For those of you who don’t know, Twinkie the Kid is the mascot for that classic American dessert cake, Twinkies. You may also be surprised to learn that Twinkies originally contained banana cream, until bananas were rationed during World War II (interesting), that a nutrition professor recently lost 27 pounds on a “Twinkie diet” (take that, Jared), or that, sadly, Twinkies do not keep forever (goodbye to the urban legend). These are some of the fascinating facts you learn when you look up Twinkies on Wikipedia.
Plaintiffs’ lawyers, though, seem more inclined to sue Hostess rather than revel in the cultural history of the Twinkie. Last week, a federal court in California shot down a putative class action complaining about Hostess’s “100 calorie packs” – not because you don’t get very many mini-Twinkies in those packs, but rather because they contain the following claim: “0 Grams of Trans Fat.” The putative class claimed this trans fat claim was misleading because the baked-goods products contained partially hydrogenated oils, which allegedly are linked to a parade of horribles – “heart disease, diabetes, cancer, obesity, liver dysfunction, Alzheimer’s disease, and female infertility.” Peviani v. Hostess Brands, Inc., Case No. 2:10-cv-02303-CBM-VBK (C.D. Cal. Nov. 3, 2010), slip op. at 2. The putative class brought claims under California and Missouri consumer protection laws, as well as a Lanham Act claim that was doomed from the get-go because consumers lack standing under the “false advertising” prong of that Act. Slip op. at 3, 12.
The consumer protection claims fared no better – they were preempted by the Food, Drug, and Cosmetic Act (FDCA) and its 1990 amendment, the Nutrition Labeling and Education Act (NLEA). When you flip over a package of food to check out the nutritional contents, all the information you see in that Nutrition Facts Panel is heavily regulated by the FDA through the NLEA. And the FDA will consider foods misbranded if the labeling is “false or misleading in any particular.” Slip op. at 7 (quoting 21 U.S.C. § 343 (a)(1)).
Not surprisingly, § 343(q) of the NLEA specifically requires labeling to include the amount of saturated fat and total fat in each serving size. Slip op. at 8 (citing 21 U.S.C. § 343(q)). The relevant FDA regulation states that if a serving of trans fat “contains less than 0.5 gram, the content, when declared, shall be expressed as zero.” Slip op. at 8 (quoting 21 C.F.R. § 101.9(c)(2)(ii)).
In addition, § 343(r) of the NLEA governs the labeling of nutrient content, and the relationship between that nutrient to diseases or health conditions. Slip op. at 8. The accompanying regulations make clear that express nutrient content claims are allowed so long as they’re not – you guessed it – “false or misleading in any respect.” Id. (quoting 21 C.F.R. § 101.13(i)(3)). And here’s the kicker – the NLEA provides that a statement required or permitted under a section like § 343(q) “is not a claim which is subject to [section 343(r)].” Slip op. at 8 (quoting 21 U.S.C. § 343(r)(1)).
The court found that these two sections of the NLEA “directly apply to whether the use of the phrase ‘0 grams of Trans Fat’ outside of a Nutrition Facts Panel constitutes false or misleading branding.” Slip op. at 7-8. That’s our emphasis, and it’s important. There’s an increasing amount of regulation and litigation involving so-called “Front-Of-Package” claims, which are what they sound like – claims made outside the Nutrition Facts Panel. If these plaintiffs had challenged the fat information contained in the Nutrition Facts Panel, they’d be DOA – there’s no question in this case that the Hostess Nutrition Fact Panels contained accurate trans fat information in accordance with § 343(q) and its accompanying regulations. That’s probably why the plaintiffs did “not claim that Defendants’ use of the phrase ‘0 Grams of Trans Fat’ in the Nutrition Facts Panel is false or misleading.” Id. at 11. But, having conceded that, the court found that “Defendants’ use of this same phrase elsewhere on the product label cannot be false or misleading.” Id. If the FDA allows a statement on one part of a box (or other container), plaintiffs can’t sue over the same statement elsewhere on the same package.
Not surprisingly, then, the NLEA and the accompanying regulatory scheme preempted plaintiffs’ claims. Among other areas, the NLEA expressly preempts state law establishing requirements that are “not identical” to the requirements of §§ 343(q) and (r). 21 U.S.C. § 343-l(4), (5). “Not identical” means state requirements that “are not imposed by or contained in the applicable provision,” and requirements that “[d]iffer from those specifically imposed by or contained in the applicable provision.” 21 C.F.R. § 100.1(c)(4). Given this preemptive framework, the court concluded, “[t]he FDA regulations explicitly define the term ‘0 Grams of Trans Fat’ and the NLEA expressly prohibits any state from directly or indirectly establishing any requirement that is not identical to the relevant federal requirements. Plaintiff’s claims seek to enjoin the use of the very term permitted by the NLEA and its accompanying regulations.” Slip op. at 11.
Going forward, it will be interesting to see how courts continue to treat the preemptive scope of the NLEA and its accompanying regulatory scheme. There’s no denying that the FDA is all over “Front-Of-Package” claims. Earlier this year, the FDA announced that nutrition labeling is “a priority,” and that it will be offering specific guidance on “Front-Of-Package” claims. Anyone can go to the FDA’s website and see the roll call of Warning and Untitled letters the FDA has sent on this issue over the past year. So it certainly seems as if these claims are all squarely on the FDA’s turf, and being handled by an active regulator that is using its enforcement efforts and guidance to establish and craft a consistent, nationwide approach to nutritional labeling and claims. Will that stop the plaintiffs’ bar from filing these claims? Probably not. But it may give courts pause before proceeding too far down the road of imposing state-law nutritional labeling requirements that are “not identical” to nationwide standards.