Editorial: Reflections On a Regulatory Model

By Len Monheit

In January 2004 Canadians (Canadian industry) rejoiced as Health Canada’s Natural Health Products Directorate (NHPD) launched a new regulatory era and separate category for natural health products. While some complained that the regulations were too ‘drug-like’ others recognized that the principle of creating a third category (distinct from foods or drugs), and one which not only allowed claims but required them, might be an interesting model for the world to watch, a model that recognized that products with demonstrated biological activity should be allowed to state their health benefits in supporting structure and function, playing a biological role and in treating disease.

Three years later, Canada’s NHPD is experiencing a 10,000 product backlog, a few thousand products have actually been licensed, with most of these bearing either traditional use claims (“traditionally used for”) or referring to simple monographs (typically single ingredients including vitamins, herbals or minerals), with more complex products still in the queue somewhere, or in the case of early 2004 submissions, simply lost.

Last week, NHPD held ‘Infosessions” in Toronto to discuss the current environment and practices and to issue new or revised requirements or interpretations on the regulations. The sessions were well attended, with numbers between 250 and 300 for each day of the two day session. For the most part, the questions and answers were direct and forthright, and only on a few occasions did industry frustration become evident. I’m not going to discuss regulatory specifics here, for that you’ll have to attend the regulatory panel at Nutracon J (Thursday March 10th, AnaheimCalifornia).

Here. I’d just like to make a few general observations…..

Having become familiar with the regulatory environment in the US, I certainly view the Canadian system with objectivity and have watched both the development and deployment of the NHP regulations over the past four to five years.

The regulations themselves were an output of a highly consultative process and so intentions were good. There was ample opportunity for industry to provide input, and in fact, the major source of input lacking was in fact market input which would have enabled NHPD to know the scope and numbers of products they would be dealing with. Lacking this information, NHPD was first of all under-resourced, and secondly, under-trained. The first two years are probably best described as a painful learning curve by both industry and government, with few product licenses processed, a general lack of communication and feedback, and poor or no appropriate interpretation of the regulation to allow industry to work better with government to facilitate communication and application processing.

The third year might be best described as a ‘systems regroup and reorganization’ as NHPD attempted to come to terms with a 12,000 license backlog, many of which it did not adequate records for. Backlog reduction and ‘performance standards’ became the ‘messages du jour’, with several thousand applications (incomplete) being removed from the queue. During this time, also significant for the temporary absence of Director General Phil Waddington on mandatory French language training, organizational systems were put in place and resources were beefed up – as were communications with industry regarding application status. There clearly appeared a light at the end of the tunnel as monograph and traditional use product license applications became almost routine.

As Dr. Waddington returns, the major gap appears to be a strategy for handling non-traditional products, an area where industry obviously needs to see solid improvement in order to address real market stagnation that has developed over the past several years. Looming on the horizon is also the issue of cost recovery, although at one point, it was confirmed that this would wait until the backlog was eliminated. Ironically, if absolutely no new product applications were to be received in the next year, it would still take well over a year for the current backlog to be eliminated at the current pace (35 per day reviewed). Fundamentally, I guess this means that it will be at least a few more years before cost recovery becomes a real issue.

Before Canadian industry gets too frustrated, here are a few observations:

  • Not only the information sessions, but also the scheduled one-on-one meetings with regulators are continued signs that the relationship between industry and NHPD, while stressed at times, is still collaborative. Compare that to the environment and relationship between industry and FDA that all too frequently exists in the United States.
  • While we still wait (maybe in my lifetime) for Canada’s Schedule A diseases to be reviewed (diseases for which no claims may be made – all the biggies) some disease claims are being allowed for NHPs.
  • Acknowledgement letters are being issued in 3 days so at least you know that your submission has been received. Batching based on ingredients appears to also speed up the process.

On the not so good side (other than the backlog):

There still appears to be massive confusion over analytical procedures and methods. Part of this is the real lack of accepted, validated methods, and while NHPD staff spoke about ICH principles for method validation, in practical reality, since this is the responsibility of the manufacturing and test site and since audit resources are slim, in reality, there are few checks on product quality control and assurance. This is an area where the interests both in Canada and the US align (and for the rest of the world for that matter) understanding that complex matrices and proprietary test methods make the analysis of NHPs far more complex than single ingredient products. Also on the analytical side, it would have made me feel better had someone actually mentioned HPTLC, a promising chromatographic technique for the analysis of botanical products. (Here’s a great opportunity to plug our Quality, testing and Certification Center (http://www.npicenter.com/news/qualitytesting/) with its Ask the Experts section for any questions viewers might have, as well as our Quality and Testing blog at: http://www.npicenter.com/news/qualitytesting/ where anyone can weight in on analytical issues and discussions.)

Having walked around health food and other stores looking for elusive NPNs (Natural Product Numbers), the signal that a product has been reviewed by NHPD, it is obvious that a fraction of the products available to consumers have had the required scrutiny. In addition, when one considers the fact that the Quality Systems and GMP requirements under the regulations are a self-check, it becomes obvious that at this point at least, the regulations are a system based largely on faith, rather than enforcement. In this matter, one can only hope that the potential of the regulations are delivered with an enforcement will that has teeth. (Maybe I’m being a bit idealistic here)

In the early days of the regulations, I had numerous conversations with ingredient companies who were extremely worried that the proposed regulations did little, if anything to support the distinctions between ingredient suppliers. While this issue is still a concern from a quality standpoint, from a ‘science base’, this issue has been recognized by the creation of ingredient master files which can be accessed and associated with specific product license applications. This means that companies attempting to make a claim based on proprietary science conducted by the ingredient supplier can do so while others not using that particular ingredient supplier cannot. While this doesn’t give full value to the intellectual property of the ingredient company, at least it provides the potential for distinction (and value) in a real market.

In closing this particular column, we’ve got various regulatory models emerging around the world, and to think that any is emerging in a vacuum is dangerously naïve. To assume that FDA and EU authorities are not watching the Canadian model, or that NHPD officials are not watching performance in the US would be a dangerous assumption. Obviously these global issues affect companies doing business globally; I suggest they also affect companies attempting to do business well – anywhere.

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