By: Michael R. Taylor
With all of our worthy focus on implementing the Food Safety Modernization Act this past year, we must not lose sight of other critical areas in which FDA, and specifically the Center for Food Safety and Applied Nutrition, must work and be effective to protect public health.
One of our core regulatory functions is ensuring that food, including all substances added to food, is safe. If evidence suggests that a product already in use is unsafe, we take steps to protect the public health. That is what we are doing in the case of partially hydrogenated oils, the major source of artificial trans fat.
There is a lot of evidence showing that trans fat intake can increase the risk of heart disease by raising low density lipoprotein (LDL) cholesterol, commonly referred to as “bad” cholesterol. Trans fat has been a concern for some time, and that is why ever since 2006, FDA has required that food manufacturers declare the amount of trans fat on the Nutrition Facts label.
We’ve come a long way since then. In the United States, consumption of trans fat from products containing partially hydrogenated oils has declined dramatically from 4.6 grams per day in 2003 to about 1 gram per day in 2012, according to FDA estimates. And food manufacturers have made significant progress to reduce the levels of trans fat in processed foods. But there are still many processed foods with trans fat including some snack foods, microwave popcorn, frozen pizzas, cakes, cookies, stick margarine products, coffee creamers, pies, and ready-to-use icing products. Many restaurants are also cooking with less trans fat. Elimination of industrially produced trans fat from foods could prevent 20,000 heart attacks and 7000 heart-related deaths each year.
So now we are ready to take the next important step that could lead to the removal of partially hydrogenated oils from processed foods. Partially hydrogenated oils have long been considered by industry to be “generally recognized as safe,” or GRAS, for their use in food. GRAS status implies that they are regarded by experts as safe under the conditions of intended use. This means they can be added to food without being approved in advance by FDA.
Because of the evidence linking trans fats to an increase in the risk of heart disease, however, FDA has preliminarily determined that partially hydrogenated oils are no longer GRAS for any use in food. We are providing a 60-day comment period to ask for additional information. If, after reviewing the comments and scientific information submitted, FDA makes the final determination that partially hydrogenated oils are not GRAS and are not otherwise authorized for use in food, such oils become unapproved food additives. That would make their use unlawful unless a company or other petitioner could prove to FDA that one or more specific uses are safe under the “reasonable certainty of no harm” safety standard.
If FDA ultimately determines that partially hydrogenated oils cannot be used in food, we recognize that it may take some time to phase out their use. Therefore, in our notice we are seeking input on the time that industry would need to remove partially hydrogenated oils from the food supply. If we finalize our tentative determination, we would provide industry with time to comply.
Consumers who are interested in reducing their trans fat intake can take steps now. First, choose products that are labeled as having “0” trans fat. But under current regulations, even these products can have up to 0.5 grams of trans fat per serving, which can add up depending on what foods you choose. So in addition to choosing products labeled “0” trans fat, you can check the ingredients statement and avoid products that contain partially hydrogenated oils.
Protecting the safety of the food supply can mean a lot of different things, and this action is just one of the many initiatives FDA is taking to meet its public health responsibility.
Michael R. Taylor is FDA’s Deputy Commissioner for Foods and Veterinary Medicine