Navigating Executive Orders and DOJ Memos That Threaten Criminal Prosecution

At our webinar earlier this month, we talked about Administration priorities as they relate to the FDC Act and noted that we expect much to remain the same with respect to enforcement.  One notable exception has been the Administration’s targeting of certain surgical procedures and the use of certain drugs for a particular intended purpose.  Specifically, these are procedures and drugs used in providing what HHS had, until recently, referred to as gender-affirming care.  The gray box at the top of the document at this link shows the change in position.

We’re not trying to bury the lead here, but the battle of labeling these surgical and drug treatments is a political one.  The political battle went into gear on January 28, 2025, with an Executive Order titled “Protecting Children from Chemical and Surgical Mutilation.”  That EO contained instructions to the Department of Justice, including that the:

Attorney General shall:

(a)  review Department of Justice enforcement of section 116 of title 18, United States Code, and prioritize enforcement of protections against female genital mutilation; . . . . [and]

(c)  prioritize investigations and take appropriate action to end deception of consumers, fraud, and violations of the Food, Drug, and Cosmetic Act by any entity that may be misleading the public about long-term side effects of chemical and surgical mutilation[.]

Late last month the Attorney General issued a memo addressing both directives.

• First, it “direct[s] all U.S. Attorneys to investigate all suspected cases of FGM [female genital mutilation]—under the banner of so-called ‘gender-affirming care’ or otherwise—and to prosecute all FGM offenses to the fullest extent possible.”
• Second, it “direct[s] the Civil Division’s Consumer Protection Branch to undertake appropriate investigations of any violations of the Food, Drug, and Cosmetic Act by manufacturers and distributors engaged in misbranding by making false claims about the on- or off-label use of puberty blockers, sex hormones, or any other drug used to facilitate a child’s so-called ‘gender transition.’ Even if otherwise truthful, the promotion of off-label uses of hormones-including through informal campaigns like those conducted by sales reps or under the guise of sponsored continuing medical education courses-run afoul of the FDA’s prohibitions on misbranding and mislabeling.”

The EO and DOJ memo were followed by a May 1, 2025 announcement of a report from the U.S. Department of Health & Human Services purporting to provide a “comprehensive review of the evidence and best practices for promoting the health of children and adolescents with gender dysphoria.”

The clear intended message from the EO and the DOJ memo is that individuals and entities who engage in conduct within their scope may be targeted for criminal investigation and prosecution.  Such a message may understandably deter the targeted conduct to avoid such a risk.

Importantly, that is not the only option, however.  As the Supreme Court has recognized: “The dilemma posed by that coercion—putting the challenger to the choice between abandoning his rights or risking prosecution—is ‘a dilemma that it was the very purpose of the Declaratory Judgment Act to ameliorate.’” MedImmune, Inc. v. Genentech, Inc., 549 U.S. 118, 129 (2007) (quoting Abbott Labs v. Gardner, 387 U.S. 136, 152 (1967)). While ensuring that a pre-enforcement challenge is properly presented to a court is not a simple task, it can be done, and for those interested, there may be much to challenge. The Supreme Court has recognized the ripeness of pre-enforcement challenges to criminal laws in a number of contexts, including where threatened injury is “certainly impending” or there is a “substantial risk that the harm will occur.”  Susan B. Anthony List v. Driehaus, 573 U.S. 149, 158 (2014).  The AG’s memo may well be relevant to establishing an impending and credible threat.

Below, we highlight some of the challenges we would see in the government’s attempt to pursue these cases.

18 U.S.C. § 116(a) – Female Genital Mutilation

This statute, as codified in 1996, criminalizes female genital mutilation (FGM) on any person under the age of 18.  There are at least two issues with DOJ’s planned use of the statute.  First, and more generally, it has already been found unconstitutional by one federal court in the first prosecution of FGM under the statute.  Specifically, in United States v. Nagarwala, 350 F. Supp. 613 (E.D. Mich. 2018), the district court ruled that Congress had exceed its constitutional bounds and had no authority to pass this law under the Necessary and Proper Clause or the Commerce Clause.  While DOJ initially appealed the lower court’s decision to the Sixth Circuit, it later moved to voluntarily dismiss the appeal.  See United States v. Nagarwala, No. 18-1156, 2018 U.S. App. LEXIS 37299 (6th Cir. Mar. 30, 2018).  In a letter to the Senate Judiciary Committee, then-Solicitor General Noel Francisco (part of President Trump’s first administration) wrote that DOJ had determined that the statute lacked a reasonable constitutional defense.  It is hard to see how the statute fairs better under constitutional scrutiny this time around, or why it is necessary to wait for a prosecution to find out.

Second, the memo makes it clear that the intended investigation targets are persons and entities providing medical care, but the statute’s own definition of FGM excludes such care.  FGM is defined as “any procedure performed for non-medical reasons . . . .  18 U.S.C. § 116(e) (emphasis added).  It seems a relatively straightforward legal issue of statutory construction, ripe for pre-enforcement review, whether a medical professional providing medical care according to recognized medical standards within their profession can be subject to prosecution.

Food, Drug & Cosmetic Act

The AG’s memo also cites the FDC Act as a tool for DOJ to “hold accountable medical providers and pharmaceutical companies that mislead the public about the long-term side effects of chemical and surgical mutilations,” although as we noted in the webinar, the Consumer Protection Branch tasked with “undertak[ing] appropriate investigations” of FDC Act violations has been slated for elimination, so that obligation may fall to other DOJ components.  The memo also instructs U.S. Attorneys’ Offices to use the False Claims Act (FCA) to investigate the submission of false claims to federal healthcare programs for non-covered services related to “radical gender experimentation.”  And the memo welcomes qui tam whistleblower suits with knowledge of “such violations.”

As to the FDC Act, substantively, the memo asserts that false claims about on- or off-label use of “puberty blockers, sex hormones, or any other drug used to facilitate a child’s so-called ‘gender transition’” may constitute misbranding under the FDC Act.  And the memo goes one step more arguing that, even if otherwise truthful, promotion of off-label uses of hormones can “run afoul” of FDA prohibitions on misbranding and mislabeling.

Recent precedent allows for misbranding prosecution of firms or their owners that engage in promotion of off-label intended uses, including by looking at truthful, non-misleading speech as evidence of a new intended use.  See United States v. Facteau, 89 F.4th 1, 22-26 (1st Cir. 2023).  However, truthful, non-misleading speech on its own cannot be a criminal act as it is protected under the First Amendment.  Id.  Additionally, courts have generally been even more receptive to pre-enforcement challenges to prosecution that impinges on First Amendment rights.

A pre-enforcement challenge is not the only option, of course.  Defenses can also be raised during an investigation. The memo’s suggested use of the FDC Act to investigate and prosecute misbranding by manufacturers may have precedent, but a misbranding charge against a practitioner who uses drugs or other products in gender-affirming procedures would be subject to multiple legal challenges.  First, the FDC Act is generally designed not to limit or interfere with the general practice of medicine.  See 21 U.S.C. § 396.  Second, absent some kind of contractual relationship between a provider and a manufacturer, a provider is generally immune from misbranding if the provider is not also selling a regulated product.

Nevertheless, individuals and organizations could be in receipt of grand jury or HIPAA subpoenas requesting records, or they could be visited by federal agents.  Healthcare providers and others that find themselves the target of a criminal investigation or recipient of a subpoena related to provision of gender-affirming care would be well-advised to obtain counsel experienced in FDA enforcement and prosecutions under the FDC Act.