FDCA Express Preemption Victory in Benecol Misbranding Class Action

by Morrison & Foerster LLP - Class Dismissed
Contact

A recent Third Circuit case brings good news for defendants making express preemption arguments under the Food, Drug and Cosmetic Act (FDCA) in misbranding class actions. Last week, the court affirmed the dismissal of a putative class action holding that Johnson & Johnson’s representations of the trans fat content and cholesterol-lowering capabilities of its Benecol® products were expressly preempted by the FDCA, as amended by the Nutrition Labeling and Education Act (NLEA). Young v. Johnson & Johnson, Case No. 12-2475, slip op. (3d Cir. May 9, 2013).

Background and District Court Ruling
Johnson & Johnson (J&J) manufacturers Benecol® butter substitute products (Benecol). The labels for the products state that Benecol contains “NO TRANS FAT,” and the “Nutrition Facts” box notes the “Amount/Serving” of “Trans Fat” as “0g.” The labels also made claims about the products’ ability to lower cholesterol, such as “Proven to Reduce Cholesterol.”

The plaintiff filed suit against J&J, alleging that the trans fat and cholesterol statements were false and misleading because Benecol contained small amounts of trans fats, which could be detrimental to heart health. Plaintiff also claimed that he paid a premium for these products in reliance on the purported false and misleading claims. J&J filed a motion to dismiss the claims arguing that plaintiff lacked standing for failure to adequately plead an injury-in-fact and his claims were expressly preempted by the FDCA.  The District Court agreed and dismissed the case.

“NO TRANS FAT” Claim Preempted
Plaintiff argued on appeal that although FDA regulations authorize Benecol to claim “0g Trans Fat Per Serving,” the regulations do not expressly permit a claim of “NO TRANS FAT” for the product as a whole. The Third Circuit rejected this argument, noting that the “FDA has long recognized this potential for a discrepancy” and has issued regulations that “authorize nutrient content claims based on per serving amounts, even if those claims are not entirely accurate on a per product basis.” As such, plaintiff sought to impose state law requirements that were not identical to the FDCA, and his “NO TRANS FAT” claim was expressly preempted.

Cholesterol Claims Preempted
Plaintiff also contended on appeal that his claims were not preempted because he sought to impose state law requirements that were identical to federal regulations prohibiting false and misleading health claims. The Court of Appeals disagreed, holding that J&J was permitted to make heart health claims regarding Benecol based on the product’s plant stanol esters content because those claims are authorized by FDA regulations (21 C.F.R. §§ 101.14 and 101.83).

Plaintiff argued that the “Proven to Reduce Cholesterol” claim was false and misleading because this statement was expressed in reference to the product as a whole, which contains harmful trans fats, and not in reference to the product’s plant stanol esters content. The Court rejected this argument, noting that FDA regulations specifically authorize these cholesterol claims based solely on the product’s plant stanol ester content.

Conclusion
The Young decision is strong support for express preemption arguments under the FDCA, particularly for cases involving trans fat and other nutrient content and health claims. Even though the Third Circuit stated that the decision is “non-precedential,” it is nonetheless persuasive authority for how courts should analyze claims in similar cases.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© Morrison & Foerster LLP - Class Dismissed | Attorney Advertising

Written by:

Morrison & Foerster LLP - Class Dismissed
Contact
more
less

Morrison & Foerster LLP - Class Dismissed on:

Readers' Choice 2017
Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up using*

Already signed up? Log in here

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
Custom Email Digest
Privacy Policy (Updated: October 8, 2015):
hide

JD Supra provides users with access to its legal industry publishing services (the "Service") through its website (the "Website") as well as through other sources. Our policies with regard to data collection and use of personal information of users of the Service, regardless of the manner in which users access the Service, and visitors to the Website are set forth in this statement ("Policy"). By using the Service, you signify your acceptance of this Policy.

Information Collection and Use by JD Supra

JD Supra collects users' names, companies, titles, e-mail address and industry. JD Supra also tracks the pages that users visit, logs IP addresses and aggregates non-personally identifiable user data and browser type. This data is gathered using cookies and other technologies.

The information and data collected is used to authenticate users and to send notifications relating to the Service, including email alerts to which users have subscribed; to manage the Service and Website, to improve the Service and to customize the user's experience. This information is also provided to the authors of the content to give them insight into their readership and help them to improve their content, so that it is most useful for our users.

JD Supra does not sell, rent or otherwise provide your details to third parties, other than to the authors of the content on JD Supra.

If you prefer not to enable cookies, you may change your browser settings to disable cookies; however, please note that rejecting cookies while visiting the Website may result in certain parts of the Website not operating correctly or as efficiently as if cookies were allowed.

Email Choice/Opt-out

Users who opt in to receive emails may choose to no longer receive e-mail updates and newsletters by selecting the "opt-out of future email" option in the email they receive from JD Supra or in their JD Supra account management screen.

Security

JD Supra takes reasonable precautions to insure that user information is kept private. We restrict access to user information to those individuals who reasonably need access to perform their job functions, such as our third party email service, customer service personnel and technical staff. However, please note that no method of transmitting or storing data is completely secure and we cannot guarantee the security of user information. Unauthorized entry or use, hardware or software failure, and other factors may compromise the security of user information at any time.

If you have reason to believe that your interaction with us is no longer secure, you must immediately notify us of the problem by contacting us at info@jdsupra.com. In the unlikely event that we believe that the security of your user information in our possession or control may have been compromised, we may seek to notify you of that development and, if so, will endeavor to do so as promptly as practicable under the circumstances.

Sharing and Disclosure of Information JD Supra Collects

Except as otherwise described in this privacy statement, JD Supra will not disclose personal information to any third party unless we believe that disclosure is necessary to: (1) comply with applicable laws; (2) respond to governmental inquiries or requests; (3) comply with valid legal process; (4) protect the rights, privacy, safety or property of JD Supra, users of the Service, Website visitors or the public; (5) permit us to pursue available remedies or limit the damages that we may sustain; and (6) enforce our Terms & Conditions of Use.

In the event there is a change in the corporate structure of JD Supra such as, but not limited to, merger, consolidation, sale, liquidation or transfer of substantial assets, JD Supra may, in its sole discretion, transfer, sell or assign information collected on and through the Service to one or more affiliated or unaffiliated third parties.

Links to Other Websites

This Website and the Service may contain links to other websites. The operator of such other websites may collect information about you, including through cookies or other technologies. If you are using the Service through the Website and link to another site, you will leave the Website and this Policy will not apply to your use of and activity on those other sites. We encourage you to read the legal notices posted on those sites, including their privacy policies. We shall have no responsibility or liability for your visitation to, and the data collection and use practices of, such other sites. This Policy applies solely to the information collected in connection with your use of this Website and does not apply to any practices conducted offline or in connection with any other websites.

Changes in Our Privacy Policy

We reserve the right to change this Policy at any time. Please refer to the date at the top of this page to determine when this Policy was last revised. Any changes to our privacy policy will become effective upon posting of the revised policy on the Website. By continuing to use the Service or Website following such changes, you will be deemed to have agreed to such changes. If you do not agree with the terms of this Policy, as it may be amended from time to time, in whole or part, please do not continue using the Service or the Website.

Contacting JD Supra

If you have any questions about this privacy statement, the practices of this site, your dealings with this Web site, or if you would like to change any of the information you have provided to us, please contact us at: info@jdsupra.com.

- hide
*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.