FDA’s Latest Regulatory Salvo at “Added Sugars” Ignores Federal Laws, Due Process, Part II

FDAThis is the second part of a two-part commentary on FDA’s requirements that added sugars be listed on the food Nutrition Facts panel, and that a Daily Reference Value (DRV) be set for added sugars and included in the panel footnote. For part I, click here.

 FDA’s Reliance Solely on a DGAC Report to Establish a DRV is Unprecedented

When implementing the Nutrition Labeling and Education Act, FDA first set daily reference values in 1993 based on “sufficient scientific consensus,” a standard established by the agency under that law. FDA did not rely on a federal advisory committee’s report. Moreover, it relied only minimally on the Dietary Guidelines for Americans itself. Instead, FDA cited numerous consensus reports which, taken together, constituted “sufficient scientific consensus.” Continue reading

FDA’s Latest Regulatory Salvo at “Added Sugars” Ignores Federal Laws, Due Process, Part I

FDAAs we discussed in an August 11 post, a “supplementary proposed rule” from the Food and Drug Administration (FDA) has taken the federal government’s contrived campaign against “added sugars” to a new level. FDA not only cites a federal advisory committee’s report as retroactive justification for added-sugars disclosure on food labels, it also seeks to establish a Daily Reference Value (DRV) for added sugars. The DRV would be used to calculate a “%DV” that would appear in addition to the grams of added sugars on the Nutrition Facts label. Finally, FDA released results of a consumer survey, completed after its initial added-sugars labeling proposal in March 2014, in support of the Nutrition Facts mandate. The public comment period for these items ends on October 13.

In this two-part commentary, we discuss some of the federal statutory and administrative procedural problems with the supplementary proposed rule. These legal infirmities, which stakeholders will likely raise in their public comments, could expose the agency to court challenges. Continue reading

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

King v. Burwell’s Implications for Employer-Sponsored Health Plans

Guest Commentary

Kim Wilcoxon, Thompson Hine LLP

Three years ago, the Supreme Court of the United States announced its decision in NFIB v. Sebelius and upheld the individual mandate under the Patient Protection and Affordable Care Act (ACA). Last week, the Supreme Court announced its decision in King v. Burwell and upheld the Internal Revenue Service’s (IRS) interpretation that tax credits were available under the ACA for taxpayers in all states, whether or not a state’s exchange was established by the state government or the federal.

There are many similarities in how these decisions affect employer-sponsored health plans. It’s déjà vu all over again, so this post revisits questions addressed in this blog three years ago in light of King v. Burwell. 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

Law Professor’s Attack on WLF’s “Legislative Grace Canon” Argument in “King v. Burwell” Brief Sails Wide of the Mark

Not a "canon"

Not a “canon”

University of Iowa College of Law Professor Andy Grewal blogged earlier this year about WLF’s amicus curiae brief in King v. Burwell at the Yale Journal on Regulation’s Notice & Comment Blog. While we’ll refrain from comment on his rather pedantic advice as to what material is best included in a brief, we did want to set the record straight about the crux of WLF’s argument, especially given the decision’s imminent release before the Supreme Court term ends later this month.

In a nutshell, WLF’s brief asks the U.S. Supreme Court to reverse an appeals court ruling that, if upheld, would allow IRS to appropriate billions of dollars a year in tax credits without authorization from Congress. IRS argued that it was entitled to Chevron deference for the agency’s interpretation of § 1321 of the Affordable Care Act (ACA), which authorizes subsidies for an exchange “established by the State.” Continue reading

California’s New Scrutiny of Patent Litigation Settlements Will Not Stand Under Federal Law

cali sealThe California Supreme Court earlier this month issued an opinion that subjects litigants who settle their patent disputes to scrutiny under state antitrust law. The court reasoned that such settlements may create unreasonable restraints on trade. While the decision in In re Cipro Cases I & II to reinstate antitrust claims was not overly surprising—after all, the U.S. Supreme Court had previously held in FTC v. Actavis, Inc. that some patent litigation settlements might violate federal antitrust law—the breadth of the California Supreme Court’s decision could have a particularly negative impact on the free-enterprise system. Indeed, the decision suggests that parties to a patent litigation settlement will have great difficulty ever avoiding California antitrust liability if the settlement entails transferring anything of value from the patent holder to the alleged infringer. Because Cipro’s new state-law antitrust standard is so much more exacting than the standard announced by the U.S. Supreme Court in Actavis, federal antitrust law may well trump California’s standard. Indeed, were Cipro to reach the U.S. Supreme Court, the Court likely would reverse on federal preemption grounds.

“Reverse-Payment” Patent Settlements

When parties to litigation enter into a settlement, one would normally expect that any cash payments would flow from the defendant to the plaintiff. The normal expectations have been reversed in the context of litigation involving prescription-drug patents, however, as a result of financial incentives created by the Hatch-Waxman Act, a federal statute designed to ensure that generic versions of prescription drugs enter the market more quickly. The Act includes a provision that permits generic companies, by declaring to the Food and Drug Administration a belief that the patent held by a brand-name drug company is invalid, to essentially force the patentee to immediately file a patent infringement suit. It also grants huge financial awards to generic companies that successfully challenge drug patents. Continue reading