FDA Sets Stage to Ban Trans Fats in Processed Foods

Disclosures

November 07, 2013

The US Food and Drug Administration (FDA) announced today that it has taken the first step to eventually remove artificial trans fats from processed foods, which, in the agency's estimation, could prevent 20,000 heart attacks and 7000 deaths from heart disease each year.

That first step is a preliminary determination by the FDA that partially hydrogenated oils (PHOs), the primary source of trans fats in processed foods, are no longer "generally recognized as safe (GRAS)." The agency said it made the decision on the basis of available scientific evidence and the findings of expert panels.

Food manufacturers can add ingredients with GRAS status to their products without advance approval by the FDA. If PHOs lose GRAS status, food manufacturers would have to reformulate their products to exclude these oils or else convince the FDA that a specific use of PHOs is safe under the agency's safety standard, called "reasonable certainty of no harm."

In a news conference today, FDA Commissioner Margaret Hamburg, MD, noted that the Institute of Medicine has concluded that trans fats "provide no known health benefit" and that "there is no safe level of consumption."

When consumed, trans fats raise the level of low-density lipoprotein, which increases the risk for coronary artery disease.

For the next 60 days, the FDA will be accepting comments on its plan to ban PHOs from processed foods. In particular, it is looking for input on the length of time food manufacturers need to comply with the ban. "We recognize that it may take some time to phase out their use," said Michael Taylor, the FDA's deputy commissioner for foods and veterinary medicine, in a blog post today. After the comment period, the agency will decide whether to make its preliminary determination final.

The preliminary determination does not apply to the small amounts of trans fats that naturally occur in some meat and dairy products.

The agency noted that the food industry has been voluntarily reducing the amount of trans fats in many of their products. However, trans fats still appear in the likes of microwave popcorn, frozen pizzas, margarines, and coffee creamers, even though many of these products can be made without this ingredient.

The FDA said that daily per capita consumption of trans fats in the United States fell from 4.6 g in 2003 to roughly 1 g in 2012. It attributes this trend to reduced levels of trans fats in processed foods and greater consumer understanding of this dietary culprit, which has been listed on Nutrition Facts labels of foods since 2006.

"However, current intake remains a public health concern," said Dr. Hamburg.

Food Manufacturers Have Had Time to Devise Alternatives

The FDA's first step toward removing trans fats from processed foods won praise from public health experts and organizations.

"The American Heart Association (AHA) has long advocated for eliminating trans fat from the nation's food supply, and we commend the FDA for responding to the numerous concerns and evidence submitted over the years about the dangers of this industrially produced ingredient," said AHA Chief Executive Officer Nancy Brown in a news release.

Brown urged the FDA to strike an additional blow against trans fats — revising the policy for classifying foods as "trans fat-free." Right now, less than 0.5 g of trans fats can be rounded down to zero on a product's Nutrition Facts label. "This policy confuses and misleads consumers about the amount...they are actually eating," she said.

Mark Urman, MD, a member of the cardiovascular disease prevention committee of the American College of Cardiology, said he was thrilled by the today's FDA announcement.

"We are hopeful and confident that [a ban] will improve cardiovascular health in the United States," Dr. Urman told Medscape Medical News. "Hopefully, the food industry will come up with healthy alternatives to trans fats."

It's not as if the proposed FDA policy is catching the industry off guard, said Dr. Urman, a clinical professor of medicine at the David Geffen School of Medicine at the University of California, Los Angeles.

"We've given them a warning over the past 5 years about trans fats," he said. "Most companies have already started going in the direction of reducing them. [They've] had time to come up with alternatives."

More applause came from Walter Willett, MD, DrPH, chair of the nutrition department at the Harvard School of Public Health in Boston, Massachusetts.

"The FDA decision is very welcome and strongly supported by massive scientific evidence that trans fat has many adverse effects on health," Dr. Willett said in an email to Medscape Medical News.

Further reductions of trans fats "will likely nudge down rates of diabetes, obesity, and other conditions as well," Dr. Willett said. "Importantly, by getting trans fat off the table entirely, we will be able to focus attention on other aspects of diet that also need to be improved."

The FDA move could have "a ripple effect worldwide," he noted, "because other countries are considering similar actions."

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