In early November, the US Food and Drug Administration (FDA) announced the first step to potentially remove artificial trans fats from processed foods. In the FDA's estimate, the removal of partially hydrogenated oils (PHOs) from foods, should it be implemented, could prevent 20,000 heart attacks and 7000 deaths from heart disease each year. The announcement set in motion a 2-month comment period, after which a final decision will be made. Medscape spoke with Dennis Keefe, PhD, Director of the Office of Food Additive Safety at the FDA, about the evidence underlying this decision and the implications for clinicians.
Medscape: Can you provide a brief review of the evidence linking trans fats and cardiovascular disease? Was the decision the result of major new evidence, or instead the accumulation of data that eventually reached a tipping point? In other words, why now?
Dr. Keefe: Why now? This is a continuation of a process that started back in the late 1990s, when we first proposed to require declaration of the level of trans fat in foods on a nutrition facts panel; at the same time, we proposed allowing a claim for zero trans fats where appropriate. The labeling proposal was finalized in 2003, and the date by which all foods had to follow these labeling requirements was 2006.
Since 2003, there's been a significant reduction in the level of trans fats in the food supply. We estimate that the dietary exposure from industrial trans fat -- that is, the trans fat contributed by PHOs, which are the primary source of trans fat in processed foods -- for the average consumer, the intake of industrial trans fat went down from 4.6 g/day in 2003 to about 1 g/day in 2012. So, at this point, we think that the next step is to remove PHOs from the food supply, and this is the process by which we can achieve that goal.
I should note that since the labeling requirements came into full effect, the industry has made some significant advances in terms of reducing the use of PHOs and has reformulated a number of products. On the basis of the information we have from our monitoring of the food supply, in every food category, there are now products that do not contain PHOs. This tells us that from a technological perspective, it is feasible to produce products in these food categories without this ingredient.
Medscape: Although the cardiovascular risk associated with these products is predominantly related to increases in low-density lipoprotein (LDL) cholesterol and decreases in high-density lipoprotein (HDL) cholesterol, are there other cardiovascular effects that can be linked to consumption of trans fats?
Dr. Keefe: In their recommendations, authoritative bodies, such as the Institute of Medicine and the American Heart Association, focus on the effect of trans fat intake on the link between LDL cholesterol and coronary heart disease. The Centers for Disease Control and Prevention has estimated that the removal of PHOs from foods could prevent an additional 20,000 coronary heart attacks per year and up to 7000 additional coronary deaths per year.
Medscape: This announcement is a preliminary determination that PHOs are no longer "generally recognized as safe" (GRAS). What will be the immediate effects of a final determination that PHOs do not meet the GRAS standard?
Dr. Keefe: The notice that appeared last week was the first step in taking action on the regulatory status of PHOs added to food. If that tentative determination is finalized, the effect would be that all foods would have to be reformulated to remove the PHOs. This could take time, and one of the points of the comment period is to gain input from the industry, from stakeholders, on what these impacts might be and what the timing of the effective date by which PHOs could no longer be lawfully added to foods.
I think the more informed consumers are, the better choices they can make. The recent media attention to the tentative decision last week will, I think, raise awareness. As we have said before to consumers, it is important to look at the nutrition facts panel to identify the amount of trans fat in the foods they are consuming and make appropriate choices. Since 2003, we have seen a significant number of reformulated food products without PHOs that have led to a decrease in trans fat intake as a result of requiring declaration of trans fat levels on food labels.
Our most recent information regarding dietary exposures is based on the NHANES (National Health and Nutrition Examination Survey), which provides data on food consumption. We also glean information from our internal label databases that allow us to focus our collection of samples for quantitative analysis to measure the actual levels of trans fat in particular foods. The exposure estimates combined the NHANES food consumption surveys with label data and quantitation of actual trans fat levels in order to estimate dietary exposure. These exposure estimates have been published and are available as part of the references provided with the Federal Register document.
The industry has made significant progress. The average consumer's intake has gone down significantly. However, consumers at a high level of consumption (90th percentile) are still consuming a significant amount of industrial trans fat in their diet. These include individuals who have brand loyalty to particular products that contain PHOs. These individuals could indeed be consuming much higher levels of trans fat than our estimate of the average consumer's intake of trans fat.
While I cannot speak to the price differential between foods with and without trans fats, I can say that our preliminary analysis of the benefits of this decision -- the annual health benefits -- are estimated to be about $15 billion per year. Over a 20-year period, we estimate the health benefits to be about $117 billion. Over that same 20-year period, we estimate the total cost to be about $12 billion. So that is an almost 10-fold increase in benefits over costs.
Of course, the initial costs will not be insignificant in terms of reformulation and labeling. However, over the long term, we believe that there is a significant net public health benefit by taking this action.
Medscape: Currently, there is an allowance for foods that contain less than 0.5 g of trans fat per serving to be labeled as having 0 grams. Would that still hold if this determination is implemented?
Dr. Keefe: This tentative decision applies to PHOs as a source of trans fat. They are not the sole source of trans fat in the diet. There are naturally occurring trans fats from other sources. Regarding labeling requirements, this action, if finalized, would not affect or change the labeling requirements in terms of declarations of trans fat levels in the nutrition facts panel.
Medscape: For the next 60 days, the FDA will be accepting comments on this announcement. As you indicated, many food manufacturers have already limited PHOs in their products, and New York City banned their use in foods served in restaurants in 2006. What do you anticipate will be a timeline that would allow the food industry to adhere to this recommendation?
Dr. Keefe: That is going to be driven primarily by the extent of comments and the comments themselves that we receive. As you say, many companies have reformulated products. There are alternative ingredients in the marketplace now, and we have examples of foods in every category that have been reformulated. But we also recognize that reformulation takes time, and this is a preliminary determination. We anticipate providing adequate time for producers to fully reformulate, with some date certain in the future that has not yet been established.