THE South African Health Products Regulatory Authority (SAHPRA) has issued a warning over children’s products said to contain selenium and zinc picolinate.

In a statement issued on January 8, the SAHPRA said it had been made aware of these products which are in the market.

“Both of these ingredients have been identified in the Guidance, SAHPRA Guideline 7.04 / SAHPGL-PEM-COMP-04 v5 CM SE Health Supplements, issued by SAHPRA as not permitted in health supplements for children, persons under the age of 18,” reads the statement.

According to SAHPRA, the safety concerns related to children are as follows:

• Zinc picolinate, at any supplemental dose, can cause side-effects which include indigestion, diarrhoea, headache, nausea, and vomiting.
• As the bio-availability of Zn from Zn-picolinate is variable due to multiple factors, the risk of side-effects may be higher and unpredictable, and it is unsuitable as a source of elemental zinc supplementation in children; and
• 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, medicines intended for children.

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“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. 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,” reads the statement.

Advice for health professionals and distributors

SAHPRA has requested 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.”

Reporting side-effects

“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.”

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