Further decreases in the trans fat content of foods is possible without the “extreme, unprecedented and unnecessary” approach of banning the use of partially hydrogenated oils, according to a March 7 letter sent by the American Bakers Association to the Food and Drug Administration.
The FDA in a Nov. 8, 2013, Federal Register notice said it tentatively had determined that partially hydrogenated oils (P.H.O.s) are no longer Generally Recognized As Safe (GRAS) because they are the primary dietary source of industrially-produced trans fat. If finalized, the FDA’s proposed rule would mean food manufacturers no longer would be permitted to sell partially hydrogenated oils, either directly or as ingredients in another food product, without prior FDA approval.
The ABA responded to the FDA’s request for comment through the March 7 letter signed by Lee Sanders, vice-president of government relations and public affairs.
“We believe that reducing consumption of trans fat in the U.S. population is an important public health goal, and ABA members’ voluntary efforts have resulted in extremely low levels of industrially-produced trans fat in finished products — lower than the levels presented by FDA in its tentative determination,” she said. “Consequently, consumption of trans fat in the U.S. has dramatically decreased and will continue to decrease as industry continues to develop alternatives for the remaining few, but difficult to replace, sources of trans fat.
“Withdrawing the GRAS status of one source of trans fat, therefore, is an extreme, unprecedented and unnecessary approach and sets an unlawful standard for withdrawing the GRAS status of ingredients.”
The ABA said it found several flaws in the FDA’s tentative determination.
According to the ABA, the determination is at odds with the World Health Organization, Health Canada and other countries’ trans fat policies in two significant ways. First, their polices are directed at all sources of trans fat rather than at a single source of trans fat. Second, Canada and several other countries that follow the W.H.O. recommendations have socialized medicine health care systems and still do not recommend a complete ban on partially hydrogenated oils or trans fat.
To enforce the rule, the FDA would need to provide standard methods for determining whether a substance is a partially hydrogenated oil, according to the ABA. The Washington-based association proposes that partially hydrogenated oils be defined as an oil produced using hydrogenation processing of the base oil to an Iodine Value (IV) of 5.1 or more.
The FDA also needs to prove why it no longer believes partially hydrogenated oils are GRAS after recognizing their GRAS status for decades, according to the ABA.
“Given the historical safe use of PHOs, FDA bears the burden of demonstrating PHOs are no longer GRAS based on the consumption levels in today’s diet,” Ms. Sanders said.
No other country comparable to the United States has taken a zero tolerance approach to partially hydrogenated oils or to trans fat, according to the ABA.
The ABA proposed several alternatives to the banning of partially hydrogenated oils. The FDA could change the rounding rule for declaration of trans fat on the Nutrition Facts panel to less than 0.2 grams per serving from less than 0.5 grams per serving. Currently, if a product has less than 0.5 grams of trans fat per serving, the FDA mandates the level must be rounded down to 0 grams.
For another alternative, the FDA could revisit the value of adding a statement to the Nutrition Facts panel recommending that consumers limit their intake of trans fat (and saturated fat). Also, the FDA could declare certain uses of partially hydrogenated oils as GRAS. Some partially hydrogenated oils contribute only trace amounts of trans fat to the finished food product, according to the ABA.
“FDA’s tentative determination that PHOs are not GRAS for any use is overly broad,” Ms. Sanders said.
Both the FDA and ABA agree trans fat intake has decreased since 2003, but they differ on how much it has decreased.
The FDA in July 2003 estimated the mean adult intake of trans fat from products containing partially hydrogenated oils was 4.6 grams per day. The FDA recently estimated the mean dietary intake of industrially-produced trans fat has decreased significantly to about 1 gram per day, or 0.5% of total energy intake. The FDA concluded some people still may consume high levels of trans fat, resulting in a daily intake of added trans fat of about 2.1 grams per day.
According to the ABA, the FDA believes high-level consumers consistently would choose products with the highest levels of trans fat, including refrigerated biscuits, ready-to-use frostings, certain brands of frozen pizza and certain brands of microwave popcorn. The ABA called these products “special occasion foods” that would not be consumed often.
“ABA members are continuing to further reduce the use of PHOs, particularly as new functional alternatives become commercially available, but certain specialty and infrequently consumed bakery products present unique challenges in trying to develop effective alternatives to PHOs,” Ms. Sanders said.
The ABA added the FDA’s dietary intake assessment assigns a value of 0.4 grams to foods that declare 0 grams of trans fat on the label. According to the ABA, most reformulated bakery products use palm oil or soybean oil and typically contain less than 0.2 grams of trans fat that is from sources other than partially hydrogenated oils.
The FDA pointed to possible unintended consequences resulting from the banning of partially hydrogenated oils.
Consumers may confuse partial hydrogenation with “essentially complete” hydrogenation and incorrectly believe “essentially complete” hydrogenation may contribute trans fat.
“Hydrogenation is a critical process to industry, especially to the baking industry, where solid fats are required for functionality, taste, texture, structure and shelf stability,” Ms. Sanders said.
The banning of partially hydrogenated oils might mean the loss of interesterification as a technology. Interesterificaiton produces saturated fats with precise melting characteristics and texture.
“Losing interesterification as a technology would be a great loss to industry and consumers,” Ms. Sanders said.
Banning partially hydrogenated oils might mean an increased use in palm oil, which has high levels of saturated fat and is associated with environmental issues such as de-forestation, according to the ABA. Banning partially hydrogenated oils also might have a negative financial impact on the domestic soybean industry.