The Launch of Trans Labeling

It was a long time in coming. While rumors about the negative health implications of trans fatty acids had begun circulating in the 1980s, the push for labeling didn’t begin until the following decade, when several significant studies showed that trans fats were as bad for the heart as the saturates they replaced.

In the beginning

In 1994, the Center for Science in the Public Interest (CSPI) petitioned FDA to mandate that all foods’ Nutrition Facts labels list the amount of trans. In 1999, FDA came up with the first proposal for trans fat labeling, but delayed issuing an actual rule pending a report on trans intake and its repercussions from the National Academy of Science’s Institute of Medicine (NAS/IOM). When the report came out, the panel recommended that people consume as little trans fat as possible because it found “a positive linear trend between trans-fatty-acid intake and LDL (low-density lipoprotein) cholesterol concentration, and therefore increased risk of CHD (coronary heart disease).” By then, it was no longer a matter of if labeling would be required, but when.

Finally, in 2003, after requesting and receiving additional comments, the other shoe dropped: FDA announced that, by Jan. 1, 2006, manufacturers had to list trans fat on nutrition labels (see Web Resources for exceptions). The agency said the impetus was scientific evidence that showed consumption of trans fatty acids increases levels of LDL-C, a primary risk factor for CHD, compared to diets containing cis-monounsaturated or cis-polyunsaturated fatty acids.
“Our choices about our diets are choices about our health, and those choices should be based on the best available scientific information. This label change means that trans fat can no longer lurk, hidden, in our food choices,” said Dr. Mark B. McClellan, Ph.D., then commissioner of FDA. “Americans will now be armed with better information to reduce their intake of saturated fat, trans fat and cholesterol--which could significantly lower the risk of heart disease, the leading cause of death in America today.”

Following the rules

In the final rule, FDA requires a nutrition-label declaration of the amount of trans fatty acids present in foods and dietary supplements. Unlike other nutrients, such as saturated fat, no % Daily Value (DV) is listed, since the NAS/IOM report did not provide a Daily Reference Intake (DRI) value. The report mentioned that the negative health effects might suggest a Tolerable Upper Intake Level (UL) of zero, but because it would be nearly impossible to avoid trans fats in a regular diet, in large part because of their natural occurrence in ruminant meat and milk, totally eliminating them would require extraordinary changes in dietary intakes that could create other undesirable effects and unknown health risks.

After weighing the pros and cons of numerous labeling options--including a combination of trans- and saturated-fat contents as proposed in the original 1999 version--FDA modified the Nutrition Facts label. The new rule requires listing trans fat on a separate line under the saturated-fat statement, with the amount expressed as grams per serving to the nearest 0.5 gram increment when the figure is below 5 grams and to the nearest gram increment when it is above 5 grams. If a serving contains less than 0.5 grams, the content will read 0, except when the label carries the statement “Not a significant source of trans fat.” FDA allows the word trans to appear in italics due to its Latin origin. When establishing the rule, FDA claimed insufficient scientific information existed to create guidelines for nutrient content claims, such as “low,” for trans fat.

In addition, FDA defined which fatty acids were to be included in the determination. Trans vaccenic acid, with one double bond, and other ruminant trans fatty acids with either one double bond or nonconjugated double bonds are included in FDA’s chemical definition of trans fatty acids. Trans fatty acids with conjugated bonds, such as conjugated linoleic acid, are not included in the total, because they do not meet the regulatory definition of “all unsaturated fatty acids that contain one or more isolated double bonds in a trans configuration.” This differs from the IOM definition, which includes both conjugated and non-conjugated double bonds in a trans configuration.

The regulations do not specify a testing method for determining trans levels for nutritional labeling. However, FDA determines compliance when a company uses appropriate analytical methods “as given in the Official Methods of Analysis of the AOAC International, 15th Ed. (1990) or, if no AOAC method is available or appropriate, by other reliable and appropriate analytical procedures.” However, because FDA considers AOAC Method 996.06 (Official Methods of Analysis of AOAC International, 17th edition, Revision 1, 2002; chapter 41.1.28A) as suitable for a wide range of food matrices for measuring trans fat for labeling purposes, this is an acceptable method. Because variations occur in the nutrient content of foods, either naturally or through processing variables, manufacturers must use a composite of 12 random samples for the analysis. The trans content of this composite must be no higher than 20% of the amount declared on the label.

Virtually all U.S. packaged products now carry trans labeling. While foodservice establishments have no federal law that compels them to label for trans, many do so voluntarily, and many local governments are contemplating mandatory notification or outright bans. While the total impact is still a subject of debate, FDA estimates that by Jan. 2009, trans-fat labeling will have prevented from 600 to 1,200 cases of CHD and 250 to 500 deaths each year