United States District Court, S.D. New York
ANNE de LACOUR individually and on behalf of all others similarly situated and ANDREA WRIGHT individually and on behalf of all others similarly situated,, Plaintiff,
COLGATE-PALMOLIVE CO. and TOM'S OF MAINE INC., Defendants.
OPINION AND ORDER
ABRAMS, UNITED STATES DISTRICT JUDGE
filed this lawsuit against two companies-Colgate Palmolive
Co. and Tom's of Maine Inc.-that use the word
"natural" in advertising their personal-care
products, including deodorant and toothpaste. Compl. ¶
l(Dkt. 1); Am. Compl. ¶¶ 1, 15, 17 (Dkt. 8). In
their Amended Complaint, Plaintiffs assert that the
Defendants' products are unnatural because they contain
"synthetic and highly chemically processed
ingredients." Am. Compl. ¶¶ 16, 18, 23.
Plaintiffs claim that Defendants' advertising was a
breach of an express warranty and was false and misleading in
violation of various state statutes. Id.
¶¶ 46-132. Defendants now move for a stay under the
doctrine of primary jurisdiction, arguing that the Court
should stay this case until the U.S. Food and Drug
Administration can weigh in on the meaning of
"natural." See Dkt. 32, 33. For the
reasons below, Defendants' motion is denied.
1993, the FDA published guidance on the meaning of the term
"natural" in the food context. See Food
Labeling, 58 Fed. Reg, 2302-01, 1993 WL 1540 (Jan. 6,
1993). Pursuant to that guidance, the term
"natural" means 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 the food."
Id. at 2407. In November 2015, the FDA began a
related investigation by requesting comment on the "Use
of the Term 'Natural' in the Labeling of Human Food
Products" in anticipation of promulgating a rule on the
subject. See 80 Fed. Reg. 69905-01, 2015 WL 6958210
(Nov. 12, 2015). The FDA sought commentary on various
questions, including whether the agency should further define
the term "natural" at all. See Id. at
69908. The agency's substantive questions to commenters
focused on issues specific to the food context, such as
whether consumers would confuse the term "natural"
with the term "healthy" and whether genetically
engineered foods should be considered natural. Id.
at 69908-09. The comment period closed on February 10, 2016.
See Id. at 69905. In the nearly two years since
then, the FDA seemingly has neither responded to comments nor
published a definition of the word "natural" in any
2016, Plaintiffs filed this lawsuit asserting among other
things that Defendants' use of the word
"natural" in advertising their personal-care
products is misleading. In the Amended Complaint, Plaintiffs
support their understanding of the term "natural"
in part by referring to the FDA's 1993 ruling on the
term's meaning in the food context. See Am.
Compl. ¶ 25. According to Plaintiffs, Defendants'
products contain synthetic and chemically processed
ingredients- allegedly including aluminum chlorohydrate,
ascorbic acid, glycerin, and potassium nitrate, among
others-that Plaintiffs say are not natural. Id.
now move for a stay under the doctrine of primary
jurisdiction, arguing that the Court should stay this case
until the FDA can weigh in on the meaning of the word
"natural" based on the comments it requested in
November 2015. See Dkt. 32, 33. Plaintiffs have
opposed the motion, see Dkt. 35, and Defendants have
replied, see Dkt. 40.
courts developed the doctrine of primary jurisdiction
"to ensure that courts and agencies with concurrent
jurisdiction over a matter do not work at
cross-purposes." Fulton Cogeneration Assocs. v.
Niagara Mohawk Power Corp., 84 F.3d 91, 97 (2d Cir.
1996). Although the scope of the doctrine is "relatively
narrow, " courts may defer to agencies to
"maintain uniformity in the regulation of an area
entrusted to a federal agency" and to "utiliz[e]
administrative expertise" on technical questions.
See Ellis v. Tribune Television Co., 443 F.3d 71,
82, 91 (2d Cir. 2006). "Despite its name, " the
doctrine is prudential rather than jurisdictional. See
Canale v. Colgate-Palmolive Co., 258 F.Supp.3d 312, 324
fixed formula exists for applying the doctrine of primary
jurisdiction" and cases are analyzed "on a
case-by-case basis." Ellis, 443 F.3d at 82
(citations and internal quotation marks omitted). Even so,
the Second Circuit has identified four guiding factors that
indicate whether the primary-jurisdiction doctrine applies:
"(1) whether the question at issue is within the
conventional experience of judges or whether it involves
technical or policy considerations within the agency's
particular field of expertise; (2) whether the question at
issue is particularly within the agency's discretion; (3)
whether there exists a substantial danger of inconsistent
rulings; and (4) whether a prior application to the agency
has been made." See Id. at 82-83. If the Court
finds that these factors weigh in favor of allowing an agency
to address the relevant questions first, the Court may stay
or dismiss the case. See Canale, 258 F.Supp.3d at
argue that all four Ellis factors weigh in favor of
granting a stay while the FDA addresses the definition of
"natural." See Dkt. 33. For the reasons
discussed below, however, the purposes of the
primary-jurisdiction doctrine would not be served by
deferring to the FDA and a balance of the Ellis
factors weighs against the imposition of a stay at this time.
the first factor, Defendants contend that defining what
counts as "natural" is a highly technical
determination falling particularly within the FDA's
expertise. In 2015, the Ninth Circuit seemed to agree with
Defendants, noting that "[determining what chemical
compounds may be advertised as natural on cosmetic product
labels is a particularly complicated issue that Congress has
committed to the FDA[.]" See Astiana v. Hain
Celestial Grp., Inc., 783 F.3d 753, 761 (9th Cir. 2015)
(internal quotation marks omitted). Courts in this District
have sometimes agreed, but they have also consistently held
that the main issue in this case-namely, whether advertising
is deceptive or misleading to consumers-is squarely within
judges' expertise. See, e.g., Canale, 258
F.Supp.3d at 325 (gathering cases). Thus, "[c]ourts are
split as to whether the issues presented by ... 'all
natural' claims are more within the conventional
expertise of judges or whether they involve technical or
policy considerations within the FDA's particular field
of expertise." In re KIND LLC "Healthy &
All Natural" Litig., 209 F.Supp.3d 689, 694
(S.D.N.Y.2016). Given this split, the Court "is
reluctant to declare" the issues in this case to be
"outside the conventional wisdom of judges" and
notes that "judges and triers of fact regularly address
complex scientific issues absent regulatory guidance."
Id. at 695. The first factor, therefore, "does
not weigh in favor of the FDA's primary
jurisdiction." Id; cf. Canale, 258
F.Supp.3d at 325 (holding that the first factor was neutral).
application of the second factor-"whether the question
at issue is particularly within the agency's discretion,
" see Ellis, 443 F.3d at 83-is more
straightforward here. The FDA has the statutory authority to
prohibit labels that are "false or misleading in any
particular." 21 U.S.C. § 343. Thus, as courts in
this District have consistently held, the FDA has the
discretion to decide what foods or personal-care products can
honestly be labeled as "natural." See, e.g., In
re KIND LLC, 209 F.Supp.3d at 695; Goldemberg v.
Johnson & Johnson Consumer Companies, Inc., 8 F.
Supp, 3d 467, 477 (S.D.N.Y. 2014); see also Canale,
258 F.Supp.3d at 325. Plaintiffs respond that the FDA is not
the only source of meaning for the term "natural"
in this case. According to Plaintiffs, the Court can use
other sources, like dictionaries, to determine what the word
means and whether it was misleading. That argument, however,
is fundamentally about whether judges can resolve the issue
here without the technical expertise of the agency, which in
essence implicates the first factor. The second factor,
meanwhile, focuses on whether Congress has specifically
delegated the applicable decision-making authority to the
agency. See generally Ellis, 443 F.3d at 84-86. As
relevant here, Congress has done so. Thus, the second factor
weighs in favor of a stay.
the third Ellis factor, courts are more likely to
defer to agencies if there is "a substantial danger of
inconsistent rulings." Id. at 83. "Courts
should be especially solicitous in deferring to agencies that
are simultaneously contemplating the same issues."
Id. at 88. Defendants assert that this factor weighs
in favor of granting a stay because there is a chance that
the FDA (by publishing a rule) and other courts (in at least
three other pending cases that Defendants contend are ...