FDA Takes First Step Toward Eliminating Partially Hydrogenated Oils in Processed Foods
The Food and Drug Administration announced Nov. 7 a preliminary determination that partially hydrogenated oils, which are the primary dietary source of artificial trans fat in processed foods, are not “generally recognized as safe” for use in food. Attorneys with Sandler, Travis & Rosenberg’s FDA Practice Group can assist those interested in submitting comments on this proposal, which are due by Jan. 7, 2014. Contact Arnie Friede or Shelly Garg for more information.
If the FDA’s determination is finalized, food manufacturers would no longer be permitted to sell PHOs, either directly or as ingredients in another food product, unless they could prove to the FDA that one or more specific uses are safe under the “reasonable certainty of no harm” safety standard. According to Friede, the likelihood of the FDA approving such a food additive petition after declaring that PHOs are not GRAS is “remote to non-existent.” At the same time, the FDA states, any prohibition on PHOs would be phased in over a number of years to give producers adequate time to reformulate their products.
The FDA has required industry to declare the amount of trans fat in food on the “Nutrition Facts” label since 2006. While many processed foods have been reformulated to remove PHOs since this requirement was instituted (e.g., frozen potato products and most frozen breaded products), a substantial number still contain PHOs, including some snack foods, microwave popcorn, frozen pizzas, cookies, stick margarine, shortening, coffee creamers, pies and ready-to-use frostings. According to an FDA press release, the independent Institute of Medicine has concluded that trans fat provides no known health benefit and that there is no safe level of consumption of artificial trans fat.
The FDA is seeking comments and additional scientific data and information concerning its preliminary determination, including comments on whether this determination should be finalized, how long it would take producers to reformulate food products to eliminate PHOs, ways to reduce the burden on small businesses, and any challenges to the removal of PHOs from foods, such as products that may not be able to be reformulated
The FDA notes that this preliminary determination does not affect trans fat that naturally occurs in small amounts in certain meat and dairy products.