The South African Health Products Regulatory Authority (SAHPRA) has issued a warning about products being sold that contain zinc and selenium intended for use to treat certain ailments in children.
The regulator says both ingredients have been identified in the guidance issued by SAHPRA as not permitted in health supplements for children under the age of 18.
It warned that zinc can cause side effects which include indigestion, diarrhoea, headache, nausea, and vomiting,
Regarding selenium supplementation, the regulator warned that it can cause overdose for children.
“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, diarrhoea, 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,” said SAHPRA’s Chief Regulatory Officer, Tammy Gopal.
She stressed that 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) 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of Category D (complementary) medicines containing Zinc picolinate or Selenium and intended for use in children must be withdrawn from the market within six months of the date of this publication.
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,” advised Gopal.
She appealed to the public to return the products when intended for use in children, to their pharmacist, supplying warehouse, or distributor.
The regulator urged all healthcare professionals to report any side effects after using a health product by using the Med Safety App.
