| Comment Record|
Mr. David Durham ||
2002-12-16 17:04:41 |
United Soybean Board |
| Comments for FDA General |
1. General Comments
Dockets Management Branch (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, Maryland 20852
submitted electronically (with hard copy to be mailed):
REF: Docket Number 94P-0036
The United Soybean Board (USB) submits the following comments in response to the proposed footnote rule as relates to trans fatty acids under Docket # 94P-0036.
The proposed footnote rule regarding trans fatty acids, which requires a label footnote indicating “intake should be as low as possible” has great potential to mislead consumers rather than provide greater consumer awareness of dietary choices. The following comments address, in three specific areas, the potential for consumers being misled by the proposed footnote.
Dietary intake of trans fatty acids
The proposed footnote conveys no information with regard to a standard by which “as low as possible” may be measured. Absent any other standard, urging consumers to keep trans fat intake “as low as possible” is a de facto zero standard. Zero is an impossible standard to meet. As the Institute of Medicine’s (IOM) Letter Report on Dietary Reference Intakes for Trans Fatty Acids states: “small amounts of trans fatty acids … are present in all (emphasis added) diets.”
The report also states that trans fatty acids are present in “milk, butter, and meats. … Human milk contains approximately 1 to 5 percent of total energy as trans fatty acids.” This prevalence is why, in part, no daily recommended value (DRV) for trans fats has been proposed and why the the IOM report qualified the recommendation of “as low as possible” with the language “while consuming a nutritionally adequate diet.” Truncating that recommendation to “as low as possible” without the context of “while consuming a nutritionally adequate diet” has great potential to mislead consumers.
Replacing trans fats with saturated fats
While trans fats are present in a wide range of foods, their contribution to average dietary fat intake in America is only two to four percent of total calories. This level is relatively small compared with saturated fat which stands at 12 percent of total calories. Indeed, current saturated fat consumption is already higher than the level recommended by the American Heart Association’s Nutrition Committee that saturated fat account for no more than 10 percent of total calories. Yet, in anticipation of the final labeling rule on trans fats (even prior to the footnote proposal), evidence in the marketplace suggests that consumers would substitute saturated fat intake for trans fat. This trend would be contrary to the general consensus among nutritional experts that consumers should not accomplish a reduction in trans fatty acid intake by replacing it with saturated fat in the diet.
One practical example of the probable substitution effect can be found in the microwave popcorn category. At least one national brand of microwave popcorn makes a claim to be trans fat free. The ingredient statement confirms that palm oil, which is high in saturated fat, is used in lieu of partially hydrogenated vegetable oil, heretofore the industry standard for such products. In such a case, were a consumer to refer to the proposed footnote urging that trans fat “intake should be as low as possible,” when making comparisons among microwave popcorn brands, he or she likely would be misled on the basis of the footnote and thus likely to select the product that had substituted saturated fats for trans fats.
Trans fats in context of total fat intake
A recent consumer survey by the International Food Information Council (IFIC) revealed that while 90 percent of consumers agree that referring to label information is helpful and important to decide which foods to purchase, more than half agreed that current information about health and nutrition is confusing. The addition of a nutrition footnote has great potential to add to this confusion.
Moreover, there is confusion about the overall intake of fat; fifty percent of consumers are unaware that monounsaturated and polyunsaturated fats are healthy for the body. IFIC surveys also show that consumers are confused about saturated and trans fats; approximately forty percent believe trans fats are healthier than saturated fats, while approximately 20 percent believe that saturated fats are healthier than trans fats, and approximately 30 percent don’t know.
Indeed, according to the Food and Drug Administration’s Dr. Alan Levy speaking at a forum at Georgetown University’s Center for Food and Nutrition Policy:
“Population awareness and knowledge of trans fatty acids is in the 20 percent range. If it appeared on the label, there would have to be an extensive education campaign. We have learned from our experience with saturated fat, however, that it is very hard to teach people the intricacies of fatty acid chemistry. … You are not going to appreciate some of these distinctions, and it really has not been only a failure in our messages or lack of effort. There is a level of complexity that people will just not comprehend.”
In this regard, adding a footnote on trans fats does not address the overall issue of lowering and/or limiting fat intake. The IOM recommendation that “intake should be as low as possible while consuming a nutritionally adequate diet” extended to saturated fatty acids and cholesterol as well as trans fatty acids. Thus the proposed footnote, as it is directed only to trans fat has great potential to mislead consumers’ dietary decisions with regard to overall fat intake and the mix of saturated, unsaturated, and trans fats, and cholesterol.