Published in Landslide, Volume 15, Number 1, 2022. © 2022 by the American Bar Association. Reproduced with permission. All rights reserved. This information or any portion
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41
Competitor
Advertising
Challenges
Considerations for FDA-Regulated Companies
By Paul D. Rubin and Melissa Runsten
Paul D. Rubin is a partner based in the Washington, D.C.,
oce of Debevoise & Plimpton LLP, where he is the cochair
of the firm’s Healthcare & Life Sciences Group and the chair
of the FDA Regulatory practice. His practice focuses on FDA/
FTC regulatory matters. He can be reached at pdrubin@
debevoise.com. Melissa Runsten is an associate based in the
Washington, D.C., oce of Debevoise & Plimpton LLP, where
she focuses her practice on FDA/FTC regulatory matters. She
can be reached at mrunsten@debevoise.com.
T
he Food and Drug Administration (FDA) regulates products
that comprise approximately 25% of consumer nondurable
spending in the United States, including food, dietary supple-
ments, cosmetics, prescription and over-the-counter drugs, medical
devices, and tobacco. These product categories are highly regulated
and subject to signicant litigation risk.
With the exception of prescription drugs and a narrow category
of medical devices (known as “restricted devices”), the FDA has
primary jurisdiction over product labeling
1
and the Federal Trade
Commission (FTC) has primary jurisdiction over product adver-
tising.2 While FDA-regulated companies have long been aware of
the need to comply with FDA and FTC promotional requirements,
a number of developments have converged in recent years that
make it increasingly important for companies to assess exposure
to private party advertising challenges while concurrently consid-
ering “self-help” to challenge competitor advertising.
For FDA-regulated consumer products (e.g., food, dietary
supplements, and cosmetics), the vast majority of product claims
are not FDA-approved or authorized. Particularly in the absence of
FDA approval or authorization, claims disseminated by consumer
product companies are frequently subject to class action lawsuits
and challenges by competitors in federal court pursuant to section
43(a) of the Lanham Act or before the National Advertising Divi-
sion of Better Business Bureau National Programs (NAD).
For prescription drugs and restricted devices, even though certain
claims are approved by the FDA, a notable development in recent
years has been the increasing prevalence of competitor advertising
challenges, including challenges under section 43(a) of the Lanham
Act. Based upon the 2014 POM Wonderful LLC v. Coca-Cola Co.
U.S. Supreme Court decision,3 decreased FDA advertising enforce-
ment, and recent FDA guidance documents, prescription drug
companies (and companies selling restricted devices) are increas-
ingly susceptible to competitor advertising challenges.
These developments suggest we are in a new era where private
enforcement targeting prescription drug (and restricted device)
advertising is likely to proliferate, while consumer product chal-
lenges continue to ourish. This article summarizes recent key
developments and identies claims susceptible to competitor chal-
lenge pursuant to section 43(a) of the Lanham Act, before the
NAD, and in class action lawsuits. Finally, we provide advice on
developing substantiated and non-misleading advertising claims
capable of surviving legal challenge. This includes the use of
consumer surveys, which can be used to rebut allegations that a
claim is misleading or to challenge competitor advertising.
Lanham Act Challenges
Section 43(a) of the Lanham Act creates a private cause of action
for false advertising.
4
No government agency directly enforces
section 43(a); rather, private lawsuits are brought between compet-
itors.
5
Because no private right of action exists under either the
Federal Food, Drug, and Cosmetic Act (FDCA) or the Federal
Trade Commission Act (FTCA), and enforcement authority under
those statutes is solely vested in the FDA and FTC, respectively, the
Lanham Act provides an important pathway for FDA-regulated
companies to challenge objectionable marketing practices by their
competitors.
Private suits under the Lanham Act are increasingly replac-
ing agency action as a method of challenging false or misleading
