Trans fatty acids are in the spotlight now. What is the history behind their regulation, what are the regulations now, and what does the future hold?

The Past

When the 1993 Nutrition Labeling and Education Act (NLEA) became law, trans fatty acids were not regulated. Trans fatty acids became an issue in 1994 when the Center for Science in the Public Interest (CSPI) petitioned the FDA to require trans fat to be declared on the Nutrition Facts Panel. This petition was amended in 1998. In November 1999, the FDA issued a proposed rule to include trans fat to be listed on the Nutrition Facts Panel. There were several comment periods about the regulation in general, “reduced claims,” and the use of a footnote.

On July 9, 2003, the FDA issued the final rule on trans fat labeling. This was the first major change to the NLEA regulations since they were finalized in 1993. One of the analysis methods in the 1993 regulations for total fat was AOAC 963.22. This is a Gas Chromatograph (GC) method that breaks down the fats into individual fatty acids before analysis. However cis and trans isomers are not separated well enough to fully quantify them. Since the initial 1993 ruling, other methods have been developed that have increased the ability to differentiate between cis and trans isomers.

The Present

The current regulation mandates that by January 1, 2006, food manufacturers will list trans fat on their Nutrition Facts (NF) Panels. Thus, there is less than one year before trans fat must be on the label. This is similar to the phase in period for the initial NLEA. With the phase-in period, manufacturers can add trans fat to the NF panel as they need to print more labels and packaging. Also, companies with many different products can spread out their re-labeling costs over time to reduce the economic impact.

What are the present regulations? The trans fat per serving must be placed on the NF panel directly below saturated fat. The amounts and rounding rules follow those for saturated fat, except that there is no percent daily value for trans fat. Therefore, if the amount of trans fat is less than 0.5 grams per serving, then the amount on the NF panel would read “trans fat 0 g.” There will not be a % DV (daily value) for trans fat because the FDA has not seen sufficient evidence to establish a daily reference amount.

One group of trans fat does not have the same reputation as most trans fats. They are called conjugated linoleic acids (CLAs). CLAs are found in ruminant meat and milk. They are formed from the bacteria in an animal’s digestive system. The animals incorporate them into their fat just like other dietary sources, including other trans fats. However, CLAs are considered helpful instead of harmful. With this in mind, the FDA regulation is worded so as to exclude CLAs from the definition of trans fat.

The method for determining total fat and trans fat is now AOAC 996.06. The theory behind this method is similar to 963.22, but the separation between the fatty acids is now better. This allows laboratories to differentiate the trans isomers from the cis isomers, as well as separate out the CLAs. However, with the more advanced techniques and longer analysis times, this method demands more instrument time and more expensive equipment.

The Future

When the FDA issued its final ruling about trans fat, many companies in the industry began to look at their products and the trans fat in them. Some companies are reformulating to reduce and/or remove the trans fat from their product. With this in mind, U.S. consumers can expect changes in some products that have not changed in many years. Some companies will use non-hydrogenated oils and some will use oils and fats that are high in saturated fat. All of these changes will produce products with different sensory qualities, shelf-life, and nutritional content. Companies that have yet to reformulate continue to review how the trans fat regulations will affect their label, and potentially, their market share.

When the FDA issued the final rule for trans fat, they also issued advance notice of proposed rulemaking (ANPRM). The deadline for comments to the FDA was October 9, 2003. This was to solicit information and data for claims and footnotes dealing with trans fat. Nutrient content claims and health claims under consideration included statements about trans fat alone, and trans fat in conjunction with saturated fat and cholesterol. The FDA is investigating whether to allow claims about trans fat on food labels. These claims and footnotes include statements such as “Intake of trans fat should be kept low while maintaining a nutritionally adequate diet.”

Should trans fat reporting limits be lower? The method used for trans fat analysis may allow lower detection limits. However, will a lower limit be meaningful or helpful to the consumer? The FDA plans to research whether consumers would benefit from a footnote concerning dietary advice about trans fat. This appears to be geared toward trans fat, saturated fat, and cholesterol, in combination, as all three affect the different types of cholesterol in the body. High-density lipoprotein (HDL) and low-density lipoprotein (LDL) are affected in different ways by different factors.

Irrespective of whether more legislation regarding trans fat will continue, U.S. Nutrition Facts Panels will look different by January 1, 2006. If you need more information, it’s available online at www.fda.gov and in the latest Code of Federal Regulations (21CFR part 101.9). You can browse the complete CFR at www.gpoaccess.gov/cfr/index.html.