Food manufacturers have urged the FDA to give them more time to consider its proposal to revoke the GRAS status of partially hydrogenated oils (PHOs) in a bid to eradicate artificial trans fats from the American diet.
When the FDA published its tentative determination on PHOs (where liquid oils have hydrogen added to make them more stable and/or solid at room temperature), it gave firms until Jan 7, 2014, to respond, with many observers arguing that the sooner the determination is finalized, the better, given there is little dispute about how harmful artificial trans fats are.
GMA: Industry needs time to consult with partners and suppliers internationally
However, in comments filed in the docket, the Grocery Manufacturers Association (GMA) and the Institute of Food Technologists (IFT) urged it to grant a two-month extension to the comment period - creating a March 7 deadline.
IFT VP, science & policy initiatives, William Fisher, CFS, said: “In light of the scientific data and information requested… and the complexity of the issues raised, additional time is needed to collect data and information.”
GMA VP, consumer product safety & science policy, Emilia Lonardo, PhD, said: “The issues … should be approached and evaluated from a global regulatory and trade perspective. Therefore industry also needs time to consult with its food industry partners and suppliers internationally.”
Attorney: Some firms might push for an alternative to a ban on PHOs and instead seek changes to labeling or propose a maximum threshold for trans fats
Speaking to FoodNavigator-USA last month, Venable LLP Food and Drug attorney Dr John Moore said he expected some firms might push hard for an alternative to a ban on PHOs and instead seek changes to labeling or propose a maximum threshold for trans fats.
But if a PHO phase-out is deemed the best way forward, firms will push for it to take place “over a number of years”, he predicted, even though from a technical perspective, some stakeholders claim viable alternatives are already available for every application.
Speaking to FoodNavigator-USA last night about what might be a reasonable timetable, IFT president Dr Janet Collins said the IFT needed more time to clarify this - hence its calls for a longer comment period - but as a rough estimate she said at least a couple of years after any determination was finalized was probably needed for any PHO phase out.
She added: "I don't think anyone saw this coming. We've spoken to a lot of people since the FDA made its tentative determination and no one had any idea."
While there are alternatives to PHOs out there and many firms have eradicated them already, "There are still a lot of companies out there using PHOs as frying oils in foodservice so the oil stays fresh for longer," she said.
Asked about the issue of replacing PHOs with palm-based products, which are naturally high in saturated fat, she said it was true that saturated fats in general had been getting better PR lately in the wake of studies challenging their association with cardiovascular disease.
However, it was "disingenuous" of palm oil suppliers to talk about saturated fat being unfairly demonized, she said. "Not all saturated fats are equal, but the ones in palm oil [primarily palmitic acid] probably are the nutritional bogeymen."
‘The FDA actually did something that will have a positive effect on the human body’
So what other comments has the FDA received so far?
Several commentators praised the FDA proposal, with Zaher Albashabsheh noting: “The FDA actually did something that will have a positive effect on the human body. I would call this a modern-day miracle.”
Others focused on the timetable, with the surgeon general for Arkansas Joseph W Thompson, MD, MPH, suggesting that 2015 would be a good deadline by which the industry should phase out PHOs, adding that Walmart aims to remove all industrially-produced trans fats from store brands by this date.
Stearic, lauric, myristic and palmitic…
Other commentators focused on the merits or otherwise of the various alternatives, particularly palm oil.
Eduardo Dubinsky, a technical consultant in fats and oils in food applications, added: “The Dietary Guidelines for Americans state a very clear distinction between the neutral effect of stearic acid on cholesterol and cardiovascular disease risk and the increasing effect of other saturates, mainly lauric, myristic and palmitic.
“This was also reflected in the Program of the PAHO (Panamerican Health Organization): Trans fats free Americas (Declaration of Rio - June 2008) and in the FAO document: Fats and Fatty Acids in human nutrition released in 2010. The alternatives rich in stearic acid are currently in the market and are: interesterified fats, exotic fats like shea butter and high stearic high oleic sunflower oil.”
American Soybean Association: We need to tackle trans fats without raising saturated fats
The American Soybean Association, meanwhile, believes that oil from the next generation of zero trans-fat high oleic soybeans (which have been genetically engineered by Monsanto and DuPont) are the best alternative for frying and some other applications as they don't need to be partially hydrogenated to be stable, but also contain less saturated fat than regular soybean oil and significantly less than palm oil.
“If the FDA were to finalize this determination, food processors may be pressured to replace remaining partially hydrogenated oils with those high in saturated fat such as palm or coconut oils, which would not be a good outcome for consumers.
"Since it will take a few years to ramp up high oleic soybean production to provide an economical alternative to food processors, we believe any final FDA determination on the matter should reflect this timeframe."
Canola Association: High oleic canola oil offers 'immediate solution'
Meanwhile, the Canola Association says there is no need to wait for high oleic soybean oil, and that the canola industry “offers immediate solutions” in the form of high-stability high-oleic canola oil with a long fry life for food service operations.
President Ryan Pederson said: "High-stability canola oil offers a trans fat solution without increasing - and in most cases, decreasing - saturated fat."
IOI Loders Croklaan: Saturated fat is not the nutritional bogeyman it was once believed to be
However, Tim Surin, director of sales and marketing at palm oil expert IOI Loders Croklaan Americas, told FoodNavigator-USA last month that saturated fat had got an unfairly bad rap during this debate, citing a high-profile meta-analysis (click here ) led by Ronald Krauss in the American Journal of Clinical Nutrition (AJCN) which found “no significant evidence … that dietary saturated fat is associated with an increased risk of coronary heart disease or cardiovascular disease”.
In its preliminary determination - which you can read here - the FDA acknowledges that all refined edible oils contain some trans fat as an unintentional byproduct of their manufacturing process, while trans fats also occur naturally in some meat and dairy products in small quantities.
However, it has focused on PHOs as they are the primary source of trans fats in the diet - and can contain 10-60% trans fats.
Asked whether it had agreed to extend the deadline, an FDA spokesperson told FoodNavigator-USA last night: "At this time we have not extended the comment period", but would not say whether it is considering doing so.
Click here to submit your comments to the FDA docket.
Click here to read comments already submitted.
Click on the links below to read more on the FDA crackdown on artificial trans fats.