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Federal Register / Vol. 86, No. 145 / Monday, August 2, 2021 / Rules and Regulations
those involving commercial speech, are subject to strict scrutiny, effectively overruling the Central Hudson and Wisconsin v. Mitchell lines of cases.
Relying primarily on Sorrell and mentioning Barr, another comment asserted that FDA understated the constitutional limits on its authority in the NPRM. Another comment suggested that heightened scrutiny is warranted under Sorrell in the fields of medicine and public health.
Response We disagree. As we discussed in the NPRM, the Supreme Court in Sorrell suggested that contentand speaker-based restrictions would be subject to heightened scrutiny, but nevertheless continued to apply the commercial speech inquiry as outlined in Central Hudson 85 FR
59718 at 59724 n.11. Several courts of appeals have subsequently concluded that Sorrell did not overrule or fundamentally alter the Central Hudson analysis see Retail Digital Network, LLC
v. Prieto, 861 F.3d 839, 846 9th Cir.
2017 en banc Sorrell did not mark a fundamental departure from Central Hudsons four factor test, and Central Hudson continues to apply to regulations of commercial speech, regardless of whether they are content based; Missouri Broad. Assn v. Lacy, 846 F.3d 295, 300 n.5 8th Cir. 2017
The upshot of Sorrell is that when a court determines commercial speech restrictions are contentor speakerbased, it should then assess their constitutionality under Central Hudson. quotation marks omitted;
alteration in original; see also Vugo, Inc. v. City of New York, 931 F.3d 42, 50 2d Cir. 2019 No Court of Appeals has concluded that Sorrell overturned Central Hudson. We agree with our sister circuits that have held that Sorrell leaves the Central Hudson regime in place, and accordingly we assess the constitutionality of the Citys ban under the Central Hudson standard., cert.
denied, 140 S. Ct. 2717 2020.
In Reed v. Town of Gilbert, the Court applied strict scrutiny to content-based restrictions on non-commercial speech in sign ordinances. Although some of the language in the majority opinion in that case is broad, most lower courts have subsequently rejected arguments that Reed applies to the regulation of commercial speech see, e.g., Vugo, Inc.
v. City of New York, 931 F.3d 42, 49
50 & n.6 2d Cir. 2019 holding that Central Hudson still applies to commercial speech after Reed and Sorrell, cert. denied, 140 S. Ct. 2717
2020; Nationwide Biweekly Admin., Inc. v. Owen, 873 F.3d 716, 732 9th Cir.
2017 Reed did not relate to commercial speech . . . and therefore
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did not have occasion to consider that doctrine.. Indeed, as one comment noted, in Matal v. Tam, a decision regarding content-based commercial speech issued after Reed, only one Justice advocated overruling Central Hudson in favor of strict scrutiny 137
S. Ct. 1744, 1769 2017 Thomas, J., concurring in part and concurring in the judgment. No other Justice joined that opinion. While no First Amendment analysis garnered five votes in Matal, one four-Justice opinion applied Central Hudson id. at 1764; the other fourJustice opinion stated that heightened scrutiny should be applied to viewpoint discrimination, but explained that viewpoint discrimination is an egregious subcategory of contentbased regulation, and further noted that regulations regarding product labeling or consumer protection may be evaluated differently from the trademark matter at issue in that case id. at 1766, 1768.
There was similarly no majority First Amendment analysis in Barr v. Am.
Assn of Political Consultants, 140 S. Ct.
2335 2020. There, the plurality opinion explained that strict scrutiny should be applied to a law that singled out a specific subject matter for differential treatmentpermitting robocalls for collecting money owed to the Government while prohibiting robocalls for all other purposes see id.
at 2346. Similarly, Justice Gorsuchs opinion emphasized that the statute under review favored certain voices while punishing others see id. at 2364
Gorsuch, concurring in the judgment in part and dissenting in part. In addition, the plurality opinion further circumscribed the scope of its holding:
The issue before us concerns only robocalls to cell phones. . . . Our decision is not intended to expand existing First Amendment doctrine or to otherwise affect traditional or ordinary economic regulation of commercial activity see id. at 2347; see also Am.
Hosp. Assn v. Azar, 983 F.3d 528, 542
D.C. Cir. 2020 in upholding an HHS
rule challenged in part on First Amendment grounds, the court distinguished Barr on the grounds that the restrictions in Barr involved political speech and the regulation at issue in Am. Hosp. Assn involved ordinary regulation of commercial activity.
Accordingly, given that the Supreme Court has not overruled Central Hudson or Wisconsin v. Mitchell and given that the laws being reviewed in the cited cases were quite different from the premarket review provisions of the FD&C Act, we believe it would be wrong to conclude that the Supreme Court has
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implicitly but sweepingly reversed these long-standing precedents to invalidate the regulatory regime under the FD&C
Act. And even if some form of heightened scrutiny were applicable to reliance on speech as evidence of intended use, FDA believes that the public health necessity of the premarket review provisions discussed in this preamble, including its references, justifies and necessitates this regime under any standard.
Comment 16 One comment asserted that scientific speech has been recognized as core speech that merits the highest degree of constitutional protection, citing Washington Legal Foundation v. Friedman, 13 F. Supp. 2d 51, 62 D.D.C. 1998.
Response FDA agrees that, in certain contexts, scientific speech merits the highest degree of constitutional protection. However, the comment failed to note that the cited opinion determined that scientific speech will be evaluated under the First Amendment as commercial speech when a commercial entity seeks to distribute it in order to increase its sales of the product see id. at 6465.
Comment 17 One comment urged FDA to follow the Sixth Circuits decision in Intl Outdoor, Inc. v. City of Troy, 974 F.3d 690 6th Cir. 2020, which the comment claimed held that all content-based speech restrictions are subject to strict scrutiny, even when the restrictions concern commercial speech.
Response FDA declines that suggestion for several reasons. First, Intl Outdoorlike Reedinvolved review of a sign ordinance, which does not raise the same complex regulatory and public health issues as premarket review under the FD&C Act and PHS
Act. Second, a holding that strict scrutiny applies to all content-based commercial speech would run contrary to the weight of circuit court authority discussed above, including the Second Circuits recent decision in Vugo, Inc.
confirming that Central Hudson continues to govern review of commercial speech see 931 F.3d at 50.
Third, the Sixth Circuit in Intl Outdoor did not actually hold that strict scrutiny applies to all content-based commercial speech; the Sixth Circuit distinguished Vugo on the ground that the Second Circuit case involved only commercial speech, where Intl Outdoor involved both core and commercial speech see 974 F.3d at 705.
Comment 18 One comment asserted that FDA should not continue to rely on Wisconsin v. Mitchell and its progeny because the district court in Amarin Pharma, Inc. v. FDA, 119 F. Supp. 3d 196 S.D.N.Y. 2015 construed United
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