Partially Hydrogenated Oil and Trans Fatty Acids-GRAS Removal

Landmark Ban from GRAS List:  In June 2015, FDA issued a landmark determination that partially hydrogenated oils (PHOs) are not “generally recognized as safe” (GRAS) for use in food. http://www.regulations.gov/#!docketDetail;D=FDA-2013-N-1317 The “declaratory order” (which has the “force and effect” of a rule) was issued pursuant to 5 U.S.C. 554(e) (section 5(d) of the Administrative Procedure Act (APA)). PHOs are the principal dietary source of artificial trans fat in processed foods. This decision means that the use of these oils in the food supply will be phased out over a number of years and removed from the United States food supply. In so doing, FDA estimates that annually approximately 7,000 deaths from heart would be prevented. FDA received 6000 comments and 4500 letters in response to the November 2013 notice about the FDA tentative determination regarding the GRAS elimination. The Federal Register notice concerning hydrogenated fat was published November 8, 2013 (78 FR 67169) and the comment period was extended until March 8, 2014. Upon review of the comments FDA found that there is no longer a consensus among qualified experts that partially hydrogenated oils (PHOs), which are the primary dietary source of industrially-produced trans fatty acids (IP-TFA) are generally recognized as safe (GRAS) for any use in human food.

Background: Years ago, studies revealed that the consumption of trans fatty acids contribute to increased blood LDL cholesterol, known as the “bad” cholesterol, thereby raising the risk of coronary heart disease. Trans fatty acids or trans fat are made through the process of hydrogenation that solidifies liquid oils. Types of foods that may contain trans fatty acids include vegetable shortenings, some margarines, some cookies and some snack foods. A citizen’s petition (docket number 94-P0036/CP1), filed in 1994 by the Center for Science in the Public Interest (CSPI), addressed the issue of dietary trans fats and the link to coronary heart disease. A proposed rule was published in the Federal Register (64 FR 62746 November 17, 1999). FDA extended the comment period to April 17, 2000 (65 FR 7806); however, the proposal generated enormous response and the comment period was reopened until January 19, 2001 (65 FR 75887 December 5, 2000). The final rule, (68 FR 41434 July 11, 2003) effective January 1, 2006, required the declaration of trans fatty acids or trans fats on nutrition labels of conventional foods and dietary supplements. However, since implementation of the trans fat regulation, FDA found that although many processed foods have been reformulated to reduce the amount of trans fat, a significant number of products still contain PHOs.

What the Order Means: The FDA Order specific to the PHO ban means that food manufacturers would no longer be permitted to sell PHOs, either directly or as ingredients in another food product, without prior FDA approval for use as a food additive. This means compelling scientific demonstrating that the proposed use is reasonably certain not to present a risk of harm to consumers.  A good review of the Final Order is available at:

http://www.fda.gov/Food/IngredientsPackagingLabeling/FoodAdditivesIngredients/ucm449162.htm

Compliance Date:  No later than June 18, 2018.

Looking Ahead: There is a three-year phase-out period for reformulation and product relabeling. Did FDA utilize the correct approach? Apparently, it is a long time in coming and FDA is mandated under the Food, Drug, and Cosmetic Act to protect the public. Valid scientific evidence exists today that the GRAS removal is long overdue. The issue is whether industry will comply without legal challenges. Yet, it is likely that litigation will result from the FDA Order and Determination to Ban PHOs from the GRAS list.