The F.D.A. in a Nov. 8, 2013, notice in the Federal Register requested comments on the agency’s tentative determination that PHOs are not GRAS for any use in food based on current scientific evidence, and therefore are subject to regulation as food additives. The comment period initially was set to expire on Jan. 7, 2014, but it was extended to March 8 at the request of stakeholders.
Partially hydrogenated oils are the primary dietary source of industrially produced trans fat in the diet. Trans fat occurs naturally in low levels in meat and dairy products. It also is present at low levels in other edible oils, such as fully hydrogenated oils, where it is unavoidably produced during the manufacturing process.
PHOs have been regarded GRAS since the 1950s, and in the 1980s, food manufacturers made considerable investments to increase production of PHOs as prevailing scientific evidence suggested the need to develop alternatives to oils high in saturated fat in the interest of public health. But subsequent research established a correlation between consumption of trans fat and the incidence of coronary heart disease.
In response, the F.D.A. in 1999 proposed that manufacturers be required to declare the amount of trans fat in foods on Nutrition Facts labels. A final rule to that effect was announced in 2003, and the requirement took effect on Jan. 1, 2006.
The F.D.A. acknowledged the food industry responded by voluntarily changing food formulations to reduce or eliminate trans fat in their food products.
“However, there are still many processed foods made with partially hydrogenated oils, the major dietary source of trans fat in processed food,” the F.D.A. said.
The F.D.A. said if its preliminary determination is finalized, PHOs would become food additives subject to premarket approval by the agency. Foods containing unapproved food additives are considered adulterated under U.S. law, meaning they cannot legally be sold.
“If F.D.A. determines that PHOs are not GRAS, it could, in effect, mean the end of artificial, industrially produced trans fat in foods,” said Dennis M. Keefe, Ph.D., director of F.D.A.’s Office of Food Additives. “If F.D.A. makes a final determination that PHOs are not GRAS, the agency and food industry would have to figure out a way to phase out the use of PHOs over time.”
Rethinking the F.D.A.’s proposal
The Grocery Manufacturers Association said in its comments that if the proposal is implemented as written, “it is unlikely to achieve the public health benefits desired by the F.D.A. and has the potential to cause significant unintended public health, economic and environmental consequences.”
The G.M.A. said there are other approaches the FDA could implement to achieve the desired outcome that are far more likely to be successful, such as setting a specification in food to allow low levels of trans fat.
“G.M.A. therefore urges F.D.A. to withdraw its tentative determination and replace it with a fundamentally different approach that will achieve a policy aim that will be supported by consumers, industry and the agency,” the G.M.A. said.
The association noted consumers have reaped the benefit of industry efforts to reformulate food products to reduce or eliminate the use of PHOs. It said those efforts have succeeded to the point that the estimated mean intake of trans fat attributable to PHOs declined from 2% of energy in the late 1990s to 0.5% of energy in 2012, a reduction of 75%.
The G.M.A. asserted the F.D.A. analysis of the scientific data it used to develop its tentative determination that PHOs no longer were GRAS was inadequate.
“In fact, when a broader base of publicly available data are appropriately considered, the data indicate that low levels of trans fat intake have no effect on serum L.D.L. and total cholesterol levels,” the G.M.A. said. “This finding suggests intake of low levels of trans fat has no adverse effect on cardiovascular health.”
The association added that it would be “prudent for F.D.A. to withdraw the tentative determination and replace it with a less onerous proposal that builds on already existing programs that are successfully driving trans fat consumption to lower levels.“
A sudden and dramatic change in the GRAS status of PHOs might lead to a significant disruption of the food supply as thousands of food products may be deemed adulterated by the F.D.A. and unable to proceed in interstate commerce, the G.M.A. said. The resulting economic consequences would be severe.
“Consumers would be unjustifiably denied access to products such as baked goods, pastries, confectioneries, some flavors, seasonings and many other products,” the G.M.A. added.
Alternative proposals offered
“We have been decreasing trans fat to zero grams on the label, which has been achieved through either reducing or removing PHOs in more than 270 products since 2008,” said General Mills, Inc., Minneapolis, in its comment. “We recognize and support efforts made by the F.D.A. to reduce trans fat consumption from PHOs. However, we do not support the agency’s tentative determination to revoke the GRAS status of PHOs, as current low intakes of trans fat are safe. We urge the agency to use other effective regulatory alternatives to make continued progress and achieve F.D.A.’s goal of significantly reducing consumption of industrial produced trans fat in a timely manner.
“Two options General Mills recommends F.D.A. consider are revise nutrition labeling regulations to permit a declaration of 0 grams of trans fat only if the product contains less than 0.2 grams of trans fat (current label regulations allow a declaration of zero grams of trans fat if a product contains less than 0.5 grams) and/or establish a threshold limit of <0.2 grams of industrial produced trans fat per serving in foods.”
Mark B. Andon, Ph.D., vice-president, research, quality and innovation, ConAgra Foods, Omaha, said removing the GRAS status of PHOs “would in essence result in the prohibition of a production process, and otherwise would place potentially thousands of food products at risk of being deemed adulterated due to the presence of an ingredient that has been safely and commonly used in foods for over 50 years.”
Matt Jansen, senior vice-president of Archer Daniels Midland Co. and president of ADM’s global oilseeds and cocoa business, said F.D.A.’s tentative determination was simultaneously both too narrow and too broad. Mr. Jansen said the approach was too narrow because it did not address all trans fats that exist in the food supply.
“If F.D.A. is concerned with trans fatty acids, its rationale should apply with equal force to all substances containing the nutrient,” he said.
Mr. Jansen said the F.D.A. approach was too narrow also “because it would inevitably lead to increased use of fats and oils higher in saturated fatty acids, making it more difficult for consumers to comply with the Dietary Guidelines recommendations on saturated fat intake.”
Additionally, the approach was too broad in that the F.D.A. has proposed to remove the GRAS status of PHOs without defining them, he said.
“F.D.A. must define PHOs in a meaningful way, a way that distinguishes PHOs from fully hydrogenated oils with little or zero trans fat,” he said. “Moreover, this definition must have sufficient technical clarity to render it useful for industry in food formulation.”
The approach also was too broad because it fails to recognize the variability of trans fat levels across the broad spectrum of PHOs, Mr. Jansen continued.
“Using new, modified hydrogenation techniques, processors can produce PHOs with desirable functional properties, and with very low levels of trans fat,” he said.
Revoking the GRAS status of PHOs also would deprive the food chain of many helpful trans fat replacements, he asserted.
“This flexibility should be supported by F.D.A., not constrained by an overly broad determination,” he said.
Mr. Jansen said there were a number of regulatory alternatives to the tentative determination. He said the F.D.A. could set a limit on the amount of trans fat permitted in foods, it could set a limit on the amount of trans fat permitted in fats and oils, or it could use labeling to encourage further reduction in the consumption of trans fat.
If the F.D.A. does go forward with its determination that PHOs are not GRAS, it should permit a lengthy phase-out process, work with industry to define fully hydrogenated oils and preserve hydrogenation technology, Mr. Jansen said.
The Institute of Shortening and Edible Oils indicated if the F.D.A. does require removal of PHOs from the food supply, the oilseed processing industry would need at least three years to fully commercialize alternative oils capable of replacing PHOs in foods.
“While some alternatives can be readied more quickly, fully commercialized means that a sufficient quantity of all necessary alternative oils would be available to provide year-round supplies in all regions of the country to replace all current uses of PHOs,” the institute said in its comments. “This estimate only addresses the time needed to provide the supply of alternative oils. It does not take into account the amount of time food manufacturers would need to reformulate their products.”
