United States: Court Finds That Class Action Plaintiffs’ False Advertising Claims Are Stripped Bayer Based On Federal Preemption

In the recent case of Gallagher v. Bayer AG, Case No. 14-cv-04601-WHO (N.D. Cal. March 10, 2015), the plaintiffs asserted that the defendants Bayer AG and related entities (collectively, "Bayer") engaged in false advertising under California, New York, and Florida law.  The products in question were 20 varieties of One-A-Day vitamins that each included advertising on their labels stating that they supported "heart health," "immunity" and "physical energy."  On behalf of a putative class of purchasers, the plaintiffs alleged that the statements were false, misleading, and constituted illegal advertising under state law based on the regulations of the Food & Drug Administration (the "FDA").  Bayer moved to dismiss the complaint on multiple grounds, including the argument that the claims satisfied federal law, thereby preempting the plaintiffs' state law claims.

To understand Bayer's preemption argument, some context is necessary.  The FDA, through the Federal Food, Drug, and Cosmetic Act ("FDCA"), is empowered to regulate the labeling of foods and drugs.  The FDCA expressly preempts state laws that purport to impose "more or inconsistent burdens on manufacturers than the burdens imposed by the FDCA."  Bayer, p. 6.  Thus, a manufacturer that complies with the FDCA's labeling requirements need not also comply with different labeling requirements established by 50 different states.

The other relevant statute to this case, the Dietary Supplement Health and Education Act ("DSHEA"), defines the rules regarding advertising and labeling for dietary supplements.  DSHEA, generally, defines two types of advertising claims:  "disease" claims and "structure/function" claims.  "Disease" claims are "express or implied claims 'to diagnose, mitigate, treat, cure, or prevent a specific disease or class of diseases.'"  Bayer, p. 6.  "Structure/function" claims, on the other hand, may "...describe the role of a nutrient or dietary ingredient intended to affect the structure or function in humans, [and/or] characterizes the documented mechanism by which a nutrient or dietary ingredient acts to maintain such structure or function."  Bayer, pp. 5-6.  Importantly, while a supplement manufacturer must receive pre-approval from the FDA before making any "disease" claims in its advertising, a "structure/function" claim only requires that the manufacturer make appropriate disclosures and submit the claim to the FDA within 30 days of its first appearance.  Bayer, p. 6 n. 2. 

In this case, the plaintiffs argued that Bayer's advertising of "heart health" and support for "immunity" were unapproved "disease" claims (the plaintiffs conceded that the statement "supports physical energy" was a structure/function claim).  Thus, if these claims were, in fact, "disease" claims that had not been preapproved by the FDA, then Bayer could be liable for unlawful advertising practices.

In addressing Bayer's motion to dismiss, the Court first found that the express preemption language of the FDCA applied equally to the supplement advertising rules set forth under DSHEA.  Bayer, pp. 7-8.  The Court reasoned that, because DSHEA gives the FDA authority to regulate the labeling of supplements, the language of the FDCA must apply to the regulations of DSHEA such that no state may impose burdens that "exceed or contradict the labeling requirements" of the DSHEA.  Bayer, pp. 8-9.  Thus, if Bayer's advertising claims were permissible under DSHEA, then they could not be illegal under state law.

The Court then evaluated whether the alleged advertisements were "disease" or "structure/function" claims.  With respect to the "supports heart health" claim, the Court relied on guidance and regulations from the FDA that found that similar advertisements (like "helps maintain cardiovascular function") were structure/function claims.  Bayer, pp. 9-10.  For the "supports immunity" claim, again, the Court relied on FDA guidance to note that similar claims (like "supports the immune system") had been determined to be structure/function claims.  Bayer, p. 11.  Thus, because Bayer's advertising consisted of structure/function claims, the express preemption of the FDCA prevented the plaintiffs from using state law to impose liability against Bayer for making illegal "disease" claims.  The plaintiffs were given leave to amend, however, to allege "by virtue of specifically identified packaging or marketing" that Bayer was actually linking these advertisements to the prevention or treatment of disease.  Bayer, p. 11.

Simply proving that the FDCA and DSHEA preempted the plaintiffs' attempts to impose liability under state law was only half the battle.  Indeed, under both state law and DSHEA, advertisements may not be false or deceptive, so state laws requiring truthful advertising of supplements are not preempted.  Bayer, p. 9.  Thus, as an alternative theory, the plaintiffs argued that the statements "supports heart health," "supports immunity," and "supports physical energy" were false and misleading even if they were not illegal "disease" claims.  Bayer, pp. 12-13.

The Court found that the plaintiffs' complaint failed to adequately allege the falsity of the "heart health" and "immunity" claims.  The Court noted that the complaint cited numerous studies attempting to show that the ingredients in Bayer's products did not treat or prevent heart disease or provide immunity from diseaseBayer, p. 13.  Those studies, however, would only disprove the advertising if the advertising consisted of "disease" claims.  Bayer, p. 13.  Since, under preemption, the "heart health" and "immunity" claims were permissible structure/function claims, the plaintiffs "are limited to alleging that Bayer's statements that its Supplements 'support' or help heart health and immunity are false."  Bayer, p. 13.  As the complaint's allegations did not disprove the structure/function claims, the claims based on the "heart health" and "immunity" statements were dismissed with leave to amend.  Bayer, p. 14.

The Court reached a different result with respect to the "supports physical energy" advertisement.  The complaint alleged that scientific evidence "confirms that the vitamins Bayer asserts help support immunity do 'not affect the energy levels of typical Americans.'"  Bayer, p. 14.  Although Bayer attempted to argue that the studies were only inconclusive, the Court found that, on a motion to dismiss, the record was too undeveloped to dismiss the claims as a matter of law and, therefore, claims based on the advertisement of supporting "physical energy" were allowed to proceed.  Bayer, p. 14.

The Bayer decision shows the interplay between federal regulations governing supplement advertisements and state laws addressing false advertising.  In finding that the FDCA's preemption provisions apply to DSHEA, the Court suggests that, if the advertising adheres to federal law, then a defendant can limit its liability for "illegal" advertising under state law.  That being said, no amount of preemption will allow supplement manufacturers to use false statements to advertise their products: regardless of whether it is a "structure/function" claim or a "disease" claim, the advertising must not be misleading.  However, as demonstrated by the Bayer decision, the distinction between these kinds of claims is still relevant because it defines what evidence would be required to prove their falsity, greatly magnifying the importance of finding FDA guidance and regulations regarding advertisements that are similar to the claims at issue.

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.

Events from this Firm
16 Oct 2018, Webinar, Washington, DC, United States

Last month, the U.S. District Court for the District of Columbia vacated the Centers for Medicare and Medicaid Services’ overpayment rule for the Medicare Advantage Program.

17 Oct 2018, Conference, Los Angeles, United States

This interactive data simulation will help you prepare your company for a data breach. We will address how to handle tricky legal notice situations and multi-jurisdictional notice law by walking through a step-by-step experience.

17 Oct 2018, Other, Los Angeles, United States

​The recent overhaul of the U.S. tax code impacts nonprofits significantly, from reducing incentives for charitable giving to taxing certain executive compensation.

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