Health Canada Gets it Right, While FDA Goes Further Astray, on “Added Sugars” Labeling

FDAIn a comment critical of his former employer’s proposal to mandate “added sugars” labeling, a former Director of the Food and Drug Administration’s Office of Food Labeling  wrote, “‘Added Sugar’ is the ‘bête noir‘ of this decade for many in the nutrition community.” That community’s obsession with added sugars has hit an all-time high (or low) with FDA’s July 27 release of a proposed rule that “supplements” its March 3, 2014 proposed revision of the ubiquitous food Nutrition Facts panel. While U.S. regulators have been busy affirming the righteousness of their irrational approach, health officials in neighboring Canada have taken a far more reasoned stance. The contrast between the latter’s position and FDA’s proposal is quite instructive.

“Added Sugars” Charade.  Sound science and the history of government nutrition policy dictate that narrowly focusing on one food, ingredient, or nutrient is exactly the wrong way to reduce obesity. Past government pronouncements on the evils of fat and cholesterol pushed consumers away from items such as lean meat and eggs, and toward products like fat-free cookies packed with sweeteners. Now, government is admitting that we shouldn’t worry so much about fat. It’s also no longer clear that salt deserves its status as a longtime public-health bogeyman. Continue reading

Federal Judge, Referencing FDA Order on Trans Fat, Permits State-Law Class Action to Proceed

food-courtThe Food Court strikes again.

On July 15, U.S. District Court for the Northern District of California Judge William Alsup rejected Nissin Foods Company’s motion to dismiss a claim alleging that Nissin’s use of trans fat in its instant noodles was an unfair trade practice under California law. The decision comes just a month after the federal Food and Drug Administration (FDA) issued a Declaratory Order removing the generally recognized as safe (GRAS) designation from partially hydrogenated oils (PHOs), the main source of trans fat in Americans’ diets. Judge Alsup’s opinion is the first we know of to reference FDA’s order. Continue reading

A Case with Teeth?: Federal Circuit to Review International Trade Commission’s Jurisdiction over Digital “Articles”

ITCNext Tuesday, August 11, the U.S. Court of Appeals for the Federal Circuit will hear oral argument in ClearCorrect Operating, LLC v. International Trade Commission, a case that nominally involves a cease-and-desist order the International Trade Commission (ITC) imposed on a data file that contained a digital model of crooked teeth. As numerous amici in the case assert, however, the court’s ultimate decision could have significance well beyond digital teeth images; it could establish standards for the Commission’s jurisdiction over international trade in digitalized goods.

The case followed a routine path from ITC to the Federal Circuit. Align Technology complained to ITC that ClearCorrect was importing goods into the United States that infringed Align’s patents. Both companies create patient-specific “aligners” to correct crooked teeth. ClearCorrect’s facility in Texas would download data of a model created in Pakistan from a foreign-based server, and then use that data to create the aligner. Align alleged that the data “imported” from the foreign server constituted an “article,” under 19 U.S.C. § 1337, over which ITC had jurisdiction. Continue reading

Eleventh Circuit Weighs in on Need for Consumer Class Actions’ Plaintiffs to be Ascertainable

11th CircuitWhether a class of plaintiffs must be “ascertainable”—i.e. capable of being feasibly identified through an objective process—continues to be one of the most contested legal issues in class-action litigation. We’ve written about ascertainability mostly in the context of food labeling lawsuits (our collection is here) but it has arisen in claims involving other consumer products. The U.S. Court of Appeals for the Eleventh Circuit is the latest jurisdiction to weigh in on the issue with a decision that directly addresses one of the common objections to ascertainability—that it dooms small-dollar class-action suits.

The plaintiff in Karhu v. Vital Pharmaceuticals accused the defendant of falsely advertising its dietary supplement, “Meltdown Fat Incinerator,” because it did not in fact incinerate his fat. The federal district court dismissed Karhu’s claims because he failed to demonstrate the class members were ascertainable. The Eleventh Circuit affirmed the district court. Judge Richard Goldberg of the U.S. Court of International Trade, sitting by designation, authored the majority opinion and Judge Beverly Martin wrote a cautionary concurrence. Continue reading

FDA Trans-Fat Order Sets the Table for More Food Product “Regulation by Litigation”

Partially hydrogenated oil  chemical structure

Partially hydrogenated oil
chemical structure

To no one’s surprise, the Food and Drug Administration (FDA) has confirmed its November 8, 2013 initial determination that the agency no longer considers the main source of trans fat in Americans’ diet, partially hydrogenated oils (PHOs), “generally recognized as safe” (GRAS). In its announcement, FDA emphasizes how the three-year window it has granted food companies to comply with the order would “allow for an orderly [transition] process.” Before anyone applauds FDA for being reasonable or magnanimous, however, consider what else the agency says, and doesn’t say, in its Declaratory Order (“Order”). FDA’s statements and omissions essentially set the table for an explosion of private lawsuits that could require PHO-containing products to be reformulated, or removed from the market, far earlier than June 2018.

What the Order Says. Under federal law, an FDA determination that a substance is no longer GRAS is not the equivalent of it being “unsafe.” It means that because some level of uncertainty has arisen from studies of the substance, food producers must seek approval for its use in specific products through a food additive petition. The Order, however, glosses over this inconvenient nuance, and instead consistently and repeatedly states that FDA has concluded PHOs are unsafe. The media has slavishly echoed FDA’s distorted conclusion to an American public that includes prospective judges and jurors for the lawsuits to come. Continue reading

EPA Shifts its Legally Suspect “Environmental Justice” Agenda into Higher Gear

EPA-LogoIn one of our first WLF Legal Pulse posts five years ago, we wrote about efforts at the Environmental Protection Agency (EPA) to revitalize “environmental justice” (EJ), which had essentially laid dormant since the Clinton Administration. The EJ movement’s influence has gradually spread, with EPA citing “EJ concerns” among its reasons for opposing the Keystone XL pipeline, and activists utilizing EJ to successfully oppose express toll lanes in Arlington, Virginia and agitate for severe development limits in the Los Angeles area.

Several recent developments at EPA aim to inject the environmental justice movement even further into federal regulatory policy-making. Continue reading

FTC’s Actions on In-App Purchases Reflect Chilling Move Toward “Mother-May-I” Paternalism

amazonFederal regulatory agencies routinely act as table-setters for the plaintiffs’ bar. Class-action lawsuits can require targets of federal enforcement actions, even after those actions end in settlement, to defend against the same allegations in court. A federal judge’s April 3, 2015 dismissal of a class action on the ground that the company had already entered into a settlement with the Federal Trade Commission (FTC), therefore, was a commendable outcome. The underlying FTC action that inspired the suit, however—an industry-wide investigation into companies’ in-app purchase procedures—is far less welcome. The Commission’s investigation is yet another example of government’s steady drift away from respecting permissionless innovation and toward “mother-may-I” paternalism.

FTC’s In-App Purchase Inquest. FTC initiated an investigation in 2011 of various companies’ mobile-app sales practices. The Commission had received complaints from parents that their children were making “unauthorized” purchases on mobile app stores. On January 15, 2014, Apple agreed to settle with FTC over charges that its in-app purchase process constituted an unfair business practice under § 5 of the FTC Act. On September 4, 2014, Google entered into a similar settlement. Both app sellers agreed to provide customers with refunds and alter their app sales practices.

In addition to Google and Apple, FTC also accused Amazon of unfair business practices for failing to prevent “unauthorized” in-app purchases.  Amazon, however, refused to settle the charges. The Commission filed suit on July 10, 2014 in the U.S. District Court for the Western District of Washington. On December 1, 2014, Judge John C. Coughenour denied Amazon’s motion to dismiss. Continue reading