United States: DOJ Addresses FDA Jurisdiction Over Capital Punishment Drugs

Last Updated: July 4 2019
Article by Rachael G. Pontikes, John D. Kendzior and Shaylynn Veeder

In May 2019, the Department of Justice, Office of Legal Counsel (“OLC”) issued a slip opinion addressing the Food and Drug Administration’s (“FDA”) jurisdiction over articles intended for use in lawful executions. The opinion was issued pursuant to a request by the U.S. Attorney General’s Office for the OLC to address this matter because of years of conflict regarding the use of sodium thiopental in executions.  Importantly, the OLC concludes that FDA does not have jurisdiction over such articles.  It states “that articles intended for use in capital punishment by a state or the federal government cannot be regulated as 'drugs' or 'devices' under the FDCA [Federal Food, Drug and Cosmetic Act]" as the FDCA’s regulatory framework for drugs devices cannot sensibly be applied to articles intended in lawful executions.  The opinion emphasizes that if the FDCA applied to these types of articles, the statute would effectively ban them since these articles literally affect the structure and function of the body by causing all bodily functions to cease – thus these articles could never be found safe and effective for their intended use.

Background of the Underlying Conflict Regarding Sodium Thiopental in Executions

The opinion is the result of years of conflict regarding sodium thiopental. As the opinion explains, sodium thiopental was used by many States and the federal government in lethal injections from as far back as the 1970’s.  Prior to using the substance in lethal injections, sodium thiopental was widely used as a surgical anesthetic. Historically, FDA declined to use its enforcement discretion to regulate the use of sodium thiopental in executions.  Heckler v. Chaney, 470 U.S. 821 (1985).  However, in 2012 the sole American Manufacturer of sodium thiopental ceased production and States could only obtain the substance by importing it from foreign suppliers.  In 2011, a group of inmates from Arizona, California, and Tennessee brought suit against FDA for allowing the import of “misbranded” and an “unapproved new drug,” thiopental, to be imported in the U.S.  In 2012 the U.S. District Court for the District of Columbia issued a permanent injunction requiring FDA to block the importation of sodium thiopental on these grounds.  See Beaty v. FDA, 853 F. Supp. 2d 30 (D.D.C. 2012), aff ’d, Cook, 733 F.3d 1.  The Texas Department of Criminal Justice (“TDCJ”) has fought vehemently against this injunction and for the release of sodium thiopental that has been seized by FDA.  In 2017, FDA issued a letter confirming its authority over the imported substance (which the state of Texas did not deny) and determined the use of the drug for lethal injection was an unapproved new drug and misbranded.

The OLC Uses FDA v. Brown & Williamson Tobacco Corp. as the Basis to Limit FDA’s Jurisdiction to Regulate Drugs Intended for Execution 

The OLC also addresses the limits of FDA’s jurisdiction in this opinion.  When addressing FDA’s jurisdictional limits, the OLC relied heavily on FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120 (2000), a Supreme Court case that held FDA had a limited authority to regulate tobacco products.  In that case, the Court determined that if tobacco products were regulated as drugs or devices under the Food, Drugs, and Cosmetics Act (“FDCA”), their sale would be prohibited because they could not be “safe” or “effective” for their intended use.  See 21 U.S.C. § 355; see also 21 C.F.R. § 314.50(d)(5).  The OLC characterized this decision as the Court concluding that a ban on all tobacco products could not be the outcome that Congress intended.

Using the same logic, the OLC concluded the FDCA could not apply to articles intended for use in capital punishment.  If it did, the FDCA would essentially ban their use because they would not be “safe” and “effective” for their intended use.  As such, the OLC determined the FDCA cannot apply to articles used for execution because the Constitution and federal law contemplates the availability and lawfulness of capital punishment.  

The OLC Opinion May Raise Other FDA Jurisdictional Challenges

The opinion raises a number of questions regarding FDA’s jurisdiction.  For example, it is an open question as to how the OLC opinion, a decision binding to the executive branch, will be reconciled with the sodium thiopental injunction in effect from Beaty. The opinion makes clear its conclusion is narrow, such that it does not apply to the use of the drug for anesthetic purpose or FDA’s jurisdiction over physician-assisted suicide.  Additionally, the arguments set forth in this opinion may open the door for other more creative challenges to FDA’s authority to regulate drugs and devices outside of the execution context.

Should you have any questions regarding the slip opinion or any of the issues raised in this alert, please do not hesitate to reach out to Rachael Pontikes, John Kendzior, or Shaylynn Veeder for further discussion.

This article is presented for informational purposes only and is not intended to constitute legal advice.

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.

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
Mondaq Free Registration
Gain access to Mondaq global archive of over 375,000 articles covering 200 countries with a personalised News Alert and automatic login on this device.
Mondaq News Alert (some suggested topics and region)
Select Topics
Registration (please 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