Health issues warning for selenium and zinc picolinate-containing products for children

The South African Health Products Regulatory Authority (SAHPRA) has been made aware of products in the market containing Zinc picolinate (as a source material for zinc) and/or Selenium intended for use in children.

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).

The safety concerns related to children are as follows:

1. Zinc picolinate, at any supplemental dose, can cause side effects which include indigestion, diarrhea, 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
2. 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.

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 (6) months of the date of this publication.

Advice for health professionals and distributors:

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.

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.
 

Enquiries:
MTammy Gopal
CRO: SAHPRA
Tammy.Gopal@sahpra.org.za

For further enquiries/information, contact:
SAHPRA media contact: Yuven Gounden Cell: 083 297 1214 E-mail: yuveng@sahpra.org.za

Notes to Editors:
SAHPRA will post this media release on its website. Navigate to the News section on the website.
Should you wish to request an interview, please send your request to media@sahpra.org.za and yuveng@sahpra.org.za

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