On June 17, 2015, the U.S. Food and Drug Administration (FDA) issued its much-anticipated Final Determination Regarding Partially Hydrogenated Oils (Order),finding there is “no longer a consensus that partially hydrogenated oils (PHOs), the primary source of industrially-produced trans fat, are generally recognized as safe (GRAS) for use in human food, based on current scientific evidence.” See Order at 71. The Order’s key points are as follows:
- PHOs are not GRAS for any use in human food.
- Food additive approval is not granted but the possibility is not foreclosed. Industry is invited to submit food additive petitions for specified uses of PHOs, which will require a compelling scientific showing that the proposed use is reasonably certain not to present a risk of harm to consumers.
- Industry is provided a three-year phase-out period for reformulation and relabeling of products.
- As of June 18, 2018, food manufacturers will not be permitted to sell PHOs or food products containing PHOs without prior FDA approval for use as a food additive.
- The Order does not contain any express preemption or safe harbor from civil litigation.
- The Order does not change PHO or trans-fat labeling requirements.
The Order is the culmination of a process that began with the FDA’s November 8, 2013, Tentative Determination Regarding Partially Hydrogenated Oils and more than 18 months of input from stakeholders. During the comment period, the FDA received extensive feedback from the industry – including industry groups such as the Grocery Manufacturers Association and American Baking Association – urging the FDA to reconsider its position. Many of those comments are summarized and addressed throughout the Order. As many stakeholders pointed out, many food manufacturers steadily reduced PHO content in the marketplace since the FDA began requiring trans-fat labeling in 2006. As a result of manufacturers’ efforts and consumer education, American PHO consumption has fallen substantially.
Some stakeholders argued PHOs should remain GRAS and that trans-fat consumption should be addressed using alternative methods, such as labeling. Other stakeholders sought implementation of a threshold level, below which PHOs would be permitted, pointing out that PHOs at certain low levels have not been shown to adversely affect human health, yet play an important role in the texture and stability of products (e.g., frostings, cake sprinkles and chewing gums). These commenters requested that PHOs be allowed below a certain permitted level or for certain limited applications. Commenters also noted that, should the FDA revoke the GRAS status of PHOs, a lengthy implementation period would be necessary to allow the industry time to reformulate products and to cultivate and source appropriate PHO replacements. Finally, many stakeholders requested a safe harbor period from civil litigation, noting the FDA’s determination otherwise could lead to a glut of PHO class action lawsuits. The potential flood of litigation prompted Forbes to deem the Order “FDA's Next Gift to the Litigation Industry.”
With the exception of allowing a three-year implementation period, the FDA was largely unresponsive to industry concerns.
II. The Final Order and its Impact
Significance of Non-GRAS Status
The FDA’s Order that PHOs are no longer GRAS represents a sea change. PHOs, created when hydrogen is added to vegetable oil through a process called hydrogenation, have been widely used to increase the shelf life and flavor stability of foods in the United States since the 1940s. PHOs generally have been considered GRAS by the food industry based on a history of common use in foods prior to 1958. Because PHOs are no longer GRAS, they are deemed “food additives” subject to premarket approval by the FDA.
Foods containing unapproved food additives are considered “adulterated” under U.S. law, meaning they cannot legally be sold. As Dennis M. Keefe, Ph.D., director of F.D.A.’s Office of Food Additives, explained before this Order was issued: “If F.D.A. determines that PHOs are not GRAS, it could, in effect, mean the end of artificial, industrially produced trans fat in foods. If F.D.A. makes a final determination that PHOs are not GRAS, the agency and food industry would have to figure out a way to phase out the use of PHOs over time.” That future begins now.
The Order contains a compliance date of June 18, 2018. Although some stakeholders sought longer implementation periods (with some seeking periods up to 10 years), the Order states that based on FDA experience and observation of market changes, a three-year implementation period is sufficient to minimize market disruptions, identify suitable replacement ingredients for PHOs, exhaust existing product inventories, and reformulate and modify labeling of affected products. The FDA also believes the implementation period will allow agriculture sufficient time to grow, harvest and process new oilseeds, and to address the supply chain issues associated with the transition to new oils.
Absent a successful food additive petition allowing PHO usage, the Order requires all products be PHO-free by the compliance date – at which time their presence will render the food “adulterated.” Accordingly, producing, distributing or selling PHO-containing products after June 18, 2018, absent an additive petition being granted almost certainly will expose a producer to regulatory action and further civil liability.
Opportunity to Seek Preapproval of Specified Food Additives
Despite stakeholders’ requests, the Order refused to set acceptable levels of PHOs or make exceptions for specific products or applications (such as emulsifiers, encapsulates, pan release agents, anti-caking agents, gum bases, and use in frostings, fillings and coatings). As the FDA explained, “[r]egarding the proposals for alternate approaches suggesting a threshold for trans fat in food or oils or suggesting that FDA declare some uses of PHOs as GRAS, no comments provided evidence that any uses of PHOs meet the GRAS standard, or evidence that would establish a safe threshold exposure level.” See Order at 65. Instead, the Order shifts the onus to industry to submit scientific evidence – as part of food additive petitions under section 409 of the Food, Drug, and Cosmetic Act (FD&C Act) – establishing uses and levels for which petitioners can establish to a reasonable certainty that the proposed PHO usage is not harmful. The Order notes that the three‑year compliance period allows time for such petitions and their review.
The Order does not alter PHO or trans-fat labeling. Two sections of the Nutrition Labeling and Education Act (NLEA), 21 U.S.C. §§ 343(q) and (r), directly apply to trans-fat labeling. Section 343(q) enumerates the requirements for the labeling of nutrition information that typically appears in the Nutrition Facts panel. 21 U.S.C. § 343(q). The nutrition information labeling must include, among other things, the amount of saturated fat and total fat in each serving size. 21 U.S.C. § 343(q)(1)(D). The accompanying regulation requires the trans-fat content in each serving to be expressed on nutrition information labels. 21 C.F.R. § 101.9(c)(2)(ii). The regulation further requires that, if a serving of trans fat “contains less than 0.5 gram, the content, when declared, shall be expressed as zero.” Id.
Although it may seem counterintuitive to determine PHOs are not GRAS but not alter trans-fat labeling requirements, it makes sense for several reasons. First, maintaining the current labeling regulations allows for continued labeling of PHO‑containing products during the implementation period. Second, although PHOs are the primary source of artificial trans fat, other ingredients contain naturally occurring trans fat (such as those ingredients derived from ruminant animals, fully hydrogenated oils, or edible oils that contain small levels of trans fat as an impurity). Therefore, maintaining the current labeling regime allows for the consistent labeling of trans-fat content both from PHO and non-PHO sources during the phase-out and beyond.
The Order expressly reserves the FDA’s right to “further address trans fat through labeling requirements in the future.” Id.
Finally, although some stakeholders sought protection from civil litigation during any implementation period, the Order does not contain any express preemption or safe harbor provision. Instead, the Order notes that “[t]here is no statutory provision in the FD&C Act providing for express preemption of any state or local law prohibiting or limiting use of PHOs in food, including state or local legislative requirements or common law duties.” Id. at 21. The Order further takes the position that, although state or local laws may be preempted where compliance with both federal law and state or local law is impossible or would frustrate federal objectives, “FDA believes … that state or local laws that prohibit or limit use of PHOs in food are not likely to be in conflict with federal law, or to frustrate federal objectives.” Id. at 22.
Although the lack of express preemption or other civil litigation protections is a disappointment to industry – and will invariably be a catalyst for attempted PHO litigation – whether such litigation is viable during the three-year implementation period is highly questionable. Prior to this Order, attempted class action lawsuits against food manufacturers based on PHO content and labeling were generally rejected. For example, in Simpson v. Cal. Pizza Kitchen, Inc., 989 F. Supp. 2d 1015, 1022 (S.D. Cal. 2013), the plaintiff alleged she suffered personal and economic injury caused by the purchase and consumption of frozen pizzas containing PHOs. While the court found that the plaintiff had sufficiently established the harmful effects of prolonged consumption of PHOs (and associated trans fats), the court was not convinced the plaintiff’s consumption of PHOs from the subject pizza caused her a physical or economic injury-in-fact and, therefore, the plaintiff lacked Article III standing. Additionally, in dicta, the Simpson court opined that PHOs could not be deemed an adulterant because they were considered GRAS by the FDA.
Similarly, in Peviani v. Hostess Brands, Inc., 750 F. Supp. 2d 1111, 1117 (C.D. Cal. 2010), the plaintiff asserted a slew of California state law claims based on a product’s PHO content and the label statement that the product contained “0 Grams of Trans Fat.” In granting the defendants’ motion to dismiss, the court found all of the plaintiff’s state law-based claims were preempted by the NLEA express preemption provision, which required products containing less than 0.5 gram of trans fat per serving to be labeled as “0 Grams of Trans Fat.” As the Peviani court explained, “Plaintiff's claims seek to enjoin the use of the very term permitted by the NLEA and its accompanying regulations. Plaintiff's claims must therefore fail because they would necessarily impose a state-law obligation for trans fat disclosure that is not required by federal law.” Id.
Although some plaintiffs’ counsel invariably will invoke the Order in an attempt to bring suits involving PHO-containing products, those efforts will face substantial challenges. For example, the NLEA’s labeling preemption, relied on in Peviani, remains in full force and effect. Additionally, putative plaintiffs will still face the heavy burden of establishing an injury-in-fact and Article III standing – hurdles found insurmountable inSimpson. Finally, although the Simpson Court’s reliance on FDA GRAS status to reject claims that PHOs are an adulterant appears in question, courts could find such claims foreclosed during the three-year implementation period.
The FDA’s determination that PHOs are no longer GRAS has widespread implications for many manufacturers and producers. While the three‑year implementation period appears reasonable, the plaintiffs’ bar likely will argue that the Order opens the door to civil litigation during the implementation period.