Unregulated Supplement Industry
Following a string of liver failures and severe illnesses linked to the dietary supplement OxyElite Pro, the product has been pulled from international shelves and was until recently also being sold in South Africa. OxyElite Pro contains the stimulant Methylhexanamine, commonly known as 1,3-dimethyl or DMAA, the use of which is banned in professional sport. The supplement is currently being investigated by the Medicines Control Council in South Africa.
According to Deon Lewis, MD of Cipla Nutrition, the quality sports nutrition company and extension of leading pharmaceutical company Cipla, the recent fatalities allegedly linked to the use of OxyElite Pro highlights the need for local consumers to proceed with caution when considering lifestyle supplements, or risk facing potentially devastating health risks.
Lewis says that as the supplements industry is unregulated in South Africa, dangerous substances can still be found in products being sold to the consumer. In addition, he says that DMAA, which has been linked to a number of deaths, is still used in over the counter supplements – without any warning to consumers. He says that the regulatory status of DMMA differs from country to country.
“As the supplements industry is unregulated, the potential for companies with sub-par manufacturing practices to sell their products to consumers is rife. Although the Medicines Control Council of South Africa (MCC) monitors the manufacturing of certain, but not all, supplement products in South Africa, it is difficult to monitor the safety of products that are imported into the country, until after a safety warning is issued by the originating country. In addition to the MCC in South Africa, the Federal Drug Administration (FDA) in the USA, the TGA in Australia or the EMA in Europe may issue such a warning.
“This means that unfortunately, until such time that the supplements industry is better regulated, consumers may be unaware of the hidden dangers in their supplements and must therefore take all the necessary precautions to ensure their health is not at risk,” says Lewis.
In addition, Lewis adds that it is not just the consumer who may be at risk, but the professional athlete as well. He says that whereas some athletes use drugs to seek a competitive advantage, others, including amateurs, may inadvertently consume banned ingredients through sports nutrition and supplement products.
“Doping in professional sport is not a new phenomenon, and has been happening for a long time. The practice unfortunately happens in many sports and the products used by dopers are often not illegal, meaning that it is not a criminal offence to take them. However, these substances are banned by the World Anti-Doping Agency (WADA), as they are seen as an enhancing stimulant, and as such, are banned in professional sport.”
He says the fact that sports nutrition products and supplements are generally manufactured in facilities that are not regulated is compounding the problem. “This means that products are manufactured in facilities where both ‘clean’ substances and WADA-banned substances are found under one roof. Thus, when manufacturing takes place, both ‘clean’ and WADA-banned substances may have been used in sequential batch runs to manufacture different products in the same equipment, but the equipment may not be thoroughly cleaned or sterilized between batches. The opportunity for cross-contamination between non-banned and banned substances therefore increases dramatically.”
Lewis says that the only way consumers can be guaranteed of the safety and quality of ingredients that many sports nutrition and supplement products claim to possess is to ensure that their products comply with various good quality standards.
“Products that are manufactured in an approved MCC-licensed facility that has also been certified for current Good Manufacturing Practice (cGMP) are potentially much safer. The MCC in South Africa governs the medicines landscape to ensure that all medicines available to the public meet strict criteria. When a product is manufactured in a (MCC)-licensed facility, it means that the product manufacturing complies with good quality and efficacy standards.
“In addition, consumers should look out for quality assurance partnerships and networks linked to the supplement you are taking. Badges on products carrying the name of Informed Sport, for example, show that the company is willing to have its products tested by an independent third party, thereby committing to quality manufacturing standards.”
Cipla Nutrition recently joined the Informed Sports Programme; a highly sought-after certification programme which assures athletes that products carrying this mark are regularly tested for substances prohibited in sport and ensures consumers that products have been manufactured to high quality standards.
Cipla Nutrition products are manufactured in a MCC-licensed, cGMP-certified and Halaal approved facility, ensuring the supply of high quality products.