At our webinar earlier this month, we talked about Administration priorities as they relate to the FDC Act and famous that we anticipate a lot to stay the identical with respect to enforcement. One notable exception has been the Administration’s concentrating on of sure surgical procedures and using sure medicine for a specific meant function. Particularly, these are procedures and medicines utilized in offering what HHS had, till lately, known as gender-affirming care. The grey field on the high of the doc at this hyperlink exhibits the change in place.
We’re not making an attempt to bury the lead right here, however the battle of labeling these surgical and drug therapies is a political one. The political battle went into gear on January 28, 2025, with an Govt Order titled “Defending Kids from Chemical and Surgical Mutilation.” That EO contained directions to the Division of Justice, together with that the:
Legal professional Common shall:
(a) assessment Division of Justice enforcement of part 116 of title 18, United States Code, and prioritize enforcement of protections towards feminine genital mutilation; . . . . [and]
(c) prioritize investigations and take acceptable motion to finish deception of customers, fraud, and violations of the Meals, Drug, and Beauty Act by any entity that could be deceptive the general public about long-term unwanted side effects of chemical and surgical mutilation[.]
Late final month the Legal professional Common issued a memo addressing each directives.
- First, it “direct[s] all U.S. Attorneys to research all suspected circumstances of FGM [female genital mutilation]—below the banner of so-called ‘gender-affirming care’ or in any other case—and to prosecute all FGM offenses to the fullest extent doable.”
- Second, it “direct[s] the Civil Division’s Client Safety Department to undertake acceptable investigations of any violations of the Meals, Drug, and Beauty Act by producers and distributors engaged in misbranding by making false claims concerning the on- or off-label use of puberty blockers, intercourse hormones, or another drug used to facilitate a baby’s so-called ‘gender transition.’ Even when in any other case truthful, the promotion of off-label makes use of of hormones-including via casual campaigns like these carried out by gross sales reps or below the guise of sponsored persevering with medical schooling courses-run afoul of the FDA’s prohibitions on misbranding and mislabeling.”
The EO and DOJ memo had been adopted by a Might 1, 2025 announcement of a report from the U.S. Division of Well being & Human Providers purporting to offer a “complete assessment of the proof and finest practices for selling the well being of youngsters and adolescents with gender dysphoria.”
The clear meant message from the EO and the DOJ memo is that people and entities who have interaction in conduct inside their scope could also be focused for prison investigation and prosecution. Such a message might understandably deter the focused conduct to keep away from such a danger.
Importantly, that’s not the one choice, nonetheless. Because the Supreme Court docket has acknowledged: “The dilemma posed by that coercion—placing the challenger to the selection between abandoning his rights or risking prosecution—is ‘a dilemma that it was the very function 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)). Whereas guaranteeing {that a} pre-enforcement problem is correctly offered to a court docket just isn’t a easy process, it may be finished, and for these , there could also be a lot to problem. The Supreme Court docket has acknowledged the ripeness of pre-enforcement challenges to prison legal guidelines in various contexts, together with the place threatened damage is “actually impending” or there’s a “substantial danger that the hurt will happen.” Susan B. Anthony Checklist v. Driehaus, 573 U.S. 149, 158 (2014). The AG’s memo might be related to establishing an impending and credible risk.
Under, we spotlight a few of the challenges we might see within the authorities’s try and pursue these circumstances.
18 U.S.C. § 116(a) – Feminine Genital Mutilation
This statute, as codified in 1996, criminalizes feminine genital mutilation (FGM) on any individual below the age of 18. There are no less than two points with DOJ’s deliberate use of the statute. First, and extra typically, it has already been discovered unconstitutional by one federal court docket within the first prosecution of FGM below the statute. Particularly, in United States v. Nagarwala, 350 F. Supp. 613 (E.D. Mich. 2018), the district court docket dominated that Congress had exceed its constitutional bounds and had no authority to go this legislation below the Vital and Correct Clause or the Commerce Clause. Whereas DOJ initially appealed the decrease court docket’s determination to the Sixth Circuit, it later moved to voluntarily dismiss the attraction. See United States v. Nagarwala, No. 18-1156, 2018 U.S. App. LEXIS 37299 (sixth Cir. Mar. 30, 2018). In a letter to the Senate Judiciary Committee, then-Solicitor Common Noel Francisco (a part of President Trump’s first administration) wrote that DOJ had decided that the statute lacked an inexpensive constitutional protection. It’s laborious to see how the statute festivals higher below constitutional scrutiny this time round, or why it’s vital to attend for a prosecution to search out out.
Second, the memo makes it clear that the meant investigation targets are individuals and entities offering medical care, however the statute’s personal definition of FGM excludes such care. FGM is outlined as “any process carried out for non-medical causes . . . . 18 U.S.C. § 116(e) (emphasis added). It appears a comparatively easy authorized difficulty of statutory development, ripe for pre-enforcement assessment, whether or not a medical skilled offering medical care in keeping with acknowledged medical requirements inside their career may be topic to prosecution.
Meals, Drug & Beauty Act
The AG’s memo additionally cites the FDC Act as a instrument for DOJ to “maintain accountable medical suppliers and pharmaceutical corporations that mislead the general public concerning the long-term unwanted side effects of chemical and surgical mutilations,” though as we famous within the webinar, the Client Safety Department tasked with “undertak[ing] acceptable investigations” of FDC Act violations has been slated for elimination, in order that obligation might fall to different DOJ elements. The memo additionally instructs U.S. Attorneys’ Places of work to make use of the False Claims Act (FCA) to research the submission of false claims to federal healthcare packages for non-covered companies associated to “radical gender experimentation.” And the memo welcomes qui tam whistleblower fits with information of “such violations.”
As to the FDC Act, substantively, the memo asserts that false claims about on- or off-label use of “puberty blockers, intercourse hormones, or another drug used to facilitate a baby’s so-called ‘gender transition’” might represent misbranding below the FDC Act. And the memo goes one step extra arguing that, even when in any other case truthful, promotion of off-label makes use of of hormones can “run afoul” of FDA prohibitions on misbranding and mislabeling.
Current precedent permits for misbranding prosecution of corporations or their homeowners that have interaction in promotion of off-label meant makes use of, together with by taking a look at truthful, non-misleading speech as proof of a brand new meant use. See United States v. Facteau, 89 F.4th 1, 22-26 (1st Cir. 2023). Nevertheless, truthful, non-misleading speech by itself can’t be a prison act as it’s protected below the First Modification. Id. Moreover, courts have typically been much more receptive to pre-enforcement challenges to prosecution that impinges on First Modification rights.
A pre-enforcement problem just isn’t the one choice, after all. Defenses can be raised throughout an investigation. The memo’s urged use of the FDC Act to research and prosecute misbranding by producers might have precedent, however a misbranding cost towards a practitioner who makes use of medicine or different merchandise in gender-affirming procedures could be topic to a number of authorized challenges. First, the FDC Act is mostly designed to not restrict or intrude with the overall apply of medication. See 21 U.S.C. § 396. Second, absent some form of contractual relationship between a supplier and a producer, a supplier is mostly immune from misbranding if the supplier just isn’t additionally promoting a regulated product.
Nonetheless, people and organizations may very well be in receipt of grand jury or HIPAA subpoenas requesting data, or they may very well be visited by federal brokers. Healthcare suppliers and others that discover themselves the goal of a prison investigation or recipient of a subpoena associated to provision of gender-affirming care could be well-advised to acquire counsel skilled in FDA enforcement and prosecutions below the FDC Act.
