The FDA is expected to announce a final rule that could effectively eliminate most trans fat from food in the United States. In 2013 the FDA announced its preliminary finding that partially hydrogenated oils (PHOs) – – the source of most trans fatty acids in American’s foods – – are not generally recognized as safe (GRAS) for use in any food. If the FDA makes final its preliminary finding, PHOs will no longer enjoy GRAS status and will be subject to greater scrutiny by the FDA.
The regulation of trans fats can be traced back to 1999 when the FDA first proposed that manufacturers be required to declare the number of grams of trans fat on their nutrition labels. Due to growing public health concerns, the FDA finalized this rule in 2006. That rule resulted in reduced amounts of trans fat in food products. A final rule that strips trans fat of GRAS status would subject food products with trans fat to greater scrutiny and may effectively eliminate all trans fat from those products.
[A] determination that PHOs are not GRAS could in effect mean the end of trans fat in food . . . .
Under section 409 of the Federal Food, Drug, and Cosmetic Act, any substance intentionally added to food is a “food additive” subject to premarket review and approval by the FDA. However, there are some exceptions to this rule, including GRAS substances, which are generally recognized by experts as safe when used as intended. A final rule that makes PHOs a “food additive” that is no longer GRAS would require premarket approval by the FDA. If there is no such premarket approval, then foods containing trans fats will be considered adulterated, meaning they cannot legally be sold in the United States. The director of the FDA’s Office of Food Additive Safety, Dennis M. Keefe, Ph.D., said that a determination that PHOs are not GRAS could in effect mean the end of trans fat in food (although there would still be some trans fat that occurs naturally in meat and dairy products, as well as some oils). It is unclear if and how the FDA plans to regulate these natural trans fats.
Eating trans fats has been associated with raising the level of low-density lipoprotein (LDL or “bad cholesterol”) in the blood. Elevated levels of LDL in the blood can increase the risk of developing cardiovascular disease, which is a leading cause of death in both men and women in the United States.
Several class action lawsuits have been filed in the last five years over the health problems associated with trans fat. Some speculate that if the FDA finalizes a rule requiring manufacturers to get pre-market approval to sell foods containing PHOs, a second wave of consumer litigation may follow over any remaining PHOs on the market. Regardless of consumer litigation, however, stakeholders in the food industry will need to stay informed about the FDA’s final rule and how it impacts the food they manufacture, process, and sell.