U.S – In a resolute stride toward prioritizing public health, the U.S. Food and Drug Administration (FDA) has issued a direct final rule that unequivocally declares the use of partially hydrogenated oils (PHOs) in foods as no longer Generally Recognized as Safe (GRAS).

This sweeping decision culminates years of research and administrative efforts by the FDA, reflecting the agency’s unwavering commitment to improving the nutritional landscape of the nation.

Building upon a prior determination made in June 2015, the FDA has now completed a comprehensive set of administrative actions, formalizing the conclusion that PHOs are unfit for human consumption.

The 2015 decision pinpointed outdated references to PHOs in regulations, which the agency has systematically addressed.

To ensure a smooth transition for food manufacturers, the FDA set January 1, 2021, as the ultimate compliance date, affording companies the time to reformulate their products and usher in a seamless shift in the market.

The FDA’s stringent actions targeting PHOs primarily address their artificial origins, aiming to eliminate the harmful trans fats originating from these sources.

However, it’s important to note that natural trans fats found in meat and dairy products will not be entirely removed from the food supply. The decision acknowledges the low levels of trans fats present in other edible oils as well.

Redrawing the regulatory landscape

The direct final rule comprises a series of pivotal amendments designed to eliminate PHOs from the food realm.

The regulations for peanut butter and canned tuna have been revised to exclude PHOs as optional ingredients and partially hydrogenated forms of menhaden and rapeseed oils are no longer considered GRAS under FDA regulations.

The regulation for partially hydrogenated fish oil as an indirect food substance has also been revoked. In addition, the authorization for using PHOs in margarine, shortening, bread, rolls, and buns, dating back to before the Food Additives Amendment of 1958, has been repealed.

Window for public engagement

The FDA’s confidence in its decision’s reception is reflected in its direct final rule. Anticipating no significant adverse comments, the agency has chosen this route for publication. Nevertheless, it is prepared to address any concerns and contingencies.

A companion proposed rule is being introduced in the Federal Register to be prepared in the event of withdrawal of the direct final rule due to substantial adverse comments.

The FDA is welcoming public input on both the direct final rule and the proposed rule. The comment period extends for 75 days after publication in the Federal Register. The direct final rule is set to take effect 135 days after publication in the Federal Register.

By addressing the harmful impact of artificial trans fats in foods, the FDA is encouraging food manufacturers to embrace reformulation, ultimately safeguarding the well-being of the American public and paving the way for a healthier future.

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