The US Food and Drug Administration has issued a Federal Register notice with its preliminary determination that partially hydrogenated oils (PHOs), the primary dietary source of artificial trans fat in processed foods, are not “generally recognized as safe” (GRAS) for use in food.
If this preliminary determination, issued on November 8, is finalized, food manufacturers would no longer be permitted to sell PHOs, either directly or as ingredients in another food product, without prior FDA approval for use as a food additive.
The notice, titled “Tentative Determination Regarding Partially Hydrogenated Oils; Request for Comments and for Scientific Data and Information,” is subject to a 60-day comment period (until January 7, 2014), during which any interested person may submit comments.
Regulatory landscape for food additives and GRAS status
Under the Food, Drug, and Cosmetic Act (FD&C 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 GRAS substances.
A substance is GRAS if it is 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. A substance that is GRAS for a particular use in food is not a food additive and may lawfully be utilized for that use without FDA review and approval.
Currently, a GRAS determination is made when the manufacturer or user of a food substance evaluates the safety of the substance and the views of qualified experts and concludes that it is GRAS (self-determination), or when the agency, either on its own initiative or on the petition of an interested person, affirms the GRAS status. There is no legal requirement for food manufacturers to submit a GRAS notification before going to market.
Status of PHOs
PHOs have a long history of use as food ingredients. The partial hydrogenation process was developed in the 1930s and has been in widespread commercial use since the 1940s. The most commonly used PHOs have been considered GRAS, through a GRAS self-determination, by the food industry for use in food at levels consistent with good manufacturing practice based on history of use prior to 1958.
History of use prior to 1958, however, is not sufficient to support continued GRAS status if new evidence demonstrates that there is no longer a consensus that an ingredient is safe. FDA recognizes that the GRAS status of a specific use of a particular substance in food is time-dependent. In other words, as new scientific data and information about a substance for a particular use develop over time, there may no longer be a consensus that the specific use is safe. FDA regulations allow the agency to propose, on its own initiative, to determine that a substance is not GRAS, as it is proposing to do so with the present notice.
FDA explains that the present determination of the GRAS status of PHOs is based on scientific evidence, which identifies significant health risks caused by the consumption of trans fat. This evidence includes the opinions of expert panels and a 2005 recommendation of the Institute of Medicine (IOM) to limit trans fat consumption as much as possible. In addition, according to the Centers for Disease Control and Prevention (CDC), elimination of PHOs from the food supply could prevent 10,000 to 20,000 coronary events and 3,000 to 7,000 coronary deaths annually. Therefore, the agency says, there is no longer a consensus among qualified scientific experts that PHOs are safe for human consumption, either directly or as ingredients in other food products.
What this means to the industry
Long before the present determination, FDA took steps to increase transparency and consumer awareness regarding the presence of trans fat in foods produced for human consumption. FDA first proposed in 1999 that manufacturers be required to declare the amount of trans fat on nutrition facts labels because of public health concerns. That requirement became effective in January 2006.
Moreover, over the past few years, several municipalities, states and other countries have taken action to reduce the use of PHOs in food. Notably, the State of California and New York City, among others, have imposed restrictions on the use of trans fat ingredients in food service establishments. The result, FDA notes, has been reduction of trans fat intake among American consumers from 4.6 grams per day in 2003 to about 1 gram per day in 2012. The preliminary determination reflects broader trends in the field of public health, with increasing scrutiny on the health implications of food. We expect these trends to continue as consumers will continue to demand more information about the food they eat and regulators at the federal, state and local level will continue to be active in this area.
If FDA determines that PHOs are not GRAS, it could, in effect, mean the end of artificial, industrially-produced trans fat in foods, according to Dennis M. Keefe, Director of FDA’s Office of Food Additive Safety. FDA recognizes that there may be additional costs to small businesses associated with removing PHOs from food and specifically requests comment on the costs and any special considerations that might be made in order to minimize the burden.
DLA Piper will continue to monitor FDA’s rules, guidelines and other initiatives affecting the food industry. If you have any questions or concerns regarding the tentative determination or would like to submit comments and scientific data, please contact us:
Margaret D. Craig
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[i] 78 Fed. Reg. 67169 (Nov. 8, 2013).
[ii] See 21 U.S.C. § 348(a).
[iii] 21 C.F.R. § 170.30.
[vii] See 21 C.F.R. § 170.38.
[xi] See 21 C.F.R. pt. 101.
[xii] 78 Fed. Reg. 67173.