Manufacturers of over-the-counter (OTC) medications often move to dismiss consumer class actions based on federal preemption.  The Federal Food, Drug, and Cosmetic Act (FDCA) contains an express preemption clause that forbids states from enforcing laws relating to OTC drugs that are “different from or in addition to, or that [are] otherwise not identical with, a requirement under” the FDCA.  21 U.S.C. § 379r(a).  (Section 379r also contains a savings clause that exempts product liability actions from its preemptive scope.  See id. § 379r(e).)  Similar preemption provisions exist for food and cosmetics.  Id. §§ 343-1(a), 379s(a).  Although most courts have interpreted the FDCA’s express preemption provisions broadly, a minority have limited their application.  As discussed below, the minority view involves distinguishable circumstances and is inconsistent with the FDCA’s statutory text.

The U.S. Food and Drug Administration (FDA) has published “monographs” for many therapeutic categories of OTC drugs.  A monograph describes the conditions under which a category of drugs may be marketed without a New Drug Application and FDA pre-market approval.  (This post does not address preemption issues related to OTC drugs approved through a New Drug Application or other pre-market approval.)  A monograph is like a recipe for each category of OTC medications.  It sets out the FDA-approved active ingredients for a given therapeutic class of OTC medications and specifies acceptable doses, formulations, and labeling for covered drugs.  Under FDA regulations, an OTC medication that complies with a monograph “is generally recognized as safe and effective and is not misbranded.”  21 C.F.R. § 330.1.  (The Coronavirus Aid, Relief, and Economic Security Act made significant changes to the regulation of OTC drugs, including replacing the notice-and-comment rulemaking process for monograph drugs with an administrative order process.)

Where an FDA monograph exists for an OTC medication, most courts have interpreted the FDCA preemption provision broadly to preempt any state-law claims that impose requirements that are not contained within the monograph.  For example, in Bowling v. Johnson & Johnson, 65 F. Supp. 3d 371 (S.D.N.Y. 2014), the court held that “preemption is certainly appropriate when a state law prohibits labeling that is permitted under federal law.  But it is also appropriate when a state law prohibits labeling that is not prohibited under federal law.”  Id. at 375.  As the court explained, “[t]he standard, in other words, is not whether a state law actively undermines federal law. It is whether state law diverges from federal law at all.” Id.  Many other federal courts have similarly held that state-law claims that seek to impose requirements that differ from an FDA monograph are preempted by the FDCA.  See Harris v. Topco Assocs., LLC, 538 F. Supp. 3d 826, 831 (N.D. Ill. 2021) (FDCA prevents states from imposing requirements “different from or more burdensome than” federal monograph); Bimont v. Unilever U.S., Inc., 2015 WL 5256988, at *3 (S.D.N.Y. Sept. 9, 2015) (surveying cases and noting that “some hold that state laws imposing non-identical requirements in areas that the FDA could have regulated are preempted”).

A minority of courts have declined to find preemption under the FDCA, particularly in the food labeling context.  For example, in Bell v. Publix Super Markets, Inc., 982 F.3d 468 (7th Cir. 2020), the Seventh Circuit held that the FDCA did not preempt state-law claims challenging the phrase “100% grated parmesan cheese.”  Id. at 485.  Similarly, in Astiana v. Hain Celestial Group, Inc., 783 F.3d 753 (9th Cir. 2015), the Ninth Circuit held that the FDCA did not preempt challenges to “all natural” representations on a product’s label.  Id. at 758.

These minority cases should not be read broadly.  First, the cases involved situations where the FDA had been wholly silent on the subject matter of the challenged representation.  For instance, in the Astiana case, the state-law claims were allowed to proceed because the “FDA ha[d] never issued regulations” on the question of whether and when a product may be labeled as “all natural.”  783 F.3d at 758.  In the OTC medication context, however, the FDA generally issues a monograph that imposes strict labeling requirements.   Second, the minority decisions involve food labeling, and the express preemption provision for food is different from the preemption provision for OTC drugs.  Compare 21 U.S.C. § 343-1(a) (preempting state-law requirements that are “not identical to” federal requirements) with 21 U.S.C. § 379r(a) (preempting state-law requirements that are “different from or in addition to, or that [are] otherwise not identical with” federal requirements).  There is good reason that Congress would want broad preemption for OTC medications that are the product of a multi-year rigorous monograph review process to determine acceptable doses, formulations, and labeling.

The FDCA’s preemption provision for OTC medications is expansive.  Although there are a few outlier cases in the food labeling context, courts have interpreted the preemption provision for OTC medications to mean what it says:  state law claims are preempted if they seek to impose any requirements that differ in any way from an FDA monograph.