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From Health Law Daily, November 7, 2013

For trans fat, FDA determines that “no fat” is better

By Anthony H. Nguyen, JD

Based on new scientific evidence and the findings of expert scientific panels, the FDA announced that it would begin the process of eliminating the use of industrially-produced trans fatty acids, or trans fat, from foods. In an advance release of a Federal Register Notice to be published November 8, 2013, the FDA tentatively determined that partially hydrogenated oils (PHOs) are not generally recognized as safe (GRAS) for use in food.

In today’s FDA announcement, FDA Commissioner Margaret A. Hamburg, MD, stated that “[f]urther reduction in the amount of trans fat in the American diet could prevent an additional 20,000 heart attacks and 7,000 deaths from heart disease each year – a critical step in the protection of Americans’ health.”

If the FDA’s preliminary determination is made final, following a 60-day comment period, PHOs would be classified as food additives, requiring prior approval before use in foods directly or as ingredients in another food product. Foods with unapproved additives cannot be legally sold in the U.S. The FDA’s preliminary determination is only with regard to PHOs and does not affect trans fat that naturally occurs in small amounts in certain meat and dairy products. As such, the FDA would provide adequate time for producers to reformulate products in order to minimize market disruption.

Although the FDA noted in its determination that there is no safe level of consumption of trans fat, because it raises low-density lipoprotein (LDL), or “bad” cholesterol, current FDA regulations do not require labels to disclose trans fat amounts below 0.5 grams per serving. Manufacturers are permitted to declare “0g trans fat” or “not a significant source of trans fat” as long as no additional claims are made about fat, fatty acids, or cholesterol content.

GRAS. “Food additive” is defined by Food, Drug, and Cosmetic Act sec. 201(s) as any substance the intended use of which results or may reasonably be expected to result in its becoming a component or otherwise affecting the characteristics of any food, if such substance is not GRAS. More importantly, the GRAS status of a specific use of a particular substance in food is time-dependent. The FDA can, and has, based upon new scientific data and information developed about a substance or the understanding of the consequences of consumption of a substance evolves, changed its opinion regarding the safety of a substance for a particular use because there is no longer a consensus that the specific use is safe.

PHOs. Partially hydrogenated oil is formed when hydrogen is added to liquid oils to make solid fats, such as those in margarine, shortening, and baked goods. The arrangement of the PHO’s structure is such that it increases the melting point, shelf life and flavor of foods. The partial hydrogenation process was developed in the 1930s and has been in widespread commercial use since the 1940s. Two common PHOs currently used by the food industry are partially hydrogenated soybean oil and partially hydrogenated cottonseed oil, neither of which is listed as GRAS in the FDA’s regulations.

Health risks. In 2003, following a 2002 report by the Institute of Medicine (IOM) that trans fat provided no known health benefit and that there was no safe level of consumption of artificial trans fat, the FDA issued a final rule that amended its regulations on food labeling to require that trans fatty acids be declared in the nutrition label of conventional foods and dietary supplements by 2006.

In that time frame, the consumption of trans fat in American diets has been significantly reduced, with trans fat intake among American consumers declining from 4.6 grams per day in 2003 to about 1 gram per day in 2012.

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