by Bruce Dales, president, Dales Product Development and Regulatory Specialists
Have you ever wondered why you don’t see more innovative health food and natural health products (NHPs) emerging on the Canadian market? I have 18 years’ experience in product development and the Canadian food and drug regulatory compliance area involving new and innovative health foods and natural health products (NHPs). I have also qualified and testified within the Canadian judicial system as an expert in the area of Canadian food and drug regulations. The following perspectives are based on what I have witnessed and experienced:
1. One of the main problems I’ve experienced within the present Canadian Health Food and NHP regulatory model is the frequent lack of adequate feedback from the Canadian Food Inspection Agency (CFIA) and the Natural Health Products Directorate (NHPD) regarding the status of new and innovative health food and NHP applications. Often, it’s not given in a timely way, not given at all or doesn’t adequately answer the questions asked. Consequently, companies wanting to produce innovative products in this regulatory area are being asked to comply with regulations that are often confusing and they have difficulty determining what the compliance standards actually are. In my experience, this has been very damaging.
2. Based on my and the understanding of other members of industry I have spoken to in December of 2010, the NHPD was supposed to provide updated standards of evidence, but it never did. For the most part, with regard to the most innovative new natural product number (NPN) products, there’s no proper guidance from the NHPD and no consistent standards of evidence. Nor does a standard exist as to when submissions will actually be reviewed. Companies are expected to submit their applications without any idea as to if, or when, their applications will be reviewed or any knowledge of what the standards are under which they’ll be reviewed. Many experienced people within the industry, with whom I’ve spoken, claim it’s simply “the luck of the draw.” It appears the level of evidence required by a company, with regard to any NHPD application, is dependent upon which NHPD reviewer is assigned to it. Furthermore, it appears that, if a unique and innovative product does get regulatory approval, the NHPD doesn’t allow competing companies’ access to information regarding the level of evidence that was required for that approval.
3. On the basis of my experience, over the last few years, I’ve consistently found it very difficult to get clear and reliable feedback from the CFIA regarding whether or not a new innovative product can be put on the market as a food. I have also found the present Minister’s office for the CFIA ineffective in making the CFIA provide the appropriate information in a reasonable time frame, if at all.
4. Over the years, I have seen that when companies are challenged by Health Canada for not complying with these confusing standards, no scientific standard is required by the Minister of Health from the Health Canada officials who challenge the particular company’s product. With regard to such challenges, I have frequently seen Health Canada officials reference science documents that aren’t consistent with the subject of the challenge. They also seem to consistently refuse to provide a level playing field for all companies in this industry.
5. Furthermore, even when such actions have brought about disturbing consequences for a company and incompetence on the government’s part has been pointed out, neither the Minister of Health’s office nor the CFIA Minister holds anyone accountable for the damage done to the company. They seem unwilling, or unable, to clearly articulate and uniformly enforce the regulations.
6. Companies that want to put new and innovative health products on the market need transparent and clear guidelines to feel the confidence to invest. Lack of such guidelines diminishes innovation and competition and, for the consumer, diminishes product choice while increasing the costs of products already on the market.
7. I’m frustrated with the present regulatory system for the above-mentioned reasons and I believe the availability of food and NHP’s for Canadians is being significantly negatively impacted. Given everything I have outlined, Health Canada’s motto seems ironic to me: “All decisions will be based on good science.” Just as ironic is the fact our government spends money on departments whose job is to encourage companies to be innovative (like the NRC IRAP program), while at the same time maintaining a regulatory system that obstructs innovation.
8. If, like me, you want this situation to change, I believe the power to do so is in your hands. Contact the Ministers responsible for the CFIA and Health Canada as well as your local MPs and tell them you’re not satisfied with the way things are and you want to have the issues dealt with fairly. Feel free to send them a copy of this article as well.
9. Also bear in mind the senior-level people are the people we need to be dealing with and contacting; phoning your local Health Canada or CFIA offices and complaining to the receptionist or field inspector isn’t likely to be effective.
10. Finally, I want to confirm that I empathize with many of the Health Canada and CFIA employees working under the current regulatory system. I think many of them are intelligent and well meaning, but they’re unfortunately caught up in a discordant regulatory system. In my view, we need such people working with us for any constructive and effective changes to occur.