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FDA Says Partially Hydrogenated Oils are No Longer Considered Safe

Update: FDA has extended the compliance dates for certain foods using partially hydrogenated oils (PHO) to circulate through U.S. distribution.  After June 18, 2018, FDA will still prohibit the manufacture of most foods containing PHOs.  However, many foods manufactured prior to this date will remain compliant through January 1, 2020.

In May 2018, FDA denied a petition by the Grocery Manufacturers Association (GMA) requesting approval for use of PHOs as:

  • Carriers or components of flavors
  • Diluents or components of color additives
  • Incidental additives or processing aids
  • Direct additives in certain categories of food

Foods manufactured with these specific uses of PHOs have until June 18, 2019 to reformulate their products.  Foods with these uses manufactured prior to this date will remain compliant through January 1, 2021.

On June 16, 2015, the U.S. Food and Drug Administration (FDA) released its final determination that Partially Hydrogenated Oils (PHOs), the largest cause of artificial trans-fat in processed foods, are not Generally Recognized as Safe (GRAS).  Food products will no longer be able to contain PHOs unless approved by FDA.  Food manufacturers and processors have until June 18, 2018 to comply by either removing PHOs from their food products or petitioning FDA for approval for use.

Why are trans-fats no longer GRAS?

Research has revealed that trans-fats are directly related to increased levels of low density lipoprotein (LDL) cholesterol, which clogs and damages arteries.  This can lead to heart attacks and heart diseases, and according to FDA, “Cardiovascular disease is the leading cause of death in both men and women in the U.S.”  FDA made a tentative determination that PHOs were no longer GRAS in 2013.  After further review of stakeholder comments and the effects of trans-fats, FDA finalized its decision.  FDA expects its new determination will prevent thousands of heart attacks and deaths each year.

Where are trans-fats currently found?

PHOs are used to improve the taste, shelf-life, and texture of food products.  Trans-fats are found in many popular foods, including coffee creamer, premade baked goods and frostings, frozen pizzas, microwave popcorn, and more.  FDA mandated that trans-fats be listed on Nutrition Facts Charts in 2006.  However, labels can state that a food has 0grams of trans-fat if it has less than .5 grams, making it difficult for consumers to truly measure their trans-fat intake.

What does this mean for the food industry?

Over the next three years, food manufacturers and processors that currently use PHOs in their food products will need to rework recipes to exclude PHOs from their ingredient lists.  Alternatively, industry can begin gathering data to petition FDA to allow specific use of a PHO by proving its use meets FDA’s standard of safety.  Industry should begin the compliance process as soon as possible, as foods that still contain unapproved PHOs on June 18, 2018 will be considered adulterated.  It is illegal to export or market adulterated food in the United States. 

Registrar Corp, a firm that helps food companies obtain FDA compliance, stays up-to-date on FDA regulations, including the regulatory status of food ingredients.  Registrar Corp Label and Ingredient Review Specialists can review food labels for unapproved ingredients and other potential labeling errors.

For questions about the regulatory status of trans-fat or other food ingredients, or to request a label review, contact Registrar Corp at +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livehelp.