In May 2016, the FDA announced that it intended to re-evaluate its regulations concerning implied nutrient content claims, including the use of the term “healthy,” in light of evolving nutrition science. As part of that process, the FDA issued guidance this Tuesday, September 27, in which it clarified its position on two types of nutrient content claims. The FDA first announced that it will decline to require foods labeled as “healthy” to comply with the requirements for total fat content in 21 C.F.R. § 101.65(d), so long as the amounts of monounsaturated and polyunsaturated fats are declared on the label and the amounts declared constitute the majority of the product’s fat content. The FDA reasoned that this rule is consistent with recent developments in nutrition science, which has “shifted away from limiting total fat intake to encouraging intakes of mono and polyunsaturated fats.” The FDA also announced that it would no longer require foods labeled as “healthy” to contain at least ten percent of the daily value per reference amount customarily consumed of Vitamin A, Vitamin C, calcium, iron, protein, or fiber if the food instead contained at least ten percent of the daily value per reference amount of potassium and vitamin D, which the FDA characterized as “nutrients of public health concern.” As Law360 notes, this guidance may have a significant impact on lawsuits arising out of food manufacturers’ use of the term “healthy.”
In an article written by Jenner & Block Partner Nancy Libin for The Hill, Ms. Libin examines the Federal Communications Commission’s (FCC) proposed privacy rules for broadband providers, which she calls both “anti-consumer” and “anti-competitive.” The article explains that the new rules depart from the Obama Administration and Federal Trade Commission’s (FTC) well-established policy and, as a result, limit companies’ ability to innovate and offer new products and services to their customers. She explains how the proposed rules also risk undermining the US-EU privacy shield agreement as well as distort competition in the online marketplace. In addition, the new rules do not distinguish between sensitive and non-sensitive data, a critical feature of US and EU privacy policies that ensures data use restrictions are linked to real privacy risks. Not only do the proposed rules lack this distinction, Ms. Libin maintains, but the FCC has not detailed any privacy harms or possible privacy harms that could result if the FCC adopted policies in line with the traditional FTC framework.
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In 2015, following an FDA warning letter asserting that KIND LLC violated FDA regulations by advertising its signature KIND bars as "healthy and tasty," plaintiffs around the country filed lawsuits alleging that KIND misleadingly advertised its products as "healthy," "all natural, and "non GMO." Once the cases were consolidated into an MDL before Judge William Pauley of the Southern District of New York, the claims began to narrow. After the FDA declared in April 2016 that it would "reevaluate" its regulations concerning nutrient content claims in light of "evolving nutrition research," the plaintiffs dismissed their "healthy" claims but continued to maintain that KIND falsely labeled its products as "all natural" and "non GMO." Last week, however, the court issued an order disposing of both of those claims. The court first stayed the "all natural" claims under the “primary jurisdiction” doctrine. Relying primarily on a recent line of Ninth Circuit cases, the court concluded that the case should be stayed in deference to the FDA's discretion and superior technical expertise and emphasized the benefit of "harmoniz[ing] court rulings" about the meaning of the term "natural." The court then dismissed the plaintiffs’ claims that KIND falsely labeled its products as “non-GMO.” Although the court acknowledged that “non-GMO” claims were “potentially cognizable,” it held that the plaintiffs’ claims were insufficiently pled: while the plaintiffs alleged that some KIND products had tested positive for GMOs and that the presence of certain ingredients (such as corn) made it likely that the products contained GMOs, the court concluded that the plaintiffs’ “failure to specify which products included GMOs and whether they actually purchased those products renders their allegations insufficient.”
In re: KIND LLC “Healthy & All Natural” Litigation, --- F. Supp. 3d ----, 2016 WL 4991471 (S.D.N.Y. Sept. 15, 2016).
On Monday September 12, the Ninth Circuit heard oral arguments in two consumer class action appeals – Brazil v. Dole and Briseno v. ConAgra – that could significantly impact California consumer protection law. In Brazil, the plaintiffs challenged (among other things) the “all natural fruit” labels on Dole fruit products. The district court dismissed certain claims at the pleading stage, including the plaintiffs’ theory that Dole’s products were “unlawful” under California’s unfair competition law because they were misbranded and therefore illegal to possess. The district court later decertified the class based on the plaintiffs’ failure to present a viable class-wide damages model, then granted summary judgment to Dole based on the plaintiffs’ insufficient evidence of consumer deception. The plaintiffs challenged all of these decisions on appeal. During oral argument, the Ninth Circuit panel focused on the viability of the plaintiffs’ illegal product theory, questioning whether any consumer had ever been prosecuted for possessing a misbranded product under the California statute at issue. The panel also asked the parties to address whether the court should defer to the Food and Drug Administration under the primary jurisdiction doctrine, as they did recently in Kane v. Chobani, due to the agency’s anticipated rulemaking regarding “natural” labels.