By Len Monheit
As we go about our daily and weekly business, the realities and frustrations of the real world are never far from us. It is this mix of current events juxtaposed on market facts that creates our current business operating environment. In order to maintain or attain strategic leadership, a company must operate in both environments. Too often though, we, as an industry, hypothesize about the events and implications, without overlaying current realities to solve fundamental real issues. Specifically, we may speculate on the potential implications of a new Congress or regulatory declaration, but in the course of our day to day operations, these issues do not change how we run our business in the very near term. Yet changes and adaptation start somewhere, and at some point a company must address its real issues, the real issues, in order to position well for its future.
Willful adulteration, active regulatory interpretation, intellectual property wars – these are all areas where market reality collides with future strategy.
In the first case, the development of accurate methods that disclose the presence of adulterants are only part of the solution. Convincing labs and companies to first utilize these methods, and secondly, convincing unscrupulous marketers to not use inferior ingredients are the really tough issues. So long as there is economic incentive to use inferior products with relative impunity, our current and future environment is flawed. It’s obvious that the use of inferior or adulterated products lead to non-efficacious products in the marketplace, but too many people do not care. This short term gain mentality is supported by a lack of enforcement within and without, and a ‘sweeping under the rug’ mentality that prevails far too often. When top-tier ingredient manufacturers exit the North American marketplace because their investment in research, quality and science has gone unrewarded, then woe to North American consumers. And this is exactly what is happening, in far too many product classes.
In the second case, that of active regulatory interpretation, agencies are making ongoing interpretation of existing legislation as well as determining principles, presumably, for future enforcement action. It is in these areas that a market opportunity can get eroded or even closed, due to lack of industry attention or vision. If the FDA were to object to an NDI or product claim submission (AHPA NDI Database), the market implications could be significant. If the FDA were to begin restricting its definitions on a class of products, the results could be devastating. Singly, industry’s attorneys and some watchdogs monitor these behaviors – is it enough?
And finally, intellectual property, a subject talked about in general terms in structured presentations where everybody nods to an appropriate investment in science, and departs knowing that nothing fundamentally has changed; a subject where current beliefs and practices are entrenched and the likelihood of someone sufficiently protecting their IP investment is as low as anyone realizing a company has stolen the science they associate with their product.
These are the types of fundamental issues that need to be moved out of the back rooms and into the foyer, to open and ongoing discussion and action plans. They are all issues where the efforts of one company are not enough to effect the changes in policy, enforcement and action that is required. A few key industry leaders keep stepping up on these issues in attempts to raise visibility and mobilize the like-minded. Personally, I think time and patience are running short, although there are signs that the burner is heating up on some of these issues.
Digressing slightly for a moment - At NPIcenter we typically do not want to be the medium for staged ‘marketing’ pieces about ongoing litigation and sweeping allegations. We recognize that a significant part of industry’s business involves these activities, and that, in addition, from time to time, willful acts will occur. In the interests of objective reporting, and in the interests of supporting best practices, such as an investment in intellectual property and science, our viewers can expect us to present news and to try to provide some transparency, if not presented in the press release we post, then at least in the editorial decisions we make, and the content and opinions we try to secure.
Continuing my digression, I’m intrigued by a ‘trend’ creeping into the health world, one that will be presented in context at next month’s Nutracon. I’m speaking about the ‘diseaseification’ of America, to be presented by Julian Whitaker. As one scans headlines around the globe, conditions appear and are defined regularly in terms of disease. This trend has implications as these conditions, previously either unrecognized, lifestyle-change treatable or supplement preventable, are now the exclusive domain of pharmaceutical interests. The implications are potentially staggering. I look forward to finding out what’s really going on – at Nutracon, but more importantly, whether anything can be done about it.
And concluding my digression, I’d like to comment on the power of association. Whether it’s like-minded individuals or companies comparing experiences and sharing insights or an alliance built to support and strengthen a category or call out non-contributors, it’s a truism that you’re known by the company you keep. This applies to the associations you join, the causes you support, the events you attend and perhaps most importantly, the companies you do business with. I firmly believe that sooner or later, these decisions catch up with you.