New FDA Trans Fat Regulation 2003

Southern Testing and Research Labs has been providing fatty acid profile analyses using capillary gas-liquid chromatography for over 10 years.  We have also coincidently provided trans fat analyses from fatty acid profiles to clients who specifically requested this information.  Southern Testing is well equipped and staffed to carry out this analysis in quantity, as specified in the new regulation, for our clients.  Our base price for trans-fat analysis of food samples is $160 per sample, with discounts being considered by request, depending on sample matrix and number of samples, on a case by case basis.  

For a no-obligation quotation, or to request more information, please call or e-mail either  Walter Hogg, Manager, Business Development and Client Services, at 252-265-5053, or Sheila Hinnant, Section Head, Food Chemistry, 252-265-5076

Comments on the New Regulation

On July 9, 2003, FDA issued a final regulation requiring food manufacturers to list trans fatty acids, or trans fat on the nutritional labels of foods, and some dietary supplements.

Lowering trans-fat intake has been shown to significantly reduce coronary heart disease (and thus heart attacks and related deaths). The food industry has until January 1, 2006 to have all products show the trans-fat content on the nutritional label of all products that contain more than 0.5 g of total fat per serving (plus also any that have less than 0.5 g total fat, but make low-fat-related claims). The food industry will undoubtedly feel significant  pressure to reduce the amount of trans-fat in many products (i.e. reformulate the products) in order to lower the health risk.

In the FDA Final Rule,  21 CFR Part 101, Regulatory Impact Analysis section, FDA estimated that 154,400 individual products will have to be analyzed for trans-fat, at an expected cost of $200 per sample. The FDA estimate does not include products that may be analyzed multiple times as they are reformulated to lower the trans-fat content, nor related analyses by companies who may choose to redo entire nutritional labels at the same time they print new labels to provide the trans-fat information.

The impact of this rule on the food industry (and supporting laboratory industry) is going to be enormous. While some companies have already begun the process of reformulating and/or analyzing their samples for trans-fat content, many more are still planning their approach to meeting this new regulatory requirement.

The analytical method specified in the new regulation to perform this analysis is  AOAC Official Method 996.06, "Fat (Total, Saturated, and Unsaturated) in Foods, Hydrolytic Extraction Gas Chromatographic Method, First Action, 1996, Revised 2001".  Using this method, samples are extracted by hydrolytic methods (acid or base hydrolysis depending on the food type). The fat is then extracted into ether and methylated with boron trifluoride to form the fatty acids methyl esters (FAMEs). The methyl esters are then determined by capillary column gas chromatography. The chromatographic separation allows for the determination of individual trans fatty acids, which are summed to calculate the total trans fat.

It is worth noting that the total run time for the chromatogram is about 70 minutes, which with standards and quality control samples being included with each sample set, becomes a limiting step in the rate at which samples can be analyzed.  

The method is very specific in some respects, but does allow some leeway by specifying that a chromatographic column is adequate for the trans-fat analysis if certain peaks in the fatty acid profile are sufficiently resolved.  The peaks that must be resolved are the adjacent C-18:3 and C-20:1 peaks, and the trio C-22:1, C-20:3, and C-20:4 peaks with a resolution of 1 or greater.  Also of special interest are the complex cluster of peaks between C-18:1 trans 6 and C-18:1 cis 11. An illustration of these regions of a typical chromatogram obtained in our laboratory showing standards of these peaks being resolved is shown here (click on thumbnail to enlarge):

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If you have any questions or special needs regarding to the new regulation, please call us.  We will be happy to discuss them with you. 


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