United States: POM v Coca-Cola: The FDA, The Lanham Act And Regulation Through Litigation

Last Updated: June 23 2014
Article by Michael A. Walsh

The Supreme Court decided POM Wonderful LLC v the Coca Cola Company  on June 12, 2014.  If you listened to the oral argument you would have assumed Coke's chance of success was proportional to the .3% of pomegranate juice in its pomegranate beverage.  POM purported to assert a "classic false advertising case" that the de minimis amounts of pomegranate juice in the Coca Cola products rendered the labeling actionable under the federal Lanham Act.  Coca Cola's defense hinged on technical compliance and whether POM's claims were an improper attempt to enforce the Food Drug and Cosmetic Act (FDCA).  The District Court and Ninth Circuit found that Food and Drug Administration (FDA) regulations preempted POM's Lanham Act claims.

Things did not go 'better with Coke' at oral argument:

Justice Kennedy:  I think it's relevant for us to ask whether people are cheated in buying this product. Because Coca-Cola's position is to say even if they are, there's nothing (a competitor or the Court) can do about it."

The Justices' sentiments concerning the underlying claims poured into the Court's opinion:

The position Coca-Cola takes in this Court that because food and beverage labeling is involved it has no Lanham Act liability here for practices that allegedly mislead and trick consumers, all to the injury of competitors, finds no support in precedent or the statutes. Id. at 17.

Coca Cola had presented a coherent defense of technical compliance with FDA's labeling requirements but the Justices appeared more interested in consumer perceptions than technical compliance:

Justice Kennedy:  "You want us to write an opinion that sa[ys] that Congress enacted a statutory scheme because it intended that no matter how misleading or how deceptive a label it is, if it passes the FDA ... there can be no liability?  That's what you want us to say?"

Counsel for Coca-Cola:  "We do not, Your Honor."

The Court reasoned that Lanham Act suits draw upon the market expertise of competitors by empowering them to sue to protect their interests on a case-by-case basis by "serv[ing] a distinct compensatory function that may motivate injured persons to come forward," Lanham Act suits, to the extent they touch on the same subject matter as the FDCA, "provide incentives" for manufacturers to behave well.  Id. at 12.

The Government's Proposed Solomon Solution

At the request of the Court, the government had filed an Amicus brief taking a middle position favoring Coca Cola—arguing that claims seeking to impose liability for complying with labeling regulations should be precluded—but ultimately siding with POM that it "should be free to challenge aspects of the respondent's [juice] label that are not specifically addressed by the FDCA or the FDA's regulations.  The Government's middle-ground approach suggested the Court "preclude private parties from availing themselves of a well-established federal remedy because an agency enacted regulations that touch on similar subject matter but do not purport to displace that remedy or even implement the statute that is its source."   Rejecting the government's position the Court stated: "[e]ven if agency regulations with the force of law that purport to bar other legal remedies may do so, it is a bridge too far to accept an agency's after-the-fact statement to justify that result here."  Id. at 17.

Claim Preclusion is not Claim Preemption

The Court observed that "if Lanham Act claims were to be precluded then commercial interests—and indirectly the public at large—could be left with less effective protection in the food and beverage labeling realm than in many other, less regulated industries." The Court reasoned that it was "unlikely" that Congress intended the protections of the health and safety to result in less policing of misleading food and beverage labels than in competitive markets for other products.  Id. at 12.

According to the Court "[a]lthough the application of a federal statute such as the Lanham Act by judges and juries in courts throughout the country may give rise to some variation in outcome, this is the means Congress chose to enforce a national policy to ensure fair competition."  Id. at 14.  The Court reconciled the apparent inconsistency with its ruling in Geier v. American Honda Motor Co., 529 U.S. 861 (2000), barring a claim where the federal agency allowed for various options for compliance, stating:

Here, by contrast, the FDA has not made a policy judgment that is inconsistent with POM's Lanham Act suit. This is not a case where a law suit is undermining an agency judgment, and in any event the FDA does not have authority to enforce the Lanham Act.   Id. at 16-17.

Also at issue in this case are state law claims that were awaiting the Supreme Court's ruling.  Preemption and preclusion have much in common and what remains to be seen is the extent to which the Supreme Court's ruling will influence how the Ninth Circuit decides the issue of whether "Pom's California state law claims, which are based on similar allegations to Pom's Lanham Act claim" are preempted.

What Does this Opinion Mean For Prescription Drugs?

In GlaxoSmithKline LLC v Teva Pharmaceuticals USA, Inc. 2:13-cv-00726 –ER (ED PA Mar. 2014), GSK asserted a Lanham Act claim alleging that representations of bioequivalence were "literally false" (eliminating the need to prove scienter) and that [Teva] made "millions of dollars in profits to the detriment of [GSK]."  Teva argued that determinations of bioequivalence are for the FDA and GSK was trying to privately litigate the FDCA.  The parties argued to different conclusions that the area of law is well settled but the Court disagreed.  The Court cited extensively from the Ninth Circuit's opinion in POM and, nonetheless, denied the motion to dismiss finding that the claims of falsity were not precluded by FDA's earlier determination of bioequivalence, permitting the Lanham Act claims to proceed.

Lawyers will need to ensure trial courts faced with deciding whether to dismiss federal or state claims appreciate the nuanced difference between preclusion and preemption.

While the facts in POM were unique, the Court's ruling is not limited to the facts, and this opinion is a green light for companies within FDA regulated industries to sue competitors whenever there is a shift in market share.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on Mondaq.com.

Click to Login as an existing user or Register so you can print this article.

Michael A. Walsh
Similar Articles
Relevancy Powered by MondaqAI
In association with
Related Topics
Similar Articles
Relevancy Powered by MondaqAI
Related Articles
Related Video
Up-coming Events Search
Font Size:
Mondaq on Twitter
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
Email Address
Company Name
Confirm Password
Mondaq Topics -- Select your Interests
 Law Performance
 Law Practice
 Media & IT
 Real Estate
 Wealth Mgt
Asia Pacific
European Union
Latin America
Middle East
United States
Worldwide Updates
Registration (you must scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions

Mondaq.com (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of www.mondaq.com

To Use Mondaq.com you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these Terms or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.


The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use of the Content or performance of Mondaq’s Services.


Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions