FDA Takes Steps to Declare Partially Hydrogenated Oils No Longer GRAS and Seeks Comments

07 November 2013 Publication
Authors: Nathan A. Beaver Michael D. Flanagan David L. Rosen

Legal News Alert: Food & Beverage Industry

On November 7, 2013, the Food and Drug Administration (FDA) announced that it has tentatively determined that partially hydrogenated oils (PHOs) are no longer generally recognized as safe (GRAS) for any use in food. PHOs are the primary dietary source of trans fat, and trans fat appears in some processed foods, including products such as desserts, microwave popcorn, frozen pizzas, margarines, and coffee creamers. This determination does not impact foods, like certain meat and dairy products from ruminant animals, which contain naturally occurring trans fat. Under the new proposed rule PHOs would be classified as a food additive, which requires FDA approval before being sold or used in a final food product. Therefore, if the FDA’s preliminary determination is finalized, food manufacturers would no longer be permitted to sell PHOs — either directly or as an ingredient in another food product—without prior FDA approval.

This preliminary determination follows the implementation of the 2006 FDA final rule that all food labels correctly list the trans fat content of the product. Now, the FDA cites a Centers for Disease Control and Prevention study, which estimated that the elimination of PHOs could prevent 10,000 to 20,000 coronary events and 3,000 to 7,000 coronary deaths annually.

Before finalizing this determination, the FDA is statutorily-required to administer a 60-day public comment period. Starting on November 8, 2013, the FDA is seeking public comments concerning the preliminary determination that PHOs are not GRAS for any use in food. In particular, the FDA is asking for comments concerning whether the FDA should finalize its tentative determination, how long it would take food producers to reformulate food products to eliminate PHOs from the food supply, and if there are any special considerations that could be made to reduce the burden on small businesses. Comments can be submitted electronically to the FDA docket number FDA-2013-N-1317 at http://www.regulations.gov.


Legal News Alert is part of our ongoing commitment to providing up-to-the-minute information about pressing concerns or industry issues affecting our clients and colleagues. If you have any questions about this Alert or would like to discuss the topic further, please contact your Foley attorney or the following:

David L. Rosen
Washington, D.C.
202.672.5430
drosen@foley.com

Christopher J. Hanson
Milwaukee, Wisconsin
414.297.5281
chanson@foley.com

Michael D. Flanagan
Milwaukee, Wisconsin
414.297.5834
mflanagan@foley.com

Nathan A. Beaver
Washington, D.C.
202.295.4039
nbeaver@foley.com

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