Targeting trans fat: FDA issues “final rule” in long-running PHO assessment

11 Aug 2023 --- The FDA has issued a direct final rule to stop the usage of partially hydrogenated oil (PHO) in food, which solidifies its June 2015 discernment that PHOs are no longer GRAS for any human food. We examine what the finer details of the final rule mean and take a look back at what has happened in recent years since manufacturers have been developing alternative solutions to bypass PHO use and formulate workaround solutions geared toward healthy products.

The FDA expects the benefits of the rule to ”accrue from the number of coronary heart diseases averted from discontinued use of foods made with PHOs.”

Even though it has been more than two and a half years since the FDA’s January 1, 2021, date for PHOs not to be used in food, the US government agency has this week issued a new update – the final rule – which sets out some new regulations. 

The rule says that partially hydrogenated forms of menhaden and rapeseed oil can no longer be used in foods, which “revises FDA GRAS affirmation regulations.”

It also revokes using PHOs as an “optional ingredient” in peanut butter and canned tuna.

FDA revokes using PHOs as an “optional ingredient” in peanut butter and canned tuna.The GRAS status of partially hydrogenated fish oil for use as an indirect food substance is also repealed.

Based on the FDA’s conclusion that the use of PHOs in margarine, shortening and bread, rolls and buns is “injurious to health,” the federal agency has also revoked the pre-1958 authorization for their use in such foods.

Meanwhile, the FDA flags that trans fat is “naturally” present in meat and dairy products and in “very low” amounts in other edible oils. 

The final rule will come into effect from December 22, 2023.

Any industry or other stakeholder comments on the direct final rule rule must be submitted to the FDA by October 23, 2023. If the agency receives no significant adverse comments within the specified comment period, it will publish a document confirming the effective date of the final rule in the Federal Register.

Reformulation over the years
In the past, the FDA has given food manufacturers a chance to reformulate foods, such as issuing the January 2021 final compliance date to remove PHOs from the food supply. This was done to ensure an “orderly transition in the marketplace.”

The race against reformulating without trans fat has been an ongoing process for the food industry over recent years. Food companies have been researching, developing and innovating to reduce their trans fat usage in products and moreover develop PHO-free alternative solutions. 

Vegetable fat producer AAK launched a website in September 2015 for manufacturers to learn from its experience of transitioning out of PHOs. Food companies have been researching, developing and innovating to reduce their trans fat usage in products.

In 2017, Loders Croklaan developed Sanstrans, an ingredient for use in a puff pastry product with its Sanstrans Roll Rite Puff, which is free from trans fat.

Other major ingredients players like Corbion, Cargill, ADM Oils & Fats and a whole host of others switched to non-PHO products as the sector focused on the multiple workarounds there are to get to a PHO-free stage.

One of the key challenges companies face when reformulating or developing new products to eliminate or reduce industrially produced trans fat is to do so without increasing the level of saturated fats – while still maintaining the same texture, taste, shelf-stability and freshness.

Replacing PHOs has been long-established in the food industry, which once relied on PHOs in more ways than one. PHOs do not spoil as fast as other fats and have a longer shelf life, making them the most sought-after source of fat for use in commercial baked goods.

Artificial trans fat can be found in many of the same foods as saturated fat, such as baked goods, fried foods, frozen foods, snacks and various types of margarine.

According to Corbion’s scientists, the “type of application as well as the desired flavor, texture, quality and consistency” can change while modifying products, making it difficult for manufacturers to make a successful product.

The company discontinued the use of PHOs in 2017 and introduced non-PHO solutions with “full functionality.”

In recent years, the industry has been focusing on switching to healthier fats.In recent years, the industry has been focusing on switching to healthier fats, such as mono- or poly-unsaturated fatty acids to develop new products without the use of PHOs.

In 2021, Cargill announced its plan to remove industrially-produced trans-fatty acids (iTFAs) from its entire global edible oils portfolio.

Economic impact 
“The Regulatory Flexibility Act requires us to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because this rule may require some small business entities to undertake costly reformulations, we find that the final rule will have a significant economic impact on a substantial number of small entities,” the FDA states.

The quantified costs involve “reformulating” manufactured products that use PHOs currently, relabeling of PHO-containing products, recipes changes for PHO containing breads by retail bakeries, finding substitute ingredients and costs arising from “functional and sensory” product properties such as taste and texture.

Meanwhile, the edible oil industry is battling climate change and prolonged droughts are impacting oil supplies such as the recent Spanish oil shortage.

Furthermore, food innovators are shifting focus toward getting the most out of oilseeds by upcycling to maximize usage and prevent food waste.

By Insha Naureen