FDA ruling on Trans-Fats

FDA released its’ final determination that Partially Hydrogenated Oils (PHOs) are not Generally Recognized as Safe (GRAS). The determination is based on extensive research into the effects of PHOs, as well as input from stakeholders during the public comment period.

PHOs are the primary dietary source of artificial trans fat in processed foods. In FDA view, removing PHOs from processed foods could prevent thousands of heart attacks and deaths each year.

Implementation

FDA has set a compliance period of three years. This will allow food companies to either reformulate products without PHOs and/or petition the FDA to permit specific uses of PHOs. Many companies have already been working to remove PHOs from processed foods and the FDA anticipates that many may eliminate them ahead of the three-year compliance date.

It’s important to note that trans fat will not be completely gone from foods because it occurs naturally in small amounts in meat and dairy products, and is present at very low levels in other edible oils.

The FDA encourages consumers seeking to reduce trans fat intake to check a food’s ingredient list to determine whether or not it contains partially hydrogenated oil.

Background

In January 2006, FDA required the food industry to declare the amount of trans fat in food on the Nutrition Facts label. FDA data indicate that many processed foods have been reformulated to reduce the amount of trans fat since the requirement was instituted, but a substantial number of products still contain PHOs.

One of FDA’s core regulatory functions is ensuring that food, including all substances added to food, is safe. In November 2013, FDA made a preliminary determination that PHOs are not “generally recognized as safe” (GRAS) for use in food. FDA opened a 60-day public comment period on this measure to solicit data and information on a number of issues, including:

1. Whether FDA should finalize its tentative determination that PHOs are no longer GRAS;
2. How long it would take producers to reformulate food products to eliminate PHOs.

The comment period was then extended an additional 60 days and closed March 8, 2014.

The final determination was released June 16, 2015. This determination is based on extensive research into the effects of PHOs, as well as input from all stakeholders received during the public comment period (see Final Determination Regarding Partially Hydrogenated Oils, June 2015).

To learn more about trans fat, see also the FDA Trans Fat page.

EU Situation

In EU art. 30.7 of the FIC Regulation (“Food Information to Consumers” Reg. (EU) n. 1169/2011) says that “by 13 December 2014, the Commission, taking into account scientific evidence and experience acquired in Member States, shall submit a report on the presence of trans fats in foods and in the overall diet of the Union population. The aim of the report shall be to assess the impact of appropriate means that could enable consumers to make healthier food and overall dietary choices or that could promote the provision of healthier food options to consumers, including, among others, the provision of information on trans fats to consumers or restrictions on their use. The Commission shall accompany this report with a legislative proposal, if appropriate.”

Today the report has not been submitted yet and the Commission has been deeply criticized, especially from consumers associations for the unexpected delay. As a matter of fact in this situation is not even possible to declare voluntary the trans fat value in the EU format of the nutrition declaration (while in USA is mandatory from 2006).

Here below, you can find the definition of Trans fatty acids (TFA) and the advice given by EFSA in a 2010 Scientific Opinion:

“Trans fatty acids are not synthesised by the human body and are not required in the diet. Therefore, no Population Reference Intake, Average Requirement, or Adequate Intake is set. Consumption of diets containing trans-monounsaturated fatty acids, like diets containing mixtures of saturated fatty acids, increases blood total and LDL cholesterol concentrations in a dose-dependent manner, compared with consumption of diets containing cis-monounsaturated fatty acids or cispolyunsaturated fatty acids. Consumption of diets containing trans-monounsaturated fatty acids also results in reduced blood HDL cholesterol concentrations and increases the total cholesterol to HDL cholesterol ratio. The available evidence indicates that trans fatty acids from ruminant sources have adverse effects on blood lipids and lipoproteins similar to those from industrial sources when consumed in equal amounts. Prospective cohort studies show a consistent relationship between higher intakes of trans fatty acids and increased risk of coronary heart disease. The available evidence is insufficient to establish whether there is a difference between ruminant and industrial trans fatty acids consumed in equivalent amounts on the risk of coronary heart disease. Dietary trans fatty acids are provided by several fats and oils that are also important sources of essential fatty acids and other nutrients. Thus, there is a limit to which the intake of trans fatty acids can be lowered without compromising adequacy of intake of essential nutrients. Therefore, the Panel concludes that trans fatty acids intake should be as low as is possible within the context of a nutritionally adequate diet. Limiting the intake of trans fatty acids should be considered when establishing nutrient goals and recommendations.”

 

Written Q&A to EU Commission – Joint answer on trans fatty acids

In this answer to four written questions by MEPs (click the highlighted numbers to open them), Mr. Borg analyses the state of the art in EU about trans fatty acids.

In US the issue is at the top of the FDA agenda.

FDA has made a preliminary determination that partially hydrogenated oils (PHOs), the major dietary source of trans fat in the processed food supply, are no longer Generally Recognized as Safe, or GRAS. If FDA makes a final determination that partially hydrogenated oils are not GRAS, a company could not use PHOs in food without approval from the FDA, although it may take some time for the change to be fully implemented.

FDA made this preliminary determination because trans fats have significant adverse health effects. Scientific evidence has shown that consumption of trans fat raises low density lipoprotein (LDL-C or “bad) cholesterol, which increases the risk of developing heart disease. Trans fat may also have other adverse health effects, including lowering high-density lipoprotein cholesterol (HDL-C). Considering only the effects of trans fat from partially hydrogenated oils on levels of LDL-C, “bad” cholesterol, the Centers for Disease Control and Prevention estimates that eliminating intake of trans fat from partially hydrogenated oils could prevent up to 20,000 cases of coronary heart disease (CHD) and up to 7,000 deaths annually.

The trans fat found in foods can either be natural or artificial. Naturally occuring trans fat is produced in the gut of some grazing animals, and that is why small quantities can be found in animal-based foods such as milk, milk products, and certain meats. FDA’s action would not affect these foods.

Artificial trans fat is formed during food processing through hydrogenation of vegetable oils.

Joint answer given by Mr Borg on behalf of the Commission (20 December 2013) – Written questions: E-012709/13, E-012853/13, E-012895/13, E-012777/13

Based on requests of the Commission, the European Food Safety Authority adopted two Scientific Opinions, one on the presence of trans fatty acids in foods and their effect on human health and one on Dietary Reference Values for fats, including trans fatty acids.

The Commission is aware that the consumption of trans fatty acids is, along with saturated fat and overall fat intake, known to be a risk factor for the development of cardiovascular disease.

Article 30(7) of Regulation (EU) No 1169/20011 of the European Parliament and of the Council on the provision of food information to consumers requires the Commission to submit by 13 December 2014 ‘a report on the presence of trans fats in foods and in the overall diet of the Union population. The aim of the report shall be to assess the impact of appropriate means that could enable consumers to make healthier food and overall dietary choices or that could promote the provision of healthier food options to consumers, including, among others, the provision of information on trans fats to consumers or restrictions on their use.’ The Commission is also asked to accompany this report with a legislative proposal, if appropriate. This report will address the issue of consumers’ perception of trans fatty acids.

Currently, Denmark, Austria and Hungary have notified national measures limiting the presence of trans fatty acids of non-ruminant origin in foods.

Further, it should be noted that the Commission is encouraging self-regulatory action in order to further decrease the content of trans fatty acids in food products. There are commitments in the EU Platform for Action on Diet, Physical Activity and Health that concern the reformulation of products to reduce the content of trans fatty acids.