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Dairy Facts 2016

FDA Proposes Removal of GRAS Status for Partially Hydrogenated Oil

Nov 14, 2013

Citing concerns about public health, the Food and Drug Administration (FDA) announced last Friday that it will take steps to eliminate industrially produced trans fat in food.

A study by the Institute of Medicine indicates that trans fat from partially hydrogenated oils (PHOs) have no known health benefit and contribute to heart disease, leading the FDA to determine PHOs are therefore ineligible for Generally Recognized as Safe (GRAS) status in food. If this determination is finalized, companies that want to continue using partially hydrogenated oils in their products, either as ingredients or sub-ingredients, would need to petition FDA under food additive procedures.

Dairy Fats Not Under Scope of Notice

Trans fat in meat from ruminant animals and dairy fats (milk fat), including cream, cheese and butter are naturally produced and not under the scope of this notice, so these fats would still be allowed in food without a petition.

Many ingredients in dairy products that previously contained trans fats, such as bakery inclusions or coatings, were reformulated to significantly reduce or eliminate trans fats following the 2006 requirement to declare trans fat on the Nutrition Facts panel. However, a few ingredients used in dairy products may still contain low levels of partially hydrogenated oils.

If FDA’s proposal goes forward, these ingredients and the final products that contain them would need to be reformulated, or companies would be required to petition FDA to allow for the use of partially hydrogenated oils.

FDA’s tentative determination was based on scientific evidence that links trans fat consumption to higher blood cholesterol levels, heart disease and other health effects. FDA believes that this eliminates the eligibility of partially hydrogenated oils for GRAS status since there is no longer scientific consensus that they are safe under the intended conditions of use. Traditionally, safety for GRAS determination has been interpreted as acute safety, such as preventing toxicity, rather than long-term use and development of chronic disease.

FDA Requests Comments

FDA requested comments on its tentative determination, asking for information on other possible approaches to reducing partially hydrogenated oils in the food supply, a reasonable compliance date for removal of partially hydrogenated oils, the challenges of reformulating foods and special considerations for small businesses. IDFA will plan to submit comments to FDA by the published deadline of January 7, 2014.

To read the full notice, visit "Tentative Determination Regarding Partially Hydrogenated Oils; Request for Comments and for Scientific Data and Information" in the Federal Register.

To participate in IDFA’s discussions on this topic, contact Cary Frye, IDFA vice president of regulatory and scientific affairs, at (202) 737-4332 or, or Michelle Matto, IDFA’s nutrition and labeling consultant, at (202) 431-6864 or



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