The debate over the use of trans fats has been ongoing for years. Despite claims that trans fats are unhealthy, the Food and Drug Administration historically considered them safe for use in food. Many of our favorite foods contain the ingredient, including Popeyes fried chicken and Betty Crocker frosting and cake mix.
On June 16, 2015, FDA banned the use of partially hydrogenated oils (“PHOs”), the primary source of artificial trans fat, unless and until a company gets food additive approval from FDA for use of the ingredient. FDA’s final determination found that PHOs are no longer generally recognized as safe (“GRAS”) because there is no longer a consensus among experts that PHOs are safe for use in food. The ban only applies to artificial trans fats, not naturally occurring trans fats. Food manufacturers and distributors have until June 18, 2018 to make sure they remove trans fat from their foods.
FDA’s final determination followed almost two years of hot debate after releasing its tentative determination in 2013 making the same finding. The issue is obviously a sensitive one, with more than 6,000 comments submitted by manufacturers, food industry members, consumer advocacy groups, and consumers.
Food manufacturers using the ingredient (many of whom submitted comments) still have options. Companies wishing to continue using trans fat in their products can seek FDA approval for a specific use if the company can submit data demonstrating a reasonable certainty of no harm of the proposed use.
PHOs have a long history of use as food ingredients and are subject to several regulatory requirements. Historically, an ingredient such as trans fat could be GRAS based on common use in food prior to 1958. However, when new evidence demonstrates that there is no longer a consensus that an ingredient is safe (as FDA has found for PHOs), historical use is insufficient to support continued GRAS status.
Although food manufacturers are the most capable of actually changing the ingredients in its products, distributors and restaurants also have an obligation to ensure the food they distribute, make, or serve complies with the trans fat ban. However, FDA has acknowledged manufacturers will be the focus for its initial outreach and enforcement resources.
Although companies have three years to comply, the new trans fat ban will likely lead to significant litigation in the interim. Food companies should be on the lookout for litigation claiming that any use of trans fat in food is “unsafe” and therefore in violation of consumer protection statutes around the country.
The food industry, however, will have strong arguments in opposition to any such lawsuits. Claims for damages alleging that any use (either historical or current) of trans fat is unsafe should be preempted to the extent that companies have complied with FDA labeling requirements. Potential plaintiffs should arguably also be barred from seeking injunctive relief to remove trans fats from current products because FDA has given the food industry has until June 2018 to do so.