The Food and Drug Administration is giving food companies three years to phase out the inclusion of artificial trans fats in their processed food products, a move health experts say could prevent thousands of deaths from cardiovascular disease.
But consumer health advocates say federal regulators should refocus their efforts on getting the food industry to reduce the amount of sodium, which they say has been linked to even more adverse health events.
The FDA on Tuesday finalized a tentative determination the agency made in 2013 on partially hydrogenated oils, declaring that they were not “generally recognized as safe” or GRAS for use in human food. Food companies will have up to three years to remove such oils, a main source for artificial trans fats in processed foods, from their products.
“The FDA's action on this major source of artificial trans fat demonstrates the agency's commitment to the heart health of all Americans," FDA Acting Commissioner Dr. Stephen Ostroff said in a statement. “This action is expected to reduce coronary heart disease and prevent thousands of fatal heart attacks every year.”
In a statement, the Grocery Manufacturers Association said it was “pleased” with the FDA's decision to allow companies time to comply with the new requirements, saying it minimizes "unnecessary disruptions to commerce.”
“GMA will work in collaboration with FDA to further reduce PHOs in foods,” according to the statement. “The delayed effective date for FDA's Notice of Final Determination regarding the Generally Recognized as Safe (GRAS) status of Partially Hydrogenated Oils (PHOs) provides time needed for food manufacturers to complete their transition to suitable alternatives and/or seek food additive approval.”
By determining PHOs as not safe in food, manufacturers will have to petition the FDA for permission to include them in their products for specific uses.
The negative health effects that result from the consumption of trans fats has been known for years. That prompted the FDA in 2006 to require food producers to include trans fat content information on the Nutrition Facts label for their products. Eating trans fats has been associated with raising low-density lipoprotein, also known as bad cholesterol, while lowering levels of high-density lipoprotein, which is regarded as being beneficial.
Companies have been reducing trans fats levels in their products over the past decade, which the FDA estimates has been a key factor in reducing consumer trans fat consumption by 78% between 2003 and 2012. The Centers for Disease Control and Prevention estimates that avoiding artificial trans fats could prevent up to 20,000 heart attacks and as many as 7,000 deaths from heart disease each year in the U.S.
But some health experts say it is still not clear exactly how much a trans fat ban will lower heart attacks or heart-related deaths.
“It would be nice to have a randomized trial that actually says that there is a difference in outcome,” said Dr. Kim Williams, chief of cardiology division at Rush University Medical Center in Chicago. “But certainly, what we know is that having the trans fat tends to make more cholesterol issues for patients, and those cholesterol issues more than likely will become blood vessel issues over time."
While health advocates praised the FDA's decision, they contend the public health threat that comes from the levels of sodium added to processed foods has the potential to impact more people but has yet to be addressed by federal regulators.
“I think that both sodium and added sugars are, in fact, areas where the Food and Drug Administration needs to look at whether or not the current excessive levels are in fact generally regarded as safe,” said Jim O'Hara, director of Health Promotion Policy for the Center for Science in the Public Interest.
Estimates say Americans on average consume more than 3,400 mg of sodium a day, well beyond the 2,300 mg a day limit recommended by the Dietary Guidelines of America. The call for FDA action became louder after the Institutes of Medicine released a report in 2010 calling on the agency to impose mandatory limits on the amount of sodium food companies would be allowed to add to their products.
CSPI estimates reducing sodium consumption could save up to 100,000 people around the world a year, and save as much as $1 trillion in related healthcare costs over 10 years.
The FDA made an attempt last year to address the issue of sodium added to food products, with reports indicating it was looking to establish voluntary salt guidelines for food manufacturers. So far, no word has come from the agency regarding when those guidelines may be issued.