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Vitamin Metabolism Laboratory and Nutritional Epidemiology Program, Jean Mayer U.S. Department of Agriculture Human Nutrition Research Center on Aging at Tufts University, Boston, MA 02111;
The Framingham Heart Study, Boston University School of Medicine, Framingham, MA 01701; and
**
Office of Food Labeling, Center for Food Safety and Applied Nutrition, Food and Drug Administration, Washington, DC
3To whom correspondence should be addressed. E-mail: paul{at}hnrc.tufts.edu.
In 1996, the U.S. Food and Drug Administration issued a regulation requiring that all enriched cereal-grain products be fortified with folic acid by January 1998. An average increase in folic acid intake of 100 µg/d was projected as a result of this fortification. The objective of the present study was to estimate the effect of this fortification on the intake of folic acid and total folate, and on the prevalence of individuals with inadequate folate intake and with high folic acid intake. We used data on food and nutrient intake from 1480 individuals who participated in the 5th and 6th examinations of the Framingham Offspring Cohort Study. Fortification was instituted during the 6th examination so that 931 participants were examined before its implementation (nonexposed) and 549 after implementation (exposed). Published data on total folate in enriched cereal-grain products were used to correct folate content in these foods to reflect fortification. Among nonsupplement users, folic acid intake increased by a mean of 190 [95% confidence interval (CI): 176, 204] µg/d (P < 0.001) and total folate intake increased by a mean of 323 (95% CI: 296350) µg dietary folate equivalents (DFE)/d (P < 0.001) in the exposed participants. Similar increases were seen among supplement users exposed to fortification. The prevalence of exposed individuals with total folate intake below the estimated average requirement (320 µg DFE/d) decreased from 48.6% (95% CI: 44.253.1%) before fortification to 7.0% (95% CI: 3.110.9%) after fortification in individuals who did not use folic acid supplements. This prevalence was
1% or less for users of supplements both before and after fortification. Prevalence of individuals with folic acid intake above the upper tolerable intake level (1000 µg folic acid/d) increased only among supplement users exposed to fortification (from 1.3 to 11.3%, P < 0.001). No changes in folic acid intake were observed over time in the nonexposed participants. By these estimations, folic acid fortification resulted in a mean increase in folic acid intake that was approximately twice as large as previously projected.
KEY WORDS: folate folic acid fortification folate intake humans
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