‘We’ve been poisoned’

Women who were hospitalised after taking pregnancy supplements with dangerously high levels of vitamin D are demanding accountability over the way the product made it onto pharmacy shelves.

“We’ve been poisoned and then left in a hospital bed with no answers,” said a pregnant woman who spent two weeks in hospital after being prescribed Folidi by her gynaecologist.

Beyond the hospital stay, she described the emotional and practical toll.

“This is very serious, and no one is talking about it. The headlines should have been: women poisoned. I’m pregnant, and my body had to be flushed of dangerous levels [of vitamin D]. I couldn’t go to work. I couldn’t mother my two-year-old.” 

She said she went through IVF to get pregnant, together with the financial and emotional investment and now does not know how this will affect her pregnancy or the baby. 

“Who’s taking responsibility? Is the government acting? Are police investigating? Why weren’t these supplements tested before being sold to pregnant women?”

Last week, Times of Malta reported that around 10 women, including five who were pregnant, were hospitalised after taking Folidi, which contained more than 200 times the indicated amount of vitamin D.

Folidi – a supplement containing vitamin D3, iodine and folic acid – was urgently recalled due to “potentially dangerous” amounts of vitamin D. Excessive vitamin D increases calcium absorption from the intestines, potentially leading to hypercalcaemia (high calcium levels in the blood), which can cause kidney problems.

Folidi – a supplement containing vitamin D3, iodine and folic acid – was urgently recalled due to “potentially dangerous” amounts of vitamin D.

The recall came after urgent communication from the Italian manufacturer, Gruppo Farmaimpresa. The local distributor is Focused Pharma.

When contacted, a spokesperson for Gruppo Farmaimpresa blamed the issue on a supplier and said it was limited to one batch, affecting Malta only. 

Folidi has been available on the Maltese market since November 2024.

“It was an extraordinary event, and we are performing all the necessary checks to understand what happened. The problem seems to be due to an error of one of our suppliers. We would like to inform you that no other products coming from this supplier have been placed on the market of Malta,” the spokesperson said.

The company said it had notified Italian health authorities and was working to identify responsibilities.

Meanwhile, Malta’s health ministry said it was gathering information and seeking legal advice to ensure that all necessary action is taken in accordance with regulatory and legal requirements. The women impacted were also looking into taking legal action.

When asked who is responsible for ensuring supplements sold in Malta are safe and tested, a ministry spokesperson referred to the Food Supplements Regulations.

These regulations place the responsibility for monitoring on the Food Safety Commission. Companies must notify the commission when placing a supplement on the market to “permit efficient official monitoring,” and the rules include upper limits for specific vitamins and nutrients – including Vitamin D. However, they do not explicitly require product testing.

Times of Malta also contacted the European Food Safety Authority (EFSA), which provides scientific advice on food-related risks, including supplements.

“EFSA does not regulate or authorise food supplements, nor does it approve health claims or set their conditions of use,” a spokesperson said. 

“Those responsibilities lie with the European Commission and EU member states.”

Within the EU, food supplements are considered food products under the General Food Law, meaning that manufacturers, importers, suppliers  or distributors are responsible for ensuring their safety, a spokesperson said. 

“Once on the market, the member states are responsible for monitoring the safety and compliance of these products within their territory,” he said.

Questions sent to the Ministry for Agriculture, Fisheries and Animal Rights – under which the Food Safety Commission falls – remained unanswered by the time of writing.