In June 2015, the US FDA gave manufacturers three years to remove partially hydrogenated oils (PHOs) from food products, stating that trans fats are no longer ‘generally recognised as safe’ for human consumption. In this special report, we talk to the FDA about these changes, what they mean for manufacturers, and why they are so critical for public health.
On June 16 2015, the US Food and Drug Administration (FDA) made an announcement that had been in the offing for some time. Partially hydrogenated oils (PHOs) – the main source of artificial trans fats in processed foods – are no longer ‘generally recognised as safe’, meaning food manufacturers will have three years to remove these ingredients from their products.
For those who’d been paying attention, this announcement was less a matter of ‘if’ than ‘when’. In November 2013, the FDA had released a tentative determination to the same effect, giving interested parties chance to comment on the decision before it was finalised. Since then, the US food industry had been steeling itself for change, with many manufacturers determined to stay one step ahead of the game.
Even before the tentative determination, a number of restaurants had stopped using PHOs, switching to healthier alternatives such as high-oleic oils, which are trans fat free. Many of them had done so under legal duress: in some parts of the country, restrictions have been in place since as early as 2006. Others, sensing a sea change in the industry and anticipating further rulings, had moved away from trans fats on their own steam.
This said, the FDA’s final determination is still likely to cause ripples. By the time June 2018 rolls round, PHOs will no longer be classed as safe for human consumption; they will be treated not as a foodstuff, but as an illegal additive with grave potential to cause harm.
“The FDA has set a compliance period of three years,” explains Marianna Naum, of the Office of Foods and Veterinary Medicine at the FDA. “This will allow companies to make the transition — to either reformulate their products or petition the FDA to permit certain specific uses of PHOs. Companies have made strides towards reducing or eliminating PHOs and the FDA expects manufacturers may be in compliance ahead of schedule.”
The rationale behind the ban is simple: trans fats are known to have a hugely detrimental effect on human health. Once seen as a healthier counterpart to saturated fats, their true harms have since become unignorable. The FDA estimates their elimination could prevent 20,000 heart attacks and 7,000 deaths from heart disease each year.
“The ban will likely lead to a significant reduction in heart attacks and cardiovascular disease and associated health costs,” says Naum. “The estimated total cost to industry is $4.1 billion over 20 years at a 5% discount rate, a measure of inflation. The FDA estimates that monetising the lives saved, along with the value of the nonfatal illnesses and medical expenses prevented, yields an estimated 20-year value of benefits from this proposal of about $140 billion. As a result, the net health benefits far outweigh the costs.”
Formed by pumping hydrogen through vegetable oil, which causes the fat to become solid at room temperature, PHOs were first created at the start of the 1900s, with production increasing throughout the century. They quickly found uses in a wide range of food products, including baked goods, microwave popcorn, stick margarines, coffee creamers, refrigerated dough products and ready-to-use frostings.
As early as the 1960s, there were studies positing a link between trans fats and heart disease, but this prompted little in the way of public outcry. As the nutritional community started to panic over a different bogeyman – saturated fats – unsaturated fats of any variety became viewed through a favorable lens. In the 1980s, most fast food outlets replaced the animal fats in their products with vegetable oils, dramatically increasing the average consumption of trans fats in the process. By the mid 1990s, average consumption stood at around 5.6g of PHOs every day.
By this stage, however, new data was becoming available. Epidemiological studies related consumption of trans fatty acids to a rise in coronary heart disease. And human metabolic studies found that trans fatty acids both increased LDL (‘bad’) cholesterol and decreased HDL (‘good’) cholesterol, performing substantially worse than saturated fats in this regard.
The message was sobering: with as many as 30,000 deaths in the US each year linked to trans fat consumption, margarine might not be better for you than butter after all. “As is true for low-level radiation, a truly inconsequential level of trans fatty acid intake is almost impossible to establish,” stated a paper published in the American Journal of Public Health in 1994.
Today, this paper seems far ahead of its time. Its authors, having stacked up the evidence against trans fats, list various possible policy responses, including a wholesale FDA ban on artificial trans fats in foods. While it would take another 21 years for their suggestion to become a reality, this new wave of research did spell the beginning of the end for PHOs.
Another of its policy recommendations – that trans fats be included on food labels, so the public can make an informed choice – was eventually proposed by the FDA in 1999 and finalised in 2003, becoming mandatory in 2006. That year, New York City eliminated artificial trans fats from its restaurants and bakeries, with a dozen other local governments following suit.
In 2007, the shortening company Crisco – which had introduced trans fats to America’s pantries as early as 1911, and built its reputation on offering a lower saturated fat content than butter or lard – reformulated its recipe to remove the trans fats. Fast food joints, in the main, had already switched away from PHOs. Taken together, these efforts had a significant impact on the US diet.
“Between 2003 and 2012, the FDA estimates that trans fat intake decreased about 78%, largely in response to the labeling rule,” says Naum. “In addition to the labeling requirement, voluntary industry efforts to reduce trans fat in foods have contributed to the decrease of trans fat consumption.”
Elsewhere in the world, Denmark led the way, virtually eliminating trans fats from its food supply in 2003. The Scandinavian country – which has implemented several successful public health campaigns over the last few decades – saw coronary mortality fall 70% between 1985 and 2009, a drop attributable in part to the trans fats ban.
As we explored in the Winter 2014 edition of Ingredients Insight, the World Health Organization has called for this ban to be extended across the rest of Europe. Although five other EU countries have followed Denmark’s example, rates of trans fat consumption remain high overall, especially in Eastern Europe, and there would appear to be a case for stronger regulations across the board.
Other parts of the world are even further behind the curve. It is an unfortunate but not unsurprising reality that, to date, most PHO success stories have taken place in higher income countries. Low income typically correlates both with poor diet and low consumer awareness, the latter of which means minimal pressure on the food industry, and poses a serious impediment to change.
Exception to the rule
For US-based food manufacturers and restaurants, the quest is now underway to change and refine their products to remove all trace of PHOs. It is estimated that some 37% of foods in US grocery stores may still contain trans fats, meaning a large number of recipes will need to be reformulated using different additives and oils. Considerations may include maintaining shelf life (often lengthened by use of trans fats), retaining value for money, and most importantly keeping the taste intact.
If, for some reason, reformulation proves impossible, manufacturers are allowed to petition the FDA to permit specific uses of PHOs. In July, the Grocery Manufacturers’ Association (GMA) filed a petition seeking approval for small amounts of trans fats in at least 50 product categories, ranging from tea bags to breaded chicken. According to their proposal, the law ought to set various permissable levels for different foodstuffs, ranging from 0.01g per 100g for protein drinks to 3g per 100g for shortening. The FDA is reviewing this request at the time of writing.
“Companies who petition the FDA will need to establish safe conditions of use, through food additive petitions with enough data for FDA scientists to review and make a safety determination,” says Naum. “It is the petitioner’s responsibility with any food additive petition is to adequately demonstrate a reasonable certainty of no harm when used as proposed in the petition.”
So far, the GMA’s request has garnered a mixed reaction. Michael Jacobson, executive director of the Center for Science in the Public Interest, has said, “there’s no reason whatsoever to allow half a gram or more in numerous foods”, adding that “for some consumers, those modest amounts could add up to a significant health risk”.
The FDA, however, may well be amenable to smaller quantities of trans fats. In Denmark, licorice manufacturers are allowed to use a tiny surface layer of trans fat to keep the pieces from sticking to each other in the bag, and it is possible that the US will bring in similar exemptions.
Currently, the FDA’s definition of ‘zero trans fats’ is relatively loose – any food product containing less than 0.5g per 100g is allowed to label itself as trans fat free. At this stage, it is unclear whether this loophole will be closed.
“Validated analytical methodologies that provide sensitive and reliable estimates of trans fatty acids in all foods at levels below 0.5g per serving are currently not available,” says Naum. “Thus we did not propose any changes to the level considered to be zero for trans fat. FDA will review and consider all comments received when drafting the final rule and amending the regulations.”
With two and a half years remaining until the final ruling comes into force, there is ample time yet to sift through these issues, and make the changes necessary to remove artificial trans fats from the American diet. While the move is likely to cause some disruption for manufacturers, the wider benefits are not in doubt.
“Scientific evidence supports FDA’s current action, which is to determine that there is no longer a consensus among qualified experts that PHOs are safe for use in human food,” says Naum. “This determination is based on the body of available scientific evidence regarding consumption of trans fat as a risk factor for cardiovascular disease which can lead to strokes and heart attacks, and the opinions of expert panels. Consumer groups have welcomed the determination, and the industry has not challenged it.”
The happiest groups, however, are surely those who deal directly with the public’s coronary health. Speaking at the time of the FDA announcement, Dr Steven Nissen, chair of cardiovascular medicine at the Cleveland Clinic, said he was “terribly proud of the FDA for stepping in and knowing what needed to be done for the American diet”, remarking that the agency “deserves a lot of credit” for taking this “enormously important” move. For his profession above all, the ban on trans fats has not come a minute too soon.
This article appears in the 2015 Vol 2 edition of Ingredients Insight