Contrary to headlines, the Food and Drug Administration didn't ban trans fats. The agency changed the regulatory status of PHOs, the major dietary source of artificial trans fat in processed food, from GRAS to food additive. And with that change comes industry challenges ranging from costs associated with removing and replacing PHOs to petitioning the FDA to meeting consumer needs.
While the FDA was sorting out research, studying medical findings, and weighing consumer opinions, food companies had been steadily removing PHOs from products. Now that the FDA classifies PHOs as food additives, subject to section 409 of the Federal Food, Drug, and Cosmetic (FD&C) Act. Among the key questions: Will trans fats gain traction as an approved food additive?
This classification means any use of PHOs in foods requires the submission of a food additive petition, and the FDA must approve the use. According to the Final Determination Regarding Partially Hydrogenated Oils, "Any interested party may seek food additive approval for one or more specific uses of PHOs with data demonstrating a reasonable certainty of no harm of the proposed use(s)." The FDA is giving companies until June 18, 2018, to either remove all PHOs from foods or submit a petition.
Food additive petitions
The Grocery Manufacturers Association (GMA) announced it will file a petition on behalf of food manufacturers, saying "GMA’s food additive petition to FDA will show that the presence of trans fat from the proposed low-level uses of partially hydrogenated oils (PHOs) is as safe as the naturally occurring trans fat present in the normal diet."
GMA spokesperson Brian Kennedy told Food Dive that the GMA isn't releasing any details about the petition until the FDA accepts it and makes the "several hundred page document" available for public review. Kennedy also said he wasn't aware of any individual food companies planning to file a petition.
What types of low-level uses might be included in the petition? One example is PHO-derived emulsifiers, which are used in foods such as cakes, ice cream, toppings, peanut butter, margarine, and coffee whiteners. Emulsifiers include mono- and di-glycerides, which are prevalent in baked goods. Other low-level ingredients commonly containing PHOs include spices, processing aids, pan release agents, anti-caking agents, and encapsulates for flavor agents and color additives. These ingredients are the most technically challenging to reformulate to remove PHOs.
Removing artificial PHOs is also projected to be in the $12-$14 billion range, or around $200,000 per product, according to the FDA.
Given the evidence against PHOs and trans fats, "approval of exceptions seems unlikely," according to Packaged Facts. However, it's unclear how the FDA will respond to any petition.
Making a case
Removing artificial PHOs from manufactured foods "is expected to reduce coronary heart disease and prevent thousands of fatal heart attacks each year," according to a blog post written by Susan Mayne, Ph.D., Director of FDA’s Center for Food Safety and Applied Nutrition.
Therefore, any valid petition will have to show that PHOs pose no harm. Not all experts agree that PHOs are solely to blame for heart disease. Just ask Jeremy Davis, an assistant professor of animal science, food and nutrition at Southern Illinois University Carbondale.
"You can’t just single out one ingredient and say, 'There, that’s what’s causing heart disease,' " Davis said in an SIU report. "The fact is, partially hydrogenated oils are in foods that are high energy-low nutrition – foods like canned frosting and Twinkies. If your diet includes a lot of these foods, then PHOs are not the only problem in your diet."
PHOs and trans fat
The FDA determination doesn't apply to ingredients that contain naturally occurring trans fats – meat, dairy, or to the use of PHOs as raw materials to produce other food ingredients.
Since 2003, trans fat consumption has decreased by around 78%, partly because in 2006 trans fat was required to be listed on nutrition labels.
But what if the FDA did approve a petition for continued use of artificial PHOs? That sets up a challenge for marketing teams to educate consumers who read studies that link trans fat to an increased risk of heart attack and stroke. The mission will require a company to make a case for its product to fit in a healthy lifestyle when the American Heart Association recommends limiting trans fat to less than one percent of calories consumed daily (2 grams for a 2,000-calorie diet).