This “nutrient group” approach is convenient for the regulator since only one risk assessment needs to be conducted for each nutrient group. However, it very unfairly discriminates against those nutrients that are not only safer, but are usually both more beneficial and popular with consumers of supplements. This approach to risk assessment is scientifically irrational, and, if utilised by national regulatory agencies, would ultimately prevent consumer access to safe and beneficial levels of a wide range of nutrients.
A more scientifically rational methodology for nutrient risk assessment, therefore, would be to treat each individual nutrient form (e.g. ferrous sulphate, iron bisglycinate, magnesium hydroxide, magnesium gluconate, ascorbic acid, calcium ascorbate, etc) as an individual chemical entity, and to set a separate upper safe level for each. This is what is termed a “nutrient form” approach, and is essentially the same approach that risk assessment scientists already take when examining toxins, such as pesticides, herbicides and so on, where each individual substance is treated as a separate chemical entity.
Worryingly, therefore, the nutrient group approach is the one that currently seems most likely to become adopted by the European Union for setting the upper safe levels for its Food Supplements Directive, and by the Codex Alimentarius Commission to set the upper safe levels for its global Guidelines for Vitamin and Mineral Food supplements. As such, and as we shall discover, this approach could ultimately lead to the global enforcement of ‘maximum permitted levels’ (MPLs) for supplemental nutrients that are little different to the meagre government recommended daily allowances (RDAs).
The need to consider nutrient benefits
An additional problem with the nutrient group approach is that it ignores the health benefits of nutrients, and concentrates solely upon the assessment of their supposed risks. Disconcertingly, despite the obvious flaws and bias of this approach, the United States (U.S.) judiciary is nonetheless showing signs that it might give it the backing of law.
For example, an August 2006 ruling by a three-judge panel of the 10th U.S. Circuit Court of Appeals overturned an April 2005 ruling by the District Court of Utah that the US Food and Drug Administration ( FDA) was incorrect in using risk-benefit analysis to support its ban of the herb ephedra . This Appeals Court ruling was highly significant, because, when conducting its analysis of ephedra, the FDA had refused to acknowledge that the herb had any benefits.
As a result, if, in future, the FDA decides, when conducting a risk-benefit analysis of a nutrient, that its benefit is non-significant, then any level of risk could now seemingly qualify as "unreasonable risk of illness or injury", as provided for under section 4 of the Dietary Supplement Health and Education Act (DSHEA), the law under which supplements are regulated in the U.S.