Matthew G. Kaiser, Partner, Kaiser, LeGrand & Dillon PLLC
Editor’s Note: This is the second in a series of six guest commentary posts that will address the six distinct topic areas covered in Washington Legal Foundation’s recently released Timeline: Federal Erosion of Business Civil Liberties. To read the other posts in this series, click here.
To commit a crime, normally you have to have met two requirements. First, you have to have done something bad. Second, you have to have done the bad thing with a bad intent.
Take mortgage fraud. If you write on your mortgage application that you earn $1,000,000 a year, but you only earn $100,000, you’ve committed mortgage fraud if that’s what you intended to submit and you knew it was false. If, though, you’re using an online application and the “0” key on your keyboard was stuck so an extra zero appeared, you haven’t committed mortgage fraud, you’ve just made a mistake; you have no bad intent. Continue reading
Officials at the U.S. Department of Agriculture and the U.S. Department of Health and Human Services are currently finalizing the 2015 Dietary Guidelines for Americans (DGA). Those agencies will rely quite heavily on the Scientific Report of a USDA/HHS advisory panel—the Dietary Guidelines Advisory Committee (DGAC)—that Washington Legal Foundation and many other interested parties have criticized as driven more by ideology than sound science. The USDA and HHS Secretaries recently assured the public that the DGA will provide “nutritional and dietary information … based on a preponderance of the evidence.” One test of the Secretaries’ fidelity to that statutorily-mandated criterion will be whether the Dietary Guidelines embrace the Scientific Report’s thoroughly unscientific conclusions on caffeine. Continue reading
This 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
As 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
by David L. Wallace and Michael R. Kelly, Herbert Smith Freehills LLP*
Since the 1950s, partially hydrogenated vegetable oils (PHOs) have been used to produce all sorts of packaged foods. These ingredients increase food shelf life and flavor stability. They also contain artificial trans fats, which have been linked to various health risks, including cardiovascular disease. Despite these risks, PHOs were until recently “generally recognized as safe” (GRAS) for use as a food ingredient. The tide began to swing two years ago, though, when the Food and Drug Administration (FDA) tentatively proposed to withdraw GRAS status for PHOs “based on current scientific information” about the health risks of trans-fat consumption. It finalized this determination in a June 2015 order, declaring “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.”
Lawyers Running With Regulations
This regulatory action makes PHOs a “food additive” subject to pre-market approval by the FDA. Without FDA approval, foods containing PHOs would be deemed “adulterated” under both federal and state laws. The agency left industry breathing room, however, giving it until June 2018 either to comply or to obtain approval for certain uses of PHOs. But, like time, regulation-chasing plaintiffs’ lawyers wait for no one, and pounced on the agency’s new stance in the name of “consumer protection.” Before the FDA had even finalized its decision on PHOs, they had already installed trans fats as the latest bogeyman on supermarket shelves and the food-litigation landscape—alongside such hated fighting words as “natural,” “healthy,” “freshly baked,” and “handcrafted.” Continue reading
In 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
The 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