The Obama administration is expected to all but ban trans fat in a final ruling that could drop as soon as next week, killing most uses of an ingredient that has been put in everything from frozen pizza to Reese’s Pieces but since deemed harmful to human health.
The agency may create some very limited exemptions, but the ruling could force food companies to cut trans fat use beyond the 85 percent reduction already achieved over the past decade — a key piece of the Obama administration’s broader agenda to nudge Americans toward a healthier diet.
The food industry believes low-levels of trans fats are safe. Industry leaders have banded together behind-the-scenes to craft a food additive petition that will ask FDA to allow some uses of partially hydrogenated oils, such as in the sprinkles on cupcakes, cookies and ice cream. The industry hasn’t shared details, but officials maintain the uses will represent “very limited amounts.”
For more than 60 years, partially hydrogenated oils have been used in food products under the status generally recognized as safe, which does not require FDA’s approval. But since the 1990s, reams of studies have linked trans fat consumption to cardiovascular disease, causing somewhere between 30,000 and 100,000 premature deaths before the industry started phasing it out.
In late 2013 the Obama administration issued a tentative determination that partially hydrogenated oils are not generally recognized as safe. The move sent shock waves through the food industry, which has already brought down average consumption from more than 4 grams per day to about 1 gram per day — an exodus largely fueled by mandatory labeling imposed a decade ago. Scores of popular products, including Oreos and Cheetos, have quietly dropped partially hydrogenated oils over the years, but it remains an ingredient in many products, including Pop Secret microwave popcorn, Pillsbury Grands! Cinnamon Rolls and Sara Lee cheesecake, as well as some restaurant fryers and commercial bakery goods.
If FDA sticks to its guns in its final determination — and most in food policy circles assume it will — the agency will be taking a firm step toward pushing out more of the remaining uses of trans fat.
“This is a massive win for public health,” said Sam Kass, the former senior adviser for nutrition at the White House and executive director of Let’s Move!, noting that FDA has estimated removing trans fat could prevent 20,000 heart attacks and some 7,000 deaths.
“There are few targeted actions you can take in this space that have that kind of direct impact,” said Kass. He said he expects FDA will ultimately allow negligible uses of trans fat, because there’s no science that shows such levels are harmful.
The federal government’s crackdown on trans fat is an ironic twist for a substance that first came into favor in the 1950’s as a response to the perceived negative health issues linked to the use of saturated fats from animal products, like lard and butter. The oils, which are made “partially hydrogenated” by bubbling hydrogen molecules through liquid at high temperatures, become solid, giving food a better shelf life and texture.
Crisco and margarine became regular staples in American kitchens, though many of these products have now mostly phased out their use of partially hydrogenated oils.
Some naturally occurring trans fat can be found in meat and dairy, but the FDA is only going after so-called industrial or added partially hydrogenated oils, which have been shown to raise bad cholesterol and lower good cholesterol.
Public health groups are likely to praise the FDA’s final decision on trans fat, but it also will pose significant technical and economic challenges for food companies large and small. When the agency decided to rid the food supply of the heart-clogging substance, officials probably weren’t thinking about the hundreds of minor and often highly-technical uses in products like sprinkles. Trans fat, it turns out, helps keep the decorative color on certain sprinkles from leeching onto frosting — preventing unsightly cupcakes and cookies.
Some food industry experts think health officials were genuinely surprised to learn about the breadth of minor uses, including sprinkles.
Partially hydrogenated oils also used in many other technical ways, including to keep baked goods from sticking to equipment and stabilize flavors, colors or salts, whether it’s the coating of an ice cream bar or a beverage.
The industry and FDA will have to grapple with these and other remaining uses in the coming months as the agency will ultimately have to decide what levels of trans fat are safe for consumers and thus what levels will be permitted in food products during the food additive petition review process.
“Certainly FDA has no appetite for high uses,” said Bob Wainwright, a top technical expert at Cargill, one of the largest suppliers of oils in the world, but the question is what level is going to be acceptable? “Only FDA knows that.”
Even if or when FDA sets a threshold down the road, companies remain extremely nervous about the potential for an onslaught of litigation in whatever gap there is between FDA’s final determination and when a food additive petition is ostensibly approved. The food industry fears class-action attorneys will be lining up to use the federal determination as a basis or evidence in lawsuits filed against manufacturers.
There are also major environmental consequences of FDA’s decision, because many food companies look to palm oil as a substitute for partially hydrogenate oils, but harvesting palm oil sometimes means clearing rainforests to make way for palm plantations.
The industry’s food additive petition, which is still being finalized and will likely be hundreds of pages, has been drafted by a working group led by the Grocery Manufacturers Association, the food industry’s largest trade association. The group has been working on the submission for several months in what GMA officials described as a “fairly broad-based collaboration.” Officials said the petition would be filed soon.
“Just because something isn’t generally recognized as safe, doesn’t mean an ingredient is not safe for a well recognized use,” said a GMA official, who explained that the industry is gathering data for uses where the science supports a “reasonable certainty of no harm.”
“Our common objective is to ensure that public health is protected,” the official said, adding: “The good news here is that the industry has made tremendous progress in removing trans fatty acids from products.”
The food industry assumes there will be a lengthy enforcement discretion period, perhaps as long as two years, but there are big questions about what kind of legal cover the FDA’s final determination will give companies hit with lawsuits over the use of trans fat.
“It’s starting already and we don’t have a final determination,” said Wainwright, pointing to recent lawsuits against Nestlé and General Mills on allegations the companies harmed consumers by not using safe and available alternatives to partially hydrogenated oils in several of their products.
“I feel sorry for the judges in the Northern District of California,” said Glenn Lammi, chief counsel at the Washington Legal Foundation, referring to the flood of lawsuits filed in the federal the court, which is now called “the food court.”
Lammi has publicly called the FDA’s trans fat policy a “gift to the litigation industry” and hinted that WLF might consider legal action against the agency.
“I think the people in charge at FDA don’t have a problem with private plaintiffs acting as a second level of regulation to what they do,” Lammi said.
Industry leaders are quick to point out that recent class-action suits against Nestlé and General Mills were filed by the Weston Firm, the same one that’s representing Fred Kummerow, a longtime trans fat researcher who sued FDA in 2013 for not taking action against partially hydrogenated oils. In response to that litigation, FDA said it would issue its final determination by June 1, but a recent court document that indicated FDA will give an update on May 22 has set off speculation the agency’s decision could come as early as that day.
An FDA spokesperson declined to comment on the timing of the announcement or on industry concerns that have been raised about the policy the agency has in the works.
Michael Jacobson, executive director of the Center for Science in the Public Interest, said he expects FDA will in fact revoke the generally recognized as safe status for partially hydrogenated oils, but it will do so in a way that is reasonable for the industry.
“FDA’s not going to make things too tough for companies – it’s not going to be the end of the world,” he said.
Jacobson also dismissed the litigation threat because he believes the agency is likely to give companies years to phase trans fat out.
“I don’t know how far those lawsuits will go, because they’re not using and they won’t be using those substances illegally for a couple years.” Anyway, he added, the companies “could have gotten rid of them years ago.”
source: politico.com By HELENA BOTTEMILLER EVICH