United States: Supreme Court Unanimously Reverses Ninth Circuit's Decision In "POM Wonderful v. Coca-Cola"

Ruling That Competitors May Bring Lanham Act Claims Challenging FDA-Regulated Food and Beverage Labels Could Impact Other Categories of FDA-Regulated Products

On June 12, 2014, the Supreme Court in POM Wonderful LLC v. Coca-Cola Co., No. 12-761, ruled that a competitor may bring a Lanham Act false advertising claim challenging food and beverage labels regulated by the Food and Drug Administration ("FDA") pursuant to the Federal Food, Drug, and Cosmetic Act ("FDCA"). Writing for a unanimous Court, Justice Kennedy concluded that POM's Lanham Act claims were not "precluded" by the FDCA.

Facts of the Case

POM alleged that the name and overall labeling of competitor Coca Cola's juice blend was false or misleading under the Lanham Act, a federal statute that provides a private right of action to challenge a competitor's false advertising. Coca-Cola's juice, sold under the Minute Maid brand, is labeled as "Pomegranate Blueberry" (with the words "Flavored Blend of 5 Juices" in a smaller font), yet it contains only 0.3% pomegranate juice and 0.2% blueberry juice. Coca-Cola asserted this name and label comply with the applicable FDA regulation addressing the labeling of juice blends. POM contended – despite the applicable FDA regulation – that the name of the juice, and presentation of this name on the product label, misleads and confuses consumers into believing that the product contains primarily pomegranate and blueberry juices. The Ninth Circuit had barred POM's Lanham Act claim in part because of the FDA's "comprehensive regulation" of food and beverage labeling, including the specific regulation addressing juice blends.

The Court's Ruling

In reversing the Ninth Circuit, the Supreme Court observed that although this is not a state preemption case, preemption principles are nonetheless "instructive" for the applicable preclusion analysis. The Court noted that neither the Lanham Act nor the FDCA expressly prohibits or limits Lanham Act claims challenging labels of FDA-regulated products. Because the Lanham Act and the FDCA have coexisted for roughly 70 years, the Court viewed Congress's decision not to adopt any preclusion provision as "powerful evidence" that Congress did not intend the FDCA to be the only means for ensuring proper food and beverage labeling. Moreover, the Court did not view Congress's adoption in 1990 of a provision expressly preempting certain state food and beverage labeling requirements as suggesting an intent to preclude federal Lanham Act claims. The omission of any mention of preclusion of federal laws from the preemption provision suggested the opposite intent, if anything, according to the Court.

Moreover, the Court found that the FDCA and the Lanham Act complement each other in the area of food and beverage labeling. While the Lanham Act protects commercial interests against unfair competition, the FDCA protects public health and safety. The Court suggested that Lanham Act lawsuits that touch on the same subject matter as the FDCA "provide incentives for manufacturers to behave well" and reasoned that permitting such lawsuits "takes advantage of synergies among multiple methods of regulation." The Court indicated that if Lanham Act claims challenging food and beverage labeling were to be precluded, then competitors (and indirectly the public) would have less effective protection from false advertising in the food and beverage industry than in other, less regulated industries because the FDA does not preapprove food and beverage labels and does not enforce against all objectionable labels.

The Court rejected Coca-Cola's argument that POM's claims should be precluded because Congress intended national uniformity in food and beverage labeling based on three aspects of the FDCA proffered by Coca-Cola. First, the Court thought that the vesting of enforcement authority under the FDCA solely in the federal government did not indicate Congress's intent to foreclose private enforcement under other federal statutes. Second, the Court recognized that the FDCA's preemption provision applicable to food and beverage labeling expressly applies only to certain state law requirements and not to federal law. Third, the Court acknowledged that the FDCA and FDA regulations address food and beverage labeling with far more specificity than the Lanham Act but indicated this specificity would only matter if the two statutes "cannot be implemented in full at the same time," which the Court thought was not the case.

The Court also rejected the argument of the federal Government, appearing as amicus curiae, that a Lanham Act claim is precluded to the extent the FDA or FDA regulations specifically require or authorize the challenged aspects of the label. The Court rejected the Government's premise that the FDCA and FDA regulations act as a "ceiling" on the regulation of food and beverage labeling in some instances. The FDA's rulemaking on juice blends did not address or even reference the Lanham Act, so the Court held that it was "a bridge too far" to accept an after the fact statement from the Government to justify using the FDA's regulation as a basis for finding preclusion of Lanham Act claims. Additionally, the Court thought the Government's proposed standard would also be impractical because of the difficult line-drawing exercise that would be necessary to distinguish a regulation that "specifically authorizes" conduct from a regulation that "merely tolerates" that conduct. Significantly, the Court did not directly address the aspect of the Government's argument focused on Lanham Act claims that implicate specific FDA requirements (e.g., a claim challenging the use of a word in a label that is expressly mandated, rather than merely authorized, by an FDA regulation).

Implications for Manufacturers of FDA-Regulated Products

The Court's decision indicates that food and beverage labeling can still be false or misleading for Lanham Act purposes, even if such labeling complies with all applicable FDA regulations. Going forward, food and beverage manufacturers will need to recognize that compliance with FDA regulations may not necessarily insulate them from Lanham Act liability. Additionally, food and beverage companies may now be able to use the Lanham Act to challenge their competitors' labeling and promotional practices. Similarly, with respect to consumer class actions under state law challenging food and beverage labels, the Court's opinion said nothing to suggest that such claims, if not expressly preempted, are otherwise precluded.

Notably, throughout the opinion, the Court carefully avoided making a blanket statement that all Lanham Act claims challenging food and beverage labels are not precluded. Instead, the Court held that the FDCA does not preclude Lanham Act suits "like POM's" or "like the one brought by POM in this case." This limiting language appears to leave open the possibility that a Lanham Act suit unlike POM's – perhaps challenging an aspect of food and beverage labeling that would create a real conflict between the Lanham Act and a specific FDA requirement (as opposed to a mere authorization) – may still be barred.

The Court also carefully limited its holding to the context of food and beverage labeling, rather than the broader context of all FDA-regulated products. As part of its rationale for permitting Lanham Act claims challenging food and beverage labels, the Court noted that the FDA does not preapprove food and beverage labels, unlike certain drug labels, and observed that the FDA's oversight of food is "less extensive" than its oversight of drugs.

While the scope of the Court's decision was expressly limited to food and beverages, it may nonetheless have significant implications for other categories of FDA-regulated products, particularly dietary supplements, cosmetics, and tobacco products, because, as with foods, the FDA does not review and pre-approve labeling for these categories of products. On the other hand, the Court's distinction between the FDA's oversight of foods versus drugs suggests that the logic of the Court's holding may not apply with the same force to an analogous case challenging a drug or medical device label that has been affirmatively approved by the FDA. The breadth of the decision, however, remains unclear – particularly for product categories like over the-counter drugs marketed pursuant to an OTC monograph and 510(k)-exempt medical devices, where FDA does not review and approve labeling on a product-by-product basis. Also unclear is how the decision would apply to devices that FDA clears for marketing under the 510(k) premarket notification program, in which FDA reviews sample product labeling prior to clearance but does not officially "approve" it.

Ropes & Gray will continue to monitor the development of Lanham Act jurisprudence in the lower courts that impacts FDA-regulated products following the Supreme Court's decision in POM Wonderful.

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.

In association with
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
Check to state you have read and
agree to our Terms and Conditions

Terms & Conditions and Privacy Statement

Mondaq.com (the Website) is owned and managed by Mondaq Ltd and as a user you are granted a non-exclusive, revocable license to access the Website under its terms and conditions of use. Your use of the Website constitutes your agreement to the following terms and conditions of use. Mondaq Ltd may terminate your use of the Website if you are in breach of these terms and conditions or if Mondaq Ltd decides to terminate your license of use for whatever reason.

Use of www.mondaq.com

You may use the Website but are required to register as a user if you wish to read the full text of the content and articles available (the Content). 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 & conditions or with the prior written consent of Mondaq Ltd. You may not use electronic or other means to extract details or information about Mondaq.com’s content, users or contributors in order to offer them any services or products which compete directly or indirectly with Mondaq Ltd’s services and products.


Mondaq Ltd and/or its respective suppliers make no representations about the suitability of the information contained in the documents and related graphics published on this server for any purpose. All such documents and related graphics are provided "as is" without warranty of any kind. Mondaq Ltd and/or its respective suppliers hereby disclaim all warranties and conditions with regard to this information, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Mondaq Ltd 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 or performance of information available from this server.

The documents and related graphics published on this server could include technical inaccuracies or typographical errors. Changes are periodically added to the information herein. Mondaq Ltd and/or its respective suppliers may make improvements and/or changes in the product(s) and/or the program(s) described herein at any time.


Mondaq Ltd requires you to register and provide information that personally identifies you, including what sort of information you are interested in, for three primary purposes:

  • To allow you to personalize the Mondaq websites you are visiting.
  • To enable features such as password reminder, newsletter alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our information providers who provide information free for your use.

Mondaq (and its affiliate sites) do not sell or provide your details to third parties other than information providers. The reason we provide our information providers with this information is so that they can measure the response their articles are receiving and provide you with information about their products and services.

If you do not want us to provide your name and email address you may opt out by clicking here .

If you do not wish to receive any future announcements of products and services offered by Mondaq by clicking here .

Information Collection and Use

We require site users to register with Mondaq (and its affiliate sites) to view the free information on the site. We also collect information from our users at several different points on the websites: this is so that we can customise the sites according to individual usage, provide 'session-aware' functionality, and ensure that content is acquired and developed appropriately. This gives us an overall picture of our user profiles, which in turn shows to our Editorial Contributors the type of person they are reaching by posting articles on Mondaq (and its affiliate sites) – meaning more free content for registered users.

We are only able to provide the material on the Mondaq (and its affiliate sites) site free to site visitors because we can pass on information about the pages that users are viewing and the personal information users provide to us (e.g. email addresses) to reputable contributing firms such as law firms who author those pages. We do not sell or rent information to anyone else other than the authors of those pages, who may change from time to time. Should you wish us not to disclose your details to any of these parties, please tick the box above or tick the box marked "Opt out of Registration Information Disclosure" on the Your Profile page. We and our author organisations may only contact you via email or other means if you allow us to do so. Users can opt out of contact when they register on the site, or send an email to unsubscribe@mondaq.com with “no disclosure” in the subject heading

Mondaq News Alerts

In order to receive Mondaq News Alerts, users have to complete a separate registration form. This is a personalised service where users choose regions and topics of interest and we send it only to those users who have requested it. Users can stop receiving these Alerts by going to the Mondaq News Alerts page and deselecting all interest areas. In the same way users can amend their personal preferences to add or remove subject areas.


A cookie is a small text file written to a user’s hard drive that contains an identifying user number. The cookies do not contain any personal information about users. We use the cookie so users do not have to log in every time they use the service and the cookie will automatically expire if you do not visit the Mondaq website (or its affiliate sites) for 12 months. We also use the cookie to personalise a user's experience of the site (for example to show information specific to a user's region). As the Mondaq sites are fully personalised and cookies are essential to its core technology the site will function unpredictably with browsers that do not support cookies - or where cookies are disabled (in these circumstances we advise you to attempt to locate the information you require elsewhere on the web). However if you are concerned about the presence of a Mondaq cookie on your machine you can also choose to expire the cookie immediately (remove it) by selecting the 'Log Off' menu option as the last thing you do when you use the site.

Some of our business partners may use cookies on our site (for example, advertisers). However, we have no access to or control over these cookies and we are not aware of any at present that do so.

Log Files

We use IP addresses to analyse trends, administer the site, track movement, and gather broad demographic information for aggregate use. IP addresses are not linked to personally identifiable information.


This web site contains links to other sites. Please be aware that Mondaq (or its affiliate sites) are not responsible for the privacy practices of such other sites. We encourage our users to be aware when they leave our site and to read the privacy statements of these third party sites. This privacy statement applies solely to information collected by this Web site.

Surveys & Contests

From time-to-time our site requests information from users via surveys or contests. Participation in these surveys or contests is completely voluntary and the user therefore has a choice whether or not to disclose any information requested. Information requested may include contact information (such as name and delivery address), and demographic information (such as postcode, age level). Contact information will be used to notify the winners and award prizes. Survey information will be used for purposes of monitoring or improving the functionality of the site.


If a user elects to use our referral service for informing a friend about our site, we ask them for the friend’s name and email address. Mondaq stores this information and may contact the friend to invite them to register with Mondaq, but they will not be contacted more than once. The friend may contact Mondaq to request the removal of this information from our database.


This website takes every reasonable precaution to protect our users’ information. When users submit sensitive information via the website, your information is protected using firewalls and other security technology. If you have any questions about the security at our website, you can send an email to webmaster@mondaq.com.

Correcting/Updating Personal Information

If a user’s personally identifiable information changes (such as postcode), or if a user no longer desires our service, we will endeavour to provide a way to correct, update or remove that user’s personal data provided to us. This can usually be done at the “Your Profile” page or by sending an email to EditorialAdvisor@mondaq.com.

Notification of Changes

If we decide to change our Terms & Conditions or Privacy Policy, we will post those changes on our site so our users are always aware of what information we collect, how we use it, and under what circumstances, if any, we disclose it. If at any point we decide to use personally identifiable information in a manner different from that stated at the time it was collected, we will notify users by way of an email. Users will have a choice as to whether or not we use their information in this different manner. We will use information in accordance with the privacy policy under which the information was collected.

How to contact Mondaq

You can contact us with comments or queries at enquiries@mondaq.com.

If for some reason you believe Mondaq Ltd. has not adhered to these principles, please notify us by e-mail at problems@mondaq.com and we will use commercially reasonable efforts to determine and correct the problem promptly.