Children’s supplement producer disputes safety warning
The company, Zinplex, says it has requested the SAHPRA to provide it with scientific evidence, which the authority has not done.
THE producer – Zinplex – of the children’s products the South African Health Products Regulatory Authority (SAHPRA) had warned contain selenium and zinc picolinate has said “there is no published scientific evidence showing that zinc picolinate, when used within appropriate and regulated dosage levels, is unsafe for children”.
Zinplex was responding to a statement issued by the SAHPRA, which had urged the public to return children’s products containing Selenium and zinc picolinate.
In a letter to a customer, the company said it has requested the SAHPRA to provide it with the scientific evidence – “they have been unable to produce any such written report whatsoever”.
“Our products have been on the market for well over 20 years and we have never encountered any serious health-related risks. Moreover, zinc picolinate has been accepted in numerous other countries as a source of zinc for zinc supplementation in children,” reads the letter.
The company indicated that it will directly engage with SAHPRA and will “emphasise that the side-effects mentioned in their communication are consistent with zinc supplementation in general and are not specific to zinc picolinate”.
The company added that side-effects are clearly communicated to consumers in the Patient Information Leaflets of their products.
Also read: Popular children’s supplements flagged over safety concerns
“In addition, regarding the statement made about the bioavailability of zinc picolinate and how this allegedly may potentiate the possible side-effects, we have provided scientific evidence to SAHPRA on numerous prior occasions that demonstrates that this is not a factor of concern,” reads the letter.
The company added that the concern with selenium is overdose.
“Each individual’s selenium status varies based on their lifestyle, diet, the type of food eaten and where it is sourced, the other health products, medicines they consume and their underlying health.”
The company said the amount of selenium in their products is below “the tolerable upper limits that are published in the scientific literature for selenium dosages for the respective groups”.
“Our products are formulated by healthcare professionals, including pharmacists, and manufactured according to strict quality, safety and regulatory standards. We have not received any safety reports or evidence suggesting that our products pose a risk to children when used as directed.”
The company added that it was “shocked” and “taken aback” by the statement issued by SAHPRA and will approach the authority to have the issue settled.
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