|November 19, 2013|
Previously published on November 2013
On November 7, the Food and Drug Administration ("FDA" or the "Agency") announced that it has tentatively determined that partially hydrogenated oils ("PHOs"), which are the primary dietary source of industrially produced trans fatty acids, are not generally recognized as safe ("GRAS"). This tentative finding has no legal effect—for now. However, if FDA finalizes its determination that PHOs are not GRAS, food manufacturers would no longer be allowed to sell the oils, either directly or as ingredients in other food products, without first obtaining the Agency's approval to use them as food additives. Food service establishments that serve food containing PHOs would also be affected.
Under the Food, Drug, and Cosmetic Act, food cannot contain a food additive unless FDA has approved the use of the additive. However, a substance that is GRAS is not considered an additive, and the substance can be used without prior Agency approval. A substance is GRAS if qualified experts generally recognize it to be safe under the conditions of its intended use. For decades, industry, with FDA's acquiescence, has understood PHOs and trans fats to be GRAS. FDA now tentatively proposes to find that PHOs are not GRAS, thus relegating PHOs to the status of unsafe food additives. FDA based its tentative determination on current scientific evidence demonstrating the health risks associated with consumption of trans fatty acids, or trans fats, such as the increased risk for coronary heart disease.
Currently, food products on the market that contain PHOs include frozen pizzas, microwave popcorn, assorted baked goods, shortening, frosting, and stick margarine. The Agency has estimated that the initial costs of removing PHOs from the food supply would be $8 billion, plus any additional costs to small businesses. However, these efforts would not entirely remove trans fats from the American diet. Low levels of trans fat can be found in other edible oils as a result of processing, and trans fat occurs naturally in beef and dairy products
Stakeholders have the opportunity to submit public comment and additional scientific data before FDA finalizes its determination. FDA is soliciting public comment on various topics, including the amount of time it would take producers to reformulate products to eliminate PHOs from the food supply, a reasonable deadline for compliance with the Agency's determination, and other challenges regarding the elimination of PHOs from food. Specifically:
- Should FDA finalize its tentative determination that PHOs are no longer GRAS?
- Is there data to support other possible approaches to addressing the use of PHOs in food?
- How long would it take producers to reformulate food products to eliminate PHOs from the food supply? Are there likely to be differences in reformulation time for certain foods or certain types of businesses?
- If FDA finalizes its tentative determination, what would be an adequate time period for compliance?
- Are there any special considerations that could be made to reduce the burden on small businesses that would result from removal of PHOs from foods? Would these considerations be consistent with final determination that PHOs are not GRAS?
- Are there other challenges regarding the removal of PHOs from foods? Are there products that may not be able to be reformulated? What sorts of products and what challenges are faced?
- Is there any knowledge of an applicable prior sanction for the use of PHOs in food?
The deadline for submitting comments and other information to FDA (Docket FDA-2013-N-1317) is January 7, 2014.
FDA's tentative determination is only one of several actions the Agency and other stakeholders have taken to reduce the consumption of trans fat. In 2003, FDA finalized a rule that requires that trans fat content be provided in the nutritional label of conventional foods and dietary supplements. This requirement became effective on January 1, 2006. Based on studies conducted by the Agency, the overall dietary intake of trans fat has continually decreased in the United States since the final rule was released. Additionally, municipalities, states, and other countries have also taken steps to decrease the use of PHOs in food. For example, California, New York City, and Baltimore have restricted the use of trans fat ingredients in food service establishments.