United States: Regulating A Healthy Lifestyle? FDA Distributes New Draft Guidance On "General Wellness Products"

Last Updated: February 4 2015
Article by Erin M. Bosman and Joanna Simon

On January 16, 2015, the Food and Drug Administration (FDA) promulgated a much-anticipated draft guidance1 concerning the classification and regulation of general wellness products. The draft guidance is the FDA's latest attempt to provide some regulatory clarity in the wake of the explosion in popularity of wearable wellness devices and general fitness products. The draft guidance—which slightly loosens the FDA's hold on general wellness products—comports with the FDA's current policy of refocusing its resources on high-risk products and away from products that present low risk to the end-user.


Historically, the FDA has not regulated devices intended to benefit a user's overall health and wellness, unless those products made claims about disease prevention, treatment, mitigation, or cure. In the FDA's prior guidance of 1995, it stated that it would regulate fitness equipment only if the equipment was "intended to be used for medical purposes[.]" On the other hand, if the equipment was to be used for "general physical conditioning," the equipment was outside the FDA's regulatory scheme.

However, even if the equipment was only used for physical conditioning, it could still be subject to rigorous FDA regulation if the promotional materials made any medical claims or associated the device with improved medical outcomes. Such regulation includes premarket notification requirements, labeling requirements, good manufacturing practices requirements, and Medical Device Reporting (MDR) requirements. This left many wellness products with the choice of foregoing marketing activities that made reference to improved medical outcomes or facing onerous FDA regulation.


The January 2015 draft guidance concerning general wellness products finally clarifies what constitutes a "general wellness product" and allows for certain well-known promotional claims about health to be made by the manufacturers of these products.

Under the draft guidance, a general wellness product is defined as one intended for general wellness use that presents a very low risk to users' safety. In order to qualify as low risk, the product must not be (i) invasive; (ii) involve an intervention or technology that may pose a risk to users' safety (such as lasers, radiation exposure, or implants); (iii) raise novel questions of usability; or (iv) raise questions of biocompatibility. The FDA specifically lists exercise equipment, video games, software programs, and other products commonly available in retail stores as examples of devices likely to be included within the above definition of a general wellness product.

If a product falls within definition of a general wellness product, it must also have one of two identified uses in order to be covered by the new draft guidance. The product must have (1) "an intended use that relates to maintaining or encouraging a general state of health or healthy activity," or (2) "an intended use claim that associates the role of healthy lifestyle with helping to reduce the risk or impact of certain chronic diseases or conditions and where it is well understood and accepted that healthy lifestyle choices may play an important role in health outcomes for the disease or condition."

The first identified "use" category of general wellness devices are those that make no reference to diseases or conditions, including products relating to weight management, physical fitness, sleep management, and self-esteem. These types of devices have traditionally been, and continue to be, outside the FDA's regulatory purview.

More interesting is the second category of general wellness intended uses, which the draft guidance explains can be broken down into two subcategories: (i) those intended to be used to promote, track, and/or encourage choices that "as part of a healthy lifestyle, may help reduce the risk of certain chronic diseases or conditions," and (ii) those intended to be used to track and/or encourage choices that, "as part of a healthy lifestyle, may help living well with certain chronic diseases or conditions."

According to the FDA, manufacturers of devices that fall into these subcategories may now, as part of their promotional materials, make claims that using the product may help reduce the risk of disease, or help someone live better should they suffer from a certain disease or condition. The following types of claims are permissible under the draft guidance: "Product X promotes physical activity, which, as part of a healthy lifestyle, may help you reduce the risk of high blood pressure"; or "Product Z tracks activity sleep patterns and promotes healthy sleep habits, which, as part of a healthy lifestyle, may help reduce the risk for developing type 2 diabetes." Another example of a permissible claim is the statement that a calorie tracker may promote a healthy weight and/or may help living well with type 2 diabetes, or may assist in healthy living with high blood pressure. Notably, health-related claims in marketing materials (like the examples provided by the FDA) are only permissible under the draft guidance when it is well known that a healthy lifestyle is associated with the improved health outcome.

The FDA has also provided a decision algorithm so manufacturers can determine if their product qualifies as a general wellness product under the draft guidance.


The shift presented by the draft guidance is significant; if implemented, general wellness device manufacturers would be able to say more about the well-known health benefits of their products without risking FDA regulation. Indeed, under the draft guidance, manufacturers are permitted to link products to potential health outcomes, implying that the product itself may help mitigate or reduce the risk of certain diseases. Such statements—though only permitted when it is "well understood and accepted" that a healthy lifestyle is associated with the improved outcome—were impermissible (or at best, questionable) under the FDA's prior guidance.

This change may prove particularly important for the wearable activity tracker market, which has experienced significant growth in the last year. Under the guidance, promotional materials can now make specific health-related claims; manufacturers are no longer limited to marketing claims such as "helps you stay active" or "gives you feedback about your daily activity." Permitting a manufacturer to make specific health-related claims—such as "encourages activity that, as part of a healthy lifestyle, may help reduce high blood pressure"—likely opens up the market for consumer segments that may not have been interested in merely "tracking their daily activity" but are, for example, keenly interested in reducing their blood pressure.

Given these likely benefits, manufacturers should consider commenting on the draft guidance to help further shape the final outcome and to ensure that the draft guidance is implemented. Comments are due by April 20, 2015.

The draft guidance is a step in the right direction for the FDA. The shift away from needlessly regulating low-risk products, and toward allowing manufacturers to use well-known and accepted health benefits in their promotional marketing, is a welcome one.


1. FDA guidance documents do not establish legally enforceable responsibilities, but rather describe the FDA's current thinking on a topic.

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.

Erin M. Bosman
Joanna Simon
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