The South African Health Products Regulatory Authority (Sahpra) has called for all children’s immune boosters containing zinc picolinate and selenium to be withdrawn from the market.
According to Sahpra guidelines, neither of these ingredients is permitted in health supplements for children.
Tammy Gopal, Sahpra’s chief regulatory officer, says 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,” Gopal says.
She says supplementing children with selenium poses a safety concern due to varying daily intake across populations.
“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 says.
She adds that some products are marketed as ‘immune boosters’ for children, with zinc (from zinc picolinate) and selenium as the main ingredients.
“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 Sshpra. 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,” says Gopal.
She says with effect from the date of publication of this notice (January 8) 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of Category D (complementary) medicines containing zinc picolinate or selenium and intended for use in children must be withdrawn from the market within six months of the date of this publication.”
Advice for health professionals and distributors
Gopal says 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. 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,” says Gopal.
Zinplex responds
Health supplement company Zinplex has responded to Sahra’s statement, claiming that the regulator is acting outside its legal mandate, saying its products – sold for over 20 years – have no reported serious adverse effects.
Zinplex claims there is no published scientific evidence showing that zinc picolinate, when used within appropriate and regulated dosage levels, is unsafe for children.
“We have requested that Sahpra bring any such medical or scientific evidence to our attention, and they have been unable to produce any such written report whatsoever,” says Zinplex.
“Our products are formulated by healthcare professionals, including pharmacists, and manufactured according to strict quality, safety and regulatory standards. We have not received any safety reports or evidence suggesting that our products pose a risk to children when used as directed,” says Zinplex.
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