| Comment Record|
Ms. Dorothea Vafiadis ||
2002-12-16 11:25:25 |
ILSI North America |
| Comments for FDA General |
1. General Comments
December 16, 2002
Dockets Management Branch (HFA-305)
Food and Drug Administration, 5630
Fishers Lane, rm. 1061
Rockville, MD 20852
RE: [Docket No. 94P–0036]
On behalf of the International Life Sciences Institute North America (ILSI N.A.), we are submitting the following comments directed to the Federal Register notice on November 15, 2002, (67 FR 69171), regarding the reopening of the comment period on food labeling: Trans Fatty Acids in Nutrition Labeling, Nutrient Content Claims, and Health Claims.
The North American branch of the International Life Sciences Institute (ILSI N.A.) is a public, non-profit scientific foundation. ILSI N.A. advances the understanding and application of scientific issues related to the nutritional quality and safety of the food supply, as well as health issues related to consumer self-care products. The organization carries out its mission by sponsoring relevant research programs, professional education programs and workshops, seminars, and publications, as well as providing a neutral forum for government, academic, and industry scientists to discuss and resolve scientific issues of common concern for the well-being of the general public. ILSI N.A.’s programs are supported primarily by its industry membership. We appreciate the opportunity to provide comment on the scientific issues presented in this proposed rule.
Our comments address one issue of importance related to the scientific soundness of the Institute of Medicine report entitled “Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein and Amino Acids” (1).
We respectfully submit that the science used as a basis for the IOM report concluding that the magnitude of the effect of trans fatty acid intake on the LDL/HDL ratio is greater for trans fatty acids compared to saturated fatty acids (page 8-58) refers to a non-peer reviewed article by Ascherio et al (2); therefore, the article’s scientific strengths and weaknesses have not been fully evaluated.
By the New England Journal of Medicine’s own policy, articles such as that by Ascherio et al, which appeared under the journal’s Sounding Board section, are submissions categorized as “…opinion essays. They are similar to editorials but not tied to a particular article. They often present opinions on health policy issues and are normally unsolicited.”
Using the article as a basis of scientific fact, the IOM report stated that similar to saturated fatty acids, there is a positive linear trend between trans fatty acid intake and LDL-cholesterol concentration, and therefore an increased risk of CHD. The basis for this conclusion is taken from figure 1 in the aforementioned article, illustrating a dose response relationship between change in LDL/HDL ratio and percentage of energy from trans fatty acids. We submit that this data, plotted by Ascherio et al, may have an alternative explanation.
The graph incorporated data from nine published studies and was constructed using the best-fit regression lines through the origin for both percentage of energy from trans fatty acids and percentage of energy from saturated fatty acids. Both regression lines had positive slopes, however, the slope of the regression line for trans fatty acids was larger than that for saturated fatty acids. This difference in slopes led to the conclusion that trans fatty acids have a more adverse effect on CHD risk than saturated fatty acids.
Given that each study on the plot may have a different sampling weight and each study may have a different design, a different regression line than the one indicated by Ascherio et al may be possible. Furthermore, since the article is not a peer-reviewed scientific study, there is no way to determine what methods were used to select the studies included in the regression analysis. The Food and Drug Administration has demonstrated its respect for data generated from well-done meta-analyses in its prior deliberations associated with the Nutrition Labeling and Education Act of 1990. The approach taken by Ascherio et al must be described at best as a pseudo-meta-analysis, and thus should not be accorded the weight given by the IOM report. A rigorous meta-analysis along with comparisons of predictive equations to better characterize the relation between trans fatty acids and blood lipoprotein levels are needed.
Although the article by Ascherio et al reports a dose response relationship between change in LDL/HDL ratio and per cent of energy from trans fatty acids, according to unpublished work by J. Edward Hunter, an adjunct professor of Chemistry at the University of Cincinnati, an inverse relationship could be shown by considering change in LDL/HDL ratio and per cent energy from linoleic acid, suggesting that trans fatty acids may not have as much effect on LDL/HDL ratio if there is a sufficient level of linoleic acid in the diet.
In conclusion, the quality of scientific evidence offered as a basis for the proposed labeling rule is not equivalent to that generally accepted as support for public health policy.
Richard Black, Ph.D.
ILSI North America
Dorothea K. Vafiads, M.S.
Science Programs & Communications
ILSI North America
(1) IOM/NAS, “Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat,
Fatty Acids, Cholesterol, Protein and Amino Acids,” chapter 8, National Academy
Press, Washington, DC, pp. 335–432, 2002 (Internet address: http://www.nap.edu/
(2) Ascherio A, Katan M, Zock PL, Stampfer MJ, Willett WC. Trans fatty acids and coronary heart disease. N Engl J Med 1999;340:1994-1998.