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FDA Clarifies Compliance Date for PHO Rule

May 07, 2018

UPDATED May 10

Late last month, IDFA and 14 other food and manufacturing trade associations urged Food and Drug Administration Commissioner Scott Gottlieb to provide the food industry with more clarity and time as companies work to comply with FDA’s rule to remove partially hydrogenated oils (PHOs) from food and beverage products sold in the United States. In joint comments, the groups asked FDA to clarify that products containing PHOs that are already shipped and in stores before the compliance date of June 18, 2018, would not need to be removed from store shelves.

According to an article by IEG Policy, Susan Mayne, director of FDA’s Center for Food Safety and Applied Nutrition, confirmed that the agency will not require recalls for products containing PHOs that were introduced before the June compliance date. She said FDA plans to issue written clarification soon. Mayne made the statements last Friday at a Food and Drug Law Institute event in Washington, D.C. 

In 2015, FDA made a final determination that PHOs would no longer be allowed in foods sold in the United States after June 18, 2018. FDA said PHOs are no longer considered Generally Recognized as Safe (GRAS) due to their content of trans fat, which has been associated with negative health consequences.

Previously, FDA has issued several statements since the ruling, alternately suggesting that the compliance date applies to the date the food is manufactured or packaged, and that it applies to the date the food is introduced on the market. An FDA official also told IDFA earlier this year, “Food containing PHOs on or after June 18, 2018 - regardless of the manufacturing date - may be deemed adulterated unless the use has been otherwise approved by FDA.”

In the comments the groups said, “We are asking FDA to recognize that products that were already in commerce before the compliance date may continue to remain in commerce. Absent a clear statement from FDA, companies and retailers could be forced to recall or remove from store shelves those products that remain in commerce that contain PHOs. It would seem needlessly burdensome to force the removal of these products from commerce.”

Most dairy products do not contain PHOs. However, there are naturally occurring trans fats that are created in the cow’s digestive tract and are passed into the milk. The animal sources of trans fats do not have the same health concerns as the industrially produced trans fat. FDA has confirmed that its rule excludes naturally occurring trans fats, fully hydrogenated oils and ingredients derived from PHOs, such as monoglycerides and diglycerides, since the PHOs aren’t added to the products.

Ingredients with PHOs that are added to products are still under FDA’s food additive review. PHOs have historically been used in a wide variety of food ingredients such as solid shortening used in baked goods and confections for frosting or fillings, as well as in ingredients for coatings, anti-caking agents, encapsulates, emulsifiers, flavors and colors.

In the comments, the groups also urged FDA to announce if any ingredients are approved for use and suggested FDA extend the compliance date for a year after the announcement to give companies time to respond.

The groups are planning to meet with FDA staff to further discuss PHOs in food products.

Read the comments here.

For more information, contact Michelle Matto, R.D.N., IDFA’s nutrition and labeling consultant, at amfoodnutrition@gmail.com.

 
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