For ingredients, international borders mean less than ever

Given information flow, it is impossible to operate in business without at least some awareness of international events. Companies, though, may try to pretend these events have no bearing on their market or market opportunity. Frequently, they're lying to themselves.

In our industry, a company that immerses totally and exclusively in its local market cannot establish, and more importantly maintain, a leadership position. There are too many influencers and trend makers outside of both North America and even Europe that savvy companies must track and monitor in order to maintain dominance in domestic markets.

From regulatory to scientific, commercial to political to social, the use of functional and health-providing ingredients for supplements, foods, beverages and personal-care applications is complicated territory, with influencers as diverse as regulators and politicians; the entire health-care community; and groups such as farmers, CPG companies, retailers, and the ultimate in diversity, consumers. All of these groups are operating in an age where information is at fingertips and the ability of all audiences to move outside national boundaries in the search for 'answers' is far too easy.

Amazonian superfruits, fair trade and sustainability in agricultural practices are examples of international factors affecting our business environment. The search for health solutions itself is a global issue. Similarly, the scientific community is engaged globally to prove and disprove the scientific merit of the products being positioned as potential health solutions.

Access to information and a hyperactive online environment ensures that consumers quickly begin searching for the next promising ingredient, in whatever format it is made available. Market-makers the world over have realized that economic conditions in China, deregulation of an ingredient in Japan, an explosion in China or an atypical growing season in North America can all drastically impact market forces, leading to shortage, price increase, new product opportunity or the woes of deliberate economic adulteration.

In recent weeks, discussions have taken place around the world regarding health claims. Health Canada has posted a paper that gives some insights on its evolving strategy for regulating health claims, especially at the intersection point between foods and natural-health products. The Codex Nutrition committee has sent health-claim recommendations back to an earlier committee stage over concern regarding evidence required for health claims.

In the United States, the FDA has suggested denying nutrient-content claims for ALA, DHA and EPA, an action being challenged domestically at the national level, but also using the international leverage behind the Global Organization for EPA and DHA omega-3s, recognizing that any position the FDA takes with regard to intake levels of omega-3s will have some impact on other regulatory bodies around the world.

Submissions and approvals of sweeteners and fibre, and marketing and the use of health claims on products aimed at children, are two other areas where the actions of one regulatory body, in its own jurisdiction, could have an international impact. In fact, ingredients companies with a global compliance strategy aggressively leverage the dossiers and files from one process into the next.

From an industry perspective, we know that regulators around the world are in frequent contact, so while success in one regional filing does not guarantee success elsewhere, it certainly does not hurt. In fact, in a few cases, some approvals are considered a 'rite of ingredient passage' as higher-quality, safety-substantiated ingredients make moves from Japan's MHLW, to Australia's TGA to EU consideration, to a Health Canada Ingredient Master File. One can measure the commitment of the company as it proceeds through these stages.

We are talking about a shift along the entire continuum of regulatory frameworks as countries stay aligned
Looking forward, we are certainly not talking about nor expecting a harmonization of regulation, or regulatory process. What we are talking about is a shift along the entire continuum of regulatory frameworks as countries stay aligned. Similarly, for forward-focused companies, there is a certain preparation and focus that usually leads to market readiness when their company intelligence transcends national boundaries.

Len Monheit is president and CEO of NPIcenter, North America's most widely used industry portal and publisher of daily, weekly and monthly e-newsletters.

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