Trans Fat Comments

FDA's final determination to ban trans fat from the nation’s food supply would save up to an estimated 7,000 deaths annually from heart disease and prevent up to 20,000 heart attacks each year. FDA needs to hear from the public about why it should act quickly and decisively. The comment period ends March 8, 2014.

Comments can be submitted to:

Division of Dockets Management (HFA-305)
U.S. Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852

Re: Docket No. FDA-2013-N-1317

Below are points you can make in a comment to the Food and Drug Administration.


The harmfulness of the artificial trans fat that is produced in the manufacture of partially hydrogenated oil (PHO) is clear. In fact, while partially hydrogenated oil is classified as "generally recognized as safe" (GRAS), the scientific community generally recognizes it to be unsafe. Four countries have banned PHO, beginning with Denmark in 2003 and followed by Austria, Iceland, and Switzerland; Argentina will ban them as well by the end of 2014.

PHO is causing, by FDA's estimation, 3,000–7,000 deaths per year and should be phased out of the food supply as rapidly as possible. Moreover, the FDA has concluded that the economic benefits—between $117 billion and $242 billion over 20 years—of eliminating the use of partially hydrogenated oil greatly outweigh the costs of switching to healthier oils—$12 billion or $14 billion over 20 years.


In the United States, substitutes for PHO are readily available for virtually all types of food, and the food industry, oil processors, seed companies, and farmers deserve great credit for the progress that has been made over the past decade in reducing trans fat levels in processed and prepared foods by about 75 percent. That effort has probably saved several hundred thousand lives over the years.


PHO is so harmful and unnecessary that it should be eliminated from the food supply. Indeed, a panel of the Institute of Medicine (IOM) concluded: “It is recommended that trans fatty acid consumption be as low as possible while consuming a nutritionally adequate diet.” In a subsequent press release, the IOM stated, "Because they are not essential and provide no known health benefit, there is no safe level of trans fatty acids and people should eat as little of them as possible while consuming a nutritionally adequate diet." Currently, many labels indicate 0 grams of trans fat per serving, but contain up to 0.49 grams of trans. Even that seemingly small amount, though, promotes heart disease, especially in segments of the population that consume large and multiple servings of such foods over the course of a day. To protect the public’s health, the FDA should bar the use of PHO in all amounts and all foods.


The FDA recognizes that it would need to specify a tolerance for trans fat, because normal, non-hydrogenated oils contain a small amount of trans fat that develops during processing. That amount should be set as low as possible to protect health. The FDA suggests that a 2 percent limit would be appropriate. However, if a person consumed 27 grams of oils per day, the amount recommended for a 2,000-calorie diet in the 2010 Dietary Guidelines for Americans, that would introduce 0.54 grams of trans fat, a non-trivial amount, into a typical diet and significantly more into the diets of people who consume more calories or more foods with a high oil content. Hence, the tolerance should be 1 percent, which appears to be practical.


In the early 2000s, FDA finalized its trans-fat labeling regulation. That spurred some forward-thinking companies to switch from PHO to more healthful oils. In 2006–2010, restaurants and bakeries responded successfully to local regulations limiting trans fat, even though they had little experience reformulating foods and fewer alternative oils were available than are today. Companies now should be able to readily obtain trans-free soybean oil (including low-linoleic and other specialty oils), canola oil and high-oleic canola oil, corn oil, cottonseed oil, sunflower oil and high-oleic sunflower oil, safflower oil and high-oleic safflower oil, rice oil, and other oils within six months. For baked goods and certain other foods that need solid shortenings with higher melting points, companies can use oils with higher melting points, including palm and various fractions thereof, interesterified soybean oil, butter, cottonseed, and, soon, high-oleic soybean oils on their own or mixed with various other oils.

The FDA should set one standard for all oils, regardless of their end use. By focusing on the manufactured oils, instead of oil-containing foods, the FDA’s enforcement task would be greatly simplified. Clearly, it would be easier to examine the output of a small number of factories instead of testing thousands of food products. If it adopted this approach, the FDA should set a compliance deadline of 18 months from the date of the final decision (which will probably be 24 to 36 months following its preliminary decision that partially hydrogenated oil is not GRAS). (The FDA would have to test the oil component of imported foods to ensure compliance.)

If FDA’s decision distinguished between the oils in fried foods and other foods (as most state and local laws do), the FDA should set a compliance deadline of six months from the date of its final decision for fried foods and 18 months for other foods. The six-month deadline reflects the ease of switching frying oils. The longer grace period for non-fried foods would give oil processors the time to manufacture sufficient quantities of specialty oils with high melting points and give bakers, food manufacturers, and others the time to reformulate their products. Those time frames should also give all companies ample time to use up their inventories of PHO.

While some companies might argue that 18 months was not enough time, any longer would continue the uneven playing field that disadvantages those companies that have replaced hydrogenated oils in their products. Companies should not be put at a competitive disadvantage for being forward thinking and attentive to this important public health concern.


As discussed above, makers of baked goods, where solid fats are needed to provide specific structures and textures, might have a harder time switching to healthier oils than makers of fried foods. And one might think that small businesses might lack the knowledge to switch to healthier fats. In fact, though, small and ethnic bakeries and restaurants in New York City and elsewhere have shown that it is possible for these sectors to comply with replacing PHO in an 18-month period. An 18-month deadline from the date of a final FDA decision (and, of course, companies would probably have had an additional six to 12 months longer counting from the November 8, 2013, notice) should be sufficient for all manufacturers, bakeries, and restaurants, big or small, and producers of both fried foods or other foods.

Among restaurants, all of the largest companies and many smaller ones now fry in trans-free oils, while some (including perhaps thousands of smaller chains and independents) have continued to use PHO. Likewise, many food manufacturers have largely or totally switched from PHO to more healthful oils, though some companies continue to use recipes with PHO.

If small companies need technical expertise to reformulate their foods, the FDA could encourage major trade associations (such as the National Restaurant Association, Grocery Manufacturers Association, Food Marketing Institute, American Institute of Baking, and Institute of Shortening and Edible Oils) to set up a national Help Line, much like New York City did. An appropriately staffed telephone line, along with an informative website, could help many small companies and their oil suppliers.

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