Colgate Asks Court to Stay Action until FDA Defines “Natural”

June 12, 2017By Riëtte van Laack

As readers of this blog know, natural claims have been and continue to be a frequent basis for consumer class actions. Initially, lawsuits appeared to focus on natural claims for foods (and dietary supplements). However, natural claims for personal care products also have become a popular target in consumer class actions. Even the Federal Trade Commission has addressed natural claims for personal care products (see here).

Currently, there is no single authoritative legal definition of what “natural” means in the context of food or personal care products. For foods, FDA has a policy that “natural” means “nothing artificial or synthetic,” but it remains unclear how some issues such as genetically modified ingredients and presence of certain residues, such as pesticides, fit within that policy. The continuing uncertainty has encouraged litigants to seek answers from the courts.

In November 2015, in response to several petitions requesting clarification of the definition or prohibiting the term natural altogether, FDA announced that it would consider the use of “natural” and requested comments as to how to best define the term. The comment period closed in May 2016, after FDA received more than 7600 comments.

FDA’s action has provided defendants of consumer class actions with an additional reason that lawsuits should be stayed based on the primary jurisdiction doctrine. Pursuant to this doctrine, courts may in their discretion stay or dismiss a plaintiff’s claims, to permit the relevant administrative agency to reach a decision on the issue in question. The primary jurisdiction doctrine is intended to preserve the proper working relationship between administrative agencies and the judicial system. See U.S. v. W. Pac. R.R. Co., 352 U.S. 59, 63-64 (1956). In a number of natural cases, defendants have successfully argued for a stay and several lawsuits have been put on hold until FDA weighs in on the “natural” issue. See, e.g., Kane. v. Chobani, LLC, 645 Fed. Appx. 593, 594 (9th Cir. 2016).

Just recently, Colgate Palmolive Co. (Colgate) relied in part on this latest FDA action in asking the Southern District of New York to also stay lawsuits concerning natural claims for its personal care products. Colgate and its subsidiary Tom’s of Maine, Inc. (Tom’s) market and sell personal care products. Last year, after FDA already had initiated its proceedings concerning natural claims, they were sued for the marketing of a number of the personal care products with allegedly false and misleading “natural claims.” Defendants argue that these cases should be stayed based on primary jurisdiction.

Defendants provide four reasons for deferral to FDA:

  1. The determination of what constitutes “natural” is better left to the expertise of FDA;
  2. Labeling standards are within FDA’s jurisdiction and authority;
  3. The risk of inconsistent rulings regarding the meaning of “natural;” (Colgate got sued in New York and California);
  4. FDA is already reviewing the meaning of natural and natural claims.

Defendants acknowledge that FDA’s action focuses on natural claims for foods, not on personal care products. However, they point out that “there is no indication that . . . FDA’s pending guidance would not also apply to personal care and cosmetic products.”

This would not be the first time that a court would stay “natural” litigation related to personal care products. In 2015, in Astiana v. Hain Celestial Group, Inc., 783 F.3d 753, 761 (9th Cir. 2015), the 9th Circuit determined that a stay was appropriate based on the primary jurisdiction doctrine. When that decision was issued, FDA had not yet initiated proceedings regarding “natural” claims. Now that FDA has in fact taken action suggesting that guidance is forthcoming, the argument for a stay is stronger; “FDA has already completed its notice and comment period, a necessary step that will inform . . . FDA’s guidance, and [FDA] seems determined to address the natural labeling issue.” This may alter the primary jurisdiction calculus, and spells a greater likelihood of success for Colgate’s motion and those of other defendants in similar litigation.