A subsidiary of the supplements company Blackmores left a pregnancy multivitamin on shelves for more than two years despite hundreds of complaints that it was contaminated with mould-like black spots, a former staff member has alleged.
In a complaint to the Therapeutic Goods Administration, Peter Ellis alleged FIT-BioCeuticals brushed aside concerns about its products, including pregnancy vitamins and vitamin D drops being used by a children’s hospital, in potential breach of quality regulations.
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.
“Many pregnant women raised concerns for their or their unborn child’s health, concerned as to whether they had consumed mould,” Ellis told Guardian Australia.
“Many were concerned that the quality issue may cause them to miscarry; many were highly distraught; many were brought to tears; and many were understandably abusive.”
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.
“Throughout this time, myself and other staff were continually told by senior management that we were to advise customers, consumers and patients that the product was safe to consume, in the absence of safety data,” Ellis said.
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. But this did not occur until 2020, he said.
In an email to senior management in May 2019, seen by Guardian Australia, he wrote: “I’m no longer comfortable having my name on an email saying they’re safe to consume. I also think we would be hard-pressed finding a BioCeuticals employee who would consume this product whilst pregnant.”
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.
“When spring came, we again began to receive large numbers of complaints,” Ellis said. “The company continued to sell the product throughout spring and summer until it was finally discontinued in February of 2020, when a batch received already contained the dark spots prior to being released for sale.”
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.
“The dark specks were an agglomeration of the vitamins and minerals that are present in the formulation for the InNatal Plus Iron product and not indicative of foreign material contamination,” the spokesperson said.
“Measures were proposed by the Blackmores Group and accepted by the TGA in relation to a statement to be included on the label for storage conditions. The outcome of this investigation by the TGA did not require stock of InNatal Plus Iron to be quarantined or recalled.”
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.
“While we understand consumers may have had concerns on the discoloration … these concerns were investigated and no risks to safety were identified,” he said.
Ellis disputes that only 38 complaints about discoloration were received. A Blackmores report from its internal investigation into the issue, dated 31 July 2020, says Ellis “… argued that the products should be quarantined as at that point several hundreds of complaints had been received”.
This claim was “substantiated” by the investigations team, the report said. “Complaints continue to be received about InNatal PLUS Iron to this day. The absence of the product from our product portfolio affects our ability to reach sales targets and staff commissions.”
The internal investigation found the allegation that Ellis was encouraged to tell customers there was nothing wrong with the pregnancy products was “unsubstantiated”.
But in the case of another product, the investigation found the same allegation to be “substantiated”.
Testing times
In 2018, a batch of BioCeuticals D3 Drops Forte 20ml was received that was translucent, yellow to brown, thin and rancid.
Ellis asked for microbiology testing to confirm the drops were safe, but said these were ignored. Other batches had similar problems. In May 2020, he received an email from Perth Children’s hospital asking for assurances a batch it received “was safe and effective”.
Batch testing was not ordered.
“I was told to inform the hospital and customers that the product was OK to consume,” Ellis said. “I refused this directive … and advised them that their patients should not consume the product, and informed them that the issue was under investigation.”
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 internal Blackmores investigation found Ellis’s actions in response to the email from the hospital, and his claim that he was told to advise customers the product was safe to consume, were “substantiated”.
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 two raw materials in question were still within or just below specification at the label conditions of 25C,” the spokesperson said.
The internal investigation report stated: “Four years later, there is still no evidence to prove the efficacy of our probiotic range after being transported.”
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.
A spokesperson for the TGA said the complaint was under “active investigation”.
In an email to Ellis, the TGA said: “The concerns you have raised suggest multiple regulatory issues that will be investigated by various areas of the TGA responsible for manufacturing quality, pharmacovigilance and listed medicine compliance.”
Ellis said his experience left him concerned by the lack of regulation of alternative and complementary medicines.
“The reason I joined that business in the first place was because I believed in it and supporting people’s health,” he said. “For them to betray their consumers or patients taking their products … I just found it to be disgusting.”
A Blackmores spokesperson said the health, wellbeing and safety of consumers were the company’s top priorities.
“We hold ourselves to the highest standard for product quality, customer satisfaction and continuous improvement,” he said.
“If we or any of our consumers are concerned about any product we manufacture and sell, we investigate the situation thoroughly as a matter of priority.”
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
