The US Food and Drug Administration (FDA) has issued its final rule on the use of partially hydrogenated oils (PHOs) in the food supply.
When issuing the final rule on 8 August, the agency said it reflected its June 2015 final determination that the use of PHOs in food was no longer generally recognised as safe (GRAS).
Industrial trans fatty acids (TFAs) are produced when oils are partially hydrogenated to make them solid or semi-solid, increasing their stability and improving their shelf life. They were used widely in margarines, vegetable shortenings, commercial baked goods such as pastries and cookies, snack foods and in fast-food restaurant deep fryers until scientists discovered they had a ‘double whammy’ effect of increasing ‘bad’ or low density lipoprotein (LDL) cholesterol, while lowering ‘good’ high density lipoprotein (HDL) cholesterol. Trans fats increase the risk of developing heart disease and stroke and is associated with a higher risk of developing type 2 diabetes.
In its 2015 decision, the FDA indicated there were outdated references to PHOs in regulations that would be addressed separately. With respect to removing PHOs from the food supply, the agency set 1 January 2021 as the final compliance date to allow manufacturers time to reformulate foods and adapt for the marketplace.
“The FDA’s actions regarding PHOs address artificial sources of trans fat, but trans fat will not be completely removed from the food supply because it occurs naturally in meat and dairy products and is present at very low levels in other edible oils,” the FDA said in a statement on its website.
In the final rule, the FDA stated that PHOs would no longer be included as an optional ingredient for the standards of identify for peanut butter and canned tuna.
The final rule also revoked the regulation for partially hydrogenated fish oil as an indirect food substance and revised GRAS affirmation regulations to no longer include partially hydrogenated forms of menhaden and rapeseed oils.
It also revoked the pre-1958 authorisation for using PHOs in margarine, bread, rolls, buns and shortening as that authorisation was granted before the Food Additives Amendment of 1958 so those uses of PHOs could not be regulated as food additives.
The FDA said it was issuing the amendments directly as a final rule as it did not expect significant adverse comments as it followed its 2015 decision that PHOs were no longer GRAS for any human food.
However, the agency said it was issuing a companion proposed ruling in the same issue of the Federal Register in case the direct final rule was withdrawn due to the receipt of significant adverse comments, and the agency needed to move forward with a proposed rule to put these changes in place.
The FDA is accepting comments on both the direct final and proposed rules. These comments must be submitted by 75 days after the rule is published in the Federal Register.
The direct final rule would be introduced 135 days after the date of publication in the Federal Register, the FDA said.