Eckler v. Neutrogena Corp. CA2/7

Filed 6/9/15 Eckler v. Neutrogena Corp. CA2/7
NOT TO BE PUBLISHED IN THE OFFICIAL REPORTS
California Rules of Court, rule 8.1115(a), prohibits courts and parties from citing or relying on opinions not certified for
publication or ordered published, except as specified by rule 8.1115(b). This opinion has not been certified for publication
or ordered published for purposes of rule 8.1115.
IN THE COURT OF APPEAL OF THE STATE OF CALIFORNIA
SECOND APPELLATE DISTRICT
DIVISION SEVEN
KAY ECKLER, B253691
Plaintiff and Appellant, (Los Angeles County
Super. Ct. Nos. BC307288, JCCP4352)
v.
NEUTROGENA CORPORATION,
Defendant and Respondent.
STEVE ENGEL, B253899
Plaintiff and Appellant, (Los Angeles County
Super. Ct. Nos. BC307288, JCCP4352)
v.
NEUTROGENA CORPORATION et al.,
Defendants and Respondents.
APPEALS from a judgment of the Superior Court of Los Angeles County,
John S. Wiley, Jr., Judge. Affirmed.
Bonnett, Fairbourn, Friedman & Balint (Arizona) and Patricia N. Syverson;
Bonnett, Fairbourn, Friedman & Balint (California) and Manfred P. Meucke for Plaintiff
and Appellant Kay Eckler.
Abraham, Fruchter & Twersky (California), Ian D. Berg and Takeo A.
Kellar; Abraham, Fruchter & Twersky (New York), Mitchell M.Z. Twersky (pro hac
vice) and Lawrence D. Levit (pro hac vice) for Plaintiff and Appellant Steve Engel.
O’Melveny & Myers (Los Angeles), Richard B. Goetz and Cynthia A.
Merrill; O’Melveny & Myers (Newport Beach) and Amy J. Laurendeau for Defendants
and Respondents Neutrogena Corporation and Johnson & Johnson, Inc.
______________________________________
This case concerns congressional intent with respect to label information on
sunscreen products: is it to be determined solely by the federal agency it charged with
ensuring uniform labeling for those products, or, in addition, by each state through
private civil suits. Appellants Kay Eckler and Steve Engel filed separate actions against
respondent Neutrogena Corporation alleging that their sunscreen products were
misleadingly labeled and marketed in violation of California consumer protection
statutes. Appellants alleged that Neutrogena misleadingly labeled its products with the
descriptions “sunblock,” “waterproof,” and “sweatproof” (Labeling Terms), terms that
the federal Food and Drug Administration (FDA) prohibited in a regulation published on
June 17, 2011, with a compliance date of December 17, 2012. Engel contends that
Neutrogena is liable for marketing products that bore the Labeling Terms before the
December 17, 2012 compliance date. The Eckler matter raises an additional product
labeling issue with respect to sunscreen with a sun protection factor (SPF) value greater
than 50 (SPF 50+). Although Eckler does not contend that the SPF values on
Neutrogena’s products were inaccurate, she believes that consumers will be misled about
their benefits and seeks an order that Neutrogena modify its labels and alter its
advertising. The superior court sustained Neutrogena’s demurrer to Eckler’s complaint
without leave to amend, and granted its motion for judgment on the pleadings as to
Engel’s complaint. The court concluded that their claims were preempted by the federal
Food, Drug, and Cosmetic Act (FDCA) ( 21 U.S.C. § 379r) and implementing FDA
regulations. We agree and affirm.
2
Factual and Procedural Background
Appellant Engel filed suit against Johnson & Johnson and Neutrogena in
December 2003, and an amended complaint in June 2003.1 Although those pleadings
focused on purported misrepresentations concerning the ability of sunscreen products to
protect users from longer wavelength ultraviolet rays, the amended complaint did allege
that Neutrogena’s product was not truly water or sweat “proof,” or a true “sunblock.”
Engel’s action was eventually added to a Coordination Proceeding involving other parties
raising claims against sunscreen manufacturers. A Corrected Amended Master
Complaint dated April 2006 is the operative pleading. In that complaint Engel alleged
that he purchased Neutrogena Oil Free Healthy Defense Sunblock lotion “and was
damaged thereby.” The suit alleged that respondents used the Labeling Terms on its
packaging and marketing, which were deceptive advertising and unlawful business
practices under California’s Unfair Competition Law (Bus. & Prof. Code, § 17200), False
Advertising Law (Bus. & Prof. Code, § 17500), and Consumer Legal Remedies Act (Civ.
Code, § 1750 et seq.). According to Engel, the gravamen of his allegations is that
Neutrogena’s products were falsely labeled “by claiming that they: (1) were a ‘sunblock’
when in fact they did not block all of the sun’s harmful rays and did not in fact block, but
rather absorbed, the sun’s rays; (2) provided ‘waterproof’ protection, which has been
defined by the FDA to mean ‘impenetrable to or unaffected by water’ and ‘completely
resistant to water regardless of time of immersion’ when the products were not
impenetrable to, or unaffected by, or resisted over time to water; and (3) provided
‘sweatproof’ protection, which implies that they were impenetrable to or unaffected by
sweat and completely resistant to sweat regardless of time of immersion or exposure,
when they were not impenetrable to, unaffected by, or resistant over time to sweat.” He
sought injunctive, restitutionary, and other relief.
1 Johnson & Johnson, Inc. is the parent company of Neutrogena Corporation. We
refer to the defendants-respondents collectively as Neutrogena.
3
In June 2011 the FDA issued a Final Rule that among other things, prohibited
sunscreen product labels from stating that they were “sunblock,” “sweatproof,” and
“waterproof.” (21 C.F.R. § 201.327(g); 76 Fed.Reg. 35620 at 35661 (June 17, 2011)
(Final Rule).) Ultimately the compliance date for the regulation was set for 18 months
later, on December 17, 2012. Engel contends that this regulation codified a previous
alleged ban on these descriptions; Neutrogena contends that it represented the first time
the agency prohibited the Labeling Terms. Neutrogena moved for judgment on the
pleadings, arguing, among other things, that Engel’s claims were preempted by federal
law. The superior court concluded that Engel’s claims were entirely preempted, and that
the 18 months between publication of the Final Rule and its effective date represented a
“safe harbor” reflecting the FDA’s cost-benefit analysis: a delay fashioned to “minimize
transactions costs based on a global analysis of social welfare. That’s what a cost-benefit
analysis is.” Engel’s appeal challenges the trial court’s dismissal of claims arising from
purchase of products bearing the Labeling Terms with respect to three time periods: (1)
before June 17, 2011 when the Final Rule was published, (2) after the Final Rule’s
publication but before the compliance date, and (3) after the December 17, 2012
compliance date.
Appellant Eckler also filed suit against Neutrogena under California’s Unfair
Competition Law and Consumer Legal Remedies Act alleging that its sunscreen product
labels were misleading. Eckler complained of the same Labeling Terms as Engel did; she
also contended that the package labeling on SPF 50+ products was false and misleading.
Eckler did not allege that the SPF values on Neutrogena’s labels were inaccurate. Rather,
she asserted that labels for SPF 50+ products omitted what she claims is a material fact,
that they provide no added clinical benefit compared to products rated at SPF 50. Eckler
did not claim that Neutrogena affirmatively represented that SPF 50+ products conferred
enhanced clinical benefits, but she avers that consumers would naturally believe so, and
thus Neutrogena misled consumers by charging more for such products and not
disclaiming any benefits. Eckler alleged that she purchased two of Neutrogena’s
sunscreen products in May 2012 after reading the labels. Her complaint further asserted
4
that consumers read the labels before deciding to purchase the products and are deceived
by Neutrogena’s allegedly false representations and failures to disclose material facts on
the labels and packaging of its products. Eckler “seeks an order requiring Neutrogena to
disclose on its Product labels and associated advertising that the higher SPF values in the
SPF 55-100+ collection do not provide proportionately greater, or any added clinical sun
protection benefit.” (Appellant Eckler’s Opening Brief, at pp. 17-18.) She also requested
class-wide restitution and other relief.
Neutrogena demurred to Eckler’s complaint on several grounds, including express
and implied preemption. The court concluded that Eckler’s action was preempted by
federal law, sustained the demurrer without leave to amend and dismissed the action.
Eckler and Engel filed timely appeals.
Applicable Law
1. Standard of Review for Demurrer and Motion for Judgment on the Pleadings
We apply a de novo standard of review to a trial court’s order of dismissal
following an order sustaining a demurrer. (Los Altos El Granada Investors v. City of
Capitola (2006) 139 Cal. App. 4th 629, 650.) In other words, we exercise our
“independent judgment about whether the complaint states a cause of action as a matter
of law.” (Ibid.) “In reviewing a judgment of dismissal after a demurrer is sustained
without leave to amend, we must assume the truth of all facts properly pleaded by the
plaintiffs, as well as those that are judicially noticeable.” (Howard Jarvis Taxpayers
Assn. v. City of La Habra (2001) 25 Cal. 4th 809, 814.)
When a demurrer “is sustained without leave to amend, we decide whether there is
a reasonable possibility that the defect can be cured by amendment: if it can be, the trial
court has abused its discretion and we reverse; if not, there has been no abuse of
discretion and we affirm.” (Blank v. Kirwan (1985) 39 Cal. 3d 311, 318.) Such a
showing can be made for the first time before the reviewing court. (Smith v. State Farm
5
Mutual Automobile Ins. Co. (2001) 93 Cal. App. 4th 700, 711.) “The burden of proving
such reasonable possibility is squarely on the plaintiff.” (Blank, supra, 39 Cal.3d at p.
318.)
A demurrer may be sustained without leave to amend where, “‘the facts are not in
dispute, and the nature of the plaintiff’s claim is clear, but, under the substantive law, no
liability exists.’ [Citation.]” (Seidler v. Municipal Court (1993) 12 Cal. App. 4th 1229,
1233.) “A judgment of dismissal after a demurrer has been sustained without leave to
amend will be affirmed if proper on any grounds stated in the demurrer, whether or not
the court acted on that ground.” (Carman v. Alvord (1982) 31 Cal. 3d 318, 324.)
“A motion for judgment on the pleadings serves the function of a demurrer,
challenging only defects on the face of the complaint.” (Richardson-Tunnell v. School
Ins. Program for Employees (2007) 157 Cal. App. 4th 1056, 1061.) As with a demurrer,
“[t]he grounds for a motion for judgment on the pleadings must appear on the face of the
complaint or from a matter of which the court may take judicial notice.” (Ibid., citing
Code Civ. Proc., § 438, subd. (d).) We exercise our independent judgment in
determining whether the challenged complaint states a cause of action. (Gerawan
Farming, Inc. v. Lyons (2000) 24 Cal. 4th 468, 515.) “In the case of either a demurrer or a
motion for judgment on the pleadings, leave to amend should be granted if there is any
reasonable possibility that the plaintiff can state a good cause of action.” (Gami v.
Mullikin Medical Center (1993) 18 Cal. App. 4th 870, 876.)
2. Federal Statutory and Regulatory Scheme For Sunscreen Products
A. The FDCA
The FDCA authorizes the FDA to regulate, among other things, the ingredients
and labeling of nonprescription, over-the-counter (OTC) drugs such as the sunscreen
products at issue. The FDCA was amended by the FDA Modernization Act of 1997
(Modernization Act), which included a provision expressly preempting state law
6
requirements regarding nonprescription drugs, including sunscreen products. Section 751
of the FDCA, codified at 21 United States Code section 379r(a),2 specifically prohibits
state requirements that are not identical with federal requirements: “no State . . . may
establish or continue in effect any requirement – (1) that relates to the regulation of a
drug . . . and (2) that is different from or in addition to, or that is otherwise not identical
with, a requirement under this chapter. . . .” Such state “requirements” include those
concerning “public information” or “public communication relating to a warning.” (Id. at
subd. (c).) 3
2 Section 379r falls under Part F of Subchapter VII of the FDCA titled: “National
Uniformity for Nonprescription Drugs and Preemption for Labeling or Packaging of
Cosmetics.” (Pub. L. No. 105-115 (Nov. 21, 1997), 111 Stat. 2296 at pp. 2374-2375.)
3 Section 379r, titled “National uniformity for nonprescription drugs,” provides, in
pertinent part:
“(a) In general
“Except as provided in subsection (b), (c)(1), (d), or (f) of this section, no State
or political subdivision of a State may establish or continue in effect any
requirement –
“(1) that relates to the regulation of a drug that is not subject to the
requirements of section 353(b)(1) or 353(f)(1)(A) of this title; and
“(2) that is different from or in addition to, or that is otherwise not identical
with, a requirement under this chapter, the Poison Prevention Packaging
Act of 1970 (15 U.S.C. 1471 et seq.), or the Fair Packaging and Labeling
Act (15 U.S.C. 1451 et seq.).
“. . . .
“(c) Scope
“. . . .
“(2) Safety or effectiveness
“For purposes of subsection (a) of this section, a requirement that relates to
the regulation of a drug shall be deemed to include any requirement relating
to public information or any other form of public communication relating to
a warning of any kind for a drug.”
7
A savings clause excepts from preemption product liability suits (§ 379r(e).)4
Further, the statute permits state enforcement of “a requirement that is identical to a
requirement of this chapter.” (Id. at subd. (f).)
Section 379r reflects Congress’s express intention generally to preempt state
requirements on the labeling of nonprescription drugs such as the sunscreen products at
issue. This intent is amply supported by the legislative history of the Modernization Act.
The language in section 379r was added by amendment in the Senate Committee on
Labor and Human Resources. (Sen. Rep. 105-43 (filed June 27, 1997) at p. 13.) The
Senate Report on the Modernization Act stated that “[a]n essential element of a
nationwide marketplace is a national uniform system of regulation. It is intended that the
FDA provide national leadership in assuring the safety, effectiveness, and proper labeling
and packaging for nonprescription drugs and cosmetics marketed throughout the country
. . . .” (Id. at p. 63.) The report also emphasized that states may not impose different or
additional requirements relating to labeling and advertising: “No State or local
government is permitted to impose different or additional requirements that relate to the
subject matter covered by the three Federal laws as they apply to nonprescription drugs
and cosmetics. These include requirements imposed on product manufacture or
composition, labeling, advertising, or any other form of public notification or
communication.” (Id. at p. 64.)5 The Conference Committee on the Senate bill adopted
4 These appeals do not arise from claims for personal injury or damage to property
and thus the section 379r(e) savings clause does not apply. (See Kanter v. Warner-
Lambert Co. (2002) 99 Cal. App. 4th 780, 790-791 (Kanter).)
5 The Senate Report explained the reason for federal preemption in this area:
“Under our Federal system, it is important that State and local officials enforce the same
regulatory requirements for products as do our Federal officials. Different or additional
requirements [at] the State or local level can work against our national marketplace,
confuse consumers, raise prices, undermine public confidence in our regulatory system
and in products important to the public health, and result in divergent public health
protection throughout the country.” (Sen. Rep. 105-43, supra, at p. 64.)
8
the preemption language added by the Senate. (House of Representatives Conference
Report No. 105-399 (Nov. 9, 1997) (Conference Report) at pp. 81-83.) The Conference
Report reiterated that the “scope of national uniformity” applied to “state requirements
that relate to labeling and packaging or, if they go beyond labeling and packaging, to
requirements relating to warnings.” (Id. at p. 103.)
The 1997 legislation, as part of a major reform of all food, drug and cosmetic
regulation, also singled out sunscreen products for future FDA regulatory action. Section
129 of the Modernization Act provided: “Not later than 18 months after the date of
enactment of this Act, the Secretary of Health and Human Services shall issue regulations
for over-the-counter sunscreen products for the prevention or treatment of sunburn.”6 (21
U.S.C. § 393 note; 111 Stat. 2331.)
B. FDA regulations concerning sunscreen products
Sunscreen products have been the subject of exhaustive federal regulatory action
for many years. The FDA’s regulations cover, among other topics, permissible active
ingredients, highly technical standards for the testing and measurement of sun protection,
and required and prohibited statements on product packaging. During over three decades
of proposed rules, comments, new data, and reconsiderations, the agency’s view has
evolved with medical and chemical advances, and in response to the data and comments
it has received in the rulemaking process.7
6 The Conference Report notes that the conferees “recognize that various technical
and scientific issues may take longer to resolve than other aspects of the rulemaking,”
and that they did “not intend that all regulation in this area be complete or comprehensive
by a specified date.” (Conference Report at p. 96.)
7 See, e.g. 43 Fed.Reg. 38206 (Aug. 25, 1978); 58 Fed.Reg. 28194 (May 12, 1993);
64 Fed.Reg. 13254 (Mar. 17, 1999); 64 Fed.Reg. 27666 (May 21, 1999); 68 Fed.Reg.
33362 (June 4, 2003); 72 Fed.Reg. 49070 (Aug. 27, 2007).
9
For example, in 1978 the FDA issued a proposed rule based on a panel
recommendation concerning sunscreen products. (43 Fed.Reg. 38206 (Aug. 25, 1978).)
Among other things, the proposal stated that sunscreen products that satisfy testing
procedures may be labeled “waterproof,” and those that satisfy sweat resistance testing
procedures may be labeled “sweat resistant.” (Id. at 38215.)
In 1993, in another notice of proposed rulemaking, the agency issued a “Tentative
Final Monograph” based on its consideration of comments to the 1978 proposed rule.
(58 Fed.Reg. 28194 (May 12, 1993).) The FDA stated that it was concerned that “the
term ‘waterproof,’ as used in the Panel’s recommended monograph, may be confusing or
misleading to consumers . . . .” The FDA continued: “Therefore, the agency is not
proposing the labeling claim ‘waterproof,’ but is proposing instead the term ‘very water
resistant.’” (Id. at 28228.) The proposed rule also provisionally authorized use of the
term “sunblock.” “The agency agrees with the comment that the descriptive term
‘sunblock’ would be informative to users of OTC sunscreen drug products. The agency
believes that the term ‘sunblock’ may be used as an additional statement of product
performance on sunscreen drug products that contain the ingredient titanium dioxide and
provide an SPF of 12 or higher.” (Id. at 28240.) No changes in the Code of Federal
Regulations concerning the Labeling Terms were made in 1993.
In 1999 the FDA published as a final rule a Final Monograph regarding sunscreen
products. (64 Fed.Reg. 27666 (May 21, 1999).) This monograph provided that
sunscreens with SPF values over 30 be labeled no higher than 30+. (Id. at 27675.) The
agency found that data was lacking to “support or dismiss limiting the maximum SPF
value in this final rule.” (Id. at 27674.) Based upon the comments it received, the agency
concluded that “OTC sunscreen products with SPF values above 30 should be available
for those sun-sensitive consumers who require such products . . . .” (Id. at 27675.) The
1999 final rule, however, was stayed and never went into effect. (See 69 Fed.Reg. 53801
(Sept. 3, 2004).)
In 2007, the FDA issued another proposed rule, described as a proposed
amendment to the final monograph. (72 Fed.Reg. 49070 (Aug. 27, 2007).) That
10
document proposed a new labeling system, as well as adding combinations of ingredients,
and proposing new testing procedures. The FDA stated it “plans to grant an extended
compliance period when this proposed rule is finalized” because “some manufacturers
may not have sufficient time to incorporate labeling changes without disrupting their
production schedules.” (Id. at 49109.) In the 2007 publication, the FDA did not propose
a prohibition on the Labeling Terms.
The 2007 proposed rule also explained its preemptive effect, both express and
implied. The FDA explained that a final rule would preclude state requirements on
labeling of sunscreen products that were not identical to it:
This proposed rule, if finalized as proposed, would amend the labeling and
include new UVA testing for OTC sunscreen drug products. Any final rule
would have a preemptive effect in that it would preclude states from issuing
requirements related to the labeling and testing of OTC sunscreen drug
products that are different from or in addition to, or not otherwise identical
with a requirement in the final rule. This preemptive effect is consistent with
what congress set forth in section 751 of the act [21 U.S.C. § 379r]. Section
751(a) of the act displaces both State legislative requirements and State
common law duties. We also note that even where the express preemption
provision in section 751(a) of the act is not applicable, implied preemption
may arise (see Geier v. American Honda Co., 529 U.S. 861 (2000)).
(72 Fed Reg. 49109.)
Four years later, the FDA issued its Final Rule on sunscreen labeling.
(i) FDA 2011 Final Rule
Simultaneously in 2011 the FDA issued a Final Rule on labeling and effectiveness
testing for sunscreen products, and a Proposed Rule that invited comments concerning
limiting the labeling of sunscreen products to SPF 50. The Final Rule addressed the
labeling and effectiveness testing issues raised by nearly 2,900 submissions received in
response to the August 27, 2007 proposed rule. It promulgated two new federal
regulations: 21 Code of Federal Regulations, sections 201.327 and 310.545, which set
11
labeling requirements, specified effectiveness testing, and identified false and misleading
claims that render a product misbranded. (76 Fed.Reg. 35620 (June 17, 2011) (Labeling
and Effectiveness Testing: Sunscreen Drug Products for Over-the-Counter Human Use)
(Final Rule).)8 FDA described this regulation as “a labeling rule, and not a monograph.”
(76 Fed. Reg. 35622.) Thus, it prescribed labeling requirements that reflected the FDA’s
“current determination on appropriate regulation on these aspects of sunscreens.” (Id. at
35620-35621.) The Final Rule mandated that sunscreen labels state the SPF value
resulting from the detailed testing procedure described in the regulation. (21 C.F.R. §
201.327(a)(1) & (I) [specifying testing procedure to arrive at appropriate SPF values and
8 Reflecting the lengthy rulemaking process, the FDA noted that among other
things, the Final Rule required over-the-counter sunscreen products to comply with the
requirements for drug labeling contained in a final rule published March 17, 1999 (64
Fed.Reg. 13254) by lifting a delay of implementation date published on September 3,
2004 (69 Fed.Reg. 53801). (76 Fed.Reg. 35620.)
The FDA explained the scope and purpose of the Final Rule as follows: “This
final rule establishes the labeling and testing requirements for OTC sunscreen products
containing specific ingredients or combinations of ingredients . . . . The requirements in
this final rule will help ensure that these currently marketed sunscreen products are
appropriately labeled and tested for both UVA and UVB protection. In addition, the
requirements in this final rule will help ensure the proper use of these sunscreens and
greater consumer protection from the damaging effects of UV radiation. This final rule
also identifies claims that render a product that is subject to this rule misbranded or not
allowed on any OTC sunscreen drug product marketed without an approved application.”
(76 Fed. Reg. 35621.)
Summarizing the regulatory impact of the rule, the FDA explained: “The purpose
of this rule is to finalize labeling and testing conditions under which OTC sunscreen drug
products marketed without approved applications are not misbranded. This rule
addresses labeling and testing requirements for both UVB and UVA radiation protection.
The rule modifies the existing SPF test, specifies a test for broad spectrum protection, and
requires changes to the product label that affect both the front of the package (the
principal display panel or PDP) and the Drug Facts section. . . . all manufacturers of
sunscreens will incur some labeling costs due to revisions to both the PDP and the Drug
Facts section of the product label. . . .” (76 Fed. Reg. 35654.)
12
providing labels “shall” state the SPF value].) The FDA codified in 21 C.F.R. part 201
certain requirements for OTC sunscreen products, including “specific claims that render a
covered product misbranded or are not allowed on any OTC sunscreen drug product
marketed in the United States without an approved application.” (Ibid.) Accordingly,
sunscreen products cannot include on labels the descriptions “sunblock,” “sweatproof,”
and “waterproof.” (21 C.F.R. § 201.327(g).) The regulation promulgated by the Final
Rule expressly provides that the numerical SPF value resulting from the FDA-mandated
SPF testing procedure must be placed on a sunscreen product’s principal display panel
(see 21 C.F.R. § 201.327(a)(i)(A), (ii)).
The labeling requirements in the Final Rule are detailed. Products that pass the
broad spectrum test of 21 Code of Federal Regulations section 201.327(j) must state
“Broad Spectrum SPF” with the numerical SPF value appearing as “continuous text with
no intervening text or graphic” all in the “same font style, size and color, with the same
background color.” (21 C.F.R. § 201.327(a)(1)(B).) The rule specifies warnings about
keeping the product out of eyes, and not using it on damaged or broken skin. (21 C.F.R.
§ 201.327(d).) The rule also prohibits certain statements, such as any implication that
use, alone, reduces the risk of skin cancer or early skin aging, and use of the terms
“sweatproof,” “waterproof,” and “sunblock.” (21 C.F.R. § 201.327(c)(3) & (g).) The
Final Rule does not include as being a false or misleading claim accurately labeling a
product with an SPF value above 50. (See § 201.327(c)(3), (g).)
Noting that often additional product label information can cause more confusion
than clarity, the Final Rule repeatedly reflected a balancing of concerns. For instance, the
Final Rule eliminated a statement proposed in 2007 that “higher SPF products give more
sun protection, but are not intended to extend the time spent in the sun.” The FDA
“concluded that [this] statement, although truthful, is not necessary.” (76 Fed Reg.
35642.) (See also, 76 Fed. Reg. 35626 [“UVA star rating would likely be confusing in
conjunction with the numerical SPF rating”]; id. at 35627 [“a ‘No UVA Protection’
statement is not necessary and could be misleading”]; id. at 35628 [proposed label
requirement explaining two types of ultraviolet rays was “potentially confusing”].) The
13
FDA cited 82 studies and reports on dermatology, photochemistry, and other fields in
support of its technical judgments. (Id. at 35658-35660.)
In discussions pertinent to this appeal, the FDA Final Rule confirmed its expressly
preemptive impact except as to claims based on state product liability law. The FDA
noted that it addressed the preemption issue in its 2007 Proposed Rule. That rule noted
that 21 United States Code section 379r “is an express preemption provision.” (72 Fed.
Reg. 49070 at 49109 (Aug. 27, 2007).) While clarifying that by its terms the
Modernization Act did not preempt product liability claims, whether based on statutes or
common law, the FDA emphasized: “However, it is important to note that [section 379r]
exempts only those common law claims that are based on State product liability law.”
(76 Fed. Reg. 35624.) The agency also noted that “although implied preemption may
arise, such scenarios are necessarily case specific.” (Ibid.) Thus, in the Final Rule the
FDA made clear that section 379r requires preemption of suits based on state law (other
than product liability actions) that would seek to impose any labeling or advertising
requirements not identical to those contained in the Final Rule.
The Final Rule was initially to have a compliance date (for products with annual
sales of $25,000 or more) of June 18, 2012. This date was extended to December 17,
2012. Engel contends that during the 18-month period from publication of the Final Rule
on June 17, 2011 to the compliance date of December 17, 2012, Neutrogena should face
liability for non-compliant products. In extending the compliance date, the FDA stated
that “granting manufacturers additional time to complete testing and relabeling is in the
public interest.” (77 Fed.Reg. 27591 at 27592 (May 11, 2012).) This was consistent with
what the FDA had announced four years earlier. “FDA plans to grant an extended
compliance period when this proposed rule is finalized.” (72 Fed.Reg. 49109.)
Moreover, it had always been the FDA’s intention that products already on the market
remain and not be recalled. Recognizing that non-compliant products were in the stream
of commerce, the FDA reiterated that those products could remain on the market: “In the
2007 proposed rule, we indicated that sunscreen products which are already distributed
by the effective date of the final rule would not be expected to be relabeled or retested in
14
conformity with the final rule conditions unless these products were subsequently
relabeled or repackaged after the effective date (72 F.R. 49070 at 49109). Consistent
with this statement, we do not expect non-compliant products introduced or delivered for
introduction into interstate commerce prior to the compliance dates specified for this final
rule to be removed from the market.” (76 Fed.Reg. 35624.)
(ii) FDA 2011 Proposed Rule
On the same day it published the Final Rule, the FDA published a proposed rule
titled “Revised Effectiveness Determination; Sunscreen Drug Products for Over-the-
Counter Human Use.” (76 Fed.Reg. 35672 (June 17, 2011) (Proposed Rule).) The
Proposed Rule would further modify 21 Code of Federal Regulations section 201.327 to
limit the maximum labeled SPF value for over-the-counter sunscreen drug products to
“50+.” The agency stated that “this proposal is part of FDA’s ongoing review of these
products to ensure their safety and effectiveness.” In its discussion of the Proposed Rule,
the FDA noted that in 1999 it had proposed a maximum SPF of 30+, and in 2007
proposed a maximum of 50+, in part because of a concern that “products with SPF test
values above 50 could not be tested with acceptable accuracy and reproducibility.” (76
Fed.Reg. 35672.) The Proposed Rule noted that submissions in response to the 2007
proposal demonstrated the accuracy and reproducibility of test values as high as SPF 80.
The FDA stated that “because the record continues to lack data demonstrating that
sunscreen products with SPF values above 50 provide additional clinical benefit
compared to SPF 50 products,” it was again proposing “a maximum labeled [SPF] value
of ‘50+.’” (Ibid.)
The Proposed Rule noted that “[c]onsumers have learned to associate higher SPF
values with greater sun protection. Consumers would likely assume that a product with
an SPF value higher than 50 provides greater protection than a product with an SPF value
of 50 (e.g., assume that an SPF 80 sunscreen provides greater protection than an SPF 50
sunscreen). However, we lack evidence that a product with an SPF value higher than 50
15
provides additional clinical benefit compared to a product with an SPF value of 50. In
the absence of data demonstrating additional clinical benefit, we are concerned that
labeling a product with a specific SPF value higher than 50 would be misleading to the
consumer.” (76 Fed.Reg. 35674.) In the Proposed Rule, the agency stated that it needed
further data and invited comments. “[W]e are requiring data sufficient to support a
general conclusion that sunscreen products with specific SPF values above 50 provide
additional protection over SPF 50 sunscreen products. If we receive such data, and
sufficient accompanying data regarding accuracy and reproducibility of testing, we may
be able to allow those specific SPF values to be included in labeling.” (Id. at 35675.)
The Proposed Rule acknowledged the potential value of sunscreen products with
SPF values over 50: “We recognize that sunscreen products with SPF values above 50
could have utility for consumers in certain settings, such as skiing at high altitudes, or
with certain conditions that predispose them to developing skin cancer. If such products
are needed in unique situations but not in typical situations of sunscreen use (e.g., beach
or gardening), it is possible that different labeling may be necessary for these unique
situations. . . . Additional data would enable us to identify the appropriate target
population . . . for sunscreen products with SPF values above 50.” (76 Fed.Reg. at
35675.)
In summary, the Proposed Rule declared no final FDA position on the safety and
effectiveness of products with SPF values over 50. While the agency expressed concerns
about the efficacy of such products, it lacked scientific evidence to issue a rule.
Accordingly, the Proposed Rule invited relevant data.9 Since the publication of the 2011
9 One study on the topic was cited in the Proposed Rule. Its title summarizes its
findings: Russak, et al, “A comparison of sunburn protection of high-sun protection
factor (SPF) sunscreens: SPF 85 sunscreen is significantly more protective than SPF
50,” 62 Journal American Academy of Dermatology 348 (Feb. 2010). The FDA
concluded that the single study did not provide an adequate basis to make broader policy.
(76 Fed.Reg. 35674-35675 [“we cannot determine from the study summary the amounts
of sunscreen products applied, length of sun exposure for individual subjects, or the time
16
Proposed Rule, the FDA has issued no Final Rule limiting the maximum SPF that can
appear on sunscreen labels.
3. Principles of Preemption
Under the supremacy clause of the United States Constitution, “[w]hen a state
statute, administrative rule, or common-law cause of action conflicts with a federal
statute, it is axiomatic that the state law is without effect. [Citations]” (Geier v.
American Honda Motor Co., (2000) 529 U.S. 861, 894) (Geier).) “In determining
whether federal law preempts state law, a court’s task is to discern congressional intent.
[Citation.] Congress’s express intent in this regard will be found when Congress
explicitly states that it is preempting state authority. [Citation.] Congress’s implied
intent to preempt is found (i) when it is clear that Congress intended, by comprehensive
legislation, to occupy the entire field of regulation, leaving no room for the states to
supplement federal law [citation]; (ii) when compliance with both federal and state
regulations is an impossibility [citation]; or (iii) when state law ‘stands as an obstacle to
the accomplishment and execution of the full purposes and objectives of Congress.’
[Citations.]” (Bronco Wine Co. v. Jolly (2004) 33 Cal. 4th 943, 955; see Dowhal v.
Smithkline Beecham Consumer Healthcare (2004) 32 Cal. 4th 910, 923 (Dowhal)).) In
addition, federal agency regulation with the force of law can preempt conflicting state
requirements. (Geier, supra, 529 U.S. at pp. 874-884; Wyeth v. Levine (2009) 555 U.S.
555, 576.) A state “requirement” may include state suits based on common law or
statutory provisions. (Cipollone v. Liggett Group, Inc. (1992) 505 U.S. 504, 521-522;
Kanter v. Warner-Lambert Co. (2002) 99 Cal. App. 4th 780, 792.)
The party who asserts that state law is preempted bears the burden of so
demonstrating. (Viva! International Voice for Animals v. Adidas Promotional Retail
of day during which subjects were exposed to the sun”].) In any case, the study was
supported in part by a grant from Neutrogena.
17
Operations, Inc. (2007) 41 Cal. 4th 929, 936.) Moreover, consideration of issues under
the supremacy clause starts with the presumption that state laws are not to be preempted
by a federal statute unless it is the clear and manifest purpose of Congress to do so.
(Cipollone v. Liggett Group, Inc., supra, 505 U.S. at p. 516.)
By its terms, 21 United States Code section 379r expressly preempts state
requirements not identical with the federal requirements. The FDA maintains that
pursuant to section 379r, its sunscreen labeling regulations preempt state law
requirements not identical to the Final Rule. (76 Fed.Reg. 35624.)
A. California cases interpreting 21 United States Code section 379r
Two published California appellate cases have considered the preemptive effect of
section 379r on lawsuits aimed at enforcing state statutory requirements. Both found that
the suits were preempted, although under different theories. In Dowhal, supra, 32
Cal. 4th 910, our Supreme Court held that a suit to require a Proposition 65 warning on
nicotine replacement therapy products was preempted despite a savings clause in section
379r that exempted Proposition 65. The Court found that section 379r did not expressly
preempt the claim that the state law warning was required because of the savings clause.
However, because the state and federal requirements directly conflicted, the Proposition
65 requirement was impliedly preempted.
Proposition 65, enacted through ballot initiative in 1986, prohibits businesses from
knowingly exposing anyone to a chemical known to cause reproductive toxicity without a
warning. Regulations to implement the initiative required that products containing
nicotine warn users that it contained a chemical known to the state “to cause reproductive
harm.” In contrast to this state requirement, the FDA label for nicotine replacement
therapy products warned a pregnant or breast-feeding mother that smoking can seriously
harm her child, and urged cessation of smoking without using nicotine replacement
medicine, but also stated that “the risks to your child from this medicine are not fully
known.” (Dowhal, supra, 32 Cal.4th at pp. 918-919.) Plaintiff Dowhal, acting on behalf
18
of the public, sued to bar sale of defendant’s nicotine replacement products without the
Proposition 65 warning.
In considering whether the state warning requirement was preempted by federal
law, the Supreme Court explained that express preemption, and implied preemption
based on pervasive federal regulation that occupies the field, did not apply. “The savings
clause in the Modernization Act demonstrates both that Congress did not expressly
preempt California law, and that it did not occupy the field of labeling of over-the-
counter drugs. Thus, the issue here is the third form of preemption, referred to as
‘conflict preemption.’” (Dowhal, supra, 32 Cal.4th at p. 924.) The Supreme Court
reasoned that there was a direct conflict between the required Proposition 65 warning and
the FDA’s mandates because it was impossible for the manufacturer to comply with both
requirements. Relying on the United States Supreme Court decision in Geier v.
American Honda Motor Co., supra, 529 U.S. 861, our Supreme Court concluded in
Dowhal that the savings clause “does not entirely exclude conflict preemption” (Dowhal,
supra, 32 Cal.4th at p. 926), and accordingly, the FDA’s directive could invalidate a
Proposition 65 label “on a basis relevant to consumer health,” although not to pursue a
policy of “national uniform labeling.” (Ibid.) The Supreme Court deferred to the FDA’s
balancing of competing risks, observing that this was “an unusual case.” (Id. at p. 934.)
While in most cases the FDA and Proposition 65 warnings would both inform the
consumer of the risks involved in using a product, in this instance, the “FDA’s objection
to labels warning that nicotine ‘can’ harm the baby is not that they are false, but that
consumers may give too much weight to the warnings and decide to continue smoking
instead of using [the product] to stop smoking.” (Id. at p. 931.) Thus, the suit to require
the Proposition 65 warning was preempted.
Dowhal is our Supreme Court’s only interpretation of the statute at issue here, but
it is significant because it concluded that the doctrine of implied preemption foreclosed
enforcement of a state ballot initiative even when the federal statute contained a savings
clause crafted specifically to exempt that initiative. (See Dowhal, supra, 32 Cal.4th at p.
926, fn. 6.) And, relevant to this case concerning sunscreen rules, Dowhal indicates that
19
without the unique savings clause in that case, that is, with the express preemption
provisions of section 379r in force, the federal statute preempts state requirements that
depart from “national uniform labeling.” (Id. at p. 926.) Finally the Dowhal decision
reflects a cautious deference to the policy tradeoffs considered by the federal agency.
In the second California decision on the preemptive effect of section 379r, the
First District Court of Appeal affirmed summary judgment in favor of defendant
manufacturers of over-the-counter drugs for the treatment of head lice. (Kanter, supra,
99 Cal. App. 4th 780.) Plaintiffs alleged that the products were falsely labeled. The trial
court found that the claims were preempted by section 379r, and the Court of Appeal
agreed. (Id. at pp. 795-797.) The FDA had approved labeling for the product, but
plaintiffs alleged that the labels were inaccurate, and accordingly, defendants breached
warranties, and were guilty of fraud and false advertising. Plaintiffs sought relief under,
among other statutes, Business and Professions Code sections 17200 and 17500, and the
Consumer Legal Remedies Act. The Kanter court noted that the underlying legal
theories were based on the assertion that the FDA-approved label was inadequate and
should be changed. The court concluded that “when a state law claim, however couched,
would effectively require a manufacturer to include additional or different information on
a federally approved label, it is preempted.” (Id. at p. 795.) The court held that the
plaintiffs’ state law claims were expressly preempted by section 379r because “[e]ach
cause of action would result in the establishment of a state requirement regarding labeling
that would be ‘different from’ and ‘otherwise not identical with’ the federally required
label. . . .” (Id. at pp. 796-797.) Because the court concluded that section 379r expressly
preempted the suit, it declined to reach the issue of implied conflict preemption.
Dowhal and Kanter indicate that under section 379r: (1) the FDA may require
uniform labeling of products; (2) ordinarily, suits that seek alternatives to the FDA’s
uniform labels are expressly preempted; and (3) even without express preemption, when
state litigation poses an obstacle to the objectives of the federal agency, the suit may be
foreclosed by implied preemption.
20
B. Federal cases interpreting 21 United States Code section 379r
Most of the cases on preemption under the FDCA have arisen in federal court.
Two recent district court decisions in California considered the issue raised by Eckler,
that the California consumer protection statutes were violated by the merchandising of
sunscreen products with SPF values over 50.
In Corra v. Energizer Holdings, Inc. (E.D. Cal. 2013) 962 F. Supp. 2d 1207
(Corra), a consumer sued a sunscreen distributor alleging violations of Business and
Professions Code section 17200, Civil Code section 1750, and breach of express
warranty. The plaintiff alleged that defendant distributed sunscreen products which had
SPF values over 85, but that, while defendant charged a premium for them, such products
do not provide superior protection compared to lower SPF products. The district court
denied defendant’s motion to dismiss based on preemption.10 The court did not examine
the language of 21 United States Code section 379r, but considered the FDA’s Final Rule
regarding sunscreen products. (76 Fed.Reg. 35620 et seq. (June 17, 2011).) The court
concluded that the preemption doctrine did not foreclose the suit, noting that plaintiffs did
not seek to prohibit use of SPF ratings over 50 or change the product label: “Rather,
Plaintiff alleges the way Defendants marketed their sunscreen products beyond simply
providing an SPF rating – in effect, combining the use of SPF ratings with price
differentials and claims of proportionally greater protection – misled consumers into
purchasing more expensive, higher SPF-rated products . . . .” (962 F.Supp.2d at p. 1214.)
The court believed that if the plaintiff were to prevail under the state consumer protection
statutes, “Defendant’s SPF labeling duties would remain unchanged.” (Id. at p. 1215.)
The court also rejected defendant’s argument that 21 Code of Federal Regulations section
201.327 was a further reason to find preemptive intent. That section, listing the types of
10 The court also denied the motion to dismiss based on primary jurisdiction,
standing, and the notice provision of the Consumer Legal Remedies Act. It concluded
that the complaint failed to plead a violation of express warranty and dismissed that claim
with leave to amend. (962 F.Supp.2d at pp. 1215-1220.)
21
representations that were forbidden, was prefaced with the phrase “[t]hese claims include
but are not limited to.” This non-exclusive list, reasoned the court, “clearly evince[d] no
intent to preempt state consumer fraud claims.” (Ibid.)
A contrary result was reached by a different federal district court in Gisvold v.
Merck & Co., Inc. (S.D. Cal. Nov. 25, 2014, Case No. 14cv1371 DMS) 2014 WL
6765718, 2014 U.S. Dist. Lexis 168955 (Gisvold). As in Corra, the plaintiff in Gisvold
alleged that sunscreen products with an SPF over 50 do not provide any increase in
clinical benefit over SPF 50 products, and thus contended that labels stating SPF values
over 50 are false and misleading under Business and Professions Code section 17200,
Civil Code section 1750, and express warranty. Gisvold sought an order that defendants
charge the same price for the SPF 50+ products as SPF 50 products “and/or that they
include ‘a disclaimer on the label or packaging that a SPF value above 50 does not
provide proportional clinical benefits.’” Just as Eckler requests here, Gisvold sought an
order that the company “engage in a corrective advertising campaign.” (Slip. Op. at 2.)
In Gisvold, the district court concluded that the plaintiff’s claims were preempted.
In contrast to the Corra decision, the Gisvold court reviewed the express preemption
language in the federal statute: “The FDCA, which includes an express pre-emption
statute, is unambiguous and broad in scope” and quoted section 379r. The court also
reviewed the FDA’s final rule regarding labeling and effectiveness of sunscreen products,
noting that they mandate the SPF value. The court found that the plaintiff’s argument
was broader than her pleading: “the essence of Plaintiff’s claim is that ‘Merck’s SPF 55,
70+, 80 or 100+ representations . . . on its Coppertone SPF 55-100+ collection are false,
misleading and reasonably likely to deceive the public.’” (Gisvold, supra, slip op. at 5;
italics in original.) The court concluded that “in seeking to provide greater consumer
protections, Plaintiff targets Merck’s sunscreen label (which complies with current FDA
regulations), and proposes a disclaimer regarding the level of sunscreen effectiveness
beyond SPF 50. Because the proposed disclaimer plainly adds to and is not identical with
the FDA requirements, Plaintiff’s action is expressly pre-empted under 21 U.S.C. §
379r.” (Slip. Op. at 5; fns. omitted.)
22
The Gisvold court was unpersuaded by the Corra decision, pointing out that Corra
did not consider whether a disclaimer regarding clinical benefits would “add to or be
identical with FDA’s labeling requirements.” (Gisvold, supra, Slip Op. at 6.)11 It also
interpreted more narrowly than the Corra court the FDA’s regulation on false or
misleading claims at 21 Code of Federal Regulations section 201.327(g). That regulation
prohibits use on product labels or other advertising the terms “sweatproof,”
“waterproof,” and “sunblock,” or “similar claims.” The district court in Gisvold
reasoned: “Although the regulation does not purport to provide an exclusive list of false
and/or misleading claims, its scope is limited to claims similar to those listed. Plaintiff
does not argue, nor could she, that premium pricing or the lack of a disclaimer regarding
proportional clinical benefits of SPF 50+ products are similar to the claims precluded by
the regulation.” (Ibid.; italics in original.) Accordingly, the court granted defendant’s
motion to dismiss on grounds of express preemption.12 The timing of compliance with
the 21 Code of Federal Regulations section 201.327(g) prohibition was not before the
court.
Neither federal decision is binding on us, but Gisvold is the more persuasive
because that case, like this one, involved a plaintiff seeking a change in product labeling
and advertising. In Corra the court assumed that a change in labeling was not involved.
11 Gisvold also distinguished a Florida district court case that found preemption
commencing with publication of the Final Rule but not before. (See Lombardo v.
Johnson & Johnson Consumer Cos., Inc. (S.D. Fla. Sept. 10, 2014, Civ. No. 13-60536-
Civ-Scola) 2014 U.S. Dist. Lexis 156881.) The court in Gisvold noted: “‘Lombardo is
not attempting to enforce any sort of state labeling requirement in addition to the Final
Rule.’” (Gisvold, supra, Slip. Op. at 6.)
12 Gisvold also dismissed the complaint based on the doctrine of primary jurisdiction.
(Slip. Op. at 6-8.)
23
Other federal cases have considered the preemptive effect of section 379r with
respect to different nonprescription drug products. Over-the-counter cold medications
were the target in Carter v. Novartis Consumer Health, Inc. (C.D.Cal. 2008) 582
F. Supp. 2d 1271 (Carter). In that case plaintiffs claimed that the medications were unsafe
and ineffective for children under age six, although they alleged no injury from use of the
medications and sought recovery only for the money they paid for them. Their actions
were brought under New Jersey consumer fraud statutes and common law claims for
false and misleading advertising, deceptive business practices and breach of warranty.
The complaint requested an injunction preventing defendants from falsely advertising and
marketing the cold medicine as safe and effective for children under the age of six. The
court observed that these medications are governed by FDA regulations, which, after a
lengthy evaluation process, were issued on a range of subjects, including permissible
active ingredients, dosages and mandatory labeling. The FDA determined that the
medications should bear a warning that they not be administered to children under the age
of two. (Id. at p. 1276.)
The court in Carter found that the claims were expressly preempted under section
379r and dismissed them. The court found that the relief sought by suits under state law
constitute “requirements” that may be subject to preemption, citing Supreme Court cases
that gave an “expansive reading” to that term. (Carter, supra, 582 F.Supp.2d at p. 1281.)
And, turning to section 379r itself, the district court reasoned that subdivision (c)(2)
“expands the universe of potentially preempted state law claims to include that those
require additional warnings in the advertising for nonprescription drugs, and not only on
the labeling.” (Id. at p. 1282.)13 The plaintiffs in Carter “do not allege that Defendants
13 Section 379r(c)(2) defines a “requirement that relates to the regulation of a drug”
to include “any requirement relating to public information or any other form of public
communication relating to a warning of any kind for a drug.” The Carter court
recognized that this provision did not mean that all advertising requirements are
“automatically preempted,” but that state requirements relating to public warnings that
are “different from or in addition to” federal requirements are expressly preempted.
(Carter, supra, 582 F.Supp.2d at pp. 1281-1282.)
24
fail to comply with FDA regulations as they currently exist, so none of their claims are
parallel enforcement claims.” (Id. at p. 1282.) (See § 379r(f) [no prohibition on state
enforcement of a requirement identical to a requirement under the FDCA].) The court
rejected the plaintiffs’ argument that the relief they sought fell outside of federal
requirements based on a purported general duty on defendant’s part “not to deceive.” (Id.
at pp. 1282-1283.) It found that plaintiffs’ interpretation of authority was mistaken, and
failed to acknowledge the breadth of preemption embodied in section 379r: “The
touchstone of preemption under § 379r is the effect that a finding of liability on a
particular claim would have on the Defendants, and not the particular common law or
state law theory upon which that claim was brought. As long as that claim imposes a
‘requirement’ that is at variance with FDA regulations, it is preempted.” (Id. at p. 1283;
italics in original.) Thus, a suit to add to product labels or alter “public information” or
“public communication” from that required by the federal agency is foreclosed under
section 379r.
The Carter decision is pertinent to the appeals considered here for another reason.
Engel claims, based on comments in proposed regulations, that the FDA “banned” the
use of the Labeling Terms long before it actually issued a regulation doing so. Eckler
claims as a fact the lack of clinical benefit of SPF 50+ products, although the agency
expressed merely a lack of sufficient evidence one way or the other on that issue. Both
arguments are based on distortions of agency comments. In Carter, the plaintiff similarly
sought to stretch the meaning of a proposal published in the Federal Register, a non-final
recommendation that the agency did not adopt. (Carter, supra, 582 F.Supp.2d at p.
1276.) Carter recognizes that courts should avoid engaging in their own rulemaking
when the agency’s work is in progress.
Other federal cases applying section 379r follow Carter. In Crozier v. Johnson &
Johnson Companies, Inc. (D.N.J. 2012) 901 F. Supp. 2d 494, plaintiffs sued under New
Jersey consumer statutes claiming that a first aid antiseptic spray, which accurately
identified on its label the antiseptic ingredients, did not contain antibiotics. Plaintiffs
contended that defendant’s manner of marketing and advertising the product confused
25
and misled consumers to assume that an antibiotic was an ingredient. The district court
held that claims pertaining to the product’s label were expressly preempted under section
379r, although it declined to do so with respect to marketing claims. (Id. at pp. 503-505.)
In Bowling v. Johnson & Johnson (S.D.N.Y. Nov. 4, 2014, Case No. 14-CV-3727
(SAS)) 2014 WL 5643955, 2014 U.S. Dist. Lexis 155899 (Bowling), plaintiffs filed suit
under state and federal consumer and warranty statutes claiming that defendant’s
mouthwash bore a label falsely representing that it “restored enamel.” The court held
that these claims were preempted by section 379r: “the FDA has issued a monograph
directly on point but declined . . . to indicate . . . that ‘Restores Enamel’ is misleading. If
successful, this litigation would do exactly what Congress, in passing section 379r of the
FDCA, sought to forbid: using state law causes of action to bootstrap labeling
requirements that are ‘not identical with’ federal regulation.” (Id. Slip. op. at p. 9.) The
district court explained that “the whole point of section 379r is that it is not up to private
litigants – or judges – to decide what is ‘false or misleading.’ It is up to the FDA.”
(Id. Slip. op. at p. 11.) Concluding that the suit sought to “supercede the FDA’s
regulatory authority,” the court held that plaintiff’s claim was foreclosed.
Cases that have declined to find preemption have done so under statutory
exceptions, or because label uniformity was not at issue. For example, the district court
found no preemption in Delarosa v. Boiron, Inc. (C.D.Cal. 2011) 818 F. Supp. 2d 1177.
In that case plaintiffs used defendant’s “natural” or “homeopathic” cold medicine but
stayed sick. Unlike non-homeopathic over-the-counter drugs, however, homeopathic
OTC drugs are not evaluated by the FDA at all. (Id. at p. 1182.) The court concluded
that the homeopathic medicine was excepted from preemption under section 379r(d).
(Id. at pp. 1186-1187.) Alternatively, the court found that for this product, there were no
federal requirements that could be added to or departed from. Thus, the homeopathic
cold remedy differed from the products in Kanter and Carter which – like the sunscreen
26
products at issue here – were drugs subject to FDA’s comprehensive efficacy and
labeling regulations. (Id. at p. 1189.)14
The intent of Congress expressed in the Modernization Act, both the history and
terms of the FDA’s regulations, and California and federal decisions establish a clear
standard: State suits seeking to require product labels inconsistent with the federal
objective of national labeling uniformity, and not congruent with the FDA’s balanced
effort to achieve such uniformity, are preempted. The question is whether under this
standard appellants’ suits are foreclosed.
Appellants’ claims are preempted
With respect to Engel’s action, the question is whether Neutrogena is liable for
marketing products bearing the Labeling Terms before the FDA required it to stop doing
so.
Placing into commerce a package of sunscreen bearing the terms “waterproof,”
“sweatproof,” and “sunblock” became non-compliant with a federal regulation for the
first time on December 17, 2012. Engel, however, insists that the FDA “banned” these
Labeling Terms 18 year before the Final Rule. He is mistaken.
Contrary to Engel’s contention, the FDA did not ban the labeling terms in 1993,
18 years before the Final Rule. As recounted above, for a time the FDA proposed
permitting the terms “waterproof” and “sunblock,” provided certain ingredient or testing
conditions were met. In the August 27, 2007 proposed rule that preceded the Final Rule,
14 Other cases that have concluded that section 379r did not require preemption are
inapposite. (See Hunt v. McNeil Consumer Healthcare (E.D.La. 2014) 6 F. Supp. 3d 694,
699 [products liability action was expressly excepted from preemption by section
379r(e)]; Dapeer v. Neutrogena Corp. (S.D.Fla. Mar. 25, 2015, No. 14-22113-Civ.) 2015
WL 1395253, 2015 U.S. Dist. Lexis 37644 [in consumer claim against sunscreen
manufacturer, plaintiff disavowed seeking change in how SPF is displayed on label];
Langan v. Johnson & Johnson Consumer Cos., Inc. (D.Conn. Mar. 31, 2015, No. 3:13-
cv-01470(JAM)) 2015 WL 1476400 [challenge to use of “natural” on sunscreen labels;
removing term would not impose state requirement different from that of FDCA].)
27
the FDA did not propose that the Labeling Terms be prohibited. (See 72 Fed.Reg.
49113-49114.) What Engel refers to as a ban by the FDA in 1993 was a proposed rule
issuing a tentative final monograph to which further comments were invited. (58
Fed.Reg. 28194 (May 12, 1993).) The tentative final monograph was not an “order,” as
Engel argues, nor was it in any sense final. This proposed rule did not “ban” any of the
Labeling Terms. The agency did express concern that “waterproof” could be confusing
or misleading and proposed using the term “very water resistant” instead. (58 Fed.Reg.
28228.) But the FDA did not propose that “waterproof” be prohibited on sunscreen
labels. The term “sweatproof” was not addressed at all, although the agency proposed the
use of the term “sweat resistant.” (Ibid.) And, contrary to appellants’ contention, the
FDA agreed that the “descriptive term ‘sunblock’ would be informative to users of OTC
sunscreen drug products,” and proposed how the term could be used in certain
circumstances. (58 Fed.Reg. 28240.) To be sure, in the Final Rule, the FDA states that
the Labeling Terms “are false or misleading, as we have stated in previous sunscreen
rulemakings (58 FR 28194 at 28228; 64 FR 27666 at 276767 through 27680).” (76
Fed.Reg. 35643.) But a review of those previous comments, issued in conjunction with
proposed rules and a monograph that never became effective, do not support that broad
characterization. In any case, no prohibition of the Labeling Terms ever appeared as part
of the Code of Federal Regulations until the publication of the Final Rule on June 17,
2011.
Engel seeks to declare that product descriptions on sunscreen labels that were,
until the FDA’s Final Rule, in compliance with federal law, nevertheless violated
California law. He therefore seeks enforcement of a state requirement “that is different
from or in addition to, or that is otherwise not identical with” a requirement under the
FDCA, and thus, his suit is subject to section 379r’s express preemption provision. (See
Kanter, supra, 99 Cal.App.4th at p. 796 (assertion that approved label is inadequate and
should be changed results in “establishment of a state requirement regarding labeling that
would be ‘different from’ and ‘otherwise not identical with’ the federally required label
28
. . . is therefore preempted”); Bowling, supra, [2014 WL 5643955, 2014 U.S. Dist. Lexis
155899, Slip. op. at p. 11.] [“the whole point of section 379r is that it is not up to private
litigants – or judges – to decide what is ‘false or misleading.’ It is up to the FDA.”].)
Engel argues, however, that Neutrogena should be liable for non-compliant
Neutrogena products marketed during the 18-month period after publication of the Final
Rule to the December 17, 2012 compliance date. This was the period that the superior
court concluded was a safe harbor reflecting a utilitarian cost-benefit analysis. As
discussed above, the FDA assured manufacturers that they would have time to comply
with the new testing and labeling regime and that non-compliant products could remain
on the market. (76 Fed.Reg. 35624.) Engel, in other words urges that states may compel
compliance with a federal requirement before the federal agency requires. This conflict
is what Congress meant to avoid. The superior court was correct in concluding that the
FDA intended to permit a reasonable time to achieve compliance and that the preemption
doctrine nullifies a suit seeking to impose a requirement inconsistent with the agency’s
regulations. (See Carter, supra, 582 F.Supp.2d at p. 1283 [“touchstone of preemption
under § 379r is the effect that a finding of liability on a particular claim would have on
the Defendants . . . . As long as that claim imposes a ‘requirement’ that is at variance with
FDA regulations, it is preempted.”; italics in original]; Lombardo v. Johnson & Johnson
Consumer Cos. Inc. (S.D. Fla. Dec. 19, 2013, Case No. 13-60536-Civ-Scola) 2013 U.S.
Dist. Lexis 189043 [finding express preemption regarding sunscreen products sold after
date Final Rule enacted and labeled before December 17, 2012 compliance date].)
Engel’s claims are also impliedly preempted because they pose an obstacle to the
accomplishment and execution of the full purposes and objectives of Congress and its
delegated agency. (See Dowhal, supra, 32 Cal.4th at p. 923.) Engel seeks imposition of
a labeling regime before the agency required manufacturers like Neutrogena to comply
with it. This is contrary to Congress’s intention of enacting uniform national labeling for
nonprescription drugs, which the FDA is charged with implementing. As the recitation
above of the history of FDA’s regulatory process demonstrates, before it issued the Final
Rule, the agency sifted through thousands of comments, reviewed scientific studies,
29
changed its position on the very terms in question – “waterproof” and “sunblock” – and
determined what label information was necessary, truthful but unnecessary, and
misleading. Appellant seeks to disrupt the careful weighing of conflicting considerations
that Congress entrusted the agency to undertake. As our Supreme Court explained in
Dowhal, enforcement of the Proposition 65 notice requirements – even with an express
savings clause – were impliedly preempted by federal disclosure rules that reflected a
nuanced balance of the need to provide accurate product information while not
discouraging use of a product that could help pregnant women stop smoking. The state-
required warning label in that case – even though truthful – could be prohibited because it
conflicted with the federal purpose. (Dowhal, supra, 32 Cal.4th at pp. 928-931.) In this
case, Engel seeks to usurp the federal agency’s careful consideration of appropriate label
requirements and restrictions, and its determination of the most reasonable phase-in of
labeling requirements.15 His suit conflicts with federal law by posing an obstacle to
Congress’s objective of national labeling uniformity.
Eckler’s claim about the Labeling Terms falls with Engel’s. Eckler’s second
labeling claim is that while Neutrogena accurately states the SPF value on its products,
she maintains that consumers are likely to be misled about the efficacy of SPF 50+
products. Eckler requests that labels and advertising correct the allegedly misleading
omission. Does Eckler’s state law suit seek requirements in addition to or not identical to
federal law? The answer is yes, and thus her suit is also expressly preempted. (See
Kanter, supra, 99 Cal.App.4th at p. 795 [“when a state law claim . . . would effectively
require a manufacturer to include additional or different information on a federally
approved label, it is preempted”].) Eckler’s SPF 50+ claim is based on a distorted
reading of FDA regulations and on speculation about what consumers believe. Further,
15 Engel also asserts that he should be able to pursue claims for alleged violations
after the compliance date. But Engel’s 2006 complaint could not allege purchase of a
non-compliant product after December 17, 2012, and thus he pleaded no injury or any
basis for standing. Based on the pleadings before it, the trial court properly dismissed
Engel’s complaint with respect to this narrow time period as well.
30
in contrast to the claim arising from the Labeling Terms, her allegations about the
efficacy of SPF 50+ products have never been endorsed by the FDA. It is true that in
1999, in a monograph that never took effect, the FDA proposed capping the SPF value at
30. The 2011 Proposed Rule considerably raises that limit. (76 Fed.Reg. 35672 (June
17, 2011).) In any case, the Proposed Rule is simply that: it offers a proposal, but asserts
no final conclusions; it requests data. Eckler’s suit would involve the state court in
precisely the type of scientific inquiry and policy balancing that is within the expert
agency’s proper purview.
Eckler seeks disclosure language added to Neutrogena’s product label and a
corrective advertising campaign. Such an order is expressly preempted by section
379r(a) and (c). The conclusion of the Gisvold case, supra, is persuasive: “[I]n seeking
to provide greater consumer protections, Plaintiff targets Merck’s sunscreen label (which
complies with current FDA regulations), and proposes a disclaimer regarding the level of
sunscreen effectiveness beyond SPF 50. Because the proposed disclaimer plainly adds to
and is not identical with the FDA’s requirements, Plaintiff’s action is expressly pre-
empted under 21 U.S.C. § 379r.” (Gisvold, supra, 2014 WL 6765718, 2014 U.S. Dist.
Lexis 168955 (Slip. Op. at p. 4); fns. omitted.) Eckler’s claim also seeks to impose state
requirements “relating to public information” and is on that basis as well expressly
preempted by section 379r(c)(2). (See Carter, supra, 582 F.Supp.2d at p. 1282 [section
379r(c)(2) “expands the universe of potentially preempted state law claims to include
those that require additional warnings in the advertising for nonprescription drugs, and
not only on the labeling”].)16
16 Beyond the injunctive relief they seek, appellants’ claims for purported economic
injury are inextricably linked to their labeling and marketing claims. Eckler points to no
affirmative representations by Neutrogena concerning added benefits of SP 50+ products,
but she assumes that consumers will believe that a higher price “reinforced the deceptive
message.” (Eckler Reply at p. 24.) Eckler insists she is not alleging a “price premium
misrepresentation.” (Ibid.) Her claim of economic injury, like her efforts to modify
public communications and product labeling, is preempted.
31
Finally, for the same reasons discussed concerning Engel’s suit, we conclude that
Eckler’s action is foreclosed under the doctrine of implied preemption. That the FDA has
not issued a final determination on the issue of products with SPF values above 50 is not
a reason to permit suits like Eckler’s. It is a reason to allow the federal agency to
complete its Congressionally mandated objectives without states imposing a premature
patchwork of disparate requirements. The FDA is evaluating the safety and effectiveness
of SPF 50+ products because it had insufficient data; it therefore invited public comment.
(See 76 Fed. Reg. 35672.) At this point, it is neither Congress’s nor the FDA’s objective
to ban SPF 50+ products. The agency acknowledged that “sunscreen products with SPF
values above 50 could have utility for consumers in certain settings. . . .” (76 Fed.Reg
35675.) It thus left open consideration of a labeling program that specifies when use of
SPF 50+ products would be beneficial. Eckler’s suit, on the other hand, demands that
Neutrogena’s products bear a label that denies any added benefit, for anyone, under any
circumstances. Her suit would thus impose an obstacle to the FDA’s goal of offering
choices to consumers with different needs. The agency’s interest in providing such
choices is comparable to the circumstances underlying the implied preemption holding of
the United States Supreme Court in Geier, supra, 529 U.S. 861. The Court held that a
federal auto safety standard that required manufacturers to install either automatic
seatbelts, airbags, or some other passive restraint device in their vehicles preempted a
California tort suit seeking to hold a carmaker liable for failing to install airbags. The
Supreme Court observed that the federal Department of Transportation deliberately
permitted manufacturers “to choose among different passive restraint mechanisms.” (Id.
at p. 878.) Reasoning that a rule of state tort law requiring a single system of passive
restraints “would have presented an obstacle to the variety and mix of devices that the
federal regulation sought,” the Court held that the state tort suit conflicted with the
objectives of the federal standards and was, under the doctrine of implied preemption,
foreclosed. (Id. at p. 881.) In the case before us, the benefits and uses of SPF 50+
products, and the appropriate range of choices that will be open to consumers, are what
the FDA is investigating and is yet to pass judgment on. Eckler, though, denies such
32
investigation is needed and that such choices are desirable. Eckler’s suit presents an
obstacle to the agency’s express interest in determining if such products may be
advantageous in certain circumstances. Until the FDA issues a final rule on this topic,
Eckler’s claim usurps Congress’s express goal of uniform national labeling and the
FDA’s mandate of determining efficacy based on scientific evidence and making
balanced public policy judgments. Accordingly, Eckler’s claim concerning SPF 50+
products is preempted. The superior court correctly dismissed the appellants’ complaints.
We need not address the other grounds urged for affirmance, including standing and
primary jurisdiction, raised in respondent’s brief.
Disposition
The judgment of the superior court is affirmed. Respondents are awarded their
costs on appeal.
IWASAKI, J.*
We concur:
PERLUSS, P. J. ZELON, J.
*Judge of the Los Angeles Superior Court, assigned by the Chief Justice pursuant to
article VI, section 6 of the California Constitution.
33