Is the FDA Keeping Pace with the Current Health Adversities Through Labeling?

By Melissa Card

The marathon is coming to an end as manufacturers cross the finish line with their new products. General Mills, Kellogg, Mars, and McDonald’s have been racing to reformulate their products to remove partially hydrogenated oils (PHOs) – the primary dietary source of industrially produced trans fatty acids (IP-TFA). Manufacturers were forced to join the race by the Food and Drug Administration because Americans continue to fuel themselves on foods laden with trans fatty acids.

The race began with a slow jog in 2003, when the FDA published a final rule in the Federal Register requiring trans fatty acids to be declared on the Nutrition Facts label of conventional foods and dietary supplements. The FDA’s labeling requirement led to two behavioral changes: consumers decreased their consumption of trans fatty acids and the industry reformulated its products to reduce or remove PHOs.

Even though the labeling requirement caused positive behavioral changes, trans fatty acids were still permitted in processed foods, were still feasted upon by consumers, and were still causing adverse health consequences. Due to these consequences and others, in November 2013, the FDA made a preliminary determination that PHOs were not “generally recognized as safe” (GRAS) for use in food. The FDA released its final determination that PHOs were not GRAS for use in food in 2015.

The required labeling of trans fatty acids and final determination that the use of PHOs were not GRAS in the use of food were not arbitrary decisions by the FDA. These decisions were based on scientific evidence. In 2002, for example, the Institute of Medicine recommended that trans fatty acids needed to be replaced with alternative sources of fat, and reduced in the American diet. These recommendations were based on the finding that the consumption of trans fatty acid increases one’s risk of coronary heart disease. In 2004, FDA Food Advisory Committee, Nutrition Subcommittee agreed that reducing consumers’ trans fatty acid intake was necessary. Similar scientific evidence was established by (1) the Dietary Guidelines Advisory Committee in 2005; (2) the U.S. Department of Health and Human Services in 2005; (3) the World Health Organization in 2009; and (4) Food and Agriculture Organization in 2010.

Due to the available scientific evidence and the findings of expert scientific panels establishing the health risks associated with the consumption of trans fat, the FDA concluded that there was no longer a consensus among qualified experts that partially hydrogenated oils were generally recognized as safe for any use in human food.

While consumers are still concerned about the adverse health effects of trans fatty acids, the new craze concerns added sugars. Fad diets are eliminating added sugars from meal plans, celebrities are swearing off added sugars, and manufacturers are sprinting to reformulate their products without added sugars. The reduction of added sugars from the diet is more than a craze. Just last month the FDA published a final rule in the Federal Register requiring that added sugars be declared in the Nutrition Facts label of conventional foods and dietary supplements. It seems that the FDA is starting the slow jog to reduce (or eliminate) added sugars from the American diet, just as it has done with trans fatty acids.

Hopefully, the declaration of added sugars and the percent daily value for added sugars on the Nutrition Facts label will convince consumers to reduce their added sugar intake and manufacturers to reformulate their products. Despite the positive changes that are likely to occur, trans fatty acids exemplify that labeling is not a “be all end all” solution. Therefore, will the FDA release a preliminary determination that added sugars are not generally recognized as safe for use in food?

The Sugar Association is likely to distinguish added sugars from the trans fatty acids, arguing that the FDA has no scientific justification for releasing a preliminary determination that added sugars are not generally recognized as safe for use in food. But, the Sugar Association is wrong. Analogous to the trans fatty acid race, health organizations have established some scientific evidence:

• The Journal of the American Medical Association has found that added sugar consumption increases the risks of dying from cardiovascular disease.
• The American Heart Association has found that added sugar consumption increases the risks of developing obesity and diabetes.
• The American Institute for Cancer Research has found that added sugar consumption increases the risks of having certain types of cancers.

In addition, many health organizations have stated that added sugar consumption must be reduced.  

One can easily answer “yes” to the question of whether the FDA is keeping pace with the current health adversities through labeling. With the requirement of the declaration of added sugars and the percent daily value for added sugars on the Nutrition Facts label behavioral changes will occur with consumers and the industry.

The question that remains is whether the FDA’s release of a preliminary determination that added sugars (or at the very least fructose) are not generally recognized as safe for use in food will be a 100-meter dash or another 10-year marathon?

Melissa Card is Adjunct Professor and Associate Director of the Institute for Food Laws & Regulations at Michigan State University.