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Highlight Updates Over-the-Counter Medications

Over-the-counter drugs cannot be marketed unless the FDA has approved them as safe and effective for their intended use.268 The statute preempts state requirements that relate to the regulation of non-prescription drugs and are different from, in addition to, or otherwise not identical to a requirement under the federal statute.269 A savings clause states, however, that nothing in the federal statute should be construed to modify or affect any action or the liability of any person under state product liability law.270

Because part of the FDA’s authority includes approving or specifying requirements for labels, claims that are based on the inadequacy of the label may be preempted, but not claims relating to marketing.271 In addition, a claim that the manufacturer should have petitioned the FDA to approve stronger warnings may not be preempted.272


  • 268 {268} 21 U.S.C. § 355.

  • 269 {269} 21 U.S.C. § 379r(a).

  • 270 {270} 21 U.S.C. § 379r(e). See Orso v. Bayer Corp., 2006 WL 2794975 (N.D. Ill. Sept. 27, 2006) (negligence claim not preempted). Cf. Kanter v. Warner-Lambert Co., 122 Cal. Rptr. 2d 72 (Cal. Ct. App. 2002) (limiting savings clause to traditional product liability actions for non-economic loss, not fraud or breach of warranty claims); Reckis v. Johnson & Johnson, 28 N.E.3d 445, 456 (Mass. 2015) (savings clause does not override conflict preemption).

  • 271 {271} Corra v. Energizer Holdings, 962 F. Supp. 2d 1207 (E.D. Cal. 2013); Crozier v. Johnson & Johnson Consumer Companies, 901 F. Supp. 2d 494 (D.N.J. 2012). See also Bowling v. Johnson & Johnson, 65 F. Supp. 3d 371 (S.D.N.Y. 2014) (claim regarding false statement on label is preempted because FDA has not chosen to prohibit it). Cf. Green v. BDI Pharmaceuticals, 803 So. 2d 68 (La. Ct. App. 2001) (finding failure to warn claim preempted). But see Kanter v. Warner-Lambert Co., 122 Cal. Rptr. 2d 72 (Cal. Ct. App. 2002) (claims based on statements that are not on the label may be preempted because they might motivate the manufacturer to change the label; note that this theory was rejected by the Supreme Court in Bates v. Dow Agrosciences L.L.C., 544 U.S. 431 (2005), under a comparable statute).

  • 272 {272} Hunt v. McNeil Consumer Healthcare, 6 F. Supp. 3d 694 (E.D. La. 2014); Reckis v. Johnson & Johnson, 28 N.E.3d 445, 456–460 (Mass. 2015).