Following almost two years of deliberation, and notwithstanding a nearly 80 percent drop in the consumption of trans fats over the past decade (due in part to industry's movement away from the use of partially hydrogenated oils), the FDA has made "a final determination that there is no longer a consensus among qualified experts that partially hydrogenated oils … are generally recognized as safe for any use in human food." The plaintiffs' class-action bar will attach itself to this measure like barnacles or pilot fish.
The FDA's Declaratory Order
Bad news for the processed food industry this week from Washington. Citing studies linking the consumption of trans fatty acids (or trans fat) with an increased risk of coronary heart disease, and conflating unhealthy with unsafe, the FDA has banned artificial trans fat from the nation’s food supply. Partially hydrogenated oils (PHOs) are the primary dietary source of artificial trans fat, and effective 18 June 2018 food manufacturers will not be able to add them to processed foods. The order does not apply to naturally occurring trans fat (such as those found in meat and dairy products), fully hydrogenated oils, conjugated linoleic acid, or edible oils that contain residual amounts of industrially produced trans fatty acids as a processing-related impurity.
Here is the 79-page order.
Order's Nuts and Bolts
In summary, the FDA has declared that PHOs are no longer "generally recognized as safe" (GRAS) for use in human food, based on "a lack of consensus among qualified experts that PHOs are safe for use in food at any level." It defines PHOs as "those fats and oils that have been hydrogenated, but not to complete or near complete saturation, and with an iodine value (IV) greater than 4," adding that "partially hydrogenated fats (such as partially hydrogenated lard), are included within the definition of PHOs … and therefore within the scope of this order." This is tantamount to a ban. With loss of GRAS status, PHOs become a "food additive" subject to pre-market approval by the FDA, which will require industry to produce "data demonstrating a reasonable certainty of no harm" from the proposed use. The Food, Drug & Cosmetic Act defines a "food additive" as a substance that is not GRAS, and provides that food bearing a non-GRAS food additive is "adulterated" -- and therefore illegal to sell.
Based on "net present value" calculations over 20 years, and using the crystal ball so common in Washington, the FDA predicts that its de facto ban on PHOs will "prevent large numbers of heart attacks and deaths" at an estimated cost of $6.2 billion and yield estimated benefits of $140 billion -- in terms of expected "health gains" and "medical expenditure savings."
Industry Concerns Brushed Aside
In addition to dismissing concerns about the safety of alternatives to PHOs and how the measure might disrupt the market in terms of product reformulation and access to alternative ingredients, the agency turned aside suggestions that nutrition labeling offered a better route to reducing the consumption of PHOs (as evidenced by the significant reductions achieved as a result of changes made by the FDA to food labeling requirements nearly a decade ago), and rejected proposals for the establishment of a trans fat safety threshold or to permit "certain uses" of PHOs as GRAS. The order also states the agency’s intent: (1) to undertake rulemaking with respect to two uses of PHOs that remain permissible -- namely partially hydrogenated LEAR and menhaden oils; and (2) to consider revising other regulations referencing PHOs, including (a) the standard of identity for peanut butter and canned tuna, (b) ingredient designations for PHOs, and (c) nutrition labeling requirements for trans fats.
While the FDA order is subject to legal challenge in federal court by industry under the Administrative Procedure Act, the plaintiffs' class-action bar is not going to wait and see how any challenge plays out. They will put the FDA’s order to immediate use in ongoing food litigation in the US court system. Indeed, in a class action filed just yesterday against the H.J. Heinz Company over PHOs, repeat plaintiff Troy Backus, represented by the same counsel in PHO suits against General Mills and Nestle USA, cites the FDA's final order as evidence that these ingredients are unsafe, and notes that the FDA will begin filing its own enforcement actions against companies that use PHOs in 2018.
What It Means for Purposes of Food Litigation and Liability
As previously noted in a prior post (here and here), this is manna from heaven for the plaintiffs' class-action bar in the US, which is waging a coast-to-coast litigation campaign against the food and beverage industry over allegedly false and deceptive product labeling under state consumer protection statutes. Minting novel theories of liability from the use of words like natural, healthy, organic, handcrafted, freshly baked, non-GMO, and antioxidants on food labels and related marketing materials, aggrieved consumers claim to have been duped into paying a "price premium" for products that were not what they bargained for, or that they would not have purchased had they known the "truth" about their ingredients.
"Fighting Words" for Lifestyle Nannies and "Food Police"
In sum, certain product descriptors have been turned into fighting words that you cannot say on food labels without getting sued for actual or statutory damages on a group basis. (George Carlin must be laughing somewhere.) The FDA's de facto ban on PHOs adds further fuel to this fire. Plaintiffs will use it to bolster arguments that foods containing PHOs are "adulterated," misbranded, or defective and unreasonably dangerous (because their consumption subjects consumers to an increased risk of physical harm).
As happened with tobacco litigation, the plaintiffs' class-action bar could also form an alliance with state attorneys general and other levels of government, and seek to recover the cost of treating health conditions associated with PHO consumption from food companies -- based on theories of strict liability, negligence, fraud, public nuisance, breach of warranty, etc. (We’ve previously discussed this angle at some length, see "Lawyers, Food, and Money.")
Risk Up and Down the Supply Chain
And the whole supply chain is fair game. Responding to comments that only the manufacturer that introduces the food or ingredient into the marketplace should be held responsible for non-compliance, the FDA said:
Although we are mindful of the need to focus our enforcement efforts, those needs do not change the underlying law or FDA’s legal authority. Food that is adulterated may be subject to seizure and distributors, manufacturers, and other parties responsible for such food may be subject to injunction. We recognize that manufacturers who have previously added PHO to food, rather than other parties such as distributors who merely receive and sell finished foods, are the members of the food industry who will be most directly affected by this order, and we intend to focus our outreach and enforcement resources accordingly. However, we remind distributors and other members of the food industry that they have an obligation to ensure that the food they manufacture, distribute, sell, or otherwise market complies with the FD&C Act.
What will be lost in the name of "public health" and "good living" -- and the mad dash to the courthouse by self-deputized lifestyle nannies and "food police" -- is that FDA has not actually demonstrated that PHOs are unsafe. Only that they should be deleted from the GRAS list due to "a lack of consensus among qualified experts regarding their safety."