Regulatory Goals

The NHPPA Advisory Board has given the NHPPA the immediate goal of obtaining a regulatory environment where:

  1. NHPs are presumed to be safe. A NHP cannot be taken off of the market unless the Government 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. NHPs are not regulated as drugs. They are either regulated as food or as a third category separate from drugs and food;
  4. there are Good Manufacturing Processes that are appropriate for the low risk profile of NHPs, and
  5. there is a conflict resolution mechanism to settle disputes between the Government and industry members.

The purpose of the NHPPA will be to provide expertise in identifying threats to the natural health product industry, and through multi-lateral discussion arriving at solutions to address those threats. In providing legal, political and strategic expertise on threats to the industry, the NHPPA hopes to be an asset to both individual stakeholders in the industry, as well as to existing organizations.

The need for an industry watchdog like the NHPPA was recently demonstrated with the release of Bill C-51 on April 8, 2008. The NHPPA released a Discussion Paper the following day which has alerted stakeholders to the threats posed by the Bill. The NHPPA has provided a leadership role in educating stakeholders on the issues presented by the Bill.

The NHPPA has also played a leading role in identifying the issues in Bill C-52, the Consumer Protection Act.

At this point almost 60% of product license applications have been either refused or withdrawn. These are primarily license applications for single ingredient products. The NHPPA expects that the percentage of license refusals will increase as the NHPD starts considering multi-ingredient products. In short, the industry will remain largely illegal, or the majority of NHPs will have to be taken off of the market.

Innovation on new products is grinding to a halt. Small and medium sized manufacturers are being driven out of business.

Eventually cost recovery for the NHPD will put further strain on the industry and consumer access to Natural Health Products.

Although the Natural Health Product industry is facing an immediate threat with the imposition of the drug-style NHP Regulations, there are other threats lurking in the background. These threats include:

  • international treaties Canada and the United States are participating in such as CODEX;
  • the imposition of ever stricter standards upon the industry by Health Canada and the Food and Drug Administration in the United States;
  • the seizure of products at the border between the United States and Canada. Currently, the main problem is U.S. products entering Canada. However, with the imposition of stricter standards on dietary supplements by the F.D.A., there is a real risk that the F.D.A. will adopt the Health Canada approach of stopping products at the border;
  • the imposition of ever-widening intellectual property right agreements and treaties that will affect the Natural Health Product industry.

Stakeholders are currently not being kept up to date on these issues. The NHPPA is well placed to keep its stakeholders informed on all issues that threaten their interests.