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Tric Nutrition has been forced to pull its range of iron and B12 supplements which have up to 10 times the daily recommended dose.
A supplement company has been forced to pull its range of iron and B12 supplements, which have up to 10 times the daily recommended dose.
An anonymous complaint was made to Medsafe about the Tric Nutrition supplements, which alleged the products breached dietary supplement regulations.
It said, while the maximum daily dose of B12 was 50 mcg, Tric Nutrition products had 1000mcg. While the daily dose maximum for iron was 24mg, Tric products had up to 60mg.
But director of Tric Nutrition Andrea Schroeder said the multivitamins were essential for bariatric patients and the NZ regulations did not accommodate any bariatric patient, nor give consideration of the needs for nutritional supplementation after surgery.
People who had bariatric surgery often developed a B12 deficiency due to malabsorption and insufficient food intake post surgery.
Schroeder said 10% of her female patients were needing to take more than 60mg of iron a day, and many required regular iron infusions because they could not maintain adequate iron levels.
“During my conversation with the Medsafe adviser, she stated that our levels were not ‘supplementation’ levels but therapeutic levels, and we therefore potentially needed to have them approved as medicines, however nowhere else in the world are these expected to be approved as medicines. They are vitamin supplements only.”
The NZ regulated levels of were below the global criteria set by the American Society of Metabolic and Bariatric Surgery (ASMBS), which recommended 350mcg to 500mcg of B12 daily and 45mg to 60mg of iron for menstruating patients.
Tric Nutrition had been selling the products since 2010, firstly importing them from the USA before manufacturing it in NZ.
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“This has made me withdraw 15 products from my range – all of the essential multivitamins that are essential for bariatric patients,” Schroeder said.
If she did not remove the products she faced up to a $100,000 fine or six months’ imprisonment.
She was not able to offer the products to patients unless they had a prescription.
“This greatest effect however is on our patients who now have no appropriate or adequate quality supplements and this potentially puts their health at risk.”
A Manatū Hauora (Ministry of Health) spokesperson said Medsafe was alerted to products being sold by a small number of companies as dietary supplements which breached dietary supplement regulations in relation to the maximum levels of certain ingredients.
“We are unable to provide further comment while an investigation is underw ay.”
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