By Lehlohonolo Lehana.
The South African Health Products Regulatory Authority (SAHPRA) has issued a warning over the sale of children’s supplements containing zinc picolinate and selenium may pose health risks and are not permitted for use in those under 18.
According to the regulator, zinc picolinate may cause side effects in children, including indigestion, diarrhoea, headaches, nausea and vomiting.
SAHPRA spokesperson Yuven Gounden has called on health professionals to immediately cease the distribution, sale and dispensing of all products containing zinc picolinate and selenium that are intended for use in children.
He also urged retailers to remove these products from shelves, storage facilities and warehouses.
“The products currently on the market are marketed and sold, among others, as ‘immune boosters’ for children, with the main active ingredients being Zinc (when derived from Zinc picolinate) and/or Selenium intended for use in children. These products are indicated for supporting the treatment of colds, flu, diarrhea, and skin-related conditions, rendering the products in question medicines that require registration by SAHPRA.
“Any medicine sold that contains Zinc picolinate or Selenium intended for use in children does not qualify as a Category D (complementary) medicine. As such, their sale as a Category D medicine is illegal.”
“Therefore, with effect from the date of publication of this notice, all selenium and zinc picolinate-containing products intended for use in children shall be subject to registration as a medicine falling into Category A, as defined in Section 14(2) of the Medicines and Related Substances Act, 101 of 1965, and need to be submitted to SAHPRA for registration. The sale of Category D (complementary) medicines containing Zinc picolinate or Selenium and intended for use in children must be withdrawn from the market within six months of the date of this publication.”
Gounden has also encouraged healthcare professionals and the public to report any side effects linked to these products using the Med Safety App to support ongoing monitoring and protect public health.
The alert comes amid growing scrutiny of baby and children’s products in South Africa.
In recent months, several products aimed at infants and young children have been withdrawn or recalled, including a recent recall involving certain NAN infant formula products, which raised alarm among parents and healthcare professionals.