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REGULATORY GOALS

The TNHA’s goal is the obtaining of a non-discriminatory, transparent and appropriate regulatory environment where:

  1. Traditional & Natural Health Products (TNHPs are presumed to be safe. TNHPs cannot be taken off of the market unless the regulator can prove that it is unsafe;
  2. there are different claims structures so that:
    a) manufacturers do not have to make claims;

    b) manufacturers can make limited claims, such as structure function claims with a low evidence threshold, and

    c) manufacturers can make specific health claims if they can meet a higher evidence threshold;

  3. TNHPs are not regulated as drugs. They are either regulated as food or as a third category separate from food and drugs; 
  4. there are tailor-made Good Manufacturing Processes (GMP) that are appropriate for the low risk profile of TNHPs, and
  5. there is a conflict resolution mechanism to settle disputes between the Government and industry members.
  6. there be no discrimination in evaluation and approval of applications for herbal products based on their traditional or cultural origin or belief systems which they are ascribed to. This means that all traditional medicines, whether indigenous or non-indigenous enjoy equal evaluation, promotion and protection under the law. 

 

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ACHIEVING THESE GOALS

CHALLENGING THE STATUS QUO : The TNHA will continue to highlight the inappropriateness and unlawful manner in which the current regulatory system for TNHPs and will lobby the relevant authorities, including the Medicines Control Council / SAHPRA, National Department of Health, the Ministry of Health and National and Provincial Parliaments to reverse their destructive course on the industry.

It will also mobilise its members and public, if need be, by leading mass industry defiance campaigns which tangibly demonstrate our rejection of the regulatory regime.

LEGISLATIVE REFORM : The TNHA are currently drafting a new Traditional & Natural Health Products Bill which clearly defines TNHPs separately from food and drugs, and models a regulatory framework appropriate to their manufacture, sale and promotion. We are currently in discussions with various political parties with an aim for one of them to table this Bill for consideration by the Legislature.