Recently, the frequency of recent international regulatory activity has markedly increased. Monitoring and assessing the impact of this activity takes up most of the day-to-day workload. Over the past few months, regulatory action by countries has increasingly focused on “doing your own thing”, which is a bad phenomenon as it creates unnecessary and onerous burdens for international trade, especially the dietary supplement industry obstacles.
Tight Global Trade Requires Harmonious Regulations
It seems that the goal of all involved in global trade is a harmonized set of regulations for product acceptability among all trading partner countries. The United Nations agency, always called U.N., best suited to harmonize regulations and codes of practice is the Codex Alimentarius, shortly Codex.
The Codex Alimentarius Commission, or CAC for short people always know, is a joint body of the World Health Organization, always called WHO, and the Food and Agriculture Organization of the United Nations, always called FAO. CAC is a group of approximately 200 national delegations and nearly 75 regularly participating non-governmental organizations (NGOs). It is an intergovernmental organization that sets international food standards for safeguarding the health of consumers and ensuring fairness in the food trade. Also, the FAO of the United Nations has expert resources that are reviewed for delegation discussions and procedures. The Codex Alimentarius proposes and brings together in a uniform form all food standards that have been adopted internationally, including those for all processed, semi-processed, or food ingredients sold to consumers. General terms and guidelines on food hygiene, food additives, pesticide residues, contaminants, labelling and instructions, sampling and analytical methods, etc., are also listed. In addition, the Codex Alimentarius also includes guidelines such as Codes of Practice and other recommended measures for food processing.
If world trading countries adopted Codex as their official standard-setting tool, the world trade in supplements would be seamless. But unfortunately, national pride, insulating and “protecting” one’s citizens, or the need of some industries have made national regulators reluctant to allow Codex to provide this overall capacity for harmony.
Because there are regulations and standards for all aspects of U.S. domestic nutrition policy, like safety, quality, claims, labelling, etc., these are promulgated by the U.S. Food and Drug Administration or everyone always called FDA for short. And the current Codex Alimentarius standards do not have a relationship with what is happening in the United States. It’s no secret that the U.S. may be the best country to receive any and all global imports. However, most people are accustomed to thinking that foreign countries have established analytical restrictions or faulty regulatory actions that hinder U.S. export opportunities but often do not inhibit the flow of products entering from other countries.
Since many developed countries, such as the United States, do not use the Codex Alimentarius standard, many companies in the United States and developed countries do not consider Codex significant or influential in their home markets. Therefore, it is unfortunate that these companies are not actively participating in the proposals and deliberations of new work for the development or introduction of food standards in Codex committees, particularly the Codex Committee on Nutrition and Foods for Special Dietary Uses, or CCNFSDU for short.
U.S. Companies Not Involved in Codex Standard Setting Will Suffer
Many U.S. companies lose that developing countries, often with less powerful regulators, will adopt Codex standards as their own domestic standards. Therefore, when a trade occurs, a country with food and nutrition laws in sync with the Codex can prevent the entry of U.S. products, even if the U.S. products comply with domestic laws. Therefore, new markets cannot penetrate.
WTO, the full name of the World Trade Organization, which is also an agency of the United Nations, does not view import blockades as barriers to trade. The reason is the WTO uses Codex standards as an arbiter of any trade disputes and does not care whether products are legal in the United States.
If U.S. companies sit idle while developing-country trading partners develop and implement Codex standards, they will lose billions of dollars in trade opportunities.
The Codex Alimentarius: Challenges?
While Codex Alimentarius can be an excellent standard for international trade, it’s not perfect. In the past few CCNFSDU meetings, there has been an uproar over the addition of some puzzling and confusing new work proposals for discrete independent components or categories.
In addition, some national regulators are also concerned about the following two issues:
- It is extremely difficult to solve the problem of reducing components and pollutants to near zero or even zero detection levels;
- Promulgation of quickly enforceable opaque product registration procedures that appear to disrupt normal import and export processes and may inadvertently set up trade barriers.
How can Codex Questions be Improved?
As a policy precaution translates to “If we don’t know it’s 100% harmless and safe, then we need to ban it!” However, this exclusivity paradigm of limiting unacceptable ingredients and contaminants is usually not based on scientific principles of risk assessment. It is often a politicized prevention template. Advances in analytical technology can identify even smaller levels of unacceptable components and contaminants, known as “vanishing zeros,” because what was once zero is now suddenly measurable. Regulations then gradually dropped, requiring lower limits, simply because high-tech equipment could find the next lower magnitude level, not because it made scientific sense.
Suppose a U.S. exporter wants to sell a product, and the importer refuses due to this arbitrary precautionary restriction. The only avenue for mediation will be the WTO. The result could be an immediate trade disruption, as the WTO may not consider complaints for an extended period of time. Arbitrations between parties often go against U.S. trade policy because the WTO supports only Codex standards, which often reflect overly careful considerations.
The Voice for Codex
– The Council for Responsible Nutrition
The Council for Responsible Nutrition, simply called CRN, was founded in 1973. And it is headquartered in Washington, D.C. CRN is a leading trade association and, at the same time, represents many manufacturers and ingredient suppliers of dietary supplements and functional foods. CRN member companies manufacture the majority of dietary supplements sold in the U.S. and globally. CRN’s mission is to maintain and enhance an atmosphere in which our members responsibly develop, manufacture and market dietary supplements, functional foods and their nutritional ingredients. CRN is also leading the way internationally. And it is the first time that it received official designation as a non-governmental organization, NGO for short, which is eligible to actively participate in Codex meetings and working groups, thus becoming the first one and the only NGO for many years to represent dietary supplements in interests in this important international arena.
John J. Blair, Chairman of CRN’s Board of Directors and Vice President of NSA, LLC (JuicePlus+®), said, “CRN’s strong efforts in its first four decades have helped create an environment in which companies can responsibly develop, manufacture and marketing dietary supplements and nutritional ingredients that help consumers lead healthier lives. Not only our own member companies benefit from CRN, but the industry as a whole and consumers who have access to a variety of healthy products. I believe the development of the dietary supplements industry and CRN will continue brilliantly. I look forward to one kind of future where more people generally accept dietary supplements as an essential choice for consumers to achieve and maintain good health. And I hope that CRN helps us achieve our goals.”
Along with influential U.S. contacts and several other countries, CRN has been speaking out at in-person and virtual Codex meetings. CRN regularly submits comments to the Codex Secretariat on behalf of the dietary supplement industry to express the views of CRN members.
For example, concerns about some of these new work proposals include:
- Unfair playing field and market advantage or disadvantage due to divergence between domestic and Codex standards;
- Guidelines are often overly restrictive and therefore restrictive, adding cost but not adding value;
- New Codex standards may create barriers to trade between countries and regions, as some of them use Codex standards for their own use
- If different Codex standards were developed and implemented for some of these specific ingredients, it would set an untenable or at least unmanageable and excessive precedent for other dietary ingredients. Specifically, the creation of unique micro-segmented nutritional categories will prioritize other ingredients, giving them their own vertical standard outside of all previously established families of dietary ingredients.
Who is Best to Set Codex Standards?
The answer to this question is that Codex Alimentarius standards must be developed with all stakeholders, especially those most affected.
Without the adoption of relevant and trade-enabled Codex standards, dietary supplement manufacturers will continue to face trade challenges. The dietary supplement industry has to get involved, not sit idly by and get burned when trade is only conducted through the Codex standard channel. No one can predict the future, and no one can tell what will happen in the future. Still, the U.S. and the dietary supplement industry can minimize surprises by participating in Codex deliberations and negotiations “in real time” to gain consistent international trade opportunities happened.
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