CRN’s lengthy comments suggest many changes and tweaks, but the organization wanted to lead off with a pat on the back for FDA’s approach to determining Dietary Reference Intakes (DRIs). NPA’s somewhat briefer comments overlapped with CRN’s in the area of folic acid labeling.
“We were really pleased to see that FDA chose to keep using the Recommended Daily Allowance (RDA) as the basis for these DRIs,” said Andrea Wong, PhD, vice president of scientific and regulatory affairs for CRN. “If they had gone to the Estimated Average Requirement (EAR) for the basis of the RDI, that would have diluted the nutrient requirements. The EAR represents the daily level you would consume to meet the needs of only half the population. There was perhaps some concern about overfortification, but looking at total nutrient intakes, overconsumption is in fact not a concern. Many Americans are falling short of even the EAR levels for many nutrients,” Wong told NutraIngredients-USA.
Folic acid, or folate?
CRN comments include an in depth discussion of folic acid fortification and its relation to food folates. Folic acid is a vital nutrient for pregnant and nursing mothers to prevent neural tube birth defects. The proposed rule would mandate the term “folic acid” (pteroylglutamic acid) be used on supplement labels, and “folate” be reserved to refer to the naturally occurring folates in food (various polyglutamate forms). Wong said this appears to be based on information from an Institutes of Medicine report from 1998. But since that time the market has changed.
“We were concerned that the FDA did not recognize that synthetic folates are now used in dietary supplements,” Wong said. “Their assumption was that dietary supplements contain only folic acid. The synthetic folates are legal dietary ingredients that have either gone through an NDI notification process or a GRAS process, so FDA should have been aware of them. We assume it was just an oversight by the agency.”
CRN therefore proposes that dietary supplement manufacturers using synthetic ingredients be able to mention folates on their labels. If the intent of this labeling change is to prevent the use of synthetic folates in supplements, CRN said clarification is needed on that point.
CRN also proposes a change in the way that FDA will allow the amounts of folic acid/folates to be called out on labels. FDA is calling for a conversion factor be applied to folic acid to arrive at a value called Dietary Folate Equivalents to account for the greater bioavailability of naturally occurring food folates. CRN’s concern is that the way this change is being applied could potentially allow some manufacturers under some circumstances to decrease the amount of folic acid in a supplement and still meet the requirements to meet a 100% Daily Value label claim. CRN urges that FDA discard the conversion factor approach and continue to make clear which foods or supplements supply 400 mcg of folate or folic acid daily, which is the amount recommended by many health organizations and supported by the body of evidence.
NPA, too, objected to FDA’s proposed changes, saying that many consumers seek out a specific form of folic acid or folate, and prohibiting use of these synonyms does not serve consumers’ interest.
“FDA seems to encourage misleading practices with this change. If the conventional food contains mixed folate and folic acid, but the proposed rule requires one to list only folate, it is misleading to consumers and introduces significant confusion for those with labeling experience. Additionally, folacin is a well-recognized synonym and should not be removed from the current codified federal regulations. Tetrahydrofolate, methyltetrahydrofolate, and methyl folate, the biologically active forms of folate, should also be allowed synonyms,” NPA wrote.
A missing vitamin?
On the letter vitamin front, CRN is concerned that FDA proposes to restrict the definition of vitamin K to the K1 (phylloquinone), this excluding vitamin K2 (menaquinone) from being called out on labels. CRN notes that K2 is present in meat and dairy, and consumption of these foods can supply a meaningful amount of the overall required intake. And K2 has been shown to be the more bioavailable form of the vitamin. CRN therefore calls for K2 to be listed on labels.
“This could again be a victim of FDA using a little bit outdated data from the IOM reports rather than the most updated information. Both the European Food Safety Authority and Health Canada recognize vitamin K2,” Wong said.
CRN suggest that FDA allow manufacturers to specify amounts of EPA and DHA on food labels, rather than a callout for total abouts of polyunsaturated fatty acids only. The organization also suggested changes in the way that total carbohyrdates in a product are calculated, and changes in propsed rules for the labeling of dietary fiber. In addition, CRN calls for an extended period to enact the proposed changes, saying that the two years that FDA proposes is too short.
NPA, on the other hand, asked that FDA reconsider the specification of strength of nutrients at the end of shelf life. The proposed rule would entail the inclusion of significant overages of certain nutrients to meet 100% label claim at the end of shelf life. NPA suggests that this level be reduced to 90% to reduce the amount of overages that would need to be used at the time of manufacture. The association also suggests that flouride be allowed as a voluntary declaration.