FDA Reviews GRAS Status of PHOs
The Food and Drug Administration is currently considering comments on its proposed action to declare partially hydrogenated oils unsafe for food use due to their trans fat content.
The Food and Drug Administration (FDA) is currently considering comments on its proposed action to declare partially hydrogenated oils (PHOs) unsafe for use in food due to their trans fat content. If finalized, the decision could create waves in the product reformulation world and potentially set an ill-conceived precedent for other ingredients that contain nutrients of public health concern. While reducing trans fat intake represents an important public health goal, there are real questions as to whether FDA’s proposed approach is feasible or effective.
In November 2013, FDA issued a six-page Federal Register notice with its tentative determination that the ingredient is no longer generally recognized as safe (GRAS) for use in food. Should FDA finalize the determination, PHOs would no longer be able to be used in food in the U.S., unless the specific use and level is approved by the agency in a food additive regulation (a process that takes many years). Naturally occurring trans fats, such as those in some meats and cheeses, would not be affected. The comment period closed on March 8, 2014. There is significant interest in the topic, so FDA will have plenty of comments to read and address before it decides whether to move forward.
FDA received criticism, because the notice did not fully address a number of key issues. The tentative decision was issued as a notice, rather than a proposed rule, meaning the agency did not take the procedural steps required for rulemaking. FDA did not include proposed regulatory language, so there is no proposed definition of which oils are considered “partially” hydrogenated as opposed to fully hydrogenated. Nor is it clear how PHOs used as carriers, in encapsulated flavors, or other uses would be treated.
Effectively barring these technical uses of PHOs could have significant adverse effects on how foods are formulated. The agency also did not conduct a full regulatory impact analysis evaluating the costs and benefits of the proposed effective ban as compared to regulatory alternatives, such as labeling options or the option of not regulating.
Lastly, the agency did not undertake an environmental assessment to consider the potential impacts of substituting tropical oils for PHOs. Without conducting rulemaking to fully consider the impact of fundamentally changing its policy for GRAS assessments as applied to PHOs, the agency faces significant procedural challenges.
FDA correctly sought comment on the barriers to reformulation and the appropriate timeline for reformulation. As product development experts well know, removing PHOs from food is not a one-size-fits-all proposition, and the challenges and timeline for reformulation will vary, depending on the specific application.
First, commercially available altern-atives must be identified: a process that can take as long as three years. Once an alternative is identified, it must be tested in test kitchens and with consumers to ensure suitable performance, customer/consumer acceptance, shelflife and other factors.
While many of the “low-hanging fruits” in PHO usage have already been removed, the remaining reformulations will pose challenges and may take as long as 5-10 years in some cases, with no appropriate alternatives available in others.
Small businesses often lack the research and development resources of their larger counterparts, and there have been several instances where these companies have concluded they would need to discontinue products, should PHOs be effectively banned. There also is a risk that food processors will have no choice but to utilize alternatives that contain significantly higher saturated fat levels than PHOs, raising the question of whether the action would truly have a net public health benefit.
Beyond the number of issues created by FDA’s tentative view of the safety of PHOs, the path FDA has started down could set a bad precedent for other ingredients. The agency is mixing two questions that have been traditionally treated as separate: ingredient safety and devised public health policy to address the important role of diet and health. Here, FDA is relying on recommendations from public health officials and data on the risk of increased chronic disease, rather than considering the data traditionally used for ingredient safety determinations, such as toxicological studies.
By seemingly revising the criteria it uses for ingredient safety determinations, FDA could take further steps toward recasting the GRAS status of other ingredients that contribute to nutrients associated with increased risk of chronic disease.
The agency also has been criticized for the lack of scientific rigor in the notice. FDA based its tentative determination on studies showing that trans fat at levels in excess of 3% of daily caloric intake presents an increased risk of coronary heart disease; whereas, FDA estimates current daily intake of industrially produced trans fat at 0.5% daily energy.
While acknowledging the significant reductions the food industry has already made in use of industrially produced trans fat, FDA did not take those reductions into account when evaluating the scientific data. Moreover, the current levels are entirely consistent with dietary recommendations to keep trans fat intake below 1% daily caloric intake. Simply put, the available scientific evidence does not identify a health or safety risk at the low levels of PHOs currently in today’s U.S. food supply.
The food industry has made great strides in reducing the use of PHOs, with remaining barriers tied to technological barriers and similar challenges. Essentially outlawing any use of PHOs, based on chronic health risk concerns, would cause tremendous dislocation for food processors and their ingredient suppliers who depend on PHO functionality to deliver various product attributes critical to many foods.
FDA’s next steps with respect to PHOs will be important to watch. Companies should consider the business impact of replacing PHOs in food uses, including whether alternatives are readily available, and how many years that process is likely to take. Even a phased-in implementation period will create challenges that companies should plan for, should FDA go forward with revoking the safety status of PHOs.