Last week, the U.S. Food and Drug Administration (FDA) announced in a Federal Register notice that it has made a preliminary determination that partially hydrogenated oils (PHOs), a major source of artificial trans fat in processed foods, are not generally recognized as safe (GRAS) for use in food. The November 7, 2013 notice includes the opening of a 60-day public comment period.
Under section 409 of the Federal Food, Drug, and Cosmetic Act, any substance intentionally added to food is a food additive subject to premarket approval and review by FDA, with some exceptions. The exceptions include substances “generally recognized as safe,” or GRAS, because they are generally recognized by experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedures (or, in the case of a substance used in food prior to January 1, 1958, through either scientific procedures or experience based on common use in food) to be safe under the conditions of its intended use. PHOs, which are the primary dietary source of industrially-produced trans fat have a history of use as food ingredients and have long been considered GRAS ingredients by the food industry.
However, according to the FDA, GRAS status of a specific use of a particular substance in food is time-dependent. In its Federal Register notice the agency points out that:
as new scientific data and information develop about a substance or the understanding of the consequences of consumption of a substance evolves, expert opinion regarding the safety of a substance for a particular use may change such that there is no longer a consensus that the specific use is safe. The fact that the status of a substance . . . may evolve over time is the underlying basis for FDA’s regulation at § 170.38, which provides in part that FDA may, on its own initiative, propose to determine that a substance is not GRAS.
. . .
Further, as stated previously, history of the safe use of a substance in food prior to 1958 is not sufficient to support continued GRAS status if new evidence demonstrates that there is no longer expert consensus that an ingredient is safe.
Essentially, this means that the FDA can take action when it believes an ingredient is, in fact, not GRAS. And that is exactly what is happening here.
For some, this announcement may not come as a surprise. More than a decade ago, in 1999, the FDA proposed that manufacturers be required to declare the amount of trans fat on Nutrition Facts labels because of public health concerns. The agency issued a final rule in July 2003 amending nutrition labeling regulations to require declaration of the trans fatty acid content of food in the nutrition label of conventional foods and dietary supplements (21 CFR 101.9(c)(2)(ii)). That requirement became effective in 2006. Since then, trends have shown that U.S. consumers are making a conscious decision to avoid foods with trans fat and companies are responding by reducing the amount of trans fat in their products.
So if the FDA’s preliminary determination is finalized and PHOs are deemed not GRAS, what will this mean for the food industry? If FDA makes a final determination that PHOs are not GRAS, PHOs would become food additives subject to premarket approval by FDA. Foods containing unapproved food additives are considered adulterated under U.S. law, meaning they cannot legally be sold. Accordingly, the agency and food industry would have to figure out a way to phase out the use of PHOs over time.
Interested persons may submit either electronic comments and scientific data and information to http://www.regulations.gov or written comments and scientific data and information to the Division of Dockets Management. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.