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Food labeling: health claims and labeling statements; dietary fiber and cancer; antioxidant vitamins and cancer; omega-3 fatty acids and coronary heart disease; folate and neural tube defects; revocation. Food and Drug Administration, HHS. Final rule.

The Food and Drug Administration (FDA) is revoking its regulations codifying the agency's decision not to authorize the use of health claims for four substance-disease relationships in the labeling of foods, including dietary supplements: Dietary fiber and cancer, antioxidant vitamins and cancer, omega-3 fatty acids and coronary heart disease, and the claim that 0.8 milligram (mg) of folate in dietary supplement form is more effective in reducing the risk of neural tube defects than a lower amount in conventional food. This action is being taken in response to a decision of the U.S. Court of Appeals for the D.C. Circuit invalidating these regulations and directing FDA to reconsider whether to authorize the four health claims. This action will result in the removal of the regulations but does not constitute FDA authorization of the four claims. FDA is completing its reconsideration of the claims and expects to issue decisions on all four claims by October 10, 2000.

Antioxidants↗

Food labeling: trans fatty acids in nutrition labeling, nutrient content claims, and health claims. Final rule.

The Food and Drug Administration (FDA) is amending its regulations on nutrition labeling to require that trans fatty acids be declared in the nutrition label of conventional foods and dietary supplements on a separate line immediately under the line for the declaration of saturated fatty acids. This action responds, in part, to a citizen petition from the Center for Science in the Public Interest (CSPI). This rule is intended to provide information to assist consumers in maintaining healthy dietary practices. Those sections of the proposed rule pertaining to the definition of nutrient content claims for the "free" level of trans fatty acids and to limits on the amounts of trans fatty acids wherever saturated fatty acid limits are placed on nutrient content claims, health claims, and disclosure and disqualifying levels are being withdrawn. Further, the agency is withdrawing the proposed requirement to include a footnote stating: "Intake of trans fat should be as low as possible." Issues related to the possible use of a footnote statement in conjunction with the trans fat label declaration or in the context of certain nutrient content and health claims that contain messages about cholesterol-raising fats in the diet are now the subject of an advance notice of proposed rulemaking (ANPRM) which is published elsewhere in this issue of the Federal Register.

Community Participation↗

Food-label reform.

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Diabetes Mellitus↗

Variations in isoflavone levels in soy foods and soy protein isolates and issues related to isoflavone databases and food labeling.

The reliability of databases on the isoflavone composition of foods designed to estimate dietary intakes is contingent on the assumption that soy foods are consistent in their isoflavone content. To validate this, total and individual isoflavone compositions were determined by HPLC for two different soy protein isolates used in the commercial manufacture of soy foods over a 3-year period (n = 30/isolate) and 85 samples of 40 different brands of soy milks. Total isoflavone concentrations differed markedly between the soy protein isolates, varying by 200-300% over 3 years, whereas the protein content varied by only 3%. Total isoflavone content varied by up to 5-fold among different commercial soy milks and was not consistent between repeat purchases. Whole soybean milks had significantly higher isoflavone levels than those made from soy protein isolates (mean +/- SD, 63.6 +/- 21.9 mg/L, n = 43, vs 30.2 +/- 5.8 mg/L, n = 38, respectively, p < 0.0001), although some isolated soy protein-based milks were similar in content to "whole bean" varieties. The ratio of genistein to daidzein isoflavone forms was higher in isolated soy protein-based versus "whole bean" soy milks (2.72 +/- 0.24 vs 1.62 +/- 0.47, respectively, p < 0.0001), and the greatest variability in isoflavone content was observed among brands of whole bean soy milks. These studies illustrate large variability in the isoflavone content of isolated soy proteins used in food manufacture and in commercial soy milks and reinforce the need to accurately determine the isoflavone content of foods used in dietary intervention studies while exposing the limitations of food databases for estimating daily isoflavone intakes.

Beverages↗

Trans fatty acids in human milk in Canada declined with the introduction of trans fat food labeling.

Trans fatty acids in human milk have raised concerns because of possible adverse effects on infant growth and development. Analyses of human milk in the late 1990s in Canada showed high amounts of trans fatty acids from partially hydrogenated oils. Canada introduced labeling of trans fatty acids on retail foods in 2003. We analyzed trans and cis unsaturated and saturated fatty acids in human milk collected from 87 women in 2004-2006 and compared the levels to those in milk collected from 103 women in 1998 and analyzed using similar methods. The total trans fatty acids (mean +/- SEM, g/100 g fatty acids) in human milk in Canada decreased significantly, from 7.1 +/- 0.32 in 1998 to 6.2 +/- 0.48, 5.3 +/- 0.49, and 4.6 +/- 0.32 over 3 consecutive 5-mo periods from November 2004 to January 2006. The milk total trans fatty acids were significantly and inversely related to 16:0, 18:2(n-6), 18:3(n-3), 20:4(n-6), 22:4(n-6), and 22:5(n-6) and positively related to 18:0 and conjugated linolenic acids (P < 0.05, n = 190). The estimated exposures of exclusively breast-fed infants to trans fatty acids decreased from a mean and 95th percentile intake of 2.0 and 4.4 g x infant(-1) x d(-1) in 1998 to 1.33 and 2.41 g x infant(-1) x d(-1), respectively, in late 2005. The estimated intake of the mothers was 4.0 (range 0.51-12.3) and 2.2 (0.56-7.65) g x person(-1) x d(-1) in 1998 and late 2005, respectively. Our studies show trans fatty acids have decreased in human milk in Canada, which suggests a concomitant decrease in trans fatty acid intake among lactating women and breast-fed infants.

Canada↗

Food labelling.

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Beverages↗