United States: FDA Finalizes Genetically Engineered Food Labeling Guidance & Approves "AquAdvantage Salmon"

Last week will undoubtedly be marked in the annals of Food and Drug Administration history as an important milestone for the Agency. On November 19, 2015, FDA approved the first genetically engineered (GE) animal intended for use as human food – AquaBounty Technologies's AquAdvantage Salmon, a transgenic Atlantic salmon that contains a growth hormone gene from Chinook salmon that allows the fish to reach market size more quickly than traditional Atlantic salmon. The Agency's press release about the decision and related actions is available here.

FDA GE Labeling Guidance

At the same time that it announced the approval decision on AquAdvantage Salmon, FDA finalized its 2001 guidance document called "Voluntary Labeling Indicating Whether Foods Have or Have Not Been Derived from Genetically Engineered Plants" and also issued a new companion guidance in draft form that is specific to the voluntary labeling of foods derived from GE salmon. The main takeaway message from these documents is that the Agency's long-standing policy regarding labeling of foods containing genetically engineered ingredients has not changed, even after years of consumer and legislative pressure regarding the public's right to know whether a food contains one or more GE ingredients. In sum, when the food itself does not exhibit a "material" difference when it contains GE ingredients vs. non-GE counterparts, under existing law, FDA cannot make such labeling mandatory – however, voluntary statements about the method used to produce the food are acceptable as long as the food's label and labeling do not end up being false or misleading.

FDA's guidelines for such voluntary labeling provide basic principles to ensure that label statements are not false or misleading, along with examples of accurate statements that could be made either for foods that are not derived from GE plants or for foods that are. For example, the Agency explains that the term "GMO free" may be misleading on most foods because most foods don't contain any "organisms" and, moreover, the complete absence of any bioengineered ingredient may be difficult to substantiate. Expanding on that theme, the guidance documents also recommend ways to ensure that any voluntary labeling statements are substantiated.

AquAdvantage Salmon Approval

In addition, after reviewing information submitted in response to a specific request for comments on the labeling for GE salmon, the Agency did not find any data "showing that AquAdvantage Salmon is materially different from other Atlantic salmon in a manner that would require additional labeling." Thus, the new draft guidance document on this topic discusses ways in which voluntary label statements for the salmon may be made without running afoul of the prohibition on false or misleading representations for a food product.

The AquAdvantage Salmon approval was based on many years of data collection and regulatory review, with FDA's first involvement with the product coming in the mid-1990s. The inserted gene is regulated as a New Animal Drug because it is intended to "affect the structure or function" of the animal, so AquaBounty was required to demonstrate the safety and effectiveness of the drug, as well as the stability of the transgene in successive generations of the fish. Importantly, to mitigate any potential for environmental risks, the marketing approval includes the requirement for "multiple and redundant measures...to contain the fish and prevent their escape and establishment in the environment."

Specifically, they will only be bred and raised in land-based, contained hatchery tanks in two specific facilities in Canada and Panama (not in the U.S.), and FDA as well as the regulatory authorities in Canada and Panama will be inspecting those facilities to ensure their continued compliance with the various containment measures. Deviation from those measures will render the animal drug unsafe and adulterated, such that FDA would have authority to take enforcement action against the manufacturer even before any larger problems occur. The majority of the salmon also will be reproductively sterile and all-female to provide another layer of risk mitigation in the unlikely event of an escape.

Fallout from AquAdvantage Decision

The Agency clearly anticipated the criticism it would receive from environmental and consumer advocacy groups in response to the GE salmon decision, and it has emphasized that the fish are safe to eat and that the Agency essentially had no basis to reject the sponsor's application: "The fish are safe for humans and animals to eat, the rDNA construct is safe for the animal, and the claim about faster growth made by the sponsor has been confirmed. Because the sponsor has met these and other statutory requirements, the FDA must approve the application."

And, apparently seeking to be as transparent as possible in order to alleviate public concerns about the GE salmon and the first-ever GE animal intended for human food, FDA has prepared and released on its website numerous documents related to the regulatory action. Those AquAdvantage Salmon documents include the New Animal Drug approval letter; releasable summaries of the data and other materials reviewed; the environmental assessment and FONSI required to be prepared under the National Environmental Policy Act (NEPA) for any significant agency action; and a list of FAQs as well as a "fact sheet" that are more accessible to laypersons. The same page also provides links to documents stemming from a 2010 meeting of the Veterinary Medicine Advisory Committee in which the safety and effectiveness of the GE salmon was examined in depth.

Nonetheless, even after more than 20 years of data collection by the sponsor and many layers of active review by the Agency, opposition to the GE salmon is already intensifying. Senator Lisa Murkowski has introduced a bill, S. 738 or the "Genetically Engineered Salmon Risk Reduction Act," that would require labels of foods containing the fish to explicitly state that it contains GE salmon. And the Center for Food Safety immediately announced plans to sue the Agency along with other plaintiffs (such a challenge will likely be brought under the Administrative Procedure Act or NEPA, rather than the Federal Food, Drug, and Cosmetic Act, in light of the judicial deference afforded to agencies in interpreting and implementing their own rules). Not all consumer groups have decried the approval decision, however – for example, the Center for Science in the Public Interest issued a statement saying that it agreed with FDA's assessment that the salmon is safe to eat, is nutritionally equivalent to its non-GE counterpart, and will not harm the environment (and that it "may even be beneficial [to the environment] if AquaBounty's claims of efficiency are realized").

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.