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
Partially hydrogenated oil
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
Science and Federal Regulation: Is the Office of Management and Budget an Effective Gatekeeper?
WLF Media Briefing, Tuesday, May 19, 10:00-11:00 a.m. EDT
Location: 2009 Massachusetts Avenue, NW (WLF headquarters)—RSVP to firstname.lastname@example.org or click HERE for free registration to view program live online
In a recent post, we lampooned the “high trans fat intake consumer” the Food and Drug Administration (FDA) invented to advance its de facto ban of partially hydrogenated oils (PHOs) as being a cross between Augustus Gloop and Homer Simpson. The ramifications of such a PHO ban for many processed food makers and their customers, however, are no laughing matter. Among other things, FDA’s final determination could expose the food industry to an avalanche of lawsuits and potentially billions of dollars in liability costs.
The Current Litigation Environment. Plaintiffs’ lawyers have been working feverishly for the past decade to turn lawsuits against “Big Food” into the next big payday. As chronicled on this blog since its inception in 2011, a small but persistent segment of the Litigation Industry has filed hundreds of class-action lawsuits alleging that everything from a perceived excess of empty space in a bag of chips to the printing of “evaporated cane juice” on a label violates state consumer protection laws.
By Litigation Industry standards, this lawsuit product line has not yet met profit expectations. But the lawsuits have successfully established, especially in California, that private litigants can enforce federal food laws and regulations. Continue reading