United States: Trans Fat Labeling Requirements

On January 1, 2006, the FDA’s rule requiring trans fat labeling will become effective. The final rule, entitled "Trans Fatty Acids in Nutrition Labeling, Nutrient Content Claims, and Health Claims," was first published by the FDA on July 9, 2003 and applies to almost all food products sold within the United States. By January 1, all food manufacturers must be in compliance with this regulation. Manufacturers who do not bring their products into compliance by the mandatory date may be subject to an enforcement proceeding potentially including seizure of the offending products or monetary penalties.

By January 1, manufacturers of conventional foods (and some dietary supplements) must determine the amount of trans fatty acids (trans fat) in their products and list trans fat on their nutrition labels. The new regulations require the amount of trans fat per serving to be listed on the Nutrition Facts panel, in a separate line directly below the saturated fat content. The trans fat content generally must be listed unless the total amount of fat (including saturated and unsaturated fat) is less than 0.5 gram per serving and no claims are made about fat, fatty acids or cholesterol content. Trans fat content is to be expressed as grams per serving to the nearest 0.5-gram increment below 5 grams and to the nearest gram increment above 5 grams. If the amount of trans fat per serving is less than 0.5 gram, the content is to be expressed as 0, unless a footnote statement is inserted at the bottom of the table of nutrient values specifying that the food is "not a significant source of trans fat".

Therefore, with only limited exceptions, these regulations require labeling changes even for foods that do not contain any trans fat. The two principal exceptions are: (1) products with less than 0.5 gram trans fat per serving that also use the "simplified format" for labeling and that do not make nutrition claims or declare vitamins or minerals; and (2) products that sell less than 100,000 units per year in the United States, that are made by firms that have fewer than 100 employees, that do not make nutrition or health claims, and that have filed notifications with FDA under 21 CFR §101.9(j)(18). The regulations can be accessed on the FDA’s webpage at http://www.cfsan.fda.gov/~lrd/fr03711a.html, and in the Federal Register at 68 FR 41434 at 41468-41470.

Most trans fat is formed when liquid oils are made into solid fats. Trans fat is found in vegetable shortenings, some margarines, and many processed foods such as crackers, candies, cookies, snack foods, fried foods, baked goods, and other foods made with partially hydrogenated vegetable oils. Small amounts of naturally occurring trans fat can also be found in animal products such as butter, milk products, cheese, beef, and lamb.

Companies that have not already taken action to comply with these requirements may face significant challenges in meeting the January 1, 2006 deadline. Unfortunately, the regulations offer little relief. The effective date is clearly established, and the regulations to not provide for any phase-in period beyond the effective date. When announcing the trans fat labeling requirements in 2003, FDA responded to comments suggesting that manufacturers would incur significant costs if forced to immediately comply, including the loss and disposal of obsolete packaging inventories, product in obsolete packages, and new printing plates. Specifically, FDA noted that "setting the effective date at January 1, 2006 … will allow firms more than 2 years to implement this final rule providing some regulatory relief and economic savings for small businesses. Extending the effective date for products containing trans fat would delay the benefits of this rule to the public health."

Because of the serious legal ramifications resulting from non-compliance, as well as the consumer demand for trans fat information, we urge all manufacturers who have not already done so to take immediate steps to inform themselves of the requirements of this rule, and bring their products into compliance by January 1, 2006.

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