This is largely due to the lack of guidelines, definitions (resulting in huge confusion) and to top it all, the enormous cost involved to comply. Some industry members simply gave up or sold off while others hoped ‘someone else’ will fight this, clarify everything, and just tell them what to do next.
Well ‘next’ just happened in a major zero-tolerance crackdown on complementary medicine.
The MCC is preparing to seize many now-illegal natural health products “making claims for and purporting to treat, diagnose and modify conditions associated with high-risk” such as diabetes, heart disease and cancer as well as viral illnesses (HIV/Aids).
An official MCC announcement on the lucrative slimming and sexual hormone section of the CAMS market is expected soon.
A letter was issued to the industry this April (almost two years after the application for registration deadline), informing all stakeholders and complementary medicine applicants, that only six products* submitted in terms of the call-up notice satisfied the requirements set by the MCC.
These products could remain on the market, until further scrutiny and pending their registration. Six products! Out of 24 applications received for the above-mentioned life-threatening conditions, and hundreds on the market... To be further tested for their safety, quality and efficacy.
In May last year, the Health Products Association (HPA) held a meeting with Dr Joey Gouws, registrar of medicines. “The meeting was positive,” reported HPA chair, Norman Fels. “The registrar conceded that the current roadmap was not working, that CAMS had to be regulated differently from allopathic medicines, and that “out-of-the-box” thinking was required. She advised that the Complementary Medicines Council (CMC) had completed its assessments of the various submissions made by industry on regulations and guidelines, and said that the definition of CAMS is to be changed. A streamlined registration system for CAMS is a priority and will probably follow the Canadian system.”
Exactly a year ago, another meeting was conducted with the department of health (DoH) industry task group (ITG) that was attended by MCC chairperson, Professor Helen Reece, who stated that the CMC has been “energised” and is working on amended CAMS regulations, guidelines and a roadmap.
Negotiations, meetings, interactions and discussions continued, resulting in the HPA’s decision to suspend litigation against the DoH and the MCC. Will the HPA resume litigation? Or the Traditional and Natural Health Alliance because “the entire regulatory process has been unconstitutional on the basis of discrimination (by not including African traditional herbal medicine); it remains ultra vires (without an enabling clause in the principle Act for these products), irrational, and procedurally unlawful.”
Companies need to remove all health claims from their products and associated marketing materials and, as in many other parts of the world, simply state the name of the product and the main ingredients it contains.
* Modhomco’s Cralonin oral drops, Bioforce SA’s Crataegus Oxy Liquid, Bell Lifestyle Products’ Cardio Health, Medical Nutritional Institute’s AntaGolin, Brunel Laboratories’ Patrick Holford Cinnamon and Avid Brands’ Bioharmony Cinnabalance
