FDA has given firms three years to make their case in a food additive petition as to why the continued use of PHOs are safe or reformulate their products without PHOs, for which it revoked GRAS status based on scientific concerns they could elevate bad cholesterol levels and contribute to the increased risk of heart disease.
As promised, GMA is taking the agency up on the first option and argues in a petition that “low-level uses of PHOs are as safe as the naturally occurring trans fat present in the normal diet” through foods such as meat, milk, dairy and other foods. As such, the trade group says in a fact sheet it shared with FoodNavigator-USA that the petitioned uses are no more likely than those foods “to result in an increase in hypothetical coronary heart disease risk.”
For support, GMA points to diet intervention studies, meta-analyses and mode of action data that show people can safely consume as much as 1.5% of energy per day from trans fat without causing changes to their bad cholesterol levels. It adds, most people consume only 1.33% or less energy per day from natural and added trans fat – which leaves a sufficient buffer so that consumers would not exceed the 1.5% if FDA approved the uses in the petition.
Many of the proposed uses for PHO are related to processing and likely would contribute negligible amounts of trans-fat to finished products, GMA suggests. These include adding PHO as an anti-caking, anti-dusting and free flow agent; a lubricant or release agent; an emulsifier; and a processing aid or solvent for fat soluble ingredients.
Other uses would address “consumer desired textural characteristics” that other oils cannot provide, such as dough flakiness, according to the fact sheet. These also include their use as a dough strengthener, moisture retainer, stabilizer, thickener, surface-active and –finishing agent and as a way to heat food, such as frying, according to GMA.
Long road ahead
The food additive approval process is notoriously difficult to navigate, and often involves substantial back-and-forth, which is why most firms prefer to seek GRAS status for ingredients.
Given this, GMA estimates the formal review process for its petition “could take two or more years to complete” at which point firms could be up against the compliance deadline for removing PHOs.
Waiting to see if FDA will approve GMA’s petition before the compliance deadline could be a gamble that some companies are unwilling to take. Indeed, many companies already are reformulating rather than risk an agency denial, or more immediate negative repercussions from consumers looking for clean labels.
GMA’s chief science officer Leon Bruner acknowledged in a release that many food and beverage companies “have already voluntarily lowered the amount of trans fat added to food products by more than 86% and will continue to lower PHO use to levels similar to naturally occurring trans-fat found in the diet.”