“Removing partially hydrogenated oils – PHOs – from the food supply, as set out by the congressionally mandated food additive authorities, is a significant public health achievement,” said FDA Commissioner Scott Gottlieb, M.D.
The process of removing PHOs from food has been a priority for the FDA since 2015 when the agency determined PHOs were no longer considered generally recognized as safe (GRAS) after research suggested they could elevate bad cholesterol levels and contribute to increased risk of heart disease.
"Trans fats seem to have a progressive and linear adverse effect on blood lipid levels, notably LDL cholesterol levels," Dr. Taylor Wallace, principal and CEO of the Think Healthy Group, Inc., told FoodNavigator-USA.
While GMA presented a "compelling argument", in the end, the FDA made the "right move" to call for a ban on PHOs at all levels, Wallace continued.
"Even lower levels of trans fat seem to pose a public health concern, and in my mind should be completely removed from the food supply," he said.
"There are other ways to keep a baked good from sticking to the pan."
More time to comply
The FDA extended the deadline for some food manufacturers to remove PHOs to Jan. 1, 2020 (originally June 18, 2018) to “allow for an orderly transition in the marketplace”, the FDA said.
The extended deadline applies to limited and specific used of PHOs in food products, according to the FDA.
The agency has also given companies until Jan. 1, 2021, to exhaust their current product inventories containing PHOs.
“Most PHOs have already been removed from food, and for the most part, manufacturers may not add any PHOs to foods after June 18, 2018,” Dr Gottlieb continued.
“However, there are a handful of PHO applications that continue to be used at very small levels - typically for certain processing aids or as small components of some flavor and color ingredients.”
The FDA set a compliance deadline of June 1, 2020 for all food manufacturers to use up all their inventory of food products containing PHOs.
Where do PHOs come from and how are they used?
Partially hydrogenated oils are a form of trans-fats that are heated in the presence of hydrogen and a catalyst to form solid fats. The hydrogenation process converts some polyunsaturated fatty acids to monounsaturated and saturated fatty acids.
According to CSPI, the problem arises when some of the fatty acids are artificially converted to the “trans” form, meaning that two parts of fatty acid molecules are on opposite sides of double bonds.
Oils are partially hydrogenated to increase shelf life and obtain the cooking properties of solid shortenings. PHOs have been used to replace butter, lard, palm oil, coconut oil, and other “hard” fats in many processed foods, CSPI added.
GMA ‘disappointed’ by FDA decision
In in its petition, the GMA requested approval of three uses of PHOs including as a solvent or carrier, or a component thereof, for flavoring agents, flavor enhancers, and coloring agents; as a processing aid, or component thereof; and as a pan release agent for baked goods.
“The industry petition also gave the FDA the opportunity to further review whether certain uses of PHOs can be safe in foods, and we concluded that the petition doesn’t contain sufficient evidence that the requested uses are safe,” Dr Gottlieb said.
Leon Bruner, GMA EVP of science and regulatory affairs and chief science officer, said the trade association was “disappointed” by the FDA’s latest decision and its response to the trade association’s petition.
“Food and beverage companies have already successfully reduced PHO-related trans-fats by more than 98%,” Bruner said.
“We are disappointed by FDA’s finding; we believe the petition presented extensive and verifiable data that supported the scientific basis for a safety approval of these minor continued uses of PHOs.”
Bruner added that GMA appreciates FDA’s extension of the compliance date for the specific and limited use of PHOs outlined in the GMA’s food additive petition.
“This gives companies a year to reformulate those remaining products and additional time for any products already in commerce to exit the marketplace,” Bruner said.