FDA’s “Tentative” Determination Regarding Trans Fat: A Food Safety Assessment
By Sonali P. Gunawardhana and James N. Czaban
On November 8, 2013, the U.S. Food and Drug Administration (FDA) took the first step in the process that will likely ban the use of trans fats in most if not all processed foods. FDA’s notice, entitled “Tentative Determination Regarding Partially Hydrogenated Oils; Request for Comments and Scientific Data and Information,” states that,
“based on new scientific evidence and the findings of expert scientific panels, the FDA has tentatively determined that partially hydrogenated oils (PHOs) which are the primary dietary source of industrially produced trans fatty acids, or trans fat, are not generally recognized as safe (GRAS) for any use in food based on current scientific evidence establishing the health risks associated with the consumption of trans fat, and therefore that PHOs are food additives.”
If FDA’s plan is finalized, food manufacturers would no longer be permitted to sell PHOs directly or as an ingredient in another food product without prior FDA approval for use as a food additive. Trans fat occurs both naturally and artificially in our food; however, FDA is primarily concerned with artificial trans fat in processed foods as trans fat is known to raise low-density lipoprotein cholesterol in both men and women which in turn can increase the risk of developing coronary heart disease, a leading killer in the United States.
The evolution to move away from trans fat began over a decade ago when FDA first proposed in 1999 that manufacturers be required to declare the amount of trans fat on the Nutrition Facts label due to public health concerns. The trans fat labeling requirement became effective in 2006. As a result of this, and growing public awareness of trans fat’s health risks, the food industry has voluntarily and steadily been moving toward reformulation of many products to reduce or eliminate trans fat. FDA acknowledged that since trans fat content information began appearing in the Nutrition Facts label of foods in 2006 as well as industry’s efforts to reformulate products, trans fat intake among American consumers has declined from 4.6 grams per day in 2003 to about 1 gram per day in 2012. For some processed foods, however, a move to eliminate trans fat may increase health concerns because the only technically feasible substitute ingredients may increase the total amount of saturated fat of the product; though there are efforts underway to develop healthier profile alternatives but those products will not be available in the marketplace for several years. The food industry continues to be tasked with the difficult duty of striking a balance between merging the health benefits of alternative ingredients with necessary functional elements such as shelf stability, taste, texture and structure of the foods Americans have come to enjoy as part of their everyday life, such as baked goods including, crackers, cookies, cakes and frozen pies just to name a few.
In line with FDA, the food industry recognizes that most consumers will benefit from reduced trans fat in their diets. But, industry argues, to truly improve the health profile of a food item, any reduction in trans fat must also achieve a decrease in the sum of saturated plus trans fat in a consumer’s diet. In similar situations where questions arose regarding the safety of a particular food additive, FDA has applied the interim food additive regulation to allow the additive to remain on the market provisionally until a final safety determination could be made to either allow the additive or to withdraw its previous GRAS status. For example, in 1970, FDA used a formal rulemaking to remove brominated vegetable oil (BVO) from FDA’s GRAS list. Six months later, however, in response to a petition, FDA issued an interim food additive regulation allowing BVO to be used in the limited context of fruit-flavored beverages at a much lower level of 15 parts per million pending further study. That “interim” regulation is, 43 years later, still in effect.
Surprisingly, in the case of assessing the safety of trans fat FDA has taken a different regulatory approach by announcing its view in a notice rather than through formal rulemaking that trans fat is unsafe, yet calling for scientific data from the public to support that conclusion and remove the GRAS status of PHO. FDA clearly stated in the notice that it is seeking additional scientific data and information to determine whether it should finalize its tentative safety determination as well as to determine if there is data to support other possible approaches to addressing the use of PHOs in food, such as setting a specification for acceptable trans fat levels in foods. This gives rise to the sense that despite its conclusory assertions, quoted at the outset of this article, FDA is not convinced that it has adequate scientific and legal bases to determine that PHOs are definitively not GRAS.
The expected costs of replacing PHOs in compliance with a possible final FDA determination that PHOs are not GRAS are a major concern for the food industry. FDA has estimated that the overall first-year cost to industry for removal of PHO’s will be $8 billion, with a 20-year net present value cost to be between $12–14 billion. Many observers believe FDA has underestimated the costs by a significant degree and that many small business operations may be negatively impacted by the costs and burdens imposed should the timeline for compliance be too short to appropriate reformulation of products. Specific feedback from industry will be particularly important in helping shape the FDA’s final determination. It is not inconceivable that many of these costs will be passed on to consumers, driving the cost of foods that are considered essential pantry items even higher and making it harder for American families to adjust to the rising cost of living.
FDA initially stated that it would consider written comments received by January 7, 2014. However, FDA received numerous requests for an extension to provide written comments. Based on these requests, the agency extended the comment period by another 60 days to give industry and consumers a chance to fully comment, so now the new date for filing written comments is March 8, 2014.
Sonali Gunawardhana and James N. Czaban are members of Wiley Rein’s Food & Drug Law practice group. Ms. Gunawardhana draws on her nearly 10 years’ experience as an attorney at FDA to offer clients detailed and practical guidance on how to avoid and resolve FDA regulatory challenges. She can be reached at 202.719.7454. Mr. Czaban has extensive experience in government regulation of pharmaceutical, biotechnology, food, medical device and healthcare-related companies. He can be reached at 202.719.7411.
1. U.S. Food and Drug Administration, Notice 78 Fed. Reg. 217 (proposed November 8, 2013) p. 67169 (emphasis added).
2. U.S. Food and Drug Administration, Notice 78 Fed. Reg. 217 (proposed November 8, 2013) p. 67171.