Bye Bye Trans Fats?

WASHINGTONFDA says artificial trans fats, such as found in partially hydrogenated oils (PHOs), are not generally recognized as safe (GRAS) for use in foods and should be removed from all processed foods. FDA Commissioner Margaret Hamburg and Deputy Commissioner Michael Taylor told reporters the agency has issued a preliminary determination on the GRAS status of trans fats based on a growing body of data on their safety, and a final determination will be issued following the 60-day public comment period, and only after the agency reviews all the input. The official notice of this preliminary determination,  including detail s on the public comment period were immediately made available in the Federal Register. The comment period starts Nov. 8.

"We have been looking at these issues," Hamburg said, refeerring to studies showing trans fat intake leads to increased risk of coronary heart disease. "There has been a growing body of evidence in the scientific community."

Citing ongoing progress, Taylor said the agency mandated the inclusion of trans fat information on nutrition facts labels in 2006. Following this move, FDA noticed intake of trans fats reduced over time. He said in light of the science showing the use of these trans fats may cause health problems, FDA has decided to move forward on addressing this public health concern.

PHOs are common ingredients in processed foods such as baked goods, microwave popcorn, frozen pizza, margarine and prepared icings and frostings. While some dietary supplements also contain PHOs,  the Natural Products Association (NPA) said it does not expect this new determination by FDA to have a significant impact on the dietary supplement industry. "We support the agencys step forward in promoting the health and wellness of American consumers," said John Shaw, CEO of NPA. However, NPA noted it is always concerned with relabeling burdens and other issues that can arise from an FDA decision, and it will monitor this issue as it develops.

If FDA ends up making a final determination that trans fats must be removed from the market, the big question will be how to phase out these ingredients. Unless otherwise approved by FDA, PHOs would not be permitted for sale as an ingredient or other food product by food manufacturers. "These oils perform technical functions, so [a ban] would require product-specific innovation to get the same performance from alternative materials," Taylor noted. "These oils have played important, particular functions in the food supply."

Hamburg said FDA wants to hear from companies what they've learned about replacing PHOs with safer alternatives that are GRAS or approved food additives. "Some companies made enormous progress in removing hydrogenated oils and replacing them with [alternatives]." Taylor noted the vast majority of trans fats in the food supply are based on self-affirmed GRAS status, an independent judgment of safety fostered by food companies. However, he said FDA had not previously made a ruling one way or another on the vast majority of these cases.

Taylor said it is difficult to provide even a loose timeline for when trans fats would be officially removed from the market. He explained the timeline will depend on how long it takes to review any comments submitted as well as information from discussions with industry and other stakeholders. Also, once FDA issues any final determination, it will again solicit public comment on the steps and timeline for removing trans fats from the food supply. He assured the agency will factor  in what it knows about the current marketplace, with respect to capacity to reformulate products to no longer contain trans fats.

However, Taylor stressed the agency is intent on moving forward on trans fats. "Given the public health dimension of this, we want to move as fast as we can," he said. "We take seriously the public health dimension of this action, and we will pursue it accordingly."

Visit the FDA website for the agency's detailed announcement on the new trans fats action.