At long last, FDA has called for public comment from the food and beverage industry, citizens, and other stakeholders on the use of the term “natural” on food labeling. As many readers of this newsletter know all too well, there have been hundreds of class action lawsuits filed (primarily in the federal courts in California, sometimes referred to as the “Food Court”) over the last few years against food and beverage manufacturers whose products use the term “natural” in their marketing and labeling. These lawsuits allege that the term “natural” is often false and misleading because many products contain ingredients, or are produced using methods, that consumers would not consider “natural” at all. This litigation explosion was made possible, in part, by FDA’s long regulatory silence regarding permissible uses for the term.
FDA’s recent call for comment presents an opportunity for any company currently embroiled in litigation involving the term “natural” to request that the court apply the doctrine of “primary jurisdiction” to dismiss the lawsuit, or to stay it in light of the possibility that FDA may provide additional guidance regarding the use of the term. Primary jurisdiction is the doctrine that permits a court to dismiss a complaint (without prejudice) or to stay proceedings pending the administrative resolution of an issue within the special competence of a government agency (in this context, FDA).
Historically, the term “natural” has not been defined in the Federal Food, Drug, and Cosmetic Act or its implementing regulations. Instead, FDA regulates use of the term “natural” on a case-by-case basis. In the call for comment, FDA noted that:
Although the FDA has not engaged in rulemaking to establish a formal definition for the term “natural,” we do have a longstanding policy concerning the use of “natural” in human food labeling. The FDA has considered the term “natural” to mean that nothing artificial or synthetic (including all color additives regardless of source) has been included in, or has been added to, a food that would not normally be expected to be in that food.
www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/
LabelingNutrition/ucm456090.htm
Despite this longstanding informal approach, the formal regulatory uncertainty has led to a breathtaking amount of litigation regarding the use of the term “natural” in connection with food and beverage products. Companies have consequently submitted citizen petitions to FDA seeking clear rules on appropriate uses for the term, and in some instances defendant manufacturers have cited the doctrine of “primary jurisdiction” to dismiss or stay litigation in favor of a pronouncement from FDA. FDA has finally taken a step towards answering these requests for additional guidance from industry, litigants, and courts by calling for comment on the issue. Specifically, FDA has asked for comment on the following questions:
1. Whether it is appropriate to define the term “natural,”
2. If so, how the agency should define “natural,” and
3. How the agency should determine the appropriate use of the term on food labels.
Even before FDA’s call for comment, use of the doctrine of primary jurisdiction had begun to gain a foothold in some jurisdictions. Most notably, the Ninth Circuit, in Astiana v. Hain Celestial Grp., Inc., 2015 U.S. App. LEXIS 5833, 19-20 (9th Cir. Cal. Apr. 10, 2015), concluded that the district court did not err in invoking primary jurisdiction in a case involving cosmetic products and the term “natural.” First, the court observed that, “even when agency expertise would be helpful, a court should not invoke primary jurisdiction when the agency is aware of but has expressed no interest in the subject matter of the litigation.” Nevertheless, the “issue of what chemical compounds may be advertised as natural on cosmetic product labels” is a particularly complicated issue that Congress has entrusted to FDA. At the time when the district court dismissed the case, three other district courts had similarly referred the “natural” issue to FDA for a determination, citing its primary jurisdiction.
But the Ninth Circuit also concluded that the district court erred in choosing to dismiss the matter rather than stay it pending either a determination by FDA or a conclusion that no such determination would be forthcoming (at which time the matter would be reinstated). Since this dismissal, FDA responded to the three district courts that referred the issue to FDA, and informed them that due to limited resources it declined to make a determination on the “natural” issue at that time. Accordingly, the Ninth Circuit declared that, on remand, the district court must consider whether continued delay would unduly disadvantage plaintiffs, and whether these events during the pendency of the appeal “affect the need for further proceedings at FDA or demonstrate that another referral to the agency would be futile.” Because FDA has now formally called for comment, an argument that FDA has primary jurisdiction over such issues should be strengthened considerably.
FDA just extended this comment period by three additional months to May 10, 2016.
Author: Bradley W. Pratt, Partner, Atlanta, +1 404 572 4869, bpratt@kslaw.com.
