The South African Health Products Regulatory Authority (Sahpra) has issued a warning that all medicines containing zinc picolinate or selenium and intended for use in children must be withdrawn from the market.
Sahpra chief regulatory officer Tammy Gopal said the regulator had become aware of several products being sold for children that contain zinc picolinate and/or selenium, despite both substances being prohibited in health supplements for minors.
“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of Category D (complementary) medicines containing zinc picolinate or selenium and intended for use in children must be withdrawn from the market within six months of the date of this publication,” said Gopal.
“Sahpra requests that health professionals cease all distribution, selling, and/or dispensing and remove all selenium- and zinc picolinate-containing products intended for use in children from stores, storage facilities and shelves.
“Members of the public are urged to return products containing zinc picolinate and selenium when intended for use in children to their pharmacist, supplying warehouse, or distributor,” she said.
“Both of these ingredients have been identified in the guidance issued by Sahpra as not permitted in health supplements for children [under the age of 18].”
The regulator raised serious safety concerns about the use of zinc picolinate in children, warning that even low supplemental doses could cause adverse effects.
“Zinc picolinate, at any supplemental dose, can cause side effects which include indigestion, diarrhoea, headache, nausea and vomiting.”
She added that because the bioavailability of zinc from zinc picolinate varies widely, the risk of side effects may be “higher and unpredictable”, making it unsuitable for use in children.
Sahpra also cautioned against selenium supplementation in children, noting the potential for overdose.
“Selenium, when supplemented to children, represents a safety concern considering the potential differences in selenium daily intake between different population groups.
“While selenium intake is a viable requirement for children in areas of famine or dietary restriction, the potential adverse effects of selenium overdose are of concern when provided in general supplements or medicines intended for children,” Gopal said.
Many of the affected products are marketed as immune boosters for children and are promoted for the treatment of colds, flu, diarrhoea and skin-related conditions.
“The products currently on the market are marketed and sold, among others, as ‘immune boosters’ for children, rendering the products in question medicines that require registration by Sahpra.”
She added that any medicine containing zinc picolinate or selenium and intended for children does not qualify as a Category D complementary medicine.
“As such, their sale as a Category D medicine is illegal.”
With immediate effect, all such products will now be required to undergo full registration as Category A medicines under the Medicines and Related Substances Act.
“Therefore, with effect from the date of publication of this notice, all selenium- and zinc picolinate-containing products intended for use in children must be subject to registration as a medicine falling into Category A,” said Gopal.
“The public and healthcare professionals are encouraged to report any side effects after using a health product by using the Med Safety App. Your report will contribute to our monitoring of these health products.”
The warning comes amid growing concern about the safety of products marketed for infants and young children. In recent months, several such products have been withdrawn or recalled, including a recent recall of certain NAN infant formula products which sparked alarm among parents and healthcare professionals.
Parents are cautioned against assuming that products labelled “natural” or “supplements” are automatically safe for children.
TimesLIVE
