However, smart stakeholders must take the long view and commit to the process. Leaders from international regulatory bodies and industry must sit down and articulate their perspectives, be open — and in some cases be prepared to compromise. Nothing can replace face-to-face meetings between regulators and industry to help build trust and find common goals. And while what happens at meetings might seem like endless “babbling” the reality is those meetings are a key element in advancing what’s best for our consumers.
Getting out in front of an issue is important. For example, there is worldwide consumer demand for bioactives, but no evaluative process for communicating the strength of the science supporting their benefits or how much of a given bioactive is needed to achieve desired health effects. While traditional nutrients, such as vitamins, minerals, protein, essential fatty acids and essential amino acids have Dietary Reference Intake values (or DRIs — sometimes known by other names across international models) there is no such designation for bioactives.
Last year, the Council for Responsible Nutrition-International (CRN-I) convened experts to discuss the direction for the growing category of bioactives. The proceedings were published in the European Journal of Nutrition and further shared at the American Society of Nutrition/Experimental Biology meeting last spring, generating additional discussion.
Based partially on this activity, a proposal for new work is being readied to submit to Codex Alimentarius to develop an international Nutrient Reference Value for several long-chain omega-3 fatty acids. If successful, this would allow manufacturers of products containing these specific omega-3 fatty acids to label the amount contained compared to the amount required to derive a benefit.
Communication must be a continuous, ongoing process and the expectation should be dialogues that are slow moving and long term. But it’s keeping the dialogue open that is vital. For the past four years, CRN-I has provided a venue for international stakeholders to dig into some of the most pressing dietary supplement and functional food science and regulatory topics. Sometimes the dialogue is less scientific and more entangled in the politics of trade agreements.
A 2011 CRN-I symposium focused on the World Trade Organization’s (WTO) Sanitary and Phytosanitary Measures, probing into whether these standards were too restrictive to trade.
Because WTO recognizes Codex as the primary international authority on food issues, but Codex does not have an established scientific basis for health claims, there are concerns that decisions by the European Food Safety Authority, which does have an established scientific basis for health claims, could lead to violation of WTO agreements. This area is still in development, but each year there is more and more discussion at Codex meetings regarding the need and the scientific basis for reliable health claims.
This year’s CRN-I symposium, taking place 16 October in Brisbane, will again provide an opportunity for various stakeholders to communicate face to face, this time focusing on the supply chain, with the goal of sharing industry and regulator challenges and hopefully agreeing on solutions that work for both audiences, and ultimately benefit consumers.
The developing world has become the go-to bazaar for unique compounds, especially botanical or other nature-derived components. A 'Tower of Babel' scenario comes to mind as buyers and sellers from wide-ranging cultural — and regulatory — backgrounds converge to do business. Depending on where a product is manufactured and where it will be sold, companies may face additional requirements that are often at odds with other requirements and certainly, with some expectations.
Then there are the end customers, consumers from around the globe from different populations with different nutritional needs based on their individual diets and lifestyles, sometimes requiring different product formulations. But one thing all consumers have in common is that they desire and deserve quality supplements and functional foods formulated with untainted ingredients, manufactured according to high standards and meeting label claims throughout shelf life.
Responsible companies that wish to remain in business understand this, but the complexity of the modern global supply chain can present many challenges for raw material suppliers, buyers, product manufacturers and marketers—challenges that require working with regulators to convey an industry perspective.
Field to factory
From the field to the factory, questions abound: Are the harvesters picking the right plants? Are the conditions for transport appropriate for preserving the integrity of the raw materials? Are there protections in place to prevent ingredients from becoming contaminated or adulterated along the way?
Aside from having staff on the ground, which may not always be feasible, companies may be well served by utilising standardised systems including materials certification, testing and verification provided by reputable third parties.
The more responsible stakeholders can come to the table and discuss these important issues face to face, the better. Businesses can no longer afford to squander resources on matters “lost in translation.” Seizing opportunities for discourse should be a top priority for any companies serious about doing business internationally.
James C Griffiths, PhD, is VP of scientific & international affairs at the Council for Responsible Nutrition (CRN).