The NHP regulations are an unmitigated disaster for the industry. In the 1990s, when the industry and consumers revolted against Health Canada enforcement actions, no one predicted that the industry would be manoeuvred into voluntarily removing far more products than Health Canada enforcement actions ever could. Yet that is what is happening.
Indeed, it is the only logical consequence of the Regulations. Following the successful industry and consumer revolt, we were supposed to get regulations designed to "increase" access to NHPs. This is important to note. The regulatory scheme is supposed to provide consumers with more NHPs, not what they had, not less. The only logical consequence of the regulations is, however, to restrict access. Instead of following the U.S. model where NHPs are deemed to be safe and the FDA can only remove them with evidence of harm, our regulations deem NHPs to be illegal, unsafe and ineffective.
No NHP can remain on the market unless safety and efficacy can be proven. Deeming NHPs to be illegal and then placing barriers for entry onto the market cannot "increase" access. This can only decrease access. Tweaking barriers to entry - such as modifying evidence standards - will not solve the fundamental problem. Nor will this prevent abuses in the future. The fundamental problem is the deeming of all NHPs as dangerous and ineffective drugs.
There is no reason why regulations could not be crafted to legitimize the
industry, address fraud and safety and at the same time permit increased access to NHPs. Ironically, restricting access to NHPs in the name of safety, actually places consumers at risk. Persons who have tried pharmaceutical treatments without success are forced to forgo NHPs that provide relief. Persons managing conditions with NHPs are forced to access pharmaceutical treatments which carry significant risk.
In the name of "safety" we are putting persons at risk. We have dramatically increased the cost to the industry in efforts to comply with the regulations. We have lost tens of thousands of products. We have lost producers. Innovation has ground to a crawl on multi-ingredient products due to a belief they will not be licensed. Most surprising of all, it is the industry - and not Health Canada's Inspectorate - that is removing most of the products from the market. Prior to the regulations, only products the Inspectorate targeted were removed. As diligent as the Inspectorate is, there are limits to how many NHPs a given inspector can remove in a day.
Ironically, after fighting for regulations to increase the number of NHPs, the industry is voluntarily removing far more NHPs than Health Canada ever could. According to Health Canada's last Quarterly Report, 17,602 NHPs have failed the licensing process. Many have been voluntarily removed.
To read the full article go to:
http://nhppa.org/ or see the October 2010 issue of CANADIAN NATURAL HEALTH RETAILER MAGAZINE:
http://www.cnhr.ca/