FDA’s final guidance expresses its view that the phrase “evaporated cane juice” is false and misleading.
“Evaporated cane juice” has become a popular ingredient in everything from yogurt to cookies, attracting consumers who are interested in an organic alternative to traditional refined sugar and such “artificial” sweeteners as saccharin or aspartame. But food companies have also faced class-action lawsuits from consumers who claim that the phrase “evaporated cane juice” is misleading. What is evaporated cane juice? And should food companies using this ingredient exercise caution when writing their labels in light of recent regulatory guidance?
What Is Evaporated Cane Juice?
Evaporated cane juice is the common name for a sweetener derived directly from milled sugar cane using a single-crystallization process.1 Both evaporated cane juice and refined sugar are made from the liquid extracted from crushed cane stalks,2 but the manufacturing process for each is different. Unlike evaporated cane juice, refined sugar is made by heating the liquid into concentrated syrup, then refining it through repeated cycles of filtration and crystallization.3 Because evaporated cane juice does not go through additional refinement, some people see it (and other brown sugars) as a more natural alternative to refined sugar. Some also believe that evaporated cane juice may be healthier because it retains more of the B vitamins found in raw sugar cane.
FDA Draft Guidance on Evaporated Cane Juice
In 2009, the Food and Drug Administration (FDA) issued draft guidance on the use of the phrase “evaporated cane juice” in food labels. It found that the phrase was misleading because the fluid used to make the sweetener does not meet the regulatory definition of a “juice.”4 FDA instead recommended that manufacturers label the sweetener as “dried cane syrup” because cane syrup has a “standard of identify defined by regulation.”5 Specifically, 21 C.F.R. § 168.130(a) defines cane syrup as “the liquid food derived by concentration of and heat treatment of the juice of sugarcane.”
Litigation Ensues
As typically happens when FDA guidance is released, the floodgates of litigation opened. In the years following the FDA draft guidance, food companies using the phrase “evaporated cane juice” have faced a slew of class-action lawsuits. These suits, often filed under plaintiff-friendly statutes, like California’s Unfair Competition and False Advertising Laws, allege that the phrase misleads consumers, causing them to pay a premium for products they incorrectly believe to be healthier than products containing refined sugar. Plaintiffs claim they did not realize that evaporated cane juice referred to a sweetener and that they would not have bought products containing the ingredient if the manufacturer had accurately labeled it as “dried cane syrup.” They also claim that the term “juice” is misleading because it implies that these products contain an ingredient that is healthier than a sweetener.
Courts addressing the adequacy of such allegations have reached different conclusions. Some have dismissed the claims as “implausible,” reasoning that consumers would recognize evaporated cane juice as a sweetener.6 These courts have also rejected the argument that “juice” implies healthfulness, noting, for example, that the ingredient “fruit juice concentrate” is a recognized source of added sugar.7 Other courts have accepted the plaintiffs’ allegations as plausible and have allowed their claims to proceed beyond the pleading stage.8 After FDA reopened the comment period on the use of the phrase “evaporated cane juice” in March 2014, however,9 most courts chose to invoke the doctrine of “primary jurisdiction,” which permits a court to stay or dismiss an action that turns on an issue pending before an administrative agency.10
FDA Final Guidance on Evaporated Cane Juice
Two years after FDA reopened the comment period for its draft guidance and stated its intent to revise and finalize its position on the issue, the agency published its final guidance, which was a marked departure from the draft guidance issued in 2009. FDA withdrew its earlier recommendation that manufacturers use the phrase “dried cane syrup” in their labels after learning that evaporated cane juice does not come from cane syrup.11 Instead, FDA recommended that manufacturers identify evaporated cane juice as “sugar” in food product labeling and expressed its view that the phrase “evaporated cane juice is false and misleading:”
FDA’s view is that such sweeteners should not be declared on food labels as “evaporated cane juice” because that term does not accurately describe the basic nature of the food and its characterizing properties (i.e., that the ingredients are sugars or syrups) . . . . Moreover, the use of “juice” in the name of a product that is essentially sugar is confusingly similar to the more common use of the term “juice” — “the aqueous liquid expressed or extracted from one or more fruits or vegetables, purees of the edible portions of one or more fruits or vegetables, or any concentrates of such liquid or puree” (21 CFR 120.1(a)). Thus, the term “evaporated cane juice” is false or misleading because it suggests that the sweetener is “juice” or is made from “juice” and does not reveal that its basic nature and characterizing properties are those of a sugar.12
The guidance states that manufacturers may coin a new word or phrase to distinguish evaporated cane juice from other kinds of sugar based on source, color, flavor or crystal size.13 However, as with existing terms such as “turbinado sugar” or “muscovado sugar,” any new descriptor should still characterize evaporated cane juice as a “sugar.”
This change in position comes at a time when sugar has been on FDA’s radar. In May 2016, FDA also announced changes to the Nutrition Facts label, which will require manufacturers to report the amount of “added sugars” in a food product.14 FDA explained that the change was justified because scientific data show that people who ingest more than 10 percent of their total daily calories from added sugars cannot meet their nutritional needs without exceeding the recommended daily number of calories.15
Implications
So what does this regulatory action mean for food companies? Courts will likely start moving ahead with the lawsuits that have been on hold. We have already seen this process begin: On July 27, a court in the Northern District of California dissolved the stay of an action alleging that the phrase “evaporated cane juice” is misleading.16 How the courts view the guidance and what weight they give it, however, is less certain. FDA’s guidance is just that —guidance — and it is not binding on the courts. Plaintiffs will typically still need to plead and prove that their reliance on the phrase “evaporated cane juice” was reasonable and that the companies’ use of the phrase in their labels was the actual cause of their claimed injuries. While these are often difficult hurdles to clear, there is little doubt that plaintiffs will look at the guidance as a victory — as proof that the term “evaporated cane juice” is misleading under consumer protection laws. It is uncertain how courts will react to this argument, but it is likely that we will not see an end to litigation involving these claims anytime soon.
Endnotes
1 Sugar Ass’n, Types of Sugar, https://www.sugar.org/all-about-sugar/types-of-sugar/.
2 FDA, Ingredients Declared as Evaporated Cane Juice: Guidance for Industry (May 2016), available at http://www.fda.gov/downloads/Food/GuidanceRegulation/
GuidanceDocumentsRegulatoryInformation/UCM502679.pdf [hereinafter FDA Final Guidance].
3 See Sugar Association, supra note 1; Jan. 28, 2015, Letter to FDA from the Grocery Mfrs. Ass’n, Dkt. FDA-2009-D-0430-0069 (Feb. 5, 2010), available at http://www.regulations.gov.
4 Draft Guidance for Industry: Ingredients Declared as Evaporated Cane Juice; Availability, 74 Fed. Reg. 51,610 (Oct. 7, 2009), available at https://www.gpo.gov/fdsys/pkg/FR-2009-10-07/html/E9-24132.htm.
5 Id.
6 See, e.g., Pratt v. Whole Foods Mkt. Cal. Inc., No. 5:12-cv-05652-EJD, 2015 U.S. Dist. LEXIS 134968, at *17-18 (N.D. Cal. Sept. 30, 2015) (dismissing all ECJ claims); Kane v. Chobani, Inc., 973 F. Supp. 2d 1120, 1133 (N.D. Cal. Feb. 20, 2014), vacated on other grounds, No. 14-15670, 2016 U.S. App. LEXIS 5517, at *1 (9th Cir. Mar. 24, 2016) (remanding the case with instructions to stay under the doctrine of primary jurisdiction). The district court stayed the proceedings in Kane on July 29, 2016, noting FDA’s intervening guidance on the phrase “evaporated cane juice” and requesting notification of any similar resolution of the term “natural.” Kane, No. 5:12-cv-02425-LHK (N.D. Cal. July 29, 2016).
7 See, e.g., Kane, 973 F. Supp. 2d at 1134.
8 See, e.g., Gitson v. Trader Joe’s Co., No. 13-cv-01333-WHO, 2014 U.S. Dist. LEXIS 33936, at *1 (N.D. Cal. Mar. 14, 2014); Morgan v. Wallaby Yogurt Co., No. 13-cv-00296-WHO, 2014 U.S. Dist. LEXIS 34548, at *1 (N.D. Cal. Mar. 13, 2014). The parties in Gitson ultimately settled. See Joint Stipulation of Dismissal, Gitson v. Trader Joe’s Co., No. 13-cv-01333-WHO (N.D. Cal. May 23, 2016).
9 Request for Comments, Data, and Information re Draft Guidance for Industry, 79 Fed. Reg. 12,507 (Mar. 5, 2014).
10 See, e.g., Morgan, No. 13-cv-00296-JD (N.D. Cal. Oct. 14, 2015) (staying the case); Swearingen v. Amazon Pres. Partners, Inc., No. 13-cv-04402-WHO, 2014 U.S. Dist. LEXIS 111704, at *1 (N.D. Cal. Aug. 11, 2014) (staying the case); Gitson v. Clover Stornetta Farms, No. 13-01517-EDL, 2014 U.S. Dist. LEXIS 83880, at *1 (N.D. Cal. June 9, 2014) (staying the case). The district court in Morgan lifted its stay in January 2016, in part because FDA had not yet reached a conclusion. See Tr. of Jan. 13, 2016, Proceedings at 2:11-13, No. 13-cv-00296-WHO (N.D. Cal. Jan. 22, 2016); Order Lifting Stay, No. 13-cv-00296-WHO (N.D. Cal. Jan. 13, 2016). After FDA issued its final guidance in May 2016, the court again stayed the case pending Ninth Circuit resolution of unrelated questions concerning class certification, damages and the use of the term “natural.” See Morgan, No. 13-cv-00296-WHO (N.D. Cal. July 8, 2016).
11 See FDA Final Guidance, supra note 2, at 4.
12 Id. at 3.
13 Id. at 7.
14 21 C.F.R. § 101.9(c)(6)(iii) (July 26, 2016).
15 See Supplemental Proposed Rule re Revision of the Nutrition and Supplement Facts Labels, 80 Fed. Reg. 44,302, 44,308 (July 27, 2015) (citing the Scientific Report of the 2015 Dietary Guidelines Advisory Committee).
16 Order Dissolving Stay and Directing Filing of Motion to Dismiss, Reese v. Odwalla, Inc., No. 13-CV-947 (YGR) (N.D. Cal. July 27, 2016). The defendant company filed its motion to dismiss on August 10, 2016.
