By Len Monheit
With new EU legislation covering health and nutrition claims and essentially regulations soon to be in place covering functional foods in the EU as well, and with regulatory status changes in other jurisdictions to watch as well, our world has never been more complex.
We all certainly feel the effects of global trade drivers, from new sources of supply to new competitors. And in order to expand markets, many companies continue to look abroad, strategic partnerships continue to emerge, new products are introduced and new opportunities are realized, so some organizations must be getting it – understanding how to navigate this complex mess. For others though, the challenges of the domestic market are significant enough, without them trying to develop international activity.
I made the observation several weeks ago, that in North America, it appeared that companies, to a certain extent, had adopted a ‘wait and see’ attitude as they anticipated regulatory and compliance challenges and uncertain market conditions. It appeared from pace of new product introduction and adoption that a little reserve was in the marketplace.
One can make an even stronger argument for this reserve on a global basis – the times are quite uncertain and regulatory changes will create new opportunities, while also closing currently open doors. Justifying an investment has perhaps never been so complex. In order to participate, and in some cases, we are talking participating many years down the road, companies must not only do their homework to make sure they have all the information at hand and mechanisms in place for both gathering and submitting it on an ongoing basis, they must also ensure that they have the right infrastructure, contacts, networks and relationships to ensure their ingredients and finished products will have a home in their target markets.
Most of us realize that a global strategy means a lot of work. Understanding a market doesn’t automatically come from reading the latest report on market size in the UK or current trends in health in India. While it does involve some consideration of report-style information, this information must be presented against a backdrop consisting of trade issues, cultural considerations and the regulatory environment (not only of the country in question, but also encompassing regional pressures).
If you’re an ingredient company, this means ensuring dossiers are in order for just about any eventuality, and it is intriguing to consider whether the global compliance and strategy issue might actually be the tipping point that gives solid advantage to companies vested in their ingredients, rather than those supplying knock-offs and commodities. In Canada, this issue has been raised as ingredient dossiers submitted to NHPD are referenced by finished product manufacturers in their Natural Product Number applications.
Elsewhere, perhaps its product specific safety and efficacy that causes an ingredient to be on the approved list and allows certain substantiated health claims. Perhaps eventually, it even becomes a process specific NDI (New Dietary Ingredient) that supports the investment into science and Intellectual Property a company is expected to make.
Whatever the case, a global strategy is costly and becoming more expensive. It’s certainly not for everyone.
Depending on your product and positioning, the opportunity can be huge, though. Make sure you do your homework though, understanding not only how business is done currently, but how it will be done given all the forces at work, five years or so from now – and even more importantly the infrastructure necessary now to allow you to handle the business then, including getting connected to the right agencies, associations, organizations and partners to increase the likelihood of that future success.