From Stables to Statutes: Horse Doping and the FDC Act’s Felony Reach

In a case involving international horse-doping conspiracies, racetracks, and state horse racing regulators, the Second Circuit expanded the application of the FDC Act’s felony provisions.  There are two forms of criminal penalties for violations of the FDC Act contained in 21 U.S.C. § 333(a): a strict liability misdemeanor and a felony.  Except in cases of repeat convictions, felonies require the government to prove the defendant also acted with “intent to defraud or mislead.”  21 U.S.C. § 333(a)(2).

Despite this specific intent requirement, the FDC Act does not identify who the defendant must intend to defraud or mislead.  Given the FDC Act’s role as a public health and welfare statute, it’s to be expected that the object of the ruse would, at a minimum, be FDA and patients/consumers.  And that’s generally how federal courts have interpreted the intent element.  See, e.g., United States v. Ellis, 326 F.3d 550, 554 (4th Cir. 2003) (upholding a felony conviction where evidence supported that defendant intended to defraud or mislead FDA by failing to register his establishment with the FDA); United States v. Haga, 821 F.2d 1036, 1041 (5th Cir. 1987) (explaining that FDC Act felony prosecutions are ordinarily premised on intent to defraud or mislead “purchasers”).  Over the years, federal prosecutors have sought—and federal courts have granted—an expansion of this element to include intent to defraud or mislead other federal or state regulators tied to consumer food and drug laws or the practice of medicine.  See, e.g., United States v. Kaplan, 836 F.3d 1199, 1214 (9th Cir. 2016) (upholding felony conviction on evidence of intent to defraud or mislead the state medical board); United States v. Mitcheltree, 940 F.2d 1329 (10th Cir. 1991) (holding that the object of the intent to defraud or mislead can be an “identifiable drug regulatory agency involved in consumer protection”).

The Second Circuit’s recent decision in United States v. Fishman, No. 22-cr-1600 (2d Cir. Sept. 22, 2025), interpreted the application of the intent element to apply to additional types of state regulators.  Fishman, a licensed veterinarian, developed performance enhancing drugs (PEDs) that could not be detected in a drug test.  For years, he worked with a racehorse trainer, Navarro, to distribute these PEDs to dope horses entered into races around the world (you can read more about the doping scheme here and here).  Navarro pleaded guilty, but Fishman and his salesperson went to separate trials where they were both convicted of conspiracy to manufacture and distribute misbranded or adulterated drugs with intent to defraud or mislead.

On appeal, the defendants challenged the district court’s jury instructions that felony intent to defraud or mislead could be satisfied by evidence that defendants acted with intent to “defraud state horse racing regulators.”  The defendants argued that the FDC Act’s purpose is not to regulate the competitive integrity of horse racing.  Instead, they contended, the purpose and structure of the FDC Act is to protect consumers and purchasers, leaving only three categories of possible victims: (1) the horse trainers who purchased the PEDs (but they did so knowingly and were not deceived); (2) the horses (defendants argued they were incapable of being defrauded or misled); and (3) the FDA or “other comparable state agencies that regulate drugs, as opposed to governmental entities that regulate racing.”  Id. at 16-17.

Sadly, the Second Circuit did not contemplate the weighty philosophical question of whether a horse can be deceived or misled.  But it did reject the defendants’ argument that only a state agency that regulates drugs could trigger the intent element.  In upholding the defendants’ convictions, the court stated:

[W]e do not agree . . . that the [FDC Act] reaches only fraudulent or misleading conduct directed at certain targets.  What matters under this statute is not the identity of the target of a defendant’s intent to defraud or deceive.  What matters is the connection between the fraudulent intent and the offense of adulteration and misbranding: Was the misbranding undertaken with the intent to deceive?

Id. at 17.  In other words, the object of the fraudulent action is irrelevant for determining the scope of the felony.  Instead, the important issue is whether the violation of the FDC Act is “connected” to the intent to defraud or mislead some government agency.  Because the evidence at trial supported that some state racing regulators prohibit administering unapproved drugs to horses, the court upheld the conviction because the fraudulent intent of defendants was linked to the misbranding of the PEDs.  Id. at 24-25.

Bottom line: by refusing to limit the type of government regulators that can be the object of an intent to defraud or mislead, the Fishman decision provides a broad application of what constitutes a felony under the FDC Act.  While the Second Circuit was careful to talk only about state regulators in its analysis, the decision leaves open the possibility that the government could pursue felony charges where there is evidence of intent to defraud or mislead parties other than government actors or consumers as long as there is a connection between the FDC Act violation and the fraudulent intent.  The court’s reasoning presents a slippery slope with no clear stopping point.  As the Supreme Court noted about a decade ago, the FDC Act’s primary purpose is “to protect the health and safety of the public at large.”  POM Wonderful LLC v. Coca-Cola Co., 573 U.S. 102, 108 (2014).  Recognizing that primary purpose, other courts may rein in such a broad interpretation of the intent element by holding that only evidence of intent to defraud or mislead parties tied to public health and safety—not horse racing or other activities—can satisfy this type of FDC Act felony conviction.