The CRN, which received a 34-page document on the issue from attorneys at law firm Sidley Austin in August, is now publicly sharing its conclusions “to urge regulators to consider the potential implications”.
In its analysis – which will be debated at the CRN-International scientific symposium next month – the law firm notes that international standards body Codex Alimentarius issued a guideline in 2005 favoring a risk-based approach to setting maximum limits based on upper safe levels - and specifically rejected approaches basing maximum levels based on RDAs.
However, a number of countries including Chile and Venezuela still set maximum levels for vitamins and minerals in food supplements based on recommended nutrient intakes, while others regulate supplements with levels above the RDA as ‘drugs’ in the mistaken belief that this will exempt them from the Codex guideline, it adds.
“While governments likely justify these measures as taken to protect human health, it appears that they have imposed these regulations without any risk assessment, and that they are not based in science.”
And as a result, they were potentially breaching three different WTO agreements and would likely be struck down if challenged before a WTO dispute settlement panel, argue the attorneys.
The science
RDA values are not suited for setting maximum levels because they represent the average daily level of intake sufficient to meet the nutrient requirements of most healthy people – and not the safe upper limit, they explain.
“Indeed, many conventional foods contain vitamins and minerals in amounts above the RDA. 100g of beef liver may contain up to 50 times the RDA for vitamin B12, while a serving of boiled kale contains 660% of the daily value of vitamin K, yet are not generally considered to pose a risk to human health.
“Studies have also established that nutrient intake in amounts above RDA values can provide additional health benefits. Thus, sufficient scientific evidence does not exist to justify restricting the nutrient content of food supplements at RDA levels."
Why does it matter, and what can be done about it?
CRN senior vice president, scientific and international affairs John Hathcock told NutraIngredients-USA that it was hugely frustrating for firms supplying products to multiple markets to have to develop different formulations for each one.
"A single regulatory maximum worldwide would lower the costs of supplements because manufacturers would not have to change the formula when marketing in country B in addition to country A. Some countries have set limits so low that the amounts are sufficient only for the young and healthy, even though much, much higher amounts may be safe."
As to what could be done about it, he added: "Only governments that are members of WTO can file a complaint, and then only against another member of WTO. The WTO message is being incorporated into many conferences. The full extent of the “urging” is not yet known, but now we have a detailed legal exposition on the rationale."
Which WTO agreements are being violated?
For a detailed explanation of how the RDA-based regulations were violating the relevant agreements, click here to read the Sidley Austin analysis.
All three agreements - the WTO Agreement on the Application of Sanitary and Phytosanitary Measures, the Agreement on Technical Barriers to Trade, and the 1994 General Agreement on Tariffs and Trade (GATT) - are part of the Uruguay Round Multilateral Agreements on Trade in Goods that form the basis of the present WTO legal framework.