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Supplement Manufacturers Must Be at the Codex Table

Albion Minerals®

Of late, there has been a noticeable uptick in international regulatory activity. Monitoring and evaluating the impacts of this activity hijacks much of my daily workload. During the past several months, I’ve watched countries’ regulatory actions increasingly focus on “doing their own thing,” which is a problem because it creates unnecessary and burdensome barriers to international trade, particularly for the dietary supplement industry.

Seamless Global Trading Requires Harmonious Regulations

It would seem the goal for all involved in global trade would be to align on a harmonious and congruent set of regulations governing the acceptability of products between all trading partner countries. The United Nations (U.N.) body best poised to achieve such harmonized regulations and codes of practice is the Codex Alimentarius (Codex).

Codex, a joint body of the World Health Organization (WHO) and the Food and Agricultural Organization (FAO), is a standard-setting body of approximately 200 country delegations and nearly 75 regularly participating non-governmental organizations (NGOs), the latter having been vetted as expert resources to delegation discussions and proceedings. If the world’s trading nations adopted Codex as its official standards-setting instrument, world supplement trade could be seamless. Unfortunately, national pride, insulation and the need to “protect” one’s own citizens (and perhaps industries) has left national regulatory bodies, to date, unwilling to cede to Codex the overarching ability to provide that harmony.

Because the U.S. Food and Drug Administration (FDA) promulgates regulations and standards for all aspects of U.S. domestic nutrition policies (i.e., safety, quality, claims, labeling, etc.), currently a Codex standard has no bearing on what happens domestically. It is no secret that the United States is probably best positioned to receive any and all global imports. However, we’re too often on the wrong side of the analytical limits or regulatory actions enacted by foreign countries—thwarting U.S. export opportunities, but often not dampening the flow of products entering from other countries.

Because many developed nations, like the U.S., do not use Codex standards, many companies in the U.S. and the developed world do not view Codex as important or influential within their own national markets. As a result, these companies do not take an active part in new work proposals and deliberations at Codex committees, especially the Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU). This is quite unfortunate. (“New work proposals” are the process by which food standards are elaborated or introduced.)

U.S. Companies Stand to Lose Without Getting Involved With Codex Standard Development

The point lost on many American companies is developing countries, often with less-robust regulatory agencies, will adopt the Codex standard as their own domestic standard. Consequently, when trade ensues, that country—with its national food and nutrition law in sync with Codex—can block the entry of U.S. products even though they comply with the laws here at home. Thus, the new market cannot be penetrated.

The World Trade Organization (WTO), also a U.N. body, would not view that importation blockage as a barrier to trade since the WTO refers to Codex standards as the arbiter in any trade disputes and does not care that the product is legal in the U.S.

American companies stand to lose out on billions of dollars’ worth of trade opportunities if they sit idle while Codex standards are developed and then implemented by the developing country trade partner.

Challenges With Codex—and How to Improve It

While Codex can be an excellent standard for international trade, it’s not perfect. A brouhaha has taken place at the past few CCNFSDU meetings over adding several convoluted and confusing new work proposals for discrete stand-alone ingredients or categories.

Additionally, some national regulators have focused on (1) driving constituents and contaminants down to incredibly difficult near-zero to zero detection levels; and (2) promulgating rapidly enforceable opaque product registration procedures that seemingly disrupt the normal flow on exports/imports, possibly inserting an unintentional barrier to trade.

Precaution as a policy translates to “if we do not know it is 100 percent innocuous and safe, then it needs to be banned!” However, this preclusive paradigm as the limit for unacceptable constituents and contaminants is often not based on scientific risk assessment principles—it’s frequently a politicized precautionary template. Technological advances in analytics are able to discern even more infinitesimal levels of unacceptable constituents and contaminants, termed the “vanishing zero” as what was once zero has now suddenly become measureable. Regulations then spiral down to demand an even lower limit simply because the high-tech apparatus is able to find the next lower magnitude level, not because it is scientifically significant.

Suppose a U.S. exporter wants to sell a product and the importer declines due to that arbitrary precautionary limit. The only recourse for mediation is going to be the WTO. The result can be immediate trade disruption as the complaint may not be considered by the WTO for quite some time. Arbitration between parties often goes against the United States’ trade policies as the WTO only favors a Codex standard, which often mirrors the overly cautionary considerations.

CRN Is an Industry Voice at Codex

Along with influential U.S.-based contacts and several other countries, CRN has been vocal at the in-person and virtual Codex meetings. CRN regularly submits comments on behalf of the dietary supplement industry to the Codex Secretariat to give voice to CRN members’ perspectives.

For example, our concerns with several of these new work proposals include:

1. An uneven playing field and market advantage/disadvantage to some companies as domestic and Codex standards diverge;

2. Guidelines are often overly proscriptive, and thus restrictive, adding cost but not value;

3. The new Codex standards could foster trade barriers between countries and regions as previously stated because some of those countries adopted Codex standards as their own

4. New Codex standards, if implemented for some of these specific ingredients, set an untenable (or at least unmanageable and excessive) precedent for other dietary ingredients. Specifically, the creation of unique micro-segmented nutritionals categories would set precedence for other ingredients to have their own vertical standards outside the family of all previously established dietary ingredients.

Codex Standards Must Be Developed With All Stakeholders, Especially Those Most Affected

Without adopting relevant and trade-functional Codex standards, the trade headaches will continue for dietary supplement manufacturers. The dietary supplements industry must participate and not sit idly by and then get burned when trade is channeled only through the Codex standard doorways.

Canadian science fiction author and professional futurist Karl Schroeder is known for saying, “Foresight is not about predicting the future, it’s about minimizing surprise.” No one can predict the future—but the U.S. and dietary supplement industry can minimize surprise by getting involved ‘real time’ as Codex deliberations and negotiations are in play, for concordant international trade opportunities.

James C. Griffiths, PhD, is Senior Vice President of International and Scientific Affairs at the Council for Responsible Nutrition.

Albion Minerals®