To many the proposed FDA rule to deny GRAS status to partially hydrogenated oil—and thereby in effect banning it from use—would be a great public health benefit. However, this proposed rule is not without consequences to many individuals, so it is critical that this decision is made carefully.
The FDA and others have stated that further decreases in trans fatty acid consumption could decrease thousands of cardiac events and deaths. These calculations of saving lives by further lowering trans fatty acid consumption assume that the biological effects of trans fatty acid follow a dose dependent linear response. Unfortunately, the pharmokinetics of the biological effects of trans fatty acids are difficult if not impossible to confirm since most studies that show adverse effects of trans fatty acids had to use dietary trans levels in excess of 5% of total energy. FDA has calculated that trans fatty acid consumption of partially hydrogenated oils has decreased from 4.6 g per day in 2003 to 1.3 g per day (2.1 to 0.6% of total energy) in 2010. It is very common for kinetics to not be linear especially at extremely low or high concentrations of bioactive agents. Therefore, it does not seem scientifically prudent to make a bold statement of how many deaths a food ingredient is causing without any clinical data.
One could argue trans fatty acids should be eliminated regardless of what we know about their biological effects because they have no known nutritional benefits. However, when making policy recommendations for the removal of a food ingredient, one always needs to examine what will be used in its place so we do not repeat past problems like recommending fat removal only to increase sugar consumption. Certain foods require solid fats for function (e.g., baked goods) so partially hydrogenated oil will have to be replaced with another solid fat such as palm oil. Some may argue that this is OK because trans fatty acids are much worse than saturated fatty acids. However, oils are partially hydrogenated so that small amounts of the unsaturated fatty acids are removed and thus they can contain significant amounts of polyunsaturated fatty acids (>30%) compared to palm oil (<10%). Oils such as palm also contain higher levels of saturated fatty acids (>45%) than partially hydrogenated oil (<20%). Unfortunately, the health consequences of replacing partially hydrogenated oil with tropical oils in diets that already have low levels of trans fatty acids is unknown.
There are potential solid fats such as interesterified fats and organogels that could provide the functionality needed in foods currently containing partially hydrogenated oils without drastically increasing saturated fatty acid levels. However, these fats are more expensive and would increase food costs. At a time when large numbers of Americans require food assistance and with a political environment that will likely decrease food aid, the proposed rule would largely affect Americans who are the least food secure.
The proposed rule is also a problem for future technology development. Some partial hydrogenation technologies, such as electrochemical hydrogenation, can produce low levels of trans fatty acids. Could these products be used in foods if the proposed rule is passed? If so, what criteria would be used to determine if they are GRAS?
It is critical that food regulations and policy are based on sound scientific evidence since removal on any food ingredient could have unintended consequences. Obtaining the data to make sound regulatory decisions is very difficult under the current research funding environment and this issue again highlights the need for increased funding for food and nutrition research or the development of public-private funding mechanisms that could sponsor the clinical trials needed to evaluate the safety and health-promoting properties of foods.
Eric Decker
Professor and Department Head
Department of Food Science
University of Massachusetts
Filed under: Bakery, Product development, Public Policy & Regulations | Tagged: bakery, Eric Decker, formulation, policy, trans fats |
IFT: The ePerspective 
In December 2006, New York City banned trans-fats, ostensibly to significantly improve the cholesterol and cardiovascular metrics of its citizens. Although often promised during the last 7 years, the NYC Dept of Health has never published a follow-up report on the impact of this TF ban policy on the health of NY consumers. How serious a public health measure could this have been, if there was never an effort to show its specific impact on the health of New York citizens? After all, isn’t that why the ban was put in place? After a hiatus of seven years, what new evidence has inspired the FDA to arrive at the sudden decision that banning trans-fats will be the life-saving intervention they claim it will be? Will the FDA take on the responsibility of determining the impact of the trans-fat ban on the health of American consumers or will they simply refer to flawed models as “proof” of the benefit to consumers instead of actual evidence based on verifiable health outcomes?
We have the tendency to place an inordinate amount of credibility in institutions such as the FDA or CDC, forgetting they the staffed by people, often driven by narrow agendas. One would expect that this should inspire skepticism amongst the media and the general public regarding the pronouncements made by these institutions, but apparently it does not. Even after the catastrophe of hormone replacement therapy, we still remain confident that our public health institutions can do no harm. That confidence may be sorely misplaced.
For 1500 years, the world believed in “spontaneous generation” simply because the authorities (the ancient Greek philosophers) said it said it was so. This went on until the scientific method demanded that credibility be based on experimentally derived evidence – not on smoke, mirrors or computer models. The scientific integrity of this country and of its great institutions is in question because we seem to associate credibility with authority and institutions, rather than with actual scientific evidence. We accept notions without demanding proof. It may well be that spontaneous generation is real and that New York’s citizens have actually benefitted from the trans-fat ban, but until there is objectively obtained evidence to confirm this we cannot take it as a given. Surely, the FDA can provide some concrete evidence resulting from the NY City trans-fat ban in order to support its new initiative.
Thanks Eric — this is insightful and exemplifies the importance of stakeholder input. Please do submit your comments to the docket. After all, that’s the point of our process that includes “proposed” rules, so that we at FDA can hear from all sources as to, as Morton points out, what we may have missed.
Dr Decker put a very insight and inspiring thought on this problem. What I want to supplement is, even trans fatty acid products been banned, improper processing or cooking of oil both at home and restaurant could still cause the formation of TFA, though the amount could be low. As we all know, poison is amount, if the TFA consumption is under certain level, its side effect might not be so serious. In this way, strict banning might not be as good as a suggestion even.
As Morton pointed, spontaneous generation do show more attractiveness to normal people. I think its acceptable that you prefer more natural things, considering a lot of ads claiming the potential benefit from natural things. But, don’t forget you would choose tissue rather than a leaf or some grass after washing hands. Is it good for people to ban something only because its not “natural”?
I support both Eric’s and Morton’s comments. There has been a huge reduction in TF in the Cdn and American food supply since 2003/2004. If TF were the villain it was portrayed to be, why has there not been a concomitant decrease in heart disease indicators? I thought the days of lassooing one nutrient and blaming it for all woes was behind us – apparently not. Saturated fat and sodium are dietary contributors to heart disease, in addition to other lifestyle contributors such as inadequate exercise, all this in addition to genetic factors. If the desire to decrease heart disease through dietary intervention is genuine, why not tackle saturated fat and sodium as dietary contributors at the same time?
Since Eisenhower was President, safety meant there is “a reasonable certainty in the minds of competent scientists that the substance is not harmful under the intended conditions of use.” 21 CFR 170.3(i). The additive’s use must be safe without regard to the potential benefits to health or the economy. Are you saying the law is wrong or that there are no real questions about the safety of trans fats in current uses.
easy to say the it is declining over the years. Most scientists in EU tend to agree that total energy from TFA’s should not be more than 2 percent. however, there if no ban of TFa’s then some group of population would carry on eating products which give them more than 2%, Educating the people is only answer but with a caution! to food fat producers and users, including fast food sector.
Dear Sirs:
It is difficult to understand why the unhealthy TF must be artificially made for food. Also why saturated fats must be used for foods. For oral textures, cookie making, etc. scientific innovations have been made and now are progressing as no-tans & unsaturated fats. How about move our against-FDA efforts to developing efforts for no-tans & unsaturated fat innovations which are scientifically not difficult.
Sincerely yours.
Yasuyuki Yamada MD
I take it that none of you “educated” gentlemen would be willing to sign this petition, then..?!
Click to access FDA-petition.pdf
‘Innovation’ is not food. For me, I’ll eliminate the processed liquid vegetable oils (omega 6, PUFAs), skip the trans fat in the flavorless convenience foods, skip the innovations of the sweetener business (artificial sweeteners / chemmically modified sugar), slash added sugar intake, slash inflammatory grains, etc. I will eat: ANTIOXIDANT RICH carbohydrate sources such as in purple potatoes, sweet potatoes, and other root vegetables, antioxidant rich olive oil, omega3 sources, fruits, vegetables, meats, (saturated) coconut oil (MCFAs good for brain and body health ( I want to avoid altzheimer’s and metabolic syndrome issues that lead to T2D)), and the maligned real butter. I am poor. I WORK and am on food stamps. I do not need shelf stable twinkies. I do not want oxidized cholesterol. I want LARGE FLUFFY cholesterol particles. The kind my body can use. I want high hdl. I want a metabolism that knows how to burn excess fat. I can decide what to eat. Although, the ‘ban’ may be helpful for those who need the foresight of others. Inflammation drives disease, even heart disease, not saturated fat. WHAT ARE THE MOST AMAZING NUMBERS YOU HAVE EVER SEEN? I want THOSE NUMBERS.
On second thought, it would be highly unlikely you have seen numbers as unconnon as the bloodwork numbers I would like to accomplish. Sad, really. Seriously.
There is a much more strong correlation between the introduction of industrialized seed oils (Crisco, canola, etx) than with saturated fats which have been a intrinsic part of the human diet for millions of years. Recent studies are begining to show a much stronger association with oils that have high omega 6 and little omega 3 fatty acids as a primary driver on diet induced CVD. most likely due to their inflammatory effects.
Alright Eric, a straight up challenge- can you cite ANY evidence that natural, saturated fat (like that found in butter, palm oil. coconut oil. tallow, beef or eggs) is harmful in ANY form? My guess is you can’t- cause the entire lipid hypothesis is based on cherry picked epidemiological data that dismisses epidemiological data that doesn’t back it up (like the MONICA study) and doesn’t have a single intervention trial to back up.
Dear Fellow Food Scientists,
I have been formulating food products for 35 years. Have you looked at the data on trans fat? I’m sorry but it is not a healthy thing for people to eat! Anyone who argues the fact begins to sound like the “doctors” who told us in the 80’s that smoking is not dangerous. Okay,we have an excuse. When trans fat was invented, we didn’t know. But now we do. Fifteen or so years ago when the FDA mandated labeling of trans fat, most responsible companies stopped using it. Back then there were few alternatives, but now there are many. Today there is no reason (except ignorance and greed) for a company to continue using trans fat in any formulation.
If we are to retain our integrity as scientists, we need to admit we were wrong and do the right thing by quietly supporting a ban on trans fat. Any other action is to invite further criticism of a food industry that is already mistrusted. It is our job to produce safe and healthy food. Trans fat is not safe or healthy. It should be taken off the market.