WASHINGTON, June 18, 2014 - A wide-ranging group of food-related organizations is urging the Obama administration to have the FDA take another look at the preliminary determination it made last fall that the “Generally Regarded as Safe” (GRAS) status be removed from partially hydrogenated oils (PHOs), often made from soybeans.

The groups have been involved in recent discussions with the FDA and the White House Office of Management and Budget (OMB), requesting a formal-rule making process from the FDA instead of the tentative determination it made in November. Tom Hammer, president of the National Oilseed Processors Association (NOPA), said this would force FDA to update the data used to make the decision, which he hopes would lead to the establishment of a threshold of use for the embattled trans fat instead of a ban of the product.

“There may be a threshold that is still safe, and we may be at that threshold,” Hammer said. “If that were the case, then there might not be any necessary action or it may not be as drastic as they’ve suggested.”

The groups involved in the lobbying effort include the American Bakers Association, American Frozen Food Institute, Snack Food Association, National Confectioners Association, National Restaurant Association, Food Manufacturers Association, Grocery Manufacturers Association, the Institute of Shortening and Edible Oils, QUALISOY, NOPA, and the American Soybean Association, among others.

Industry members said they were “shocked” when they learned of the FDA’s preliminary determination. Hammer said he received notice late in the work day that there would be a conference call the next morning, and it was on that call that he and many others learned of the FDA’s decision.

“They had made a tentative determination that the GRAS status of partially hydrogenated oils was no longer supported by ‘quote-unquote evidence’,” Hammer recalled. “We just didn’t see that coming.”

The FDA said at the time that it made the decision as part of its “responsibility to the public” to ensure the American food supply is safe. FDA went on to say that if the preliminary determination is finalized, PHOs would become food additives subject to premarket approval from the FDA, and foods containing unapproved additives are unlawful to sell under U.S. law.

Doctors at the at the Mayo Clinic  and others in the medical and nutrition community say that the trans fat made from hydrogenation of vegetable oil is “the worst type of fat.” They say trans fat is a cholesterol double-whammy of sorts, both raising “bad” (LDL) cholesterol and lowering “good” (HDL) cholesterol.

“Scientists aren't sure exactly why, but the addition of hydrogen to oil increases your cholesterol more than do other types of fats,” the Mayo Clinic said in a 2011 report. “It's thought that adding hydrogen to oil makes the oil more difficult to digest, and your body recognizes trans fats as saturated fats.”

In PHOs, hydrogen is added to make the oils more stable for processes such as frying or baking. The added hydrogen also gives foods such as cookies or crackers a longer shelf life, making the ingredient a popular choice among food producers and consumers alike. The wide use and appeal of PHO has resulted in a wide swath of organizations making the case for the ingredient.

American Soybean Association CEO Steve Censky said the FDA’s determination has the potential to reduce soybean demand by about 1.5 million acres. That possible excess supply due to the elimination of such a large part of demand could also have a very detrimental effect on the marketplace, Censky said, noting that there are estimates that soybean prices could end up dropping up to 50 cents a bushel. ASA also said in comments submitted to the FDA that removal of partially hydrogenated oil’s GRAS status has the potential to reduce soybean farmer incomes by around $1.6 billion per year.

High oleic soybean varieties could possibly replace PHOs in many applications, but they are still under development and may not be available to the food industry for several years. Censky said these varieties will also have added expenses since they will have to be kept separate from the rest of the soybean supply chain during handling.

Imported palm oil is another possible substitute. In ASA’s comments to FDA, the group’s president, Ray Gaesser, called this “a ’lose-lose’ for both the government and American consumers,” noting that imports would hurt American farmers, and that palm oil has a higher saturated fat profile.

ASA and NOPA also expressed concern that this decision addresses not a product, but rather a process. Gaesser noted in ASA’s comments that this could set a dangerous precedent and potentially “stymie technological advances in oil processing that aren’t even envisioned today.” Gaesser went on to express concern about the lack of a true definition for “partially hydrogenated,” noting that the FDA’s ruling has the potential to impact a large variety of oils.

The comment period for the issue closed in March, and now the industry is awaiting a ruling. In the meantime, Hammer is hopeful the efforts to oppose the FDA will prove to be successful and give the soybean industry more time to develop alternatives to the product.

“What (the FDA is) trying to do could take three to five to 10 years,” Hammer said. “I think somehow they thought it could be done magically overnight, and that is not the case.”


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