Court Opinion

ID: 9495994
Source: CourtListenerOpinion
Date Created: 2023-08-05 16:15:01.743411+00
Date Added: 2024-06-11T17:52:49.173787
License: Public Domain

MICHAEL, Circuit Judge,
dissenting:
Although GHB is now a controlled substance under the federal drug trafficking statute (the Drug Abuse Prevention and Control Act), 21 U.S.C. §§ 801-971, it was not at the time Gary D. Ellis was caught making the stuff in 1999. Thus, to prosecute Ellis, the government had to charge him with several violations of the Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. §§ 301-399, a consumer protection act designed to prevent harmful foods, drugs, and cosmetics from entering the market. As one court has said, “[t]he problem [in a case like Ellis’s] is that the FDCA was not designed to deal with the [manufacture and] distribution of homemade substances.” United States v. Geborde, 278 F.3d 926, 928 (9th Cir.2002). Our job today is to decide to what extent “the square pegs of [Ellis’s] conduct can be pounded into the round holes of the FDCA.” Id. I respectfully dissent because one aspect of Ellis’s conduct — his failure to register his kitchen laboratory with the FDA — does not fit within the FDCA’s felony category. Because there is no evidence that Ellis failed to register “with the intent to defraud or mislead” the FDA, see 21 U.S.C. § 333(a)(2), I would vacate his felony conviction on this count and direct the district court to record a conviction for a misdemeanor.
This appeal turns on what evidence the government had and did not have against Ellis. There is considerable evidence that Ellis was aware the FDA regulated GHB and that he was aware his production and distribution of GHB violated FDA regulations. There is also evidence that Ellis took steps to conceal his activities. For example, he asked trusted acquaintances *558to buy raw materials (GBL and sodium hydroxide) for him, and he developed a cover story to explain why he had bought these materials himself. There is no evidence, however, that Ellis knew he was required to register his kitchen laboratory with the FDA or that he failed to register with the intent to mislead the FDA.
Ellis was charged with three counts, all keyed to 21 U.S.C. § 331:(1) conspiracy to commit offenses prohibited by 21 U.S.C. § 331, namely, manufacturing and selling a misbranded drug in violation of § 331(k); (2) introducing misbranded GHB into interstate commerce in violation of §§ 331(a) and (k); and (3) failing to register a laboratory in violation of § 331(p). Section 331 provides a list of over thirty prohibited acts, ranging literally from (a) to (z) and (aa) to (gg). See 21 U.S.C. §§ 331(a)-(gg). The penalties for violations of § 331 are found in 21 U.S.C. § 333. A simple violation of § 331 is a misdemeanor punishable by up to one year in prison or a maximum fíne of $1,000, or both. 21 U.S.C. § 333(a)(1). However, when a defendant violates a provision of § 331 “with the intent to defraud or mislead,” he may be convicted of a felony and sentenced to a maximum of three years in prison or a maximum fine of $10,000, or both. 21 U.S.C. § 333(a)(2). Here, the government sought felony convictions against Ellis on all three counts. The jury returned misdemeanor convictions on the first two counts (conspiracy and selling misbranded GHB), but it returned a felony conviction for Ellis’s failure to register his kitchen laboratory with the FDA. Ellis concedes that there is sufficient evidence to show that he operated an unregistered drug laboratory in violation of § 331(p). He argues, however, that the evidence is not sufficient to prove that his failure to register was attended by any intent to defraud or mislead the FDA, which is required for a felony conviction under § 333(a)(2). I agree.
A person may be convicted for a misdemeanor violation of any of the many provisions of § 331 without any knowledge or intent of wrongdoing. See 21 U.S.C. § 333(a)(1); United States v. Abbott Labs.; 505 F.2d 565, 573 (4th Cir.1975) (noting that § 333(a)(1) “prescribes a crime of which scienter is not a necessary element”); see also United States v. Park, 421 U.S. 658, 672-73, 95 S.Ct. 1903, 44 L.Ed.2d 489 (1975). To be convicted of a felony, however, a person must “commit[ ] ... a [§ 331] violation with the intent to defraud or mislead.” 21 U.S.C. § 333(a)(2). Our court recognizes that “fraud is a crime requiring specific intent.” United States v. Mandel, 591 F.2d 1347, 1363 n. 11 (4th Cir.1979). The majority concludes that specific intent may be proven when the defendant acts with the broad purpose of evading the regulatory scrutiny of the FDA, regardless of whether he is aware of his particular § 331 violation. Such a generalized intent is not sufficient to establish a specific intent to defraud or mislead for a felony conviction under § 333(a)(2). Rather, as the circuits that have considered the issue hold, a § 333(a)(2) felony requires “a knowing violation [of a § 331 provision] with the specific intent ‘to defraud or mislead.’ ” United States v. Mitcheltree, 940 F.2d 1329, 1350 (10th Cir.1991) (emphasis added). See also Geborde, 278 F.3d at 930 (reversing a felony conviction under § 333(a)(2) because “[t]here was no evidence of [the defendant’s] intent in failing to register, assuming he even knew he was required to register”); United States v. Aden, 947 F.2d 139, 143 (5th Cir.1991) (“[T]he government’s evidence is sufficient to make out a violation of this section where it shows that the defendant intentionally violated § 331 with the specific intent to defraud or mislead an identifi*559able government agency.”) (emphasis added). In other words, “[b]ecause ‘knowledge of the essential nature of the alleged fraud is a component of the intent to defraud,’ a defendant cannot act with intent to mislead or defraud under § 333(a)(2) without some knowledge of’ his specific § 331 violation. Mitcheltree, 940 F.2d at 1349 (quoting United States v. Hiland, 909 F.2d 1114, 1128 (8th Cir.1990)). A felony conviction thus requires proof of an intent to defraud or mislead that is “connected to ” a specific § 331 violation. Id.See also Hiland, 909 F.2d at 1128 (rejecting the government’s argument “that a § 333(a)(2) violation consists of a completed misdemeanor plus an intent to defraud or mislead that need not be connected to the predicate violation of § 331”). In this case, then, to convict Ellis of a felony violation of § 331(p), the government had to prove (1) that he had some knowledge that he was required to register his kitchen laboratory with the FDA and (2) that he failed to register with the intent to defraud or mislead the agency. See Mitcheltree, 940 F.2d at 1351.
Under the majority’s interpretation of § 333(a)(2), a defendant in this circuit can now be convicted of intentionally defrauding or misleading .the FDA even though he was unaware that he was violating a specific regulatory requirement and even though he did not violate the requirement with the intent to avoid detection by the FDA. According to the majority, as long as the defendant is aware that he is in some measure subject to FDA regulation and he takes some steps to avoid scrutiny by the FDA, he has acted “with the intent to defraud or mislead” the agency with respect to any of the many acts prohibited by § 331. In other words, under the majority’s interpretation of § 333(a)(2), a defendant who is unaware that he has violated a particular provision of § 331 can nevertheless be convicted of a felony as long as he has done something to avoid regulatory scrutiny by the FDA; the violation itself does not have to be committed with the intent of avoiding detection. This interpretation improperly- moves the carefully drawn fine between misdemeanors and felonies under § 333(a), leaving little on the misdemeanor side. Cfi Arlen, 947 F.2d at 143. Because I would not relax the intent requirement for a felony under § 333(a)(2), I respectfully disagree with the majority.
It appears that the jury had some difficulty in figuring out the extent to which Ellis’s illicit drug trafficking fit the provisions of the FDCA. There was evidence for the jury to find, though it did not, that Ellis specifically intended to defraud or mislead the FDA when he manufactured and sold misbranded GBH in violation of §§ 331(a) and (k). The government offered evidence that Ellis was aware that the FDA regulated GHB and that his production and distribution of the substance violated FDA regulations. The government also offered evidence that Ellis took measures, such as recruiting acquaintances to buy raw materials for him, in order to avoid detection by regulatory authorities. Thus, the jury could have concluded that Ellis had some knowledge that his production and distribution of GHB violated the law and that he engaged in these prohibited activities with the intent to avoid detection by the FDA. The same is not true for Ellis’s failure to register his kitchen laboratory.
The government did not offer any evidence that Ellis failed to register his laboratory, as required by § 331(p), for the purpose of defrauding or misleading the FDA or that he even knew of the registration requirement. As I have said, the evidence showed that Ellis knew he should not make GHB and knew he should not sell it. The evidence did not, however, *560demonstrate that Ellis knew he should register his home laboratory with the FDA. When there is no intentional violation of a particular regulatory requirement, there cannot be a specific intent to defraud or mislead. Accordingly, the evidence was insufficient to support Ellis’s felony conviction on count III for failure to register under 21 U.S.C. § 331(p). I would therefore vacate his felony conviction on this count. However, because the evidence is sufficient to sustain a misdemeanor conviction on this count under § 333(a)(1), I would direct the district court to enter an amended judgment reflecting the appropriate conviction and sentence.