Blackmores subsidiary kept selling pregnancy vitamins despite hundreds of complaints, ex-employee alleges

A subsidiary of the supplements company Blackmores left a pregnancy multivitamin on shelves for nearly a year despite hundreds of complaints that it was contaminated with mould-like black spots, a former staff member has alleged.

Ellis said he was told to tell customers the products were safe to consume, despite a lack of testing evidence. An internal investigation by Blackmores found that when Ellis said he no longer felt comfortable handling customer complaints, he was reprimanded and told that refusal to do so would be considered insubordination, which took a toll on his mental health.

Ellis held numerous roles at the company between 2016 and 2021, including quality assurance manager and sales manager.

According to his complaint, lodged with the TGA in December, the company began receiving complaints and questions about dark spots on InNatal Plus Iron capsules in about September 2017.

Staff urged senior management to quarantine the product while microbiological testing was performed to confirm its safety, but these requests were ignored, Ellis alleged. Test results were not received until June 2018, about 10 months after the first complaints.

The testing did not identify with certainty what the dark spots were, Ellis said, only that they were not caused by certain yeast, mould or bacteria. He said the business eliminated certain agents from the product, and continued to sell the reformulated vitamins.

The following week, the product was quarantined and removed from sale. But a month later it was returned to the shelves, because the black spots only seemed to emerge in warm weather.

The product has since been reformulated.

A spokesperson for the Blackmores Group said records showed there were fewer than 150 complaints over three years relating to the product, with 38 relating to the speckling, 15 relating to other quality issues such as broken seals and leaking capsules, and the rest relating to customer service.

The spokesperson said the TGA investigated InNatal Plus Iron in 2018 due to an adverse event relating to discoloration, diarrhoea and stomach cramps. The TGA requested laboratory testing of a sample product.

In 2020, batches investigated during routine monitoring had dark spots and speckles throughout the capsules, the spokesperson said. But these were tested, and no growth of mould or bacteria was found.

In 2018, a batch of BioCeuticals D3 Drops Forte 20ml was received that was translucent, yellow to brown, thin and rancid.

Batch testing was not ordered.

The product was eventually recalled in August 2020 after batch testing confirmed the product was faulty and did not contain the claimed levels of vitamin D.

The investigation also examined concerns around another product, BioCeuticals Mood Balance, which Ellis said was removed from sale in 2020 after it was found that the probiotic strains in the formula needed to be refrigerated for transport and storage, although it was released as a shelf-stable product. No communications went out to customers or consumers, and the product was not recalled.

A Blackmores spokesperson said the product was discontinued due to low demand.

The report described how Ellis told management that dealing with complaints consistently was taking a toll on his mental health.

Ellis made his complaint to the TGA in December, by which time he had left the company.

Ellis said his experience left him concerned by the lack of regulation of alternative and complementary medicines.

He said all the products mentioned in the allegations were safe and compliant with TGA regulations.

Do you know more? Email melissa.davey@theguardian.com