United States: FDA Requests Public Comments On "Natural" Food Labeling

On November 10, the federal Food and Drug Administration (FDA) announced that it is seeking public comments on use of the term "natural" on food labeling. FDA, "Natural" on Food Labeling (Nov. 10, 2015). The agency explained that its actions were prompted by the "changing landscape of food ingredients and production, and in direct response to consumers who have requested that the FDA explore the use of the term 'natural.'" The announcement came as a surprise since FDA had previously declined requests from consumers, the food industry, and federal judges to define the term.

BACKGROUND

FDA has not regulated the term "natural" on food labels. However, in 1993 it issued an informal "policy," which has two prongs: (i) "nothing artificial or synthetic (including all color additives regardless of source) has been included in, or has been added to, a food" (ii) that "would not normally be expected to be in the food." 58 Fed. Reg. 2302, 2407 (Jan. 6, 1993).

In the past few years, there has been a rising tide of food "misbranding" consumer class actions using state consumer protection laws to challenge the health and nutrition labeling and advertising of food products. Many of those class action lawsuits target food products labeled as "Natural," "All Natural," or "100% Natural," but which allegedly contained artificial or synthetic ingredients.

Some of the courts hearing food "misbranding" cases have asked FDA to weigh in on specific uses of "natural" on food labels. For example, in 2013–2014, several federal judges sent letters to FDA asking the agency to opine on whether and under what circumstances food products produced using genetically modified ingredients (GMOs) may be labeled as "natural." FDA declined to opine on the issue, noting that it had other priorities and budgetary constraints. FDA also stated that if the agency were to formally define "natural," it would do so in the context of a public process.

A number of the food "misbranding" lawsuits involving "natural" claims have settled, while others have reached class certification. There is one case—Brazil v. Dole Food Co., Case No. 5:12-cv-01831-LHK (N.D. Cal. filed Apr. 11, 2012)—in which the court granted summary judgment in favor of Dole based on an "All Natural Fruit" mislabeling claim. There, the court agreed with Dole—it is not enough to show that an ingredient is "synthetic" or "artificial," the plaintiff must also prove that the ingredient is not "reasonably to be expected" by consumers. In that case, the products contained citric and ascorbic acids, alleged to be non-natural. That case is currently pending appeal in the Ninth Circuit. (Case No. 14-17480 (9th Cir. filed Dec. 17, 2014).)

CITIZEN PETITIONS ASKING FDA TO DEFINE OR PROHIBIT USE OF "NATURAL" ON FOOD LABELING

In its announcement, FDA noted that it was taking action in part based on four citizen petitions. Three of the citizen petitions—submitted by the Grocery Manufacturers Association (GMA), Sarah Lee Corp., and The Sugar Association—ask FDA to define the term "natural" for use in food labeling. The GMA's citizen petition specifically asks FDA to permit "natural" statements on foods containing GMOs. The fourth citizen petition, filed by Consumers Union, requests that FDA prohibit use of the term "natural" on food labels altogether because it is misleading to consumers.

FDA noted that, while it has had a longstanding policy on the use of "natural" on food labeling, the policy did not address food production methods, such as the use of pesticides, nor did it address food processing or manufacturing methods, such as thermal technologies, pasteurization, or irradiation. The agency has also has not considered whether the term "natural" should describe any nutritional or other health benefit.

FDA REQUESTS INFORMATION AND COMMENTS ON SPECIFIC ISSUES

In requesting information and comments, FDA has identified a list of specific questions for comments, including:

  • Should FDA define, through rulemaking, the term "natural"?
  • Should FDA prohibit the term "natural" in food labeling?
  • If FDA defines the term "natural," what types of food should be allowed to bear the term "natural"?
  • Should only raw agricultural commodities be able to bear the term?
  • Should only single-ingredient foods, e.g., bottled water or bagged spinach, be able to bear the term?
  • If multi-ingredient foods should be able to bear the term, what type(s) of ingredients would disqualify the food from bearing the term?
  • Is the term "natural" on food labels perceived by consumers the same way as the term "organic"?
  • If FDA were to revise its policy regarding the use of the term "natural" or engage in rulemaking to establish a regulatory definition for "natural," should certain production practices used in agriculture—for example, genetic engineering, mutagenesis,hybridization, the use of pesticides, or animal husbandry practices—be a factor in defining "natural" ?
  • Is the term "natural" on food labels perceived by consumers the same way as "healthy?"
  • Should manufacturing processes be considered in determining when a food can bear the term "natural"?
  • Should the term "natural" only apply to "unprocessed" foods?
  • Should the manner in which an ingredient is produced or sourced affect whether a food containing that ingredient may be labeled as "natural"?
  • What can be done to ensure that consumers have a consistent and accurate understanding of the term "natural" in food labeling to ensure that it is not misleading?
  • What are the public health benefits, if any, of defining the term "natural" in food labeling?
  • Should "natural" have some nutritional benefit associated with it?
  • How might FDA determine whether foods labeled "natural" comply with any criteria for bearing the claim?

Use of the Term "Natural" in the Labeling of Human Food Products; Request for Information and Comments, 80 Fed. Reg. 69905, 69908-09 (proposed Nov. 12, 2015) (to be codified at 21 C.F.R. pt. 101), https://www.federalregister.gov/articles/2015/11/12/2015-28779/use-of-the-term-natural-in-the-labeling-of-human-food-products-request-for-information-and-comments. The agency also noted that it is working with the United States Department of Agriculture (USDA) to examine the use of the term "natural" in meat, poultry, and egg products, and is considering areas for coordination between the two agencies. Id. at 69905.

FDA will begin accepting public comments on November 12, 2015.

RAMIFICATIONS OF FDA'S ANNOUNCEMENT

FDA's announcement is likely to be welcome news for consumers and the food industry alike. A formal regulation defining "natural" should provide much needed clarity regarding proper use of the term and should help curb future food "misbranding" lawsuits.

A federal definition of "natural" might also help to resolve the conflict over GMO labeling. Vermont's GMO law is set to require labeling by July 2016—if it survives legal challenges. Other states have considered, or conditionally adopted, such laws as well. Regulatory action at the federal government level could preempt these state statutes. A more direct approach to preemption is also pending in the U.S. Senate. In July 2015, The Safe and Accurate Food Labeling Act of 2015 passed the House 275-150; the bill would create a federal standard for the voluntary labeling of foods with GMO ingredients and would preempt state GMO labeling laws.

In the short term, food manufacturers currently facing "natural" mislabeling lawsuits should also consider whether FDA's announcement provides grounds for staying the action under the primary jurisdiction doctrine while the agency considers formal regulatory action.

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. All rights reserved

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.

Authors
Michael Steel
William F. Tarantino
Similar Articles
Relevancy Powered by MondaqAI
Wilson Elser Moskowitz Edelman & Dicker LLP
 
In association with
Related Topics
 
Similar Articles
Relevancy Powered by MondaqAI
Wilson Elser Moskowitz Edelman & Dicker LLP
Related Articles
 
Related Video
Up-coming Events Search
Tools
Print
Font Size:
Translation
Channels
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
Password
Confirm Password
Position
Mondaq Topics -- Select your Interests
 Accounting
 Anti-trust
 Commercial
 Compliance
 Consumer
 Criminal
 Employment
 Energy
 Environment
 Family
 Finance
 Government
 Healthcare
 Immigration
 Insolvency
 Insurance
 International
 IP
 Law Performance
 Law Practice
 Litigation
 Media & IT
 Privacy
 Real Estate
 Strategy
 Tax
 Technology
 Transport
 Wealth Mgt
Regions
Africa
Asia
Asia Pacific
Australasia
Canada
Caribbean
Europe
European Union
Latin America
Middle East
U.K.
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.

Disclaimer

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.

General

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