“The proof of the pudding is in the eating,” says Thami Mtshali, the inventor of Galela immune booster oil. Mtshali (56) was responding to criticism that his concoction has not been tested to verify its effectiveness.
But, he told City Press that it had been registered with the US Food and Drug Administration (FDA) earlier this year.
The FDA is a body responsible for protecting public health by ensuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, food supply, cosmetics and products that emit radiation.
City Press has seen a copy of the certificate (see below). It was shared with the FDA for verification, and questions from City Press were acknowledged, but a response had not been received by the time of writing.
The SA Health Products Regulatory Authority (Sahpra) was also sent the certificate for verification, since it deals with such issues, with a list of questions to verify whether Galela should have been registered with the health department before being sold locally.
Sahpra is tasked with regulating, monitoring, evaluating, investigating, inspecting and registering all health products.
The entity indicated that it needed more time to respond to City Press’ questions.
In January, the product attracted attention on social media after United Democratic Movement leader Bantu Holomisa indicated that he was using it.
He wrote on social media: “Prevention is better than cure. Nxamalala (Khulubuse Zuma), since you introduced me to the Galela concoction in November last year, I managed to get few bottles from Thami Mtshali. Every morning I take a drop together with vitamins C and D. So far I’ve managed to dodge the Covid-19 bullets. Thank you.”
He received a lot of criticism, but he defended his position.
On Thursday, Holomisa told City Press that he was still using it. “I’m okay with it. I’ve been taking it every day – aim being to boost my immune system. Congrats to the guys behind it [referring to the FDA registration].”
Mtshali said FDA registration meant that he could ship millions of his product to the US without an obstruction at customs. He said registration was done under supplements – as an immune booster – and this was an easier requirement.
His preparations for the registration process had started last year. He said he opted for FDA registration, rather than that of Sahpra, because FDA-registered products were accepted by a lot of countries.
“I’m selling locally,” he said. Internationally, he had identified distributors Amazon and eBay. “They both asked for FDA registration, they didn’t ask me about Sahpra,” Mtshali said.
Stance against critics
Wits University critical care professor Guy Richards said Galela had not been tested. He said there was no published study that showed that it boosted the immune system or that it could be used for prevention of diseases.
Richards said FDA’s registration meant nothing.
He said herbal medications could be dangerous to the liver.
But, Mtshali said those who criticised his concoction needed to use it first. “Holomisa and others are talking about their experience. Who would you believe? Sometimes people like to be sceptical about something they’ve not tested.”
He said the Council for Scientific and Industrial Research (CSIR) labs were used to analyse the product. However, CSIR spokesperson David Mandaha said they did not have any records of having tested the product.
How Galela was conceived
Mtshali said he was a chemical engineer and that he had invented the product before Covid-19 hit the country.
He said he had studied at the Tuskegee University and University of Akron in the US.
Mtshali said that, when he had started the product, he had wanted an alternative in an attempt to cure his daughter, Tebogo, and himself from ulcers. He used to spend thousands of rands on medication a month. A friend in Malaysia had asked if he had looked into seed oil. That’s how the idea developed.
He said he then extracted the pumpkin and avocado oils, which are mixed with other ingredients. Mtshali started by making small doses, but, due to his family members’ and neighbours’ developing interest in the product, he then produced large batches.
However, Mtshali urged customers to follow Covid-19 protocols. “We are not saying we’re a cure for Covid-19. Galela boosts your immune system so your body soldiers can fight back any invaders.”
Sahpra spokesperson Yuven Gounden confirmed that Sahpra has not received any application for the registration of the product.
“It is important to note that even if a product is registered elsewhere, for purposes of importing and marketing in the Republic of South Africa, an application is still required to be submitted to the Sahpra for assessment / evaluation,” Gounden said.
He said Sahpra would like to advise that all medicines intended to be used or sold in the Republic of South Africa were controlled and regulated in terms of the Medicines and Related Substances Act, 1965 (Act 101 of 1965) (the Medicines Act).
“It is a regulatory requirement that all medicines intended to be sold are compliant with acceptable quality assurance principles, good manufacturing and distribution practices in addition to a review of clinical evidence with respect to the inherent risk that the medicinal substance or its claims pose. It is therefore a legal requirement that all medicines are safe, efficacious and of acceptable quality standard,” he said.
Sahpra, Gounden said, has issued a public notice warning against the use of health products for Covid-19.
The notice can be accessed on the Sahpra website: www.sahpra.org.za/wpcontent/uploads/2020/03/.
Information with respect to the registration of medicines can be accessed on the Sahpra website: www.sahpra.org.za /Health Products or e-Services/ Complementary Medicines depending on the type of activity the applicant wants to undertake.
The associated fees payable to the Sahpra are also published and can be accessed in website.
Gounden said Sahpra will however investigate the product further and act accordingly.
He said registration with other regulatory authorities is and should not be misconstrued as permission to import and market the product in the Republic of South Africa.
“An application is still required to be submitted to Saphra for assessment/evaluation,” Gounden said.
Galela comes in a 2ml bottle (that could be shared by three people) and a 5ml bottle (that could shared by six people) and the price ranges between R900 and R1 700 per bottle.
Disclosure: This journalist is currently using a sample of Galela, which was handed over by Mtshali to experience. It is still too early to tell.