The U.S. Food and Drug Administration (FDA) has announced a final rule prohibiting statements on food product labels, including dietary supplements, that claim products are “high in,” “rich in,” or an “excellent source of” docosahexaenoic acid (DHA) or eicosapentaenoic acid (EPA) as well as similar claims for alpha-linolenic acid (ALA). The rule finalizes a proposed rule the agency published in 2007 without any substantive changes. Under the U.S. Federal Food, Drug, and Cosmetic Act (the Act), nutrient-content claims such as “high in” are allowed only for nutrients for which a reference level for the claim has been set, or, in some situations, if the requirements of the Act have been met, such nutrient levels can be based on authoritative statements published by certain types of scientific bodies, such as the Institute of Medicine of the National Academies (IOM). FDA apparently received notifications in 2004 and 2005 asserting that IOM had…
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After the U.S. Alcohol and Tobacco Tax and Trade Bureau (TTB) reportedly granted and then rescinded labeling approval for a powdered alcohol product created by Lipsmark LLC, the company has fielded a number of consumer and media questions about Palcohol’s® marketing, safety and availability. Created by wine critic Mark Phillips, Palcohol® is described as “a powder version of vodka, rum and four cocktails” meant to be mixed with water or other liquids prior to consumption. Although it received approval for the new product “some time ago,” the manufacturer was apparently “caught off guard by [TTB] making some of our approved labels public which we now know is standard procedure.” According to the product website, the company has since surrendered its TTB-approved labels with the intention of revising and resubmitting them for final authorization. In the interim, however, the media attention has prompted Lipsmark to address concerns over “humorous and edgy”…
A federal court in California has denied the motion to certify statewide monetary or injunctive relief classes in litigation alleging that J.M. Smucker’s labels for Uncrustables and Crisco Original and Butter Flavor Shortening products “mislead consumers into believing that they are healthful, when in reality they both contain trans fat and Uncrustables also contain high fructose corn syrup.” Caldera v. The J.M. Smucker Co., No. 12-4936 (C.D. Cal., decided April 15, 2014). As to monetary relief, the court dismissed the motion to certify with prejudice. The court agreed with the defendant that the plaintiff could not satisfy the predominance requirement as to her claims for monetary relief because she failed to identify any method of proving damages on a class-wide basis other than relying on the defendant’s California sales data. According to the court, this is insufficient to support a claim for restitution, because “this is not a case where class…
Vermont lawmakers have reportedly passed the nation’s first state bill (H.B. 112) to require mandatory labeling of foods made with genetically modified (GM) ingredients. Passed in the Vermont House of Representatives, 114-30, and in the state Senate, 28-2, the bill would require foods containing GM ingredients sold in retail outlets to be labeled as either “partially produced with genetic engineering,” “produced with genetic engineering,” or “may be produced with genetic engineering.” The legislation would also make it illegal to describe any food product containing GM ingredients as “natural” or “all natural.” Backers of the legislation reportedly expect Governor Peter Shumlin (D) to sign it within the next few weeks, with the law taking effect July 1, 2016. “I am proud of Vermont for being the first state in the nation to ensure that Vermonters will know what is in their food,” Shumlin was quoted as saying. “The even more thrilling…
A federal court in California has denied the motion to dismiss putative class claims that Mott’s LLP deceives consumers by placing “No Sugar Added” on its 100% Apple Juice label. Rahman v. Mott’s LLP, No. 13-3482 (N.D. Cal., order entered April 8, 2014). Information about the court’s prior decision dismissing without prejudice most of the claims in the plaintiff’s first amended complaint appears in Issue 511 of this Update. As to the plaintiff’s second amended complaint, the court disagreed with the defendant’s argument that an ongoing U.S. Food and Drug Administration (FDA) rulemaking pertaining to Nutrition Facts label disclosures about the presence or absence of added sugars required dismissal of the action under the primary jurisdiction doctrine. While the court agreed that food regulation is within FDA’s purview, it stated, “plaintiff’s claims do not concern statements made on the apple juice’s Nutrition Facts label; rather, plaintiff’s claims relate to nutrient…
A federal court in California has granted beverage manufacturer Santa Cruz’s motion to dismiss a putative class action alleging that the “evaporated cane juice” (ECJ) listed on its beverage labels is merely sugar, thus violating the Food and Drug Administration’s (FDA’s) required use of an ingredient’s “common or usual name.” Swearingen et al. v. Santa Cruz Natural Inc., No. 13-4291 (N.D. Cal., order entered April 2, 2014). Finding that FDA had primary jurisdiction over the matter, the court cited a March 5, 2014, notice that the agency has reopened the comment period on its draft industry guidance pertaining to the use of the term ECJ on food labels. Details about FDA’s action appear in Issue 516 of this Update. According to the court, this notice clearly indicates that FDA is currently engaged in “active rulemaking on the issue” and intends to resolve the matter. Citing FDA’s superior resources to determine…
The U.S. Food and Drug Administration (FDA) has issued draft guidance concerning the proper labeling of honey and honey products to ensure that such products “are not adulterated or misbranded.” In light of its earlier refusal to create a new standard of identity for honey, the agency developed the guidance to respond to labeling issues raised by a March 8, 2006, petition submitted by the American Beekeeping Federation and other honey-related associations. According to FDA, the draft guidance (i) “summarizes FDA’s legal authority over honey and honey products”; (ii) “provides a commonly used definition of honey”; (iii) “offers advice on labeling issues such as the floral source of honey, blends of honey and other sweeteners, and blends of honey and other ingredients, such as flavors”; and (iv) “describes some of the measures FDA takes to guard against honey adulterated with cane sugar, corn syrup, or residues of chloramphenicol or fluoroquinolones.”…
U.S. Rep. Mike Pompeo (R-Kansas) has introduced legislation (H.R. 4432) that would prohibit states from implementing labeling laws for foods that contain genetically modified (GM) ingredients. Titled the “Safe and Accurate Food Labeling Act,” the bill would (i) require the U.S. Food and Drug Administration (FDA) to mandate GM labeling only if those foods “are found to be unsafe or materially different from foods produced without biotech ingredients”; and (ii) establish a federal labeling standard for foods with GM ingredients, giving FDA sole authority to require labeling on such foods if they are ever deemed unsafe or materially different from foods produced without GM ingredients. According to news sources, Pompeo contends that state campaigns to label foods containing GM ingredients are intended to scare consumers, not inform them. GM crops have made “food safer and more abundant,” Pompeo said. “It has been an enormous boon to all of humanity.” GM…
A federal court in California has dismissed the claims of one named plaintiff in a putative class action alleging that certain Costco Kirkland branded products are misbranded and deceptive, and narrowed the claims of the other named plaintiff. Thomas v. Costco Wholesale Corp., No. 1202908 (N.D. Cal., order entered March 31, 2014). The plaintiff whose claims were dismissed for lack of standing had alleged that the “0 grams trans fat” labeling on Kirkland Signature Kettle Chips was untruthful or misleading. The court agreed with the defendant that she had not cured the standing defects in her second amended complaint (SAC) and thus dismissed her claims with prejudice. Among other matters, she failed to (i) allege that the chips she purchased included any amount of trans fat or that she received a product different from the one as labeled, (ii) demonstrate that the label violated 21 C.F.R. § 101.13(h)(1), or (iii)…
A federal court in California has granted in part and denied in part the motion to dismiss filed in a putative class action against Whole Foods Market. Pratt v. Whole Foods Mkt. Cal., Inc., No. 12-5652 (N.D. Cal., order entered March 31, 2014). The claims relate to a number of 365 Everyday Value® products that the plaintiff purchased and involve the following allegedly unlawful or misleading label representations: “evaporated cane juice” (ECJ), “natural” and “no sugar added.” Because the plaintiff abandoned in his amended complaint all claims regarding the defendants’ whipped topping product, the court dismissed all claims based on this product with prejudice as to the plaintiff and without prejudice as to any putative class member. The “no sugar added” claims were thus dismissed, “as the only product alleged to have such a misleading claim was the whipped topping.” The court also emphasized that, per its August 2013 order, any claims…
