Shawn M. Smith v. Hi-Tech Pharmaceuticals, Inc. ( 2022 )

FIRST DIVISION
BARNES, P. J.,
BROWN and HODGES, JJ.
NOTICE: Motions for reconsideration must be
physically received in our clerk’s office within ten
days of the date of decision to be deemed timely filed.
https://www.gaappeals.us/rules
June 24, 2022
In the Court of Appeals of Georgia
A22A0170. SMITH v. HI-TECH PHARMACEUTICALS, INC.
BROWN, Judge.
Shawn Smith filed this single-count action against Hi-Tech Pharmaceuticals,
Inc., under the District of Columbia Consumer Procedures and Protection Act (“DC
CPPA”), alleging that the labels of certain Hi-Tech dietary supplements are
misleading to consumers. The trial court granted Hi-Tech’s motion for judgment on
the pleadings, concluding that Smith’s claims are preempted by the Food, Drug, and
Cosmetic Act (“FDCA”), 21 U.S.C. § 301 et seq., and that his complaint raises issues
within the primary jurisdiction of the Food and Drug Administration (“FDA”), and
dismissed Smith’s complaint with prejudice. Smith appeals from this order. For the
following reasons, we reverse in part, affirm in part, vacate the judgment, and remand
the case to the trial court to dismiss Smith’s complaint without prejudice.
On appeal from a grant of judgment on the pleadings, we conduct
a de novo review of the trial court’s order to determine whether the
undisputed facts appearing from the pleadings entitle the movant to
judgment as a matter of law. The grant of a motion for judgment on the
pleadings under OCGA § 9-11-12 (c) is proper only where there is a
complete failure to state a cause of action or defense. For purposes of
the motion, all well-pleaded material allegations by the nonmovant are
taken as true, and all denials by the movant are taken as false. But the
trial court need not adopt a party’s legal conclusions based on these
facts.
(Citation and punctuation omitted.) BCM Constr. Group v. Williams, 353 Ga. App.
811, 811-812 (840 SE2d 51) (2020). “A motion for judgment on the pleadings should
be granted only if the moving party is clearly entitled to judgment.” (Citation and
punctuation omitted.) Polo Golf & Country Club Homeowners Assn. v. Cunard, 306
Ga. 788, 792 (2) (833 SE2d 505) (2019).
According to Smith’s complaint, he was a resident of the District of Columbia
who purchased Hi-Tech’s product, “Hypderdrive 3.0+,” which contains oxilofrine,
also called methylsynephrine.1 “This purchase included the purpose of testing and
1
Smith originally filed a class action complaint in the Superior Court for the
District of Columbia, but the court granted Hi-Tech’s motion to dismiss the complaint
for lack of personal jurisdiction. Smith subsequently filed the instant action in the
Superior Court of Gwinnett County.
2
evaluating whether Hypderdrive 3.0+ or any other product sold by [Hi-Tech] with
methylsynephrine have been unlawfully and deceptively sold[.]” Smith alleges that
Hi-Tech manufactures and distributes dietary supplements in the United States which
contain methylsynephrine, which is “an unapproved drug ingredient” and “illegal
supplement ingredient,” and which may pose health risks to consumers. According
to the complaint, the FDA issued warning letters to seven companies regarding
products marketed as dietary supplements who list methylsynephrine as a dietary
ingredient because methylsynephrine does not meet the FDCA’s definition of a
dietary ingredient. Thus, Smith alleges, the inclusion of methylsynephrine in
Hypderdrive 3.0+ and other Hi-Tech products is a deceptive and unlawful trade
practice because it creates a tendency to mislead reasonable consumers in the District
of Columbia.
Smith brought a claim under the DC CPPA, “act[ing] for the benefit of the
[g]eneral [p]ublic as a Private Attorney General,” claiming that Hi-Tech (a) failed to
state material facts regarding the product’s contents that tend to mislead by omitting
that methylsynephrine is an unapproved drug that has been linked to adverse health
events and omitting that consumption of the product in accordance with the label
3
includes an unapproved drug ingredient at concentrations or dosages suitable for
prescriptive medical purposes; (b) misrepresents a material fact in claiming that
Hypderdrive 3.0+ is a “‘synergistic blend of potent herbal derivatives’ which it is
not”; (c) “[u]ses innuendo or ambiguity as to a material fact regarding the product’s
contents, because consumers may confuse ‘methylsynephrine’ with ‘synephrine,’ a
legal supplement ingredient”; (d) sells consumer goods in a condition or manner not
consistent with that warranted by operation of the DC CPPA in that Hyperdrive 3.0+
is not merchantable; and (e) “sells consumer goods in a condition or manner not
consistent with operation or requirement of federal law.” Smith sought actual
damages, statutory damages, punitive damages, injunctive relief, and attorney fees for
himself and all others similarly situated.
Hi-Tech filed a motion for judgment on the pleadings, arguing that Smith’s
claims are impliedly preempted by the FDCA based on the United States Supreme
Court’s decision in Buckman Co. v. Plaintiffs’ Legal Committee, 531 U. S. 341 (121
SCt 1012, 148 LE2d 854) (2001). Hi-Tech alternatively argued that the trial court
should dismiss Smith’s claim in deference to the FDA under the doctrine of primary
jurisdiction. The trial court concluded that Smith’s complaint is preempted by federal
4
law and raises issues within the primary jurisdiction of the FDA and dismissed
Smith’s complaint with prejudice.
Smith appeals from this order, and contends, in related enumerations of error,
that the trial court erred in concluding that his claims are impliedly preempted by the
FDCA and in finding that the doctrine of primary jurisdiction applies to his claims.
We conclude that Smith’s claims are not subject to preemption, either express or
implied, but do fall within the primary jurisdiction of the FDA.
1. Preemption. “The preemption doctrine is a product of the Supremacy Clause,
see U. S. Const., Art. VI, Cl. 2, which invalidates state laws that interfere with, or are
contrary to, federal law.” (Citation and punctuation omitted.) Fox v. Norfolk S. Corp.,
342 Ga. App. 38, 43 (1) (802 SE2d 319) (2017). See also Reis v. OOIDA Risk
Retention Group, 303 Ga. 659, 660 (814 SE2d 338) (2018).
Whether federal statutes or regulations preempt state law is a question
of congressional intent. Congress — through federal laws and
regulations — may effectively preempt state law in three ways: (1)
express preemption; (2) field preemption (regulating the field so
extensively that Congress clearly intends the subject area to be
controlled only by federal law); and (3) implied (or conflict) preemption.
5
(Citation and punctuation omitted.) Gentry v. Volkswagen of America, 238 Ga. App.
785, 787 (2) (521 SE2d 13) (1999). “Express preemption is present when Congress’s
intent to preempt state law is explicitly stated in the statute’s language.” (Citation and
punctuation omitted.) Canale v. Colgate-Palmolive Co., 258 FSupp.3d 312, 319 (II)
(B) (S.D. N.Y. 2017). “A court’s inquiry into the scope of a statute’s pre-emptive
effect is guided by the rule that the purpose of Congress is the ultimate touchstone in
every pre[ ]emption case.” (Citations and punctuation omitted.) Altria Group v. Good,
555 U. S. 70, 76 (II) (129 SCt 538, 172 LE2d 398) (2008). Whether federal law
preempts state law claims is reviewed de novo. Gentry, 238 Ga. App. at 786. With
this in mind, we turn to the federal statute at issue.
The Federal Food, Drug, and Cosmetic Act
The FDCA, 21 U.S.C. § 301 et seq., as amended by the Nutrition Labeling and
Education Act (“NLEA”), 21 U.S.C. § 343 et seq., governs the labeling of food,
including dietary supplements.2 In 1994, Congress further amended the FDCA with
2
“The NLEA was passed to ‘clarify and to strengthen the Food and Drug
Administration’s legal authority to require nutrition labeling on foods, and to
establish the circumstances under which claims may be made about the nutrients in
foods.’” Nutritional Health Alliance v. Shalala, 144 F3d 220, 223 (I) (2nd Cir. 1998).
“Pursuant to that grant of authority, Congress tasked the FDA with establishing and
maintaining a uniform federal scheme of food regulation to ensure that food is labeled
in a manner that does not mislead consumers.” Greenfield v. Yucatan Foods, 18
6
the Dietary Supplement Health and Education Act (“DSHEA”), Pub. L. No. 103-417,
108 Stat. 4325.3. “The NLEA and DSHEA together established a new category of
food products — specifically, dietary supplements — that have unique safety,
labeling, manufacturing, and other related standards.” Kroessler v. CVS Health Corp.,
977 F3d 803, 808 (I) (9th Cir. 2020). See also 21 U.S.C. § 321 (ff) (“a dietary
supplement shall be deemed to be a food within the meaning of this chapter”).
“To ensure nationwide uniformity in labeling standards, Congress has
prohibited states from directly or indirectly establishing under any authority or
continuing in effect any labeling requirement for dietary supplements that is not
identical to the requirements articulated in § 343 (r). § 343-1 (a).” Ferrari v. Vitamin
Shoppe, No. CV 17-10475-GAO, 2022 WL 974048, at *2 (III) (A) (D. Mass. March
31, 2022). See also Kroessler, 977 F3d at 808 (I) (“Private plaintiffs may not bring
actions to enforce violations of the FDCA. Instead, private plaintiffs may bring
analogous state law claims as long as the FDCA does not preempt those claims.”)
(citations omitted). FDA regulations define the term “not identical to” as follows:
FSupp.3d 1371, 1373 (I) (b) (S.D. Fla. 2014). Hi-Tech asserts, in passing, that the
NLEA is “ultimately irrelevant to this case,” but fails to elaborate on this position.
7
“Not identical to” does not refer to the specific words in the requirement
but instead means that the State requirement directly or indirectly
imposes obligations or contains provisions concerning the composition
or labeling of food, or concerning a food container, that: (i) Are not
imposed by or contained in the applicable provision [or regulation] . . .
; or (ii) Differ from those specifically imposed by or contained in the
applicable provision [or regulation.]
21 C.F.R. § 100.1 (c) (4). The preemption provision added by the NLEA “has been
repeatedly interpreted not to preempt requirements imposed by state law that
effectively parallel or mirror the relevant sections of the NLEA.” (Citation,
punctuation, and emphasis omitted.) Hughes v. Ester C Co., 99 FSupp.3d 278, 284
(III) (E.D. N.Y. 2015). Additionally, “a state statute mirroring its federal counterpart
does not impose any additional requirement merely by providing a damage remedy
for conduct that would otherwise violate federal law, even if the federal statute
provides no private right of action.” Ackerman v. Coca-Cola Co., No. CV-09-0395
(JG) (RML), 2010 WL 2925955, at *6 (E.D. N.Y. July 21, 2010), citing Bates v. Dow
Agrosciences, 544 U. S. 431, 432 (125 SCt 1788, 161 LE2d 687) (2005) (preemption
of additional requirements “does not preclude States from imposing different or
additional remedies”) (emphasis in original). “Where there is an express preemption
clause applicable to a provision of the FDCA, the Court must determine whether the
8
state law at issue falls within the scope of that preemption.” Sciortino v. Pepsico, 108
FSupp.3d 780, 798 (II) (C) (1) (N.D. Ca. 2015). And, “[i]n mapping the scope of a
pre[ ]emption clause, the Court typically must accept the reading that disfavors pre[
]emption.” Id., citing Altria, 555 U. S. at 77 (II). We now turn to the state law at issue,
the DC CPPA.
The District of Columbia Consumer Protection Procedures Act
The District of Columbia Consumer Protection Procedures Act
affords a panoply of strong remedies, including treble damages, punitive
damages and attorneys’ fees, to consumers who are victimized by
unlawful trade practices. The Act is construed and applied liberally and
establishes a consumer’s right to truthful information about consumer
goods and services that are purchased or received in the District of
Columbia.
(Citation and punctuation omitted.) Frankeny v. Dist. Hosp. Partners, 225 A3d 999,
1004 (II) (A) (D.C. Ct. App. 2020). The express purposes of the DC CPPA are to
(1) assure that a just mechanism exists to remedy all improper trade
practices and deter the continuing use of such practices; (2) promote,
through effective enforcement, fair business practices throughout the
community; and (3) educate consumers to demand high standards and
seek proper redress of grievances. D.C. Code § 28-3901 (b)[.]
9
(Punctuation omitted.) Price v. Independence Fed. Sav. Bank, 110 A3d 567, 573 (III)
(B) (D.C. Ct. App. 2015). “[T]he statute as amended expand[s] the potential plaintiff
class so as to permit representative actions on behalf of consumers, broadly defined
as ‘the general public.’” (Citation and punctuation omitted.) Rotunda v. Marriott Intl.,
123 A3d 980, 984 (III) (D.C. Ct. App. 2015). The provisions pertinent to Smith’s
complaint provide:
It shall be a violation of this chapter for any person to engage in an
unfair or deceptive trade practice, whether or not any consumer is in fact
misled, deceived or damaged thereby, including to:
...
(e) misrepresent as to a material fact which has a tendency to
mislead; . . .
(f) fail to state a material fact if such failure tends to mislead;
(f-1) Use innuendo or ambiguity as to a material fact, which has
a tendency to mislead[.]
D.C. Code § 28-3904 (e), (f), (f-1). “For claims of misrepresentation, the statute
merely provides that it is a violation of the DC CPPA if the merchant
‘misrepresented’ or ‘failed to state’ a material fact.” Frankeny, 225 A3d at 1005 (II)
(A). See D.C. Code § 28-3904 (e) and (f).
For purposes of § 28-3904 (e) or (f), a misrepresentation or omission is
‘material’ if a reasonable person would attach importance to its
10
existence or nonexistence in determining his or her choice of action in
the transaction or the maker of the representation knows or has reason
to know that the recipient likely regards the matter as important in
determining his or her choice of action.
(Citation and punctuation omitted.) Frankeny, 225 A3d at 1005 (II) (A). See also
Saucier v. Countrywide Home Loans, 64 A3d 428, 442 (D.C. Ct. App. 2013).
Express Preemption
Looking to the DC CPPA, as raised in Smith’s complaint, as well as the FDCA,
as amended by the NLEA and DSHEA, we conclude that Smith’s claims are not
expressly preempted by 21 U.S.C. § 343-1 (a).
The FDA has limited authority under the (FDCA) to regulate dietary
supplements, which include vitamin, botanical, enzyme, and amino acid
products. Unlike with drugs, the FDA does not pre-approve product
labels for dietary supplements. It, however, requires that the labels be
truthful and not misleading, 21 U.S.C. § 343 (r) (6) (B)[.]
Greenberg v. Target Corp., 985 F3d 650, 654 (I) (9th Cir. 2021). See also Ferrari,
Slip op. at *2 (III) (A) (“21 U.S.C. § 343 (r) places limits on health claims that may
be made on food and dietary supplement labels”) (citation and punctuation omitted).
According to FDA regulations, a supplement’s label is misleading if it
11
fails to reveal facts that are: (1) Material in light of other representations
made or suggested by statement, word, design, device or any
combination thereof; or (2) Material with respect to consequences which
may result from use of the article under: (i) The conditions prescribed
in such labeling or (ii) such conditions of use as are customary or usual.
21 C.F.R. § 1.21 (a). Thus, “if a supplement’s label recommends taking one capsule
per day, and that dose actually causes an increased risk of death — a material fact
‘with respect to consequences which may result from use of the article’ — the FDCA
would deem it misleading not to reveal that fact on the label.” (Citation omitted.)
Dachauer v. NBTY, Inc., 913 F3d 844, 849 (B) (9th Cir. 2019). If there are other
relevant federal requirements governing Hi-Tech’s product, i.e., provisions of the
FDCA, NLEA, or DSHEA, they must be compared to the requirement Smith seeks
to impose via state law. See Canale, 258 FSupp.3d at 320 (II) (B). Cf. Bimont v.
Unilever U.S., No. 14-CV-7749 (JPO), 2015 WL 5256988, at *4-5 (S.D. N.Y. Sept.
9, 2015) (both state and federal law generally forbid “‘misleading’ packaging of
dr[u]gs and cosmetics,” proper inquiry is whether Congress and/or FDA has
addressed specific subject matter of plaintiff’s claims). But as previously stated, the
FDA has limited authority under the FDCA to regulate dietary supplements and does
not pre-approve product labels for dietary supplements. Greenberg, 985 F3d at 654
12
(I). And we have identified no other relevant provision governing dietary supplement
labels implicated by Smith’s claims apart from the requirement that they be truthful
and not misleading.
Here, Smith alleges that the product label is misleading under the DC CPPA
in that it fails to disclose that consumption of methylsynephrine in accordance with
the label can lead to adverse health events and would lead to consumption of
methylsynephrine at concentrations or dosages suitable for prescriptive medical
purposes, both of which are material misrepresentations or omissions under the
FDCA. See Dachauer, 913 F3d at 849 (B). Because the FDCA and the DC CPPA
have the same requirement in this respect, § 343-1 (a) (5) does not preempt these
particular claims. See id. See also Yeldo v. MusclePharm Corp., 290 FSupp.3d 702,
714 (III) (F) (E.D. Mich. 2017) (plaintiff’s claims under state law, alleging “‘false and
misleading’” dietary supplement labels and advertising, “parallel the FDCA’s
requirements” and therefore plaintiff’s claims are not preempted by the FDCA).
Smith also claims that the product label violates the DC CPPA in that it falsely
claims that Hypderdrive 3.0+ is a “‘synergistic blend of potent herbal derivatives’”
and lists methylsynephrine as a dietary ingredient when it does not meet the FDCA’s
13
definition of dietary ingredient or supplement.3 Again, the state requirement
effectively parallels the federal requirement that the label not be misleading in that
it not misrepresent or omit a material fact. Compare D.C. Code § 28-3904 (e) and (f)
with 21 C.F.R. § 1.21 (a). Cf. Astiana v. Hain Celestial Group, 783 F3d 753, 757-758
(I) (9th Cir. 2015) (plaintiff’s claims that cosmetic label was false and misleading
were not expressly preempted by FDCA’s prohibition on state or local government
“‘establish[ing] or continu[ing] in effect any requirement for labeling or packaging
of a cosmetic that is different from or in addition to, or that is otherwise not identical
with’ federal rules”; plaintiff was not asking defendant “to modify or enhance any
aspect of its cosmetics labels that are required by federal law” but rather “claim[ing]
3
The FDCA defines “dietary supplement” as
a product (other than tobacco) intended to supplement the diet that bears
or contains one or more of the following dietary ingredients:
(A) a vitamin;
(B) a mineral;
(C) an herb or other botanical;
(D) an amino acid;
(E) a dietary substance for use by man to supplement the diet by
increasing the total dietary intake; or
(F) a concentrate, metabolite, constituent, extract, or combination
of any ingredient described in clause (A), (B), (C), (D), or (E)[.]
21 U.S.C. § 321 (ff) (1).
14
deception as a result of advertising statements”). In sum, because Smith’s claims
under the DC CPPA mirror the FDCA requirement that labels be truthful and not
misleading, they escape express preemption. See Yeldo, 290 FSupp.3d at 714 (III) (F).
Having found that the FDCA, as amended by the NLEA, does not expressly preempt
Smith’s claims under the DC CPPA, we turn to the issue of implied preemption.
Implied Preemption
While the “existence of an express preemption clause does not necessarily
preclude the presence of implied preemption,” Irving v. Mazda Motor Corp., 136 F3d
764, 768 (I) (B) (11th Cir. 1998), “an express definition of the pre-emptive reach of
a statute ‘implies’ — i.e., supports a reasonable inference — that Congress did not
intend to pre-empt other matters. . . .” Freightliner Corp. v. Myrick, 514 U. S. 280,
288 (IV) (A) (115 SCt 1483, 131 LE2d 385) (1995). Moreover, the NLEA contains
an uncodified express savings clause: “The [NLEA] shall not be construed to preempt
any provision of State law, unless such provision is expressly preempted under [§
343-1(a)].” Pub. L. No. 101-535, § 6 (c) (1). See Hansen Beverage Co. v. Innovation
Ventures, No. 08-CV-1166-IEG (POR), 2009 WL 6597891, at *10 (III) (B) (1) (b)
(S.D. Cal. Dec. 23, 2009). Federal courts repeatedly have found that the NLEA’s
savings clause reflects that Congress disavowed any implied preemption. See, e.g.,
15
Sciortino, 108 FSupp.3d at 807 (II) (C) (1) (b); Brazil v. Dole Food Co., 935
FSupp.2d 947, 957 (III) (A) (2) (N.D. Cal. 2013); Lockwood v. ConAgra Foods, 597
FSupp.2d 1028, 1032 (I) (B) (1) (a) (N.D. Cal. 2009); Hitt v. Arizona Beverage Co.,
No. 08cv809WQH (POR), 2009 WL 449190, at *4 (I) (C) (ii) (S.D. Cal. Feb. 4,
2009). See also Farm Raised Salmon Cases, 42 Cal. 4th 1077, 1091 (II) (A) (175 P3d
1170) (2008).
Nonetheless, Hi-Tech urges us to adopt the trial court’s conclusion that Smith’s
claims are impliedly preempted by the FDCA because Smith, in essence, seeks to
enforce the FDCA. In support of this assertion, Hi-Tech points to the Supreme
Court’s holding in Buckman that “fraud on the FDA” claims are impliedly preempted
by the FDCA as amended by the Medical Device Amendments of 1976, 21 U.S.C. §
360c et seq., (“MDA”). 531 U. S. at 348 (II). However, Buckman involved implied
preemption under the MDA which is distinct from the NLEA.4 See Corbett v.
PharmaCare U.S., ___ FSupp.3d ___ (III) (B) (2) (S.D. Cal. 2021). See also
Gustavson v. Wrigley Sales Co., 961 FSupp.2d 1100, 1118 (III) (A) (2) (N.D. Cal.
2013). Compare Mink v. Smith & Nephew, 860 F3d 1319, 1330 (IV) (A) (2) (11th Cir.
4
In Buckman, the plaintiffs sued on behalf of those injured by the use of
orthopedic bone screws, claiming that the defendant made fraudulent representations
to the FDA in the course of obtaining approval to market the screws. 531 U. S. at 343.
16
2017) (applying Buckman to conclude that some of plaintiff’s claims involving a hip
replacement device were impliedly preempted by the FDCA as amended by the
MDA). Other cases cited by Hi-Tech involve medical devices, over-the-counter
drugs, or cosmetics, which are subject to stricter requirements, and/or do not
implicate the NLEA. See Mink, 860 F3d at 1325-1327 (III) (plaintiff’s failure to
report claim based on a duty to file a report with the FDA for medical device was
impliedly preempted by federal law; plaintiff’s manufacturing defect claim involving
medical device was not preempted); Borchenko v. L’Oreal USA, 389 FSupp.3d 769
(C.D. Cal. 2019) (cosmetics); In re Bayer Corp. Combination Aspirin Product Mktg.
& Sales Practices Litigation, 701 FSupp.2d 356 (E.D. N.Y. 2010) (drug); Riley v.
Cordis Corp., 625 FSupp.2d 769 (D. Minn. 2009) (medical device). See also
Imagenetix v. Frutarom USA, No. 12CV2823-GPC (WMC), 2013 WL 6419674 (S.D.
Cal. Dec. 9, 2013). We decline to give Buckman the expansive reading urged by Hi-
Tech and adopted by the trial court in its order. Accordingly, the trial court erred in
finding that Smith’s claims are impliedly preempted by the FDCA.
2. Primary Jurisdiction. Smith contends that the trial court erred in dismissing
his claims based on the doctrine of primary jurisdiction. We disagree.
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“Primary jurisdiction is a judicially created doctrine whereby a court of
competent jurisdiction may dismiss or stay an action pending a resolution of some
portion of the actions by an administrative agency.” (Citation and punctuation
omitted.) Smith v. GTE Corp., 236 F3d 1292, 1298 (I), n.3 (11th Cir. 2001). It is “a
prudential doctrine that permits courts to determine that an otherwise cognizable
claim implicates technical and policy questions that should be addressed in the first
instance by the agency with regulatory authority over the relevant industry rather than
by the judicial branch.” (Citation and punctuation omitted.) Astiana, 783 F3d at 760
(II). “It is useful in instances where . . . courts do have jurisdiction over an issue, but
decide that a claim requires resolution of an issue of first impression, or of a
particularly complicated issue that Congress has committed to a regulatory agency.”
(Citation and punctuation omitted.) Reid v. Johnson & Johnson, 780 F3d 952, 966 (V)
(9th Cir. 2015). See also Boyes v. Shell Oil Products Co., 199 F3d 1260, 1265 (III)
(A) (11th Cir. 2000) (“[t]he main justifications for the rule of primary jurisdiction are
the expertise of the agency deferred to and the need for a uniform interpretation of a
statute or regulation”) (citation and punctuation omitted). Generally,
[c]ourts consider four factors when applying the primary jurisdiction
doctrine: (1) the need to resolve an issue that (2) has been placed by
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Congress within the jurisdiction of an administrative body having
regulatory authority (3) pursuant to a statute that subjects an industry
activity to a comprehensive regulatory scheme that (4) requires expertise
or uniformity in administration. The four factors are not exclusive and
courts seem heavily influenced by a fifth factor in cases implicating
FDA jurisdiction: whether the FDA has shown any interest in the issues
presented by the litigants.
(Citations and punctuation omitted.) Snyder v. Green Roads of Florida, 430 FSupp.3d
1297, 1307-1308 (III) (C) (iii) (S.D. Fla. 2020).
The federal “circuits are split over the standard of review of decisions whether
to recognize the primary jurisdiction of an administrative agency.” Southern Utah
Wilderness Alliance v. Bureau of Land Mgmt., 425 F3d 735, 750 (IV) (10th Cir.
2005). The Tenth Circuit along with the Fourth and District of Columbia Circuits
review decisions regarding primary jurisdiction under an abuse of discretion standard.
See Nat. Tel. Coop. Assn. v. Exxon Mobil, 244 F3d 153, 156 (II) (D.C. Cir. 2001);
Environmental Technology Council v. Sierra Club, 98 F3d 774, 789 (II) (D) (4th Cir.
1996); Brumark Corp. v. Samson Resources Corp., 57 F3d 941, 947-948 (II) (10th
Cir. 1995). Other circuits review such decisions de novo. See, e.g., Newspaper Guild
of Salem v. Ottaway Newspapers, 79 F3d 1273, 1283 (III) (1st Cir. 1996); Intl.
Brotherhood of Teamsters v. American Delivery Svc. Co., 50 F3d 770, 773 (9th Cir.
19
1995); Nat. Communications Assn. v. American Tel. & Telegraph Co., 46 F3d 220,
222 (2d Cir. 1995). Based on Boyes, 199 F3d at 1265 (II), it seems that the Eleventh
Circuit Court of Appeals reviews decisions to abstain on the basis of the primary
jurisdiction doctrine for an abuse of discretion. The Supreme Court of Georgia has
not yet weighed in on the applicable standard of review, but has described primary
jurisdiction as a “discretionary doctrine.” Ga. Power Co. v. Cazier, 303 Ga. 820, 824
(3) (815 SE2d 922) (2018). Given this language, as well as the Eleventh Circuit’s
application of an abuse of discretion standard, we will review the trial court’s
decision to apply the primary jurisdiction doctrine in this case for an abuse of
discretion.
With regard to primary jurisdiction, the trial court found as follows in its order:
Primary jurisdiction over the question whether methylsynephrine should
or should not be deemed a lawful dietary ingredient falls to the FDA. To
decide Plaintiff’s claim, this Court would have to weigh extensive,
conflicting scientific evidence to resolve issues that “have been placed
within the special competence” and expertise of the FDA. . . . The Court
exercises its discretion to dismiss the Complaint to defer to the FDA’s
primary jurisdiction.
Two federal district courts confronting nearly identical issues recently invoked
the primary jurisdiction doctrine. See Quidera v. Blackstone Labs, No. 20-CV-80898,
20
2021 WL 4958789 (S.D. Fla. Mar. 8, 2021); Rosas v. Hi-Tech Pharmaceuticals, No.
CV 20-00433-DOC-DFM, 2020 WL 5361878 (S.D. Cal. July 29, 2020). In Rosas, the
plaintiffs brought suit against Hi-Tech under California state law after purchasing
various dietary supplement products containing three substances, including
methylsynephrine. Slip op. at *1-2 (I) (B). Hi-Tech filed a motion to dismiss the
plaintiffs’ claims, asserting primary jurisdiction among other grounds. Id. at *2 (I)
(B). The district court found that the FDA’s warning letters regarding these
substances did not constitute final agency action and thus the FDA had not taken final
agency action to determine whether the three substances are safe for human
consumption. Id. at *3-4 (III) (A). The court further concluded that “[w]hether [the
three substances] constitute dietary supplements under DSHEA requires the
determination of technical and scientific questions best left to the FDA” as well as
uniformity in administration. (Citation and punctuation omitted.) Id. at *4-5 (III) (B).
In Quidera, the plaintiffs brought suit against a company distributing and
selling dietary supplements containing the stimulant DMHA, alleging, inter alia, that
the company failed to inform consumers that their products contained an illegal and
unsafe ingredient, failed to disclose the true nature of, illegality of, and danger
associated with DMHA, and marketed the products as dietary supplements but failed
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to inform consumers that the products are not, in fact, “‘Dietary Supplements’”
because they contain an unsafe food additive and a non-dietary ingredient, DMHA.
Slip op. at *1 (I). The company moved to dismiss on several grounds, including
primary jurisdiction, arguing that the FDA has not deemed DMHA illegal and the
plaintiffs’ claims would usurp the FDA’s authority to regulate dietary supplements
under the FDCA. Id. at *2 (I). The district court agreed, finding that the “FDA has
expressed interest in DMHA [in the form of warning letters] but has not taken final
agency action to determine whether DMHA is a dietary ingredient, whether it is safe
for human consumption and/or whether it is illegal.” Id. at *3 (III). Moreover,
determining based on science whether DMHA is safe or properly classified as a new
dietary ingredient, the court concluded, is a particularly complicated issue that
Congress has committed to the FDA. Id. at *3 (III). Accordingly, the district court
dismissed the plaintiffs’ complaint without prejudice. Id. at *4 (IV).
Here, as in Rosas and Quidera, the complaint presents questions of whether
methylsynephrine is a dietary ingredient as that term is defined by the FDCA, whether
consumption of methylsynephrine leads to adverse health consequences or is safe for
human consumption, and the proper dosage, if any, of methylsynephrine. Such
questions involve the evaluation of conflicting scientific evidence in the complex
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areas of product and ingredient classification and health and safety — determinations
that the FDA is in a better position to make. See Quidera, Slip op. at *3 (III); Rosas,
Slip op. at *4-5 (III) (B). See also Astiana, 783 F3d at 761 (II) (“[d]etermining what
chemical compounds may be advertised as natural on cosmetic product labels is ‘a
particularly complicated issue that Congress has committed to’ the FDA” and thus
district court did not err in invoking primary jurisdiction); Braintree Laboratories v.
Nephro-Tech, No. 96-2459-JWL, 1997 WL 94237, at *7 (II) (B) (D. Kan. Feb. 26,
1997) (“it is not for this court to interpret and apply the statutory definition of ‘dietary
supplement’” but rather is an issue “reserved solely for resolution by the FDA”).
Smith contends that “the FDA has already weighed the ‘extensive, conflicting
scientific evidence’ and, with its expertise, determined that methylsynephrine [does
not qualify as a] dietary ingredient” and consequently issued warning letters.
However, “regulatory letters do not constitute final agency action. . . . The fact
remains that the FDA has not formally established its position.” (Citation and
punctuation omitted.) Colette v. CV Sciences, No. 2:19-CV-10227-VAP-JEM(x),
2020 WL 2739861, at *4 (III) (B) (C.D. Cal. May 22, 2020). See also Hi-Tech
Pharmaceuticals v. Hahn, No. CV 19-1268 (RBW), 2020 WL 3498588, at *5 (III)
(D.D.C. June 29, 2020) (FDA warning letters do not constitute final agency action).
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This weighs in favor of deferring to the jurisdiction of the FDA. See Canale, 258
FSupp.3d at 325 (II) (C) (3)-(4). Compare Jones v. ConAgra Foods, 912 FSupp.2d
889, 898 (III) (B) (N.D. Cal. 2012) (fact that various parties have repeatedly asked
the FDA to adopt formal rulemaking to define the word “natural” and the FDA has
declined to do so weighs against applying primary jurisdiction).
As pointed out in Dabish v. Brand New Energy, No. 16-CV-400-BAS(NLS),
2016 WL 7048319, at *4 (S.D. Cal. Dec. 5, 2016), a case relied on by Smith,
“because [primary jurisdiction] is a discretionary doctrine, the court may decline to
invoke the doctrine when deciding the issue is not outside the ability of the court.”
In this case, the trial court exercised its discretion in invoking the doctrine and
deferring to the FDA. Under the circumstances, we conclude that the trial court did
not abuse its discretion in doing so. However, given our holding in Division 1, the
trial court erred in dismissing Smith’s complaint with prejudice. See Smith, 236 F3d
at 1298 (I), n.3 (pursuant to the primary jurisdiction doctrine, a court may dismiss or
stay an action pending a resolution of some portion of the actions by an
administrative agency). Accordingly, we remand the case to the trial court for
consideration of whether a stay or dismissal without prejudice is the appropriate
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disposition pursuant to the primary jurisdiction doctrine. See Davel Communications
v. Qwest Corp., 460 F3d 1075, 1093 (V) (9th Cir. 2006).
Judgment affirmed in part and reversed in part, judgment vacated, and case
remanded with direction. Barnes, P. J., and Hodges, J., concur.
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