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Key Words public health, public policy Abbreviations FDA--Food and Drug Administration NTD--neural tube defect NHANES--National Health and Nutrition Examination Survey RBC--red blood cell IOM--Institute of Medicine, IN THEIR RECENT report, Williams et al (1) examined data from 21 population-based birth defect surveillance systems for trends in prevalence of spina bifida and anencephaly for specific racial/ethnic groups […]

Mandatory fortification of enriched cereal-grain products became effective in the United States on January 1, 1998. This fortification was undertaken to assist women of child-bearing age in increasing their intake of folic acid to reduce their risk of having a pregnancy affected by a neural tube birth defect. The process by which the Food and Drug Administration modeled the level of fortification with folic acid illustrates the complex issues and general principles that emerge when fortification of a nation's food supply is evaluated as a means of addressing a public health concern. The effectiveness of fortification for a target population and safety for the much larger general population impose conflicting challenges that must be considered concurrently when making decisions regarding fortification. Recent data show improved folate status and apparent decreases in risk of neural tube birth defects in the U.S. Much about the long-term effects of the fortification program remains unknown and careful monitoring over time will be necessary to ensure that the program functions as intended. Key words: fortification, folic acid, post-fortification assessments, vitamin [B.sub.12]

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 [micro]g/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] [micro]g/d (P < 0.001) and total folate intake increased by a mean of 323 (95% Ch 296-350) [micro]g 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 [micro]g DFE/d) decreased from 48.6% (95% CI: 44.2-53.1%) before fortification to 7.0% (95% Ch 3.1-10.9%) 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 [micro]g 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

Folic acid fortification of enriched cereal-grain products (which became mandatory in the U.S. on January 1, 1998) was intended to increase folate intake among childbearing-aged women to reduce their risk of neural tube birth defect (NTD)-affected pregnancies. Interest now focuses on assessing the effects of fortification on risk of NTDs and on folate intake relative to homocysteine (Hcy) concentrations and risk of vascular disease, although a causal relationship between the latter two has not been demonstrated. Increased serum folate levels were first reported in 1999. Data from the Framingham Offspring Study cohort showed increased mean serum folate in middle-aged and older adults; additionally, the prevalence of high Hcy concentrations had decreased by ~50% in subjects examined before (1995-1996) and after (1997-1998) fortification. Another analyses of samples collected between 1994 and 1999 identified a trend of increasing serum folate values from 1996 onward with values in 1998 160% of those measured in 1996. Comparisons between 1988-1994 National Health and Nutrition Examination Survey (NHANES) III data and 1999 NHANES showed increased serum and erythrocyte folate concentrations among childbearing-aged women. While recent data show improved folate status in a short period of time, much about long-term effects of the fortification program remains unknown. Interest in the effects of increased folate intakes on risk of NTDs or vascular disease needs to be balanced against concerns about masking the anemia of vitamin B-12 deficiency and the general lack of data about safety of continuous high intakes. Careful monitoring over time is necessary to determine that the program functions as intended. KEY WORDS: * folate * fortification * folate status * serum folate * homocysteine

The Food and Drug Administration has several options that will assist the Public Health Service in implementing its September 1992 recommendation that all women of childbearing age consume 0.4 mg of folic acid daily to reduce their risk of having a pregnancy affected with a neural tube defect. The FDA can authorize the use of a health claim on labels and in the labeling of foods that characterizes the relationship between a nutrient and a health-related condition. Fortification of cereal-grain products with folic acid is a second option that has the potential for reaching most women of childbearing age without requiring them to change their food selection patterns. Consideration of these options has been intertwined with rapid developments in the scientific database that is the foundation of the health claim, by conflicting opinions regarding the effectiveness for women in the target population of FDA's proposed level of cereal-grain fortification, by lack of systematic safety data regarding the impact of fortification on persons in the general population and by changes in the regulatory environment in which the agency acts. INDEXING KEY WORDS: * fortification * health claims * folic acid * neural tube defects * public policy

Objectives. This article uses folic acid as an example to illustrate some of the complex issues and general principles that emerge when evaluating fortification of the food supply as one possible means to address a public health recommendation. Methods. Distributions of current daily folate intakes from conventional foods and dietary supplements were estimated. Intakes that might result, from fortification of cereal-grain products and ready-to-eat cereals at various levels for eight age-gender groups were also estimated by using the US Department of Agriculture's 1987-1988 Nationwide Food Consumption Survey. Results. The results illustrate that fortification of the US food supply tends to increase folate intakes of consumers at the high end of the intake distribution curves in the general population to a greater extent than it affects consumers at the low end of the intake distribution curves in the target population. Conclusions. The effectiveness of food fortification options for a target population and the safety for the general population impose conflicting challenges that must be considered concurrently when making decisions about fortifying the US food supply. (Am J Public Health. 1995;85:660-666), Fortification of the US food supply may increase nutrient intakes to a much greater extent in consumers with high intakes from food than in consumers with low intakes. Supplement use has little affect on the consumers who need it more. Increases in daily folic acid consumption with fortification of dry cereal products were measured among age and gender groups using the US Department of Agriculture's 1987-1988 Nationwide Food Consumption Survey. For the target population of childbearing age women, supplements only slightly increased folate intake. But in children aged 4 to 10 who were high consumers of folic acid from foods alone, the supplements resulted in a 70% increase. Nutrient intakes for target groups should be increased to recommended levels, but at the same time, safe levels must be managed for people with high nutrient intakes.