no preemption of state claims where FDA didn’t regulate cosmetic talc at all

Johnson & Johnson v. Fitch, No. 2019-IA-00033-SCT, —
So.3d —-, 2021 WL 1220579 (Miss. Apr. 1, 2021)

The Mississippi AG sued J&J under the Mississippi
Consumer Protection Act for selling talcum powder products, alleging that
J&J failed to warn of the risk of ovarian cancer in women who used talc. J&J
argued that the MCPA didn’t cover FDA-regulated labels and that if it did it
was preempted. In 1994 and 2008, citizen petitions to the FDA requested a
cancer warning on cosmetic talc products; the FDA denied both because it “did
not find that the data submitted presented conclusive evidence of a causal
association between talc use in the perineal area and ovarian cancer.”

The MCPA prohibits acts that constitute “unfair or deceptive
trade practices in or affecting commerce,” and provides that “[i]t is the
intent of the Legislature that in construing what constitutes unfair or
deceptive trade practices that the courts will be guided by the Federal Trade
Commission and the federal courts to Section 5(a)(1) of the Federal Trade
Commission Act (15 USCS 45(a)(1)) as from time to time amended.” But the FTCA,
J&J argued, explicitly excludes the regulation of labels on cosmetics,
which it commits to the FDA. The state pointed out that “[t]he FTC Act’s false
advertising prohibition does not include labeling, but that limit explicitly
applies only ‘For the purposes of sections 52 to 54,’ not § 45(a)(1), the
section in which the Act instructs courts to be ‘guided’ by.” Also, “guided by”
doesn’t mean “determined by.” Given that, at the federal level, the FDA and FTC
together cover the waterfront, but that “[i]f judges in Mississippi were bound
by the federal Act, then Mississippi would be left without a legal mechanism to
address labeling issues,” the state supreme court agreed with the AG.

Moreover, federal law didn’t preempt the claim. The FDCA has
an express preemption provision covering cosmetics. Except as otherwise
provided, “no State or political subdivision of a State may establish or
continue 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, a
requirement specifically applicable to a particular cosmetic or class of
cosmetics” under relevant federal law.

However, by its plain language, preemption only applies if
the FDA adopts “a requirement specifically applicable” to a given cosmetic,
which it has not. Instead, the FDA decided not to act.

Comment: I would think that the natural reading would be
that if there are no federal requirements at all for talcum powder—which seems
to be the missing premise here, itself somewhat unlikely—then there’s
preemption if the state tries to add any. But: “the preemption statute
requires the existence in federal law of a positive expression of regulation
applicable to a specific product.”

Nor did implied preemption apply.

from Blogger

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