[cross-posted at Health Affairs Blog]
On June 16, 2015, the Food and Drug Administration (FDA) released its final determination withdrawing the generally recognized as safe (GRAS) designation for partially hydrogenated oils (PHOs), which are the main source of artificial trans fat in processed foods. The agency gave the food industry three years, until June 18, 2018, to phase out the use of PHOs. The FDA’s order was expected based on the agency’s tentative determination that PHOs were no longer GRAS, published in November 2013.
This action is a milestone in — although perhaps not the culmination of — the FDA’s decades-long attempt to grapple with increasing scientific recognition that trans fat poses a serious health risk to consumers. The action is also unusual, in that it is quite rare for the FDA to withdraw GRAS status from a food product, a move that most likely will mean the ingredient is no longer used in foods.
What is not unusual, unfortunately, is the lengthy timeframe of this regulatory trajectory in the context of FDA action. To be sure, this action will lead to a dramatic reduction in the use of PHOs in processed foods, which in turn, will lead Americans to eat less trans fat – a good thing. What this regulatory action does not do, however, is speak to problems with the GRAS process as a whole.
Generally Recognized As Safe?
When Congress passed the Food Additives Amendment in 1958, which requires that all new food additives receive prior approval from the FDA, it carved out exemptions for foods that had been explicitly sanctioned before 1958 (21 C.F.R. § 181.5) and foods that had no express sanction but were in common use and were “generally recognized as safe” (21 C.F.R. §§ 182.1, et seq.).
GRAS substances are defined as “generally recognized, among 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” (21 U.S.C. § 321(s)). Pursuant to this definition, GRAS status can apply to any food ingredient (even those not in common use before 1958) that is generally recognized by scientific experts to be safe under the conditions of its intended use.
Before 1997, the FDA had a process in place for manufacturers to petition the FDA to declare a substance GRAS, but in April 1997, this process was replaced by a voluntary notification process (62 FR 18938-01). Commentators have criticized the FDA’s GRAS notification process: it leaves too much to a manufacturer’s discretion; it leaves our food supply basically unmonitored; it allows untested ingredients into the marketplace.
Partially Hydrogenated Oils
Food manufacturers have been using Partially Hydrogenated Oils in processed foods—like fried foods, snack foods, and packaged cake mixes—since the middle of the twentieth century. Foods made with these partially hydrogenated oils take longer to spoil and PHOs are less expensive than other animal fats. Because the most commonly used PHOs have been in continuous use in the food supply since before 1958, they had (until June 16) GRAS status. This meant that, despite recent research showing just how bad they are for people’s health, PHOs were implicitly approved by FDA for use in foods.
Although certain other oils and some meat and dairy products contain trans fat, PHOs are the primary source of artificial trans fat in processed foods. As recently as the 1980s, some experts believed that PHOs were healthier than other fats (remember when margarine was all the rage?). By the 1990s, however, researchers began to connect the consumption of trans fat to an increased risk of coronary heart disease. In 2002, the Institute of Medicine (IOM) recommended that people eat as little trans fat as possible because “increased risk exists at levels above zero.” Since 2006, the FDA has required that trans fat be listed on Nutrition Facts labels.
Also in 2006, the New York City Board of Health banned the use of trans fat by restaurants and bakeries, and other local governments followed. California passed a similar ban in 2008. In conjunction with mandatory labeling of trans fat, these local bans and the increased awareness of the health effects of trans fat led to an almost 80% drop in the amount of trans fat Americans consumed between 2003 and 2012. Meanwhile, the FDA received two citizen petitions, one in 2004 and one in 2009, requesting that the agency revoke the GRAS status of PHOs. Although the FDA can revoke GRAS status on its own initiative, it has done so only a handful of times. As Laurie Beyranevand explains in a law review article on the GRAS exemption, “despite recognizing that the status of a GRAS substance may change over time—as additional information is discovered about the substance’s safety—the FDA has not comprehensively reconsidered the safety of GRAS substances since 1982.”
It wasn’t until November 2013 that the FDA issued its tentative determination that PHOs were no longer GRAS, paving the way for its final determination this week. Unfortunately, it is not unusual for the FDA to act so slowly on petitions, nor is it statutorily required to act more quickly. The individual who filed the 2009 petition (a now 100-year-old professor at the University of Illinois) sued the FDA in 2013 to force a response to his petition, and it was only then that the agency acted.
The food industry has been moving away from using PHOs in products for over a decade, so compliance with the FDA’s determination should not disrupt the marketplace greatly. The FDA’s June 16 determination does permit food manufacturers to submit food additive petitions, demonstrating that a safe condition of use can be shown for PHOs, and it sets a three-year compliance window to allow time for such petitions to be filed and reviewed. The Grocery Manufacturing Association (GMA), which represents the food industry, will file a petition with the FDA to allow low levels of PHOs in food products, arguing that this use will add no more trans fat to the American diet than naturally occurring trans fat.
There will most likely be litigation regarding the FDA’s determination, in at least three areas. First, the agency did not use notice-and-comment rulemaking to withdraw GRAS status from PHOs, but instead issued a declaratory order, which may lead to a procedural challenge from opponents of the action. Second, GMA may sue the agency if it is unhappy with the resolution to its petition, or if the FDA does not render a timely decision. And finally, we may see an increase in class action lawsuits against food manufacturers that sell products with trans fat not covered by the FDA’s determination, especially if the foods are marketed as healthy.
The FDA’s action has been widely praised by consumer and health advocates and faces little opposition. There is some concern that the FDA’s focus on PHOs instead of trans fat more generally leaves other sources of trans fat in the food supply, but regardless, this determination will greatly reduce the amount of trans fat that Americans consume. Moreover, when an ingredient is removed from the food supply, there is always the possibility that its replacement will prove to be more harmful. Think, for example, about concerns that the substances used to replace bisphenol-A in food packaging may also be harmful to consumers. The FDA addressed this possibility in its determination and explained that it has considered the alternatives to PHOs and that its analysis shows a positive impact on health from the replacement of PHOs with these alternate fats. The proof, though, will be in the PHO-free pudding.
The question of whether removing PHOs from the food supply will significantly impact human health is complex. Initial evidence from New York City demonstrates that the ban on trans fat lowered the amount of trans and saturated fat in purchased foods, thereby lowering the intake of these fats. Moreover, the change in New York City was cost-neutral for food producers. Happily, the quality of the doughnuts remains high.
The FDA’s removal of the GRAS status of PHOs is remarkable in its potential health impact and in its regulatory uniqueness. The marked delay between the initial recognition of trans fats’ health impacts and the agency’s withdrawal of GRAS status—almost two decades—is problematic, however. And so is the persistence of the flawed GRAS system itself.