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FDA Tentatively Determines Trans Fats Not GRAS




by:
Melvin S. Drozen
Evangelia C. Pelonis
Keller and Heckman LLP - Washington Office

 
November 11, 2013

Previously published on November 8, 2013

On November 7, FDA announced that it has tentatively determined that partially hydrogenated oils (PHOs) are not generally recognized as safe (GRAS) under any condition of use in food and therefore are food additives that, unlike GRAS substances, require pre-market approval by FDA before they can be used in food.[1] Foods that contain unapproved food additives are considered adulterated and cannot be legally sold. PHOs are the primary dietary source of industrially-produced trans fatty acids (trans fats).

The basis for FDA’s determination is the link between trans fat and health risks, such as coronary heart disease (CHD), as identified by scientific evidence and expert scientific panels, such as the Institute of Medicine (IOM) and the Center for Disease Control and Prevention (CDC). FDA Commissioner Margaret A. Hamburg stated that a reduction in trans fat “could prevent an additional 20,000 heart attacks and 7,000 deaths from heart disease each year.” Trans fat raises low-density lipoprotein (LDL) or “bad” cholesterol, increasing the risk of CHD.

For a substance to be GRAS there must be a consensus among qualified experts that the substance is safe under the intended conditions of use. FDA believes there is no longer a scientific consensus to support the safety of PHOs in food. 21 CFR 170.38 gives FDA the authority to publish a notice when it determines a substance is not GRAS and is a food additive. If the comments received support FDA’s tentative conclusion, FDA will finalize its determination.

FDA is specifically seeking comments on whether it should finalize its tentative determination, whether another approach such as setting a specification for trans fat levels in food is possible, how long it would take the food industry to stop using PHOs in order to establish a reasonable compliance period, and whether there are any challenges associated with removing PHOs from foods. Comments are due by January 7, 2014.

We will be closely watching the progress of this development as it will likely be relevant to other ingredients of concern, such as caffeine and sodium, and will have an impact on the regulation of trans fats in other countries.



[1] 78 Fed. Reg. 67169 (Nov. 8, 2013), available at, http://www.gpo.gov/fdsys/pkg/FR-2013-11-08/pdf/2013-26854.pdf; FDA Press Release, available at, http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm373939.htm; FDA Consumer Update, available at, http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm372915.htm.



 

The views expressed in this document are solely the views of the author and not Martindale-Hubbell. This document is intended for informational purposes only and is not legal advice or a substitute for consultation with a licensed legal professional in a particular case or circumstance.
 

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