United States: 23 Skidoo – Genomes, Gamesmanship And The First Amendment

Last Updated: November 28 2013
Article by Kenneth J. Wilbur

On November 22, 2013, the Inquisition collided with the Internet.  On that date, the Food and Drug Administration issued a Warning Letter threatening 23andMe, Inc. with seizure of product, injunctions and civil monetary penalties based on allegations that 23andMe – which provides customers with information about their personal genomes – is selling misbranded and adulterated medical devices.  In plain terms, FDA has sought to restrict dissemination of this information for no other reason than an undocumented fear people might misuse it.  If FDA follows through on its threats of regulatory action, this dispute could provide the forum for defining the First Amendment limits of the FDA's power to regulate public health by restricting dissemination of information.

By way of brief background, for $99, 23andMe provides a receptacle for a saliva sample and a mailer.  Upon receipt, 23andMe extracts selected genetic information from the sample and provides on-line access to the results, including information about genealogy and a short synopsis of selected publically-available, non-patient specific research on medical conditions associated with those genes.  The company's terms of service caution that:

You should not change your health behaviors solely on the basis of information from 23andMe. Make sure to discuss your Genetic Information with a physician or other health care provider before you act upon the Genetic Information resulting from 23andMe Services. For most common diseases, the genes we know about are only responsible for a small fraction of the risk. There may be unknown genes, environmental factors, or lifestyle choices that are far more important predictors. If your data indicate that you are not at elevated genetic risk for a particular disease or condition, you should not feel that you are protected. The opposite is also true; if your data indicate you are at an elevated genetic risk for a particular disease or condition, it does not mean you will definitively develop the disease or condition. In either case, if you have concerns or questions about what you learn through 23andMe, you should contact your physician or other health care provider. 1

23andMe thus makes clear the information it provides is not intended as a diagnostic tool or for use in making medical decisions, but merely as a starting point for dialog and investigation with health care professionals.

FDA's pretext for regulation is a self-serving classification, first articulated in a June 2010 letter, of this service as a device.  The only tangible item that comes in contact with the customer is the saliva collector, which poses no threat to human health and is substantially equivalent to collectors in common use.  The only other possible "instrument, apparatus, implement, machine, contrivance, in vitro reagent or other similar or related article" within the meaning of 21 U.S.C. §321(h)'s definition of "device" is the "chip" used to identify the selected genetic information.  Since the chip does not come into contact with the customer and is not "intended to affect the structure or any function of the body" see 21 U.S.C. §321(h)(3), the "hook" FDA relies on to ban this service is 21 U.S.C. §321(h)(2), which classifies as a device an instrument, apparatus etc. "intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease[.]"  (emphasis added).  The statutory interpretation FDA relies upon to ban 23andMe's service thus depends entirely on FDA's view of the intent of the service as a diagnostic tool, an intent directly contrary to 23andMe's clear disclaimer.

In the Warning Letter, FDA makes clear that its intent is to censor dissemination of information.  It gives as one example of the need to keep consumers in the dark the possibility that a false positive for BRCA-related risk assessment "could lead a patient to undergo prophylactic surgery, chemoprevention, intensive screening, or other morbidity-inducing actions, while a false negative could result in a failure to recognize an actual risk that may exist." (emphasis added).  The key word "could" simply glosses over the various intervening, superseding events necessary to create even the potential for harm.  It also overlooks the fact that none of the false positive risks are possible without a physician's intervention and the informed consent of that physician's patient.  It also ignores that the "false negative" risk of failing to recognize a risk exists not only always exists, but is also specifically addressed in 23andMe's disclaimer, which warns, in no uncertain terms, "[t]here may be unknown genes, environmental factors, or lifestyle choices that are far more important predictors. If your data indicate that you are not at elevated genetic risk for a particular disease or condition, you should not feel that you are protected."

The Warning Letter thus reflects an assertion by FDA of the right to ban dissemination of information based on fear that it might be misused.  Courts, however, have been painfully clear that, as much as FDA desires this power, its exercise would violate the First Amendment.  In 2002, for example, the Supreme Court struck down an effort by FDA to bar advertising of compounded drugs out of fear that advertising might lead to excessive demand for compounding, observing that "[t]he First Amendment directs us to be especially skeptical of regulations that seek to keep people in the dark for what the government perceives to be their own good[,]" noting the preferred alternative "is to assume that this information is not in itself harmful, that people will perceive their own best interests if only they are well enough informed[.]"2  The Court recently made a similar statement striking down Vermont's efforts to ban dissemination of prescribing information as a means of limiting marketing of brand-name drugs, noting that "fear that people would make bad decisions if given truthful information cannot justify content-based burdens on speech."3 Lower federal courts have repeatedly found FDA cannot rely on fear of misuse to justify restricting speech, at least without proof that the risk of misuse is significant and cannot be controlled by disclaimers similar to those 23andMe has already provided.4

It is possible that nothing will come of the Warning Letter.  Such communications, by their nature and FDA regulations, do not represent formal agency findings and do not commit the agency to enforcement action.  Given the tone of the letter and the publicity it has received, however, follow-up action would not be surprising.  If the FDA attempts to pursue enforcement, however, 23andMe may prove to be a different kind of opponent than FDA is used to dealing with.  For decades, FDA has actively sought to insulate its regulatory actions from First Amendment scrutiny by using Warning Letters threatening misbranding actions – or when that fails, misbranding actions themselves – to raise the stakes of judicial review so high no regulated entity can afford the risk of losing.5  Where it has not been able to deter litigation on the merits, FDA has made concessions to moot adverse determinations on appeal6 or not pursued further appeals of adverse decisions that might result in more-broadly binding precedent7

Unlike a pharmaceutical company that cannot afford to risk its ability to make money selling a drug on the outcome of litigation over the ancillary issue of what it can say to market the drug, here the product 23andMe is selling is information, making FDA's efforts a direct threat to its core business.  Second, 23andMe is not a traditional drug or device company with other products subject to FDA regulation, but an internet start-up with backing from Google.  It is not vulnerable to the need to placate FDA over regulation of other product lines, and may be more likely to make a legal stand on principle.  In 23andMe, FDA may have picked on an adversary it can't intimidate.



2.Thompson v. Western States Medical Center, 535 U.S. 357, 375 (2002), citing44 Liquormart, Inc. v. Rhode Island, 517 U.S. 484, 503 (1996);   Virginia Bd. Of Pharmacy v. Virginia Citizens Consumer Council, Inc., 425 U.S. 748, 769-70 (1976)).

3.Sorrell v. IMS Health, Inc., 131 S. Ct. 2653, 2670-71 (2011) (internal citations omitted).

4.Pearson v. Shalala, 164 F.3d 650, 659 (D.C. Cir. 1999);   Alliance for Natural Health, US, v. Sebelius, 786 Supp.2d 1 (D. D.C. 2011).

5.See, e.g.,Washington Legal Foundation v. Kessler, 880 F. Supp. 26, 36 (D. D.C. 1995).  This process was also apparently at play in FDA conditioning settlement of a misbranding action on Allergan Inc.'s dismissal of a declaratory judgment action seeking clarification of FDA's power to restrict off-label promotion.

6.Washington Legal Foundation v. Henney, 202 F.3d 331 (D.C. Cir. 2000).

7.United States v. Caronia, 703 F.3d 149 (2nd Cir. 2012).

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.

Kenneth J. Wilbur
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