FDA Proposes to Phase Out Use of Partially Hydrogenated Oils

By Etan J. Yeshua –

The Food and Drug Administration last week initiated a process that could prohibit the sale of partially hydrogenated oils (PHOs), as well as food products containing industrially manufactured PHOs, such as certain baked goods, microwave popcorn, frozen pizzas, frostings, and stick margarine.  Citing evidence that the trans fatty acids in PHOs provide no known benefit to human health and that any incremental increase in trans fat consumption increases the risk of coronary heart disease (CHD), FDA announced its tentative determination that food manufacturers should be prohibited from selling PHOs, or adding them to foods, without first obtaining FDA approval for their use.  The Agency is seeking comments on its tentative determination, including information about the costs that the move would impose on the food industry, and particularly the costs to small businesses (see here).  The deadline for submitting comments is January 7, 2014.

Current Regulatory Status of PHOs

With the exception of two oils that FDA says are not widely used (i.e., partially hydrogenated versions of rapeseed and menhaden oil), FDA maintains that it has never directly authorized the use of a PHO in food.  That is, FDA has never approved the use of a PHO as a food additive, affirmed it as generally recognized as safe (GRAS), or granted a prior sanction.  Instead, according to FDA, “commonly used PHOs… have been considered GRAS (through a GRAS self-determination) by the food industry for use in food at levels consistent with good manufacturing practice based on a history of use prior to 1958” – the year that the Food Additives Amendment to the Federal Food, Drug, and Cosmetic Act was passed.  With last week’s notice in the Federal Register, FDA announced that it does not believe there exists a “consensus of expert opinion regarding the safety of” PHOs.  If the announced “tentative determination” is finalized, food manufacturers would effectively be prohibited from selling PHOs without first obtaining FDA approval for a specific use of a specific oil in specific amounts as a food additive. 

Health Effects of Trans Fats

Despite what it described as a significant decrease in the average consumption of industrially produced trans fatty acids in the U.S., FDA stated that “[o]n the average day, at least eight Americans die as a result of the trans fats in partially hydrogenated oils” and that “[m]ost of these deaths could be prevented by removing industrially produced trans fats from the US food supply.”  FDA cited controlled trials and observational human studies on trans fats, as well as the opinions of expert review panels from the Institutes of Medicine, the American Heart Association, the American Dietetic Association, the World Health Organization, the Dietary Guidelines Advisory Committee, and the FDA Food Advisory Committee Nutrition Subcommittee, all of which purportedly concluded that “there is no threshold intake level for industrially-produced trans fat that would not increase an individual’s risk of CHD, or adverse effects on risk factors for CHD.”  FDA also cited evidence that the trans fats in PHOs may worsen insulin resistance, increase diabetes risk, and put fetuses and breastfeeding infants at higher risk of impaired growth.  Given these findings, FDA has tentatively determined that PHOs are not GRAS for any use in food.

FDA’s Cost-Benefit Analysis

The Agency believes that “the benefits of this action would be much higher than the costs,” although it noted that “in many cases we have very limited data to support our rough estimates.”  Taking into account the cost to industry of reformulating and relabeling products and substituting ingredients, as well as the cost to consumers of changing recipes, FDA estimated the cost of its proposal to be between $12 and $14 billion (net present value) over 20 years.  On the other hand, the 20-year net benefit for removing PHOs from the food supply – including the medical costs that would be avoided, as well as the monetary value of preventing deaths and illnesses (e.g., each fatal heart attack prevented is valued at about $1.76-million) – is estimated by FDA to be between $117 and $242 billion.

Request for Comments

Comments related to FDA’s announcement can be submitted with regard to any aspect of the Agency’s tentative determination, but FDA has specifically requested input with regard to certain issues, including, among others:

• Whether there are data to support other approaches to addressing the use of PHOs in food (e.g., setting a limit on the levels of trans fats in food);
• How long it would take manufacturers to reformulate food products to eliminate PHOs from the food supply;
• What FDA could do to reduce the burden on small businesses that would result from removal of PHOs from foods; and
• Whether there are products that cannot be reformulated.