The Immediate Threat
The immediate threat facing the Natural Health Product industry is the implementation of the drug-style Natural Health Product Regulations. The NHPPA is concerned that the industry is:
- being subjected to drug-style regulations that are too onerous for the risk profile presented by Natural Health Products;
- open to arbitrary attacks by the regulatory body;
- unprepared for upcoming challenges such as cost recovery for the Natural Health Product Directorate, and increasingly onerous standards for site and product licenses.
The NHPPA believes that the industry cannot afford to be inactive while:
- the new NHP Regulations are driving small and medium manufacturers out of business;
- manufacturers continue to drop low selling Natural Health Products due to the high cost of compliance;
- the NHP Regulations unduly increase the cost of products;
- the NHP Regulations drive products from the market that Canadians depend upon for their health;
- the majority of NHP License applications are denied under Regulations that were to legitimize the industry. At this point almost 60% of license applications have been either refused or withdrawn.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 grinds to a halt as it becomes clear that novel multi-ingredient products will not pass Health Canada?s scrutiny without drug-style evidence in the form of clinical trials;
- natural health products that consumers, retailers and distributors depend upon are stopped at the border due to non-compliance with the NHP Regulations.
Other Threats facing the Natural Health Product Industry
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.
The Natural Health Product industry cannot afford to focus solely upon the immediate threat posed by the drug-style NHP Regulations. All threats to the industry need to be addressed.