bean products, benzoates and sulfites in the medicine. However, the presence of milk or milk products was not included in the warning, said the TGA.
It is alleged the advertisements for these medicines were misleading or likely to mislead consumers as they conveyed the false impression – by including an apparently comprehensive ingredient warning list – that the medicine did not contain milk products.
Under the Act, therapeutic goods advertising to consumers, including labels, must comply with the Therapeutic Goods Advertising Code, which prohibits advertising that is misleading or likely to mislead.
Following the TGA investigation into the first report of an allergic reaction, a safety alert was published on the TGA website.
Subsequently, in July, PharmaCare Laboratories initiated two recalls of Nature’s Way Kids Smart Vita Gummies Omega 3 DHA Fish Oil.
New medicine labels have been implemented, and the web pages for both medicines have now been revised to include milk products in the ingredient warning.
PharmaCare Laboratories was contacted for comment but did not respond by time of publication.