FDA Finds that Artificial Trans Fats Are Unsafe
On June 16, 2015, FDA announced it has finalized its determination that partially hydrogenated oils ("PHOs") are not "generally recognized as safe" ("GRAS") for use in human food. This finding effectively bans PHOs, which are the primary source of artificial trans fat in processed foods. FDA has set a compliance date of June 18, 2018, allowing industry three years to adjust to the order. Although the FDA's action will not eliminate naturally occurring trans fats from the American diet (found in small amounts of some meat and dairy products), it will drastically reduce the amount of artificial trans fat in the U.S. food supply and, according to FDA's Acting Commissioner Stephen Ostroff, M.D., "prevent thousands of fatal heart attacks every year."
Under the Federal Food, Drug, and Cosmetic Act ("FDCA"), a substance that will be added to food is deemed to be unsafe (and hence illegal) unless the ingredient is (i) specifically authorized by FDA or (ii) considered GRAS by a consensus of qualified experts. FDA's determination that PHOs are not GRAS means that food manufacturers can no longer use PHOs in their food without FDA approval. Although many food companies have gradually been phasing them out (often switching to mixtures of palm and coconut oils), PHOs are still commonly found in food products such as frostings, margarines, frozen pizzas, coffee creamers, pie crusts, and microwave popcorn.
The food industry has used PHOs since the 1950s to improve the shelf life of processed foods. Many scientists and public health advocates believed PHOs to be healthier than natural saturated fats, such as lard or butter, until studies in the 1990s found a correlation between trans fat intake and increased levels of low density lipoprotein, or LDL, cholesterol (so-called "bad" cholesterol). Since 2006, in response to growing public health concerns, food manufacturers have been required to include trans fat content information on the Nutrition Facts panels of their products. Between 2003 and 2012, FDA estimates that public trans fat consumption decreased by about 78 percent. Nonetheless, because FDA still considered trans fat consumption a public health concern, in December 2013 FDA made a tentative determination that PHOs could no longer be considered GRAS. FDA is now finalizing this determination.
The June 16, 2015, finding by FDA does not entirely ban trans fat from the American diet. Trans fat occurs naturally in beef, butter, and other products derived from ruminants. FDA took pains to state that the order does not apply to those products. Furthermore, trans fat can be found in most refined oils as an unintended byproduct of the refining process. The order likewise does not reach this source of trans fat. Finally, FDA leaves open the possibility that it will permit specific uses of PHOs. However, a person applying for such permission will need to provide "data demonstrating a reasonable certainty of no harm of the proposed use(s)," a daunting standard given FDA's insistence that there is no threshold below which PHOs may be safely used in the food supply.
FDA's ruling will also be viewed with interest by the parties to the many lawsuits relating to the use of trans fat in foods. Numerous lawsuits allege that products containing trans fats (or PHOs) are unreasonably dangerous. There are also numerous lawsuits alleging that it is deceptive to claim that there is no trans fat present when trans fat is present in trace amounts, or where other fats are present in the product.
Industry will have until June 18, 2018, to either reformulate products to remove PHOs and/or petition FDA to permit specific uses of PHOs. After the three-year period expires, food manufacturers will be prohibited from adding PHOs to human food without FDA approval.
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Colleen M. Heisey
Emily K. Strunk
Stephanie L. Resnik
Marina E. Moreno, FDA Coordinator in the Miami Office, assisted in the preparation of this Alert.
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