Complementary and alternative medicines (CAMs) are regulated in terms of the General Regulations to the Medicines Act.
“Certain classes of complementary medicines have been called up for registration purposes,” explains Neil Kirby, a director of Werksmans Attorneys. “However, proposed amendments to the General Regulations will change the definition of complementary medicines, introducing formal regulation over so-called health supplements. It’s not certain when this will come into force.
“To complicate matters further, we are currently between two regulatory regimes. The Medicines Control Council (MCC) will become the South African Health Products Regulatory Authority in due course.”
To date, however, not one CAMs product has been registered under these regulations. “Registering their products with the MCC often isn’t an option for the makers of CAMs, not only due to capacity constraints at the MCC, but also because these products are considered food supplements in many first-world countries,” says Wayne Robinson, director of scientific and regulatory affairs at the Health Products Association of South Africa (HPA). “So, currently, all CAMs products must contain the MCC disclaimer: ‘This medicine has not been evaluated by the Medicines Control Council. This medicine is not intended to diagnose, treat, cure or prevent any disease.’”
The HPA, a non-profit organisation representing the interests of South Africa’s natural health products, nutritional dietary supplements and CAMs industry, has worked for 30 years to establish an ethical, credible, relevant and vibrant local health products industry, says Robinson.
It develops and maintains standards that ensure the quality, safety and efficacy of CAMs and health products, and engages extensively with the MCC on legislative and regulatory issues.
“Over recent years, member companies have worked towards responsible manufacturing that adheres to a specific set of processes, safety procedures, packaging and labelling standards,” he states.
“The HPA also has guidelines about claims, to ensure that labels are truthful, and actual supplement contents match the contents on the Supplement Facts label and are not misleading in any way. A further safety control is that CAMs products are subjected to safety and quality evaluation criteria depending on the ingredients and product composition.”
In the absence of MCC registration, the HPA recommends that consumers go through a checklist (see box) when buying products.
And, while consumers of CAMs do not yet enjoy the specific rights contained in the Medicines Act, Kirby advises: “CAMs are ‘goods’ for the purposes of the Consumer Protection Act (CPA). If goods do not meet the standards of quality and, potentially, efficacy, a consumer has rights in terms of the CPA.”
The HPA’s consumer checklist:
Check on www.hpasa.co.za whether the company is a member of the HPA. All members have to comply with a set of ethical criteria.
Research the company’s product on its website.
Check the label for the product ingredient list. “The quality of the raw materials will determine the quality of the final product,” says Robinson.
Look for the expiration date, as supplements can lose potency over time.
Store the product in accordance with its storage requirements.
Avoid the marketing hype. The HPA’s marketing code guidelines don’t permit claims that products cure or prevent disease (because no premarket testing is done).
Natural means safe. Right?
Wrong! Like manufactured products, natural products can be toxic. Yes, honey may be completely natural, but so is oleander and hemlock. Natural products are not necessarily healthy or safe.