Even if error did occur, we review plain error claims against a backdrop of the entire record to determine whether the error was sufficient to "undermine the fundamental fairness of the trial and contribute to a miscarriage of justice." United States v. Young, 470 U.S. 1, 16, 105 S. Ct. 1038, 1046-47, 84 L. Ed. 2d 1 (1985). To find reversible plain error, we must be satisfied that the error not only affected substantial rights in a serious way, but also that the "error had an unfair prejudicial impact on the jury's deliberations." Id. at 16-17 n. 14, 105 S. Ct. at 1047 n. 14. "Only then would a court be able to conclude that the error undermined the fairness of the trial and contributed to a miscarriage of justice." Id. Consequently, plain error is " 'both obvious and substantial.' " United States v. Jefferson, 925 F.2d 1242, 1254 (10th Cir.1991) (quoting United States v. Brown, 555 F.2d 407, 420 (5th Cir.1977), cert. denied, 435 U.S. 904, 98 S. Ct. 1448, 55 L. Ed. 2d 494 (1978)).

An error of constitutional significance may be "noticed more freely than less serious errors." See 3A C. Wright, Federal Practice & Procedure Sec. 856 at 336, 342 (1982 & 1990 Supp.); Jefferson, 925 F.2d at 1254. Notwithstanding, many constitutional errors are "not prejudicial per se." 8B J. Moore, Moore's Federal Practice p 52.03 (1990). Rather, under Chapman v. California, 386 U.S. 18, 24, 87 S. Ct. 824, 828, 17 L. Ed. 2d 705 (1967), many constitutional errors may be deemed harmless and not reversible when a reviewing court is "able to declare a belief that it was harmless beyond a reasonable doubt." See also United States v. Rivera, 900 F.2d 1462, 1469-70 (10th Cir.1990) (en banc) (discussing differing standards of review for nonconstitutional and constitutional claims).6 The harmless error doctrine embodies the oft-stated concept that the Constitution only requires that a defendant receive a fair trial, not a perfect one, and the "virtually inevitable presence of immaterial error" does not impair a jury's resolution of the central inquiry in every criminal trial: "the factual question of the defendant's guilt or innocence." Delaware v. Van Arsdall, 475 U.S. 673, 681, 106 S. Ct. 1431, 1436, 89 L. Ed. 2d 674 (1986).

On appeal, defendant contends that (1) the district court admitted evidence concerning a surreptitiously recorded conversation between a government informant and the defendant, in violation of defendant's sixth amendment right to counsel, (2) trial counsel rendered ineffective assistance by failing to move for the suppression of that evidence, (3) the district court erred by not defining "misleading conduct" in the jury instructions concerning witness tampering, (4) the district court should not have considered defendant's witness tampering conviction as an offense committed while on release for purposes of enhancement under 18 U.S.C. Sec. 3147, and (5) insufficient evidence supports the conviction on counts one and four of the indictment (the MDMA misbranding counts) because the government did not demonstrate an intent to mislead or defraud a natural person or a government agency pursuant to 21 U.S.C. Sec. 333(a)(2). We reverse.

As for the counts involving MDMA offenses, we agree with the defendant that her sixth amendment right to counsel was violated by the introduction of her surreptitiously taped conversation with the government's informant. However, we need not reach the issue of whether the introduction of these statements constituted plain error because we reverse the MDMA convictions (counts one and four) on other grounds and remand for a new trial.

As for the witness tampering count conviction (count ten), we hold that evidence of the taped conversation is a product of the sixth amendment violation concerning the MDMA counts, notwithstanding that the government's purpose was to investigate the separate offense of witness tampering. Upon a proper suppression motion, the taped conversation should have been excluded as evidence on count ten, given the charge (contained in the government's bill of particulars) that defendant misled her pretrial services officer concerning the substance of the conversation. Even absent proper objection, we still must reverse and remand for a new trial on count ten because we cannot say that this constitutional error was harmless beyond a reasonable doubt.

Because we reverse and remand for a new trial on count ten, we do not consider defendant's arguments that the district court erred by (1) failing to define misleading conduct in the jury instructions7 and (2) enhancing her sentence under 18 U.S.C. Sec. 3147; nor do we resolve the ex post facto sentencing guideline problem suggested by defendant on appeal. Likewise, given our disposition, we need not consider defendant's claim of ineffective assistance of counsel.

Returning to MDMA counts one and four, we hold that while sufficient evidence exists concerning defendant's intent to mislead or defraud consumers, by no means does the record contain sufficient evidence of misleading or defrauding a government agency. We reject the government's assertion that, for purposes of 21 U.S.C. Sec. 333(a)(2) and 18 U.S.C. Sec. 371, an intent to defraud a local police department by selling misbranded drugs is a sufficient basis to sustain convictions of this nature. Because the case was submitted to the jury on either theory (misleading consumers or defrauding a government agency including a local police department) and a general verdict form was used, we cannot tell on which theory or theories the jury convicted. Accordingly, defendant's convictions on MDMA counts one and four must be reversed and remanded for further proceedings.

The events in this case involve MDMA, a "designer drug" sometimes known as "ecstasy," which did not become subject to federal controlled substance penalties until October 27, 1986. MDMA is a controlled substance analogue. As such, it produced effects similar to various controlled substances, but differed enough to fall outside the classification of existing controlled substances. Rec. supp. vol. VI at 871-73. The government's efforts to schedule MDMA as a controlled substance did not fare well initially. Pursuant to 21 U.S.C. Sec. 811(h), the DEA sought to schedule temporarily MDMA as a schedule I controlled substance. 50 Fed.Reg. 22,119 (1985). In United States v. Spain, 825 F.2d 1426 (10th Cir.1987), we held that this attempted temporary scheduling was invalid because the DEA had not been subdelegated the authority8 and that an order scheduling the drug had not been timely issued. Id. at 1429. See also United States v. Caudle, 828 F.2d 1111, 1113 (5th Cir.1987) (holding MDMA temporary scheduling procedurally defective). A final rule placing MDMA in schedule I, effective November 13, 1986, 51 Fed.Reg. 36,552 (1986), was vacated for further agency consideration. Grinspoon v. Drug Enforcement Adm'n, 828 F.2d 881, 898 (1st Cir.1987).

As a controlled substance analogue, MDMA was treated as a schedule I controlled substance as of October 27, 1986. The Controlled Substance Analogue Enforcement Act of 1986, Pub.L. 99-570, tit. I, subtit. E, Sec. 1202, 100 Stat. 3207-13 to 3207-14 (Oct. 27, 1986), provided that a controlled substance analogue intended for human consumption would be treated as a schedule I controlled substance. 21 U.S.C. Sec. 813. Effective March 23, 1988, however, MDMA was permanently scheduled in schedule I as a controlled substance. 53 Fed.Reg. 5,156 (1988).

Defendant began using and distributing MDMA in the summer of 1985, before it was scheduled as a controlled substance analogue.9 After being indicted in 1989 for her activities in connection with MDMA, defendant was arraigned and eventually released on bond. In the order setting conditions of release, the defendant was directed to initial each condition which applied. One of the conditions marked as applicable, but not initialed by the defendant, was a requirement that she "avoid all contact with persons[ ] who are considered either alleged victims or potential witnesses[ ]." Two lines, apparently for the purpose of naming the potential witnesses, were left blank. Although the defendant signed the order setting conditions of release, the pretrial services officer indicated that it was possible that defendant was not made aware of the condition prohibiting contact of potential witnesses, given that defendant did not initial. Rec. supp. vol. VII at 1099. However, the pretrial services officer also testified that defendant indicated that "her attorney had advised her not to talk to anybody that might be a potential witness." Id. at 1078. See also id. at 1105.

While released, defendant contacted her friend, B.J. Rizzo, a potential witness. Rizzo, a hairstylist, had been a participant in defendant's MDMA distribution network, being paid in-kind. Rizzo's father had cut defendant's hair four or five times over a four-year period and Rizzo had assisted by shampooing. In June 1989, Rizzo coincidentally met defendant at the Varsity Sports Grill in Oklahoma City. Defendant inquired whether Rizzo had been contacted by Detective Randy Yarborough of the Oklahoma City Police Department, who had been investigating MDMA distribution in Oklahoma City. Rizzo replied that she had not. Rizzo also told defendant that she was working at a new hair styling salon about to have its grand opening.

A few weeks later, Rizzo received a call from defendant while at the salon. According to Rizzo, defendant inquired whether she had heard from Detective Yarborough. Rizzo volunteered that she had. Defendant then scheduled a hair appointment for June 26, 1989. Rec. supp. vol. VII at 1052. Rizzo testified that she did not know what to do, so she called the detective. The detective then contacted Richard Wintory, the prosecutor. An agreement was reached whereby Rizzo would secretly tape her conversation with defendant during the hair appointment. According to Rizzo, the purpose was "[t]o see if she [defendant] was going to try to change my testimony." Id. at 1054.

The prosecutor advised defendant's pretrial services officer that defendant may have contacted a female witness. He further advised that someone would take the witness's statement and that the pretrial services officer should review, with the defendant, defendant's conditions of release, including the condition that defendant not contact potential witnesses. That review would not occur until after the taping of the conversation on June 26.

The transcript of the June 26 conversation between defendant and Rizzo contains many personal details about the defendant that one might reveal to a close friend. At least eight times during the conversation, Rizzo, using the ruse that the detective kept calling her and she needed defendant's advice, encouraged defendant to talk about the pending MDMA charges. Defendant gave a variety of responses, sometimes ambiguous, and in the process discussed her views concerning the government's case, including codefendants, and whom Rizzo might implicate by her testimony. Concerning Rizzo's status as a witness, defendant advised Rizzo to make the government subpoena her. The following exchange occurred:

Rizzo: I don't know. (inaudible) I really don't want to talk to him [the detective]. But I know that I have to otherwise I'll have to go to court and I don't want to go to court.

Defendant: You will have to go to court anyway.

Rizzo: You think they got me down there as a witness?

Defendant: They got you down on a grand jury thing as a witness, that you witness that Sampson10 sold drugs.

Tr. 6/26/89 at 3. In the course of advising Rizzo about what to say to the detective, defendant discussed Rizzo's potential testimony against codefendant Raymer and defendant.11 In a later taped conversation, Rizzo requested further advice using the same ruse. Defendant suggested that she retain a lawyer and offered to assist with the fee.

On July 5, 1989, defendant met with her pretrial services officer. The officer inquired whether defendant had been in contact with any potential witnesses. Initially, defendant said no, but when told that by the officer that the officer had received contrary information, defendant thought about it for a moment and said that she had been in contact with Rizzo.

Prosecutor: What happened next?

Officer: We proceeded to talk--I cannot recall verbatim the conversation but, in general, she stated that she had been in to see B.J. [Rizzo] recently to get her hair done and that in getting her hair done, B.J. had stated that she had not been contacted by anybody in law enforcement since JoAnn's [defendant's] arrest but that she thought she was going to be cooperating and that she probably needed to get an attorney.

Rec. supp. vol. VII at 1077. According to the officer, defendant explained that: (1) Rizzo thought she needed an attorney; (2) Rizzo had been her hairdresser for the last three to five years and that she saw her on a regular basis; and (3) she and Rizzo did not discuss the case. Id. at 1078-79. Defendant inquired where the officer's information had come from and the officer identified prosecutor Wintory as the source. According to the officer, defendant "said 'Well, don't tell Wintory about this,' something to the effect, 'I'm in enough trouble,' or something, but, 'Don't tell Mr. Wintory about this.' " Id. at 1079-80.

Concerning the relationship between Rizzo and defendant, the officer understood that Rizzo was defendant's "hairdresser of longstanding, that she had been seeing her on a regular basis for many years." Id. at 1082. This was based in part on the defendant's remarks at the July 5 meeting:

Officer: After we talked for a while and she [defendant] was ready to leave, she--I told her I would be talking to her next week and she said, well, next time you see me, if my hair looks rather scraggly, it will be because she hadn't been to the hairdresser and we kind of laughed about that she did have pretty hair and that I would see her next week.

Id. at 1080. A violation of a defendant's conditions of release is reported to an appropriate judicial officer by the pretrial services officer. The officer in this case testified that in deciding whether a violation occurred it would have been significant to her that (1) "[June 26, 1989] was the only time she [defendant] had gone to Ms. Rizzo to have her hair cut," and (2) defendant had inquired into the substance of Rizzo's testimony. Id. at 1083.

Prior to trial, the government was ordered to provide defendant a bill of particulars concerning count ten.12 Rec. supp. vol. I, doc. 77, doc. 111. The government indicated that the federal offense involved was defendant's witness tampering with Rizzo and the condition of release violated was a prohibition on contact with government witnesses. According to the government, defendant engaged in several acts of misleading conduct or corrupt persuasion toward the pretrial services officer: (1) initially denying that she contacted a government witness; (2) after admitting the contact with Rizzo, falsely claiming that Rizzo had been cutting defendant's hair for five years; (3) indicating that no substantive discussion of the case had occurred; (4) not disclosing that she had advised Rizzo to withhold names of coconspirators who had distributed MDMA to Rizzo; and (5) requesting that the officer not inform the prosecutor of the defendant's contact with Rizzo.

On a plain error theory, defendant contends that her incriminating statements elicited by Rizzo should have been suppressed as violative of her sixth amendment right to counsel.

The sixth amendment right to counsel "does not attach until after the initiation of formal charges." Moran v. Burbine, 475 U.S. 412, 431, 106 S. Ct. 1135, 1146, 89 L. Ed. 2d 410 (1986); accord United States v. Gouveia, 467 U.S. 180, 189, 104 S. Ct. 2292, 2298, 81 L. Ed. 2d 146 (1984) ("right to counsel attaches at the initiation of adversary judicial criminal proceedings"); Kirby v. Illinois, 406 U.S. 682, 689, 92 S. Ct. 1877, 1882, 32 L. Ed. 2d 411 (1972) (right to counsel attaches "at or after the initiation of adversary judicial criminal proceedings--whether by way of formal charge, preliminary hearing, indictment, information or arraignment"). The right to counsel applies to pending charges but not to "other and different charges against the same defendant." Hoffa v. United States, 385 U.S. 293, 308, 87 S. Ct. 408, 416, 17 L. Ed. 2d 374 (1966). Thus, a defendant's incriminating statements concerning pending charges surreptitiously coaxed by the government in the absence of counsel may not be used in prosecuting those charges. Massiah v. United States, 377 U.S. 201, 206, 84 S. Ct. 1199, 1203, 12 L. Ed. 2d 246 (1964). However, other incriminating statements pertaining to different crimes may be used in a subsequent trial of those crimes. Maine v. Moulton, 474 U.S. 159, 180 n. 16, 106 S. Ct. 477, 489 n. 16, 88 L. Ed. 2d 481 (1985). Accord Moran, 475 U.S. at 431, 106 S.Ct. at 1146.

Where no charges have been filed regarding the subject of interrogation, the sixth amendment right to counsel does not attach. Illinois v. Perkins, --- U.S. ----, 110 S. Ct. 2394, 2399, 110 L. Ed. 2d 243 (1990). But once charges have been filed, the defendant is in a different position because the right to counsel has attached on those charges. Id. The purpose of the sixth amendment is to afford a defendant a "right to rely upon counsel as a 'medium' between him and the State." Moulton, 474 U.S. at 176, 106 S.Ct. at 487. The government has an "affirmative obligation not to act in a manner that circumvents the protections accorded the accused by invoking this right." Id. Whether a sixth amendment violation has occurred must be evaluated in light of this affirmative obligation. Id. The government is not precluded from utilizing incriminating statements obtained from the defendant as a result of "luck or happenstance." Id. Proscribed is "obtain[ing] incriminating statements by knowingly circumventing the accused's right to have counsel present in a confrontation between the accused and a state agent." Id.

At the time the government elicited the statements in question (June 26, 1989), defendant had been indicted on count one, alleging a conspiracy to commit an offense against the United States, 18 U.S.C. Sec. 371, and specifically introducing misbranded MDMA in interstate commerce with intent to mislead and defraud, 21 U.S.C. Sec. 333(a)(2). See Rec. supp. vol. XII, doc. 6/7/89. Defendant also had been indicted on count two, conspiracy to distribute MDMA, a controlled substance analogue, 21 U.S.C. Secs. 813, 846. See Rec. supp. vol. XII, doc. 6/7/89. Thus, defendant's right to counsel had attached on the two MDMA conspiracy counts. It had not attached on count ten, the witness tampering charge.

The government argues that a "separate offense" exception to the sixth amendment applies in this case. Perkins, 110 S. Ct. at 2399; Moulton, 474 U.S. at 176, 106 S.Ct. at 487. According to the government, the defendant was not immune from investigation or prosecution for witness tampering during the pending MDMA case, a proposition with which we agree. See United States v. Terzado-Madruga, 897 F.2d 1099, 1111-12 (11th Cir.1990). Also, according to the government, the defendant has failed to establish that the government deliberately circumvented her right to counsel on the pending MDMA charges.

The government explains that defendant "launched into further criminal activity while under indictment. Specifically, while on pretrial release, she made arrangements to visit with a government witness whom she had no significant contact for years, for the ostensible purpose of having her haircut, but only after first ascertaining that the witness had been contacted by law enforcement." Appellee's Brief at 24. According to the government, "the detective recognized the fact pattern--the defendant meant to attempt to influence the government witness and had in fact taken definitive steps towards implementing her criminal intent." Id.

About two weeks after informant Rizzo and the defendant met by chance at the Varsity Sports Grill, the detective contacted Rizzo. Rizzo "did not want to get in any trouble," rec. supp. vol. VII at 1050, so she agreed to discuss the whole case, including information about defendant Samuel Raymer. After being contacted by defendant for a hair appointment, Rizzo contacted the detective. The detective and the government prosecutor, Mr. Wintory, then cooperated in investigating the defendant's predisposition for witness tampering. Id. at 1076, 1093-94. After a series of meetings between Rizzo and the detective, Rizzo was wired and ready to tape the conversation. According to Rizzo her purpose was "[t]o see if she [defendant] was going to try to change my testimony." Id. at 1054.

We have carefully reviewed the transcript, the taped conversation and the trial testimony. Though a confidential informant, Rizzo's actions must be evaluated as those of a government agent subject to the limitations of the sixth amendment. Hoffa, 385 U.S. at 311, 87 S.Ct. at 418. Defendant argues that "[t]he statements elicited and introduced by the government amount to a confession by [defendant] Mitcheltree that she had engaged in a conspiracy to distribute MDMA." Appellant's Brief at 29 n. 9. We think that defendant's characterization may be somewhat overstated, but we cannot ignore the incriminating implications of defendant's statements concerning her coconspirators and her own distribution and consumption of misbranded MDMA. See, e.g., tr. 6/26/89 at 13 ("I got it for people but I wasn't that huge [a drug dealer]...."); at 16 ("I know I used to give you most of them [MDMA tablets]"; "Anything you got from me I pretty much gave you."); at 21 ("I was an x-freak"). Defendant's taped statements concerning misbranded MDMA cannot be categorized as the product of "luck or happenstance." Rather, during the course of the conversation, Rizzo asked the defendant broad, open-ended questions about the subject matter of the charged offenses. At least seven times, Rizzo sought the defendant's advice as to what she should say and do in connection with the investigation. See, e.g., id. at 2 ("I don't know what to say JoAnn."); ("But, I mean, what do you think I should say?"); at 3 ("So I don't know what to do."); at 7 ("Well, what do you think we should do then?"); at 16.

Rizzo also asked about defendant's testimony and her knowledge of the conspiracy. See, e.g., id. at 7 ("Now are you testifying against Sampson?"); ("Well, I need to ask you a question, what about the Lobaughs?"); at 8 ("Who's Lynn [Ricks]?"). Rizzo admitted that she elicited conversation about the drug trade, rec. supp. vol. VIII at 1208, and this included names of other coconspirators and activities highly relevant to the conspiracies charged. Although the government contends that Rizzo never pressed for details on the MDMA counts, her repeated, open-ended questions made it virtually certain that defendant would discuss the details of the pending MDMA counts. Equally important, the government's informant prompted defendant to discuss her trial strategy vis-a-vis the other alleged coconspirators with comments like "JoAnn, if you don't testify against Sampson you're gonna get thrown in jail." Id. at 13.

Rizzo was more than a passive listener; she exercised skill at leading the conversation into particular topics and prompting particular replies. See United States v. Henry, 447 U.S. 264, 271 n. 9, 100 S. Ct. 2183, 2187 n. 9, 65 L. Ed. 2d 115 (1980). Merely because Rizzo and defendant were in a non-custodial setting does not bar a finding of deliberate elicitation. Id. at 273 n. 11, 100 S. Ct. at 2189 n. 11. Concerning the charged MDMA counts, we strongly believe that the government breached its affirmative obligation not to circumvent defendant's sixth amendment right to counsel. Here, the government's purpose in taping the conversation was to see if defendant would attempt to influence Rizzo's possible testimony. Rather than investigating a crime which had occurred, the government sought to determine whether defendant would commit a crime while she was being taped. The government is free to investigate suspected criminal activity, even in advance of the commission of a crime. But such investigation must proceed with due regard for the government's affirmative obligation not to defeat sixth amendment rights which have attached. That due regard was not present in this case: in an effort to lead the defendant into witness tampering, Rizzo inquired into the pending charges in more than a tangential way, and violated the defendant's sixth amendment rights on the pending MDMA charges.13

The government also learned defendant's mistaken views concerning the likelihood of her conviction and the tack she planned to take concerning the prosecutor. See, e.g., tr. 6/26/89 at 14-15, 17, 19-20. Whether the government had legitimate reasons for investigating witness tampering is beside the point. Moulton, 474 U.S. at 180, 106 S.Ct. at 489. The taped conversation reveals that the government deliberately elicited statements which the defendant had the right not to make prior to consulting with counsel. Terzado-Madruga, 897 F.2d at 1111.

Where proper objection has been made, statements concerning pending counts obtained in violation of a defendant's sixth amendment right to counsel are inadmissible in a trial concerning those counts. Moulton, 474 U.S. at 180, 106 S.Ct. at 489. The government contends that defendants taped statements were not offered in support of the MDMA counts; however, the record contains no such limiting instruction. See rec. supp. vol. VIII at 1137, 1144. Rather, the trial judge told the jury that the taped conversation would be received against defendant only. Trial counsel having failed to make a proper objection or seek a severance, we would next be required to evaluate this constitutional error on the MDMA counts to determine whether reversible or harmless error occurred. See United States v. Wade, 388 U.S. 218, 242, 87 S. Ct. 1926, 1940, 18 L. Ed. 2d 1149 (1967). However, because we reverse the MDMA counts of conviction (counts one and four) on other grounds, we do not undertake that evaluation.

Next we consider the relationship between the sixth amendment violation concerning the MDMA counts and the evidence relied upon to prove the witness tampering count conviction, count ten. Defendant's sixth amendment rights had not attached on count ten when the incriminating statements were made because she had yet to be indicted for witness tampering. However, she claims that any statements concerning count ten "were the direct result of the violation of [her] sixth amendment rights with respect to counts one and four, the MDMA charges." Appellant's Brief at 7.

We view defendant's derivative evidence (fruit of the poisonous tree) claim in light of the general rule that, even though a defendant's right to counsel has attached for indicted offenses, she still may be questioned without counsel concerning uncharged offenses. Moran, 475 U.S. at 431, 106 S.Ct. at 1146. "To hold that the government is prohibited from investigating the defendant's involvement in new crimes, simply because [her] right to counsel has attached for a separate offense, would be essentially to immunize a defendant from further prosecution." Terzado-Madruga, 897 F.2d at 1112. The sixth amendment does not require such a result, indeed, the government should investigate efforts to derail a pending prosecution such as witness or jury tampering or other attempts to obstruct justice. Id. This type of investigation does not require that defendant's counsel be present, but due regard must be shown for defendant's right to avoid uncounseled statements, deliberately elicited by the government, pertaining to pending charges. Id.

The government may violate a defendant's sixth amendment right to counsel when it deliberately elicits uncounseled statements about very closely related crimes which arise out of the same course of conduct as the charged offenses. People v. Clankie, 124 Ill. 2d 456, 125 Ill. Dec. 290, 294, 530 N.E.2d 448, 452 (1988). This principle may apply when the government's investigation concerning a charged offense is incomplete for want of specific details. Id. In Brewer v. Williams, 430 U.S. 387, 97 S. Ct. 1232, 51 L. Ed. 2d 424 (1977), the defendant was charged with abduction, arraigned and confined when the police deliberately elicited uncounseled statements concerning the location of the victim's body. Id. at 390, 399-400, 97 S. Ct. at 1235, 1240. Thereafter, defendant was indicted for first degree murder; however, the Court determined that the sixth amendment right to counsel applied to the subsequent murder charge given the closely related prior abduction charge. Id. at 399, 97 S.Ct. at 1240.

Likewise, in Moulton, the defendant had been charged with theft by receiving certain vehicles and automotive parts. 474 U.S. at 162, 106 S.Ct. at 480. Thereafter, his sixth amendment right to counsel on the pending charges was compromised during an investigation which pertained in part to other crimes. 474 U.S. at 162, 106 S. Ct. at 480. Defendant was subsequently charged with burglary in relation to the same items; he was convicted of theft and burglary. Id. at 167, 106 S.Ct. at 482. In announcing the rule that "incriminating statements pertaining to pending charges are inadmissible at the trial of those charges," the Supreme Court affirmed the lower court disposition that the defendant's statements must be suppressed and a new trial granted on the charges of conviction, theft and burglary. Id. at 167-68, 180, 106 S. Ct. at 482-83, 489 (emphasis supplied). Thus, the Supreme Court did not permit the statements to be used for either offensethe theft originally charged, or the burglary subsequently charged.

We believe that when a deliberate sixth amendment violation occurs concerning pending charges, the government may not use defendant's uncounseled incriminating statements at a trial of those or very closely related subsequent charges. See Moulton, 474 U.S. at 180, 106 S.Ct. at 489; Brewer, 430 U.S. at 398-99, 97 S.Ct. at 1239-40. Uncounseled incriminating statements about different uncharged offenses normally would be admissible at a later trial of those offenses. Id. n. 16. Thus, when the government violates a defendant's sixth amendment right to counsel on pending charges in the course of investigating other suspected crimes, and then issues a superseding indictment incorporating new charges on the suspected crimes, a prudent course is to sever the new charges from the old charges. Terzado-Madruga, 897 F.2d at 1111-12 (sixth amendment violation occurred on pending drug charges while government was investigating defendant's involvement in a murder-for-hire scheme; severance of new and old charges adequately protected defendant).

Here, the MDMA counts on which the sixth amendment violation occurred are theoretically distinct from the witness tampering count. The difficulty is the somewhat unconventional manner in which the government sought to prove witness tampering. Certain statements obtained in violation of defendant's sixth amendment right to counsel relate directly to both the MDMA counts and the witness tampering count. Defendant has chosen to proceed on a derivative evidence theory which we now address, keeping in mind the scope of defendant's sixth amendment right to counsel on the MDMA counts. The derivative evidence doctrine is implicated if challenged evidence concerning the witness tampering count is closely related in time and subject matter to the sixth amendment violation, in other words, if the challenged evidence is a product of the earlier exploitation of the constitutional violation. See Hoffa, 385 U.S. at 308-09, 87 S.Ct. at 416-17 (evidence of bribing jurors was not obtained through exploitation of an alleged sixth amendment violation concerning underlying charges; held, evidence was not derivative).

The derivative evidence doctrine has been applied in other sixth amendment right to counsel cases. See, e.g., Nix v. Williams, 467 U.S. 431, 442, 104 S. Ct. 2501, 2508, 81 L. Ed. 2d 377 (1984); United States v. Wade, 388 U.S. 218, 241-42, 87 S. Ct. 1926, 1939-40, 18 L. Ed. 2d 1149; Terzado-Madruga, 897 F.2d at 1112-13. Merely because incriminating evidence would not have been discovered but for the constitutional violation does not require exclusion. Wong Sun v. United States, 371 U.S. 471, 487-88, 83 S. Ct. 407, 417, 9 L. Ed. 2d 441 (1963). Instead, the core issue is " 'whether, granting establishment of the primary illegality, the evidence to which instant objection is made has been come at by exploitation of that illegality or instead by means sufficiently distinguishable to be purged of the primary taint.' " Wong Sun, 371 U.S. at 488, 83 S.Ct. at 417 (citation omitted). Three exceptions to the derivative evidence doctrine have developed. First, facts obtained as a result of a constitutional violation still may be used at trial if they can be proven by a lawful source independent of the violation. Silverthorne Lumber Co. v. United States, 251 U.S. 385, 392, 40 S. Ct. 182, 183, 64 L. Ed. 319 (1920). Second, evidence which would have ultimately or inevitably been discovered by lawful means also is admissible. Nix, 467 U.S. at 444, 104 S.Ct. at 2509. Finally, if the causal connection between the constitutional violation and the evidence in question is so attenuated as to dissipate the taint, the evidence is admissible. Nardone v. United States, 308 U.S. 338, 341, 60 S. Ct. 266, 267, 84 L. Ed. 307 (1939).

Normally, we review a district court's legal determinations on a suppression motion de novo and its factual findings under a clearly erroneous standard. United States v. Soto-Ornelas, 863 F.2d 1487, 1490 (10th Cir.1988). In this case, we lack a trial court suppression hearing developing this derivative evidence claim because no objection was made below. In this unusual case, however, a remand for further factfinding is not necessary because the record contains the material facts and establishes as a matter of law that the sixth amendment violation concerning the MDMA counts (the taped conversation) became a primary basis for the offense contained in count ten. Stated another way, the circumstances of the constitutional violation evolved into another offense.

Count ten charged the defendant with engaging in several acts of misleading conduct toward Cynthia Cranford, the pretrial services officer (not the informant, B.J. Rizzo), with the intent to hinder communication by the officer concerning the commission of a federal offense. In other words, defendant was charged in count ten with misleading the officer about the nature of defendant's earlier conversation with Rizzo, as well as other acts of misleading conduct. These acts did not occur until nine days after the taped conversation with Rizzo, and were never mentioned, let alone contemplated, in the taped conversation. The taped conversation between Rizzo and the defendant largely concerns the then-pending MDMA counts.

In its bill of particulars on count ten, the government charged one of the acts of defendant's corrupt persuasion and misleading conduct as follows:

After admitting the contact [between defendant and Rizzo] the defendant did mislead [pretrial services] Officer Cranford as to the purpose and content of her discussion with Ms. Rizzo by claiming falsely ... that there had been no substantive discussion of the defendant's pending case....

Rec. supp. vol. I, doc. 111 at 2, p 2(ii). Thus, one of the charges on count ten was that defendant denied having discussed the merits of the pending case with Rizzo, after having been indicted.

The government relied upon the sixth amendment violation concerning the MDMA counts as part of the proof on count ten. See, e.g., Rec. supp. vol. VII at 1083. Any doubt about the government's reliance is dispelled by the government's view of the case as outlined at closing argument:

[A]nd finally, ladies and gentlemen, the [sic] is clear that she [defendant] engaged in misleading conduct with Officer Cynthia Cranford. She lead [sic] her to believe that witness Rizzo had been regularly cutting her hair from three to five years and that they had not substantively discussed the case. You heard that conversation, ladies and gentlemen. There is not by any reasonable stretch of the imagination a way you can characterize that conversation as not substantially discussing the case. You heard the evidence.

. . . . .

Ladies and gentlemen, the evidence is absolutely unquestioned in this case. Cynthia Cranford [the pretrial services officer] was misled by this defendant and the only motive, the only motive for this defendant to mislead Officer Cranford was to prevent her from communicating the information about her contacting witnesses, discussing the substance of the case. That's the only motive. That evidence is clear.

Rec. supp. vol. IX at 1440, 1503 (emphasis added). The substantive discussion of the MDMA counts between the government (through informant Rizzo) and the defendant was violative of defendant's sixth amendment right to counsel.

What the government asks us to do is to allow use of the uncounseled statements on the MDMA counts to prove that the defendant's subsequent account of those statements to the pretrial services officer was false. This we will not do. Plainly, the taped conversation, even though it was used for a slightly different purpose on the witness tampering count, is wholly a result of the sixth amendment violation on the MDMA counts. It is not a product of means sufficiently distinguishable so as to be purged of the sixth amendment violation on the MDMA counts, rather it is the same evidence. Thus, as far as proof on count ten, it is more than "closely related" in time and subject matter to the underlying sixth amendment violation. See Hoffa, 385 U.S. at 309, 87 S.Ct. at 417.

We acknowledge Moulton's statement that "[i]ncriminating statements pertaining to other crimes, as to which the Sixth Amendment right has not yet attached, are, of course, admissible at a trial of those offenses." 474 U.S. at 180 n. 16, 106 S. Ct. at 489 n. 16. Here, the incriminating statements pertained to both the pending offenses and the other crime on which the sixth amendment right had not yet attached. We think that the Court implied that such multi-purpose evidence would be excluded when it rejected a rule that the sixth amendment would not apply when the police undertook investigation of a separate crime. See Moulton, 474 U.S. at 191-92, 106 S.Ct. at 45 (Burger, C.J., dissenting). See also W. LaFave & J. Israel, Criminal Procedure Sec. 6.4 at 470 (1984 & 1991 Supp.). Although the Court recognized that police have an incentive to discover evidence pertaining to both the charged and uncharged offense, it reaffirmed that

In seeking evidence pertaining to pending charges ... the Government's investigative powers are limited by the Sixth Amendment rights of the accused. To allow the admission of evidence obtained from the accused in violation of his Sixth Amendment rights whenever the police assert an alternative, legitimate reason for their surveillance invites abuse by law enforcement personnel in the form of fabricated investigations and risks the evisceration of the Sixth Amendment right recognized in Massiah.

Moulton, 474 U.S. at 179-80, 106 S.Ct. at 489. This emphasis on deterrence suggests that multi-purpose derivative evidence must be excluded in the trial of the uncharged offense in order to uphold the deterrence rationale. The derivative evidence doctrine, together with its exceptions, limits those cases in which exclusion is available, but this is clearly a case in which the government "seeks to maintain its right to avail itself of the knowledge obtained by that means which it otherwise would not have had." Silverthorne Lumber, 251 U.S. at 385, 40 S.Ct. at 182.

We must reverse the conviction on count ten and remand for a new trial because we cannot say that introduction of the defendant's statements (in the taped conversation) was harmless beyond a reasonable doubt. The proof on count ten consisted of the taped conversation and the testimony of two witnesses, the pretrial services officer and the informant. The jury could not reach agreement on count nine which charged the defendant with witness tampering vis-a-vis the informant. The jury may have questioned the credibility of the informant. The admissible proof on count ten, consisting of some testimony of the informant and the pretrial services officer, while sufficient, was by no means overwhelming.

Adopting the argument contained in codefendant Raymer's appellate brief, defendant next contends that the evidence is insufficient to convict her on counts one and four of the indictment. Trial counsel raised this point on motion for judgment of acquittal. Rec. vol. I, doc. 205 at 3-6; supp. vol. VIII at 1330. Count one charged defendant and Raymer with participation in conspiracy to commit an offense against the United States, 18 U.S.C. Sec. 371. The underlying offense was introducing misbranded drugs into interstate commerce and failing to register and provide information and notice about the MDMA, 21 U.S.C. Sec. 331(a), (k) & (p), all with the intent to mislead or defraud, 21 U.S.C. Sec. 333(a)(2). See rec. supp. vol. IX at 1360 (conspiracy falls under "commit any offense" portion of 18 U.S.C. Sec. 371). The time period of the conspiracy was from June 1985 until April 1987, which predated in part the valid scheduling of MDMA as a controlled substance or controlled substance analogue. The government alleged that the MDMA was misbranded because it was distributed in interstate commerce without labels containing information such as the name and place of business of the manufacturer, packer or distributor and the name and quantity of the active ingredients. 21 U.S.C. Secs. 352(b), (c) & (e). Additionally, the government claimed that it was misbranded because it was health endangering and was manufactured in an unregistered establishment, 21 U.S.C. Sec. 360, and because notice and informational requirements were not followed. 21 U.S.C. Secs. 352(j) & (o ). Count four was a substantive count charging the defendant and Raymer with introducing misbranded drugs into interstate commerce in January 1986, 21 U.S.C. Sec. 331(a), with intent to mislead or defraud, 18 U.S.C. Sec. 333(a)(2).

We review the evidence and its reasonable inferences in the light most favorable to the government to determine "whether any rational trier of fact could have found the elements of the crime beyond a reasonable doubt." Jackson v. Virginia, 443 U.S. 307, 319, 99 S. Ct. 2781, 2789, 61 L. Ed. 2d 560 (1979) (emphasis omitted). The legal issue on this point is whether the government can establish a felony violation under 21 U.S.C. Sec. 333(a)(2) on a theory that defendant, in committing violations under 21 U.S.C. Sec. 331 such as misbranding, acted "with the intent to mislead or defraud" natural persons or government agencies. The jury was instructed that for conviction a defendant must act "with the specific intent to mislead or defraud natural persons to whom the drug was sold, or government agencies." Rec. supp. vol. I, doc. 288, instr. 11, 27. To uphold the verdict on these counts, we must determine that either theory is legally viable. We also may consider whether sufficient evidence supports each theory.

In making this argument, codefendant Raymer claims that the government did not proceed on the theory that he defrauded natural persons, but only government agencies. The evidence concerning defendant Mitcheltree, however, indicates that she acted with the intent to mislead or defraud at least one identified natural person concerning the composition of MDMA, coconspirator Kevin Volk.14 While the record suggests that at least one of Raymer's distributers was aware of some of the negative effects of MDMA, rec. supp. vol. III at 108, it nowhere suggests that the unknown third persons supplied by the coconspirators in this case were informed of the actual nature of the drug. In this large-scale distribution network, Raymer and defendant plainly knew that the MDMA would be resold without warning or accurate explanation to unknown third parties. That is sufficient evidence for a jury to find that Raymer and his coconspirators, including defendant, introduced misbranded drugs into interstate commerce with the requisite intent to mislead and defraud those who would purchase on resale. See United States v. Bradshaw, 840 F.2d 871, 874 n. 4 (11th Cir.1988). That defendants and some of their customers may have known the true nature of MDMA does not matter; intent may be inferred from their almost certain knowledge that the misbranded MDMA would pass to unknown third parties. See United States v. Goodwin, 455 F.2d 710, 713 (10th Cir.) (under 18 U.S.C. Sec. 473, government agent and defendant may know that notes are counterfeit, where government proves that notes were to be used as genuine), cert. denied, 409 U.S. 859, 93 S. Ct. 146, 34 L. Ed. 2d 105 (1972). Sufficient evidence indicates that defendant Mitcheltree introduced misbranded MDMA into interstate commerce while acting with intent to mislead or defraud natural persons as required by 21 U.S.C. Sec. 333(a)(2).

The government's expert pharmacologist testified that "MDMA has pharmacological properties which it shares in common with two classes of controlled substances." Rec. supp. vol. VI at 878-79. Like methamphetamine and cocaine, it is a central nervous system stimulant. Id. In low doses, it is an hallucinogenic substance like marijuana; in higher doses, it produces visual hallucinations like LSD. Id. It has addictive properties. Even when MDMA was not scheduled as a controlled substance, its lawful manufacture would have required FDA registration. Id. at 873. As a drug, MDMA's lawful use in humans would have required FDA approval involving factors such as safety and efficacy. Id. at 874. The government pharmacologist testified that "the FDA did not nor does it now permit the manufacture or human use or importation of MDMA." Id. at 877. MDMA is not manufactured by any legitimate pharmaceutical house; rather it is manufactured clandestinely, solely for those "who are making it for others to abuse." Id. at 873.

The government may premise criminal liability under Sec. 333(a)(2) based upon an intent to mislead or defraud not only natural persons, but also government agencies if there is evidence that a defendant consciously sought to mislead drug regulatory authorities such as the FDA or a similar governmental agency. The case law from this circuit recognizes such a result. In United States v. Industrial Laboratories Co., 456 F.2d 908 (10th Cir.1972), the defendant company and its chief chemist were convicted of introducing an adulterated drug into interstate commerce with intent to mislead and defraud. The defendants had performed testing for a Denver veterinary lab, which then consigned the tested product to a veterinary products firm in Canada. The Canadian firm (consignee) requested defendants to perform more tests in compliance with new standards set by the Canadian government. After agreeing with the consignor to perform the tests, defendants did not and represented otherwise. Two lots of drugs were adulterated.

We held that the district court's instructions failed to state clearly that an element of the offense under Sec. 333(a)(2) was an intent to mislead or defraud. Id. at 910-11. In so holding, we stated:

The jury should have been further directed that it was necessary for it to find that defendant knew that several tests had not been made, that [the individual defendant] intentionally misrepresented that they had, and that he did so for the purpose of misleading and defrauding the consignee and the Canadian authorities that such several tests had been performed.

Id. at 910. Thus, the specific intent requirement of the statute could be satisfied by a showing that defendants intended to mislead or defraud the Canadian authorities and the Canadian consignee. Although the jury instruction was phrased in the conjunctive, "misleading and defrauding the consignee and the Canadian authorities," id. (emphasis added), it does not appear that the proof would admit one without the other.

Thereafter, in United States v. Cattle King Packing Co., 793 F.2d 232 (10th Cir.), cert. denied, 479 U.S. 985, 107 S. Ct. 573, 93 L. Ed. 2d 577 (1986), we considered the sufficiency of the evidence on a conspiracy count and a substantive count involving, among other things, returning rejected meat to the packing company while bypassing the required federal meat inspection. We held that sufficient evidence supported the convictions. Id. at 237. Defendants consciously misled government meat inspectors and a government veterinarian. Id. at 237. In discussing a substantive count in which the meat was ultimately discarded, we found sufficient evidence that defendants "directed the illegal circumvention of federal inspection when the Western Grocers' shipment was returned" to the plant. Id. at 237-38. We also noted the correspondence between the Federal Meat Inspection Act provision at issue, 21 U.S.C. Sec. 676(a), and the provision of the Food, Drug, and Cosmetic Act (FDCA) at issue in this case, 21 U.S.C. Sec. 333(a)(2). Id. at 240.

In Cattle King Packing, one of the parties defrauded was the government agency charged with federal meat inspection, acting through federal meat inspectors and a government veterinarian. Cattle King Packing is consistent with Industrial Laboratories which recognized that the Canadian authorities involved in setting standards for drugs could be misled or defrauded. Although we have not squarely addressed the issue, the government urges us to follow and apply the Eleventh Circuit's decision in Bradshaw, which held that an intent to mislead or defraud under Sec. 333(a)(2) may extend to government enforcement agencies. Bradshaw, 840 F.2d at 874-75. Defendant, on the other hand, suggests that we follow the comments in United States v. Haga, 821 F.2d 1036 (5th Cir.1987), cert. denied, 488 U.S. 924, 109 S. Ct. 305, 102 L. Ed. 2d 324 (1988), which cast some doubt as to whether an intent to mislead or defraud under Sec. 333(a)(2) may extend to government regulatory systems.

We think it important to discuss what we perceive as the operative facts in Bradshaw. There, defendant "admitted that he operated an illegal wholesale drug business." Bradshaw, 840 F.2d at 871 (emphasis added). He sold steroids, without prescriptions, for body building, a use not approved by the FDA. This constitutes misbranding. Id. at 871 n. 2. He went to great lengths to avoid detection, including mislabeling the packages containing the steroids as vitamins and " 'Herbalife products.' " Id. at 873. He also made affirmative misrepresentations and omissions to the Florida state drug authorities while attempting to obtain a valid Florida drug wholesalers permit. Bradshaw, 840 F.2d at 873. The government claimed that the defendant "had defrauded or misled both the FDA and the Florida enforcement agencies." Id. The jury was instructed on either theory. In considering defendant's conduct, the appellate court held that an intent to defraud under Sec. 333(a)(2) could extend to federal and state drug enforcement authorities, i.e., the FDA and the Florida state drug authorities. See id. at 873, 875 n. 9.

The general scheme of the Act and its legislative history indicate that the overriding congressional purpose was consumer protection--the protection of the public against any misbranded or adulterated food, drug, device, or cosmetic. When Bradshaw misled governmental agencies, thereby frustrating their efforts to protect the public, he indirectly misled and defrauded the public.

Id. at 874. State drug enforcement agencies, like the Florida authorities who issue permits and licenses, also are involved in consumer protection and work closely with their federal counterpart, the FDA. Id. at 875 n. 9. Accordingly, state drug agencies also may be misled or defrauded under Sec. 333(a)(2). Id. Bradshaw seems to apply when there is proof of a conscious effort to mislead or defraud the FDA or a state counterpart involved in consumer-oriented drug regulation. In Bradshaw, such proof involved evidence of conscious misbranding for the purpose of deliberately evading the FDA's restrictions concerning steroids and misleading the Florida state drug authorities issuing drug wholesaler permits.

Defendant relies heavily upon United States v. Haga, 821 F.2d 1036 (5th Cir.1987), a case involving a prosecution under 18 U.S.C. Sec. 371 (conspiracy statute) and 21 U.S.C. Sec. 333. Haga noted that "the cases construing section 333[ (a)(2) ] have ordinarily been based on a seller's intent to defraud or mislead purchasers, and not on the theory that a defendant has defrauded or misled the government by evading or violating its regulatory systems." Id. at 1041 (footnote omitted).15 We do not read this observation as foreclosing a prosecution on the theory that during the course of misbranding drugs the FDA or its state counterpart has been misled or defrauded by a misrepresentation or omission.

Moreover, according to the Fifth Circuit, Haga is a variance case; the indictment charged a "commit any offense" conspiracy rather than the alternative "defraud the United States" conspiracy under Sec. 371. Haga, 821 F.2d at 1043. The district court judge, however, found that defendant was " 'guilty of the felony offense of conspiracy to defraud an agency of the United States, the FDA....' " Haga, 821 F.2d at 1044-45, 1043 n. 14. A fatal variance existed between the indictment as construed by the appellate court and the proof at trial as reflected in the district court's findings. Id. at 1045; United States v. Allred, 867 F.2d 856, 867 (5th Cir.1989). But see United States v. Smith, 891 F.2d 703, 711-13 (9th Cir.1989) (rejecting Haga 's construction of Sec. 371), amended, 906 F.2d 385, cert. denied, --- U.S. ----, 111 S. Ct. 47, 112 L. Ed. 2d 23 (1990).

In rejecting the government's theory of the case, however, the court in Haga expressed reservations concerning the validity of a "commit any offense" conspiracy, 18 U.S.C. Sec. 371, which relies upon "distributing prescription drugs in knowing violation of federal and state regulatory systems and rules," 21 U.S.C. Sec. 333(a)(2), for the offense. Haga, 821 F.2d at 1044 (emphasis omitted) & 1044-45 n. 17. According to the court, such a theory would

as a practical matter have the effect of rendering the "defraud and mislead" language of Sec. 333[ (a)(2) ] mere surplusage in the prosecution of any defendant charged with a conscious (and not publicly proclaimed) violation of section 331--only inadvertent (or publicly announced) violations of section 331 would be misdemeanors, because all conscious (and not publicly confessed) violations would necessarily involve a deliberate evasion of established regulatory systems.

Id. We think that this criticism is tempered somewhat by the specific intent required in a Sec. 333(a)(2) prosecution. And if the government proceeds on this theory, there must be a demonstrated link between the Sec. 331 violation and an intent to mislead or defraud an identifiable drug regulatory agency involved in consumer protection. See Cattle King Packing, 793 F.2d at 237-38; Industrial Laboratories, 456 F.2d at 910-11. Distributing drugs in knowing violation of federal and state regulatory systems and rules is too general.

We believe that the specific intent requirement in Sec. 333(a)(2) requires not only proof of misbranding under Sec. 331, but also proof of an intent to mislead or defraud which is connected to the misbranding violation under Sec. 331. See Industrial Laboratories, 456 F.2d at 910-11; United States v. Hiland, 909 F.2d 1114, 1128 (8th Cir.1990). See also United States v. Agnew, 931 F.2d 1397, 1408-09 (10th Cir.1991) (felony conviction under Federal Meat Inspection Act, 21 U.S.C. Sec. 676(a) for transporting adulterated meat). Because "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 Sec. 333(a)(2) without some knowledge of the misbranding. Hiland, 909 F.2d at 1128; Industrial Laboratories, 456 F.2d at 910 (jury should have been instructed that "defendant knew that several tests had not been made").

These limitations are consistent with the Supreme Court's prior interpretation of the Act. In construing the predecessor of the 1938 Act, the Supreme Court observed that it

was passed by Congress, under its authority to exclude from interstate commerce impure and adulterated food and drugs and to prevent the facilities of such commerce to be used to enable such articles to be transported throughout the country from their place of manufacture to the people who consume and use them, and it is in the light of the purpose and of the power exerted in its passage that this act must be considered and construed.

McDermott v. Wisconsin, 228 U.S. 115, 128, 33 S. Ct. 431, 433, 57 L. Ed. 754 (1913) (construing Food and Drugs Act of 1906, 34 Stat. 768). See also United States v. Lexington Mill Co., 232 U.S. 399, 409, 34 S. Ct. 337, 340, 58 L. Ed. 658 (1914) (identifying the primary purpose of misbranding and adulteration provisions concerning food as consumer protection). The current Act protects the consuming public by allowing the government to regulate the conditions under which drugs are manufactured and distributed and it requires those responsible to comply with its provisions. United States v. Park, 421 U.S. 658, 673, 95 S. Ct. 1903, 1912, 44 L. Ed. 2d 489 (1975). Misdemeanor criminal responsibility does not require "consciousness of wrongdoing." 21 U.S.C. Sec. 333(a); United States v. Dotterweich, 320 U.S. 277, 284, 64 S. Ct. 134, 138, 88 L. Ed. 48 (1943) ("The offense is committed ... by all who do have such a responsible share in the furtherance of the transaction which the statute outlaws, namely, to put into the stream of interstate commerce adulterated or misbranded drugs."); United States v. Abbott Laboratories, 505 F.2d 565, 573 (4th Cir.1974), cert. denied, 420 U.S. 990, 95 S. Ct. 1424, 43 L. Ed. 2d 671 (1975). On the other hand, felony criminal responsibility requires a knowing violation with the specific intent "to defraud or mislead," 21 U.S.C. Sec. 333(a)(2); that this may be proved with facts indicating knowledge of the misbranding activity and a concomitant intent to defraud or mislead the FDA or its state counterpart seems consistent with the statute's purpose as interpreted by the courts.

The government contends that sufficient circumstantial evidence suggests that defendant conspired to violate 21 U.S.C. Sec. 331(a), (k) and (p) with the intent to mislead law enforcement agencies.16 Appellee's Brief (No. 89-6362) at 37-39. In particular, the government maintains that defendant and Raymer misbranded the MDMA with the intent to mislead and defraud local police departments in Dallas, Plano and Oklahoma City. Timely objection was made to instructing the jury on this theory. Rec. supp. vol. IX at 1360-61. The prosecutor told the jury, over an objection, that defendant Raymer "was misleading and defrauding while holding himself out as someone cooperating with law enforcement, not stopping his activity but continuing in an even more covert manner than flying through these commercial airlines." Id. at 1427. At the trial's conclusion, the trial judge expressed his view that the government's theory was somewhat far afield. Id. at 1362.

Relying upon Bradshaw, however, the district court determined that a state or local agency could be defrauded under Sec. 333(a)(2), while acknowledging that it was "a very close legal issue." Rec. supp. vol. X at 5. See also id. ("Let me just say that I have real concern as to whether or not the Food, Drug and Cosmetic Act was intended to apply to schemes to defraud the Plano Police Department."). When sentencing codefendant Raymer, the district court recognized that the misbranding counts were

frankly, ... a nontraditional, perhaps innovative indictment by the government on conduct that was not squarely labeled as illegal by Congress and not dealt with directly by Congress until the passage of the Controlled Substance Analogue Act [in October 1986].

....

Almost all the cases under the misbranding theory deal with situations that are completely different than the situation we have here. I have struggled with those counts since the outset of the case, indeed, to the point that I considered dismissing them at the conclusion of the case and even up until today.

Rec. supp. vol. X at 34-35. We share the district court's reservations about counts one and four.

After a thorough review of this record, no rational trier of fact could conclude beyond a reasonable doubt that the defendants (Mitcheltree and Raymer) acted to mislead or defraud a government agency responsible for drug safety and efficacy with the objective of consumer protection. Moreover, not a scintilla of evidence links the defendants' misbranding activities with a specific intent, 21 U.S.C. Sec. 333(a)(2), to violate or defeat agency enforcement of the actual federal drug regulatory provisions alleged in counts one and four of the indictment, i.e., 21 U.S.C. Secs. 331(a); 352(b), (c), (e), (j) & (o ); 331(k); 331(p) & 360. See Hiland, 909 F.2d at 1128. This conclusion is even more apparent considering the type of proof (involving fraudulent conduct) which courts have found sufficient to uphold Sec. 333(a)(2) convictions. See, e.g., United States v. Jamieson-McKames Pharm., 651 F.2d 532, 543-50 (8th Cir.1981) (counterfeit drug operation), cert. denied, 455 U.S. 1016, 102 S. Ct. 1709, 72 L. Ed. 2d 133 (1982); United States v. Barnett, 587 F.2d 252, 254 n. 1, 257 (5th Cir.1979) (adulterated cottonseed meal), cert. denied, 441 U.S. 923, 99 S. Ct. 2031, 60 L. Ed. 2d 396 (1979).

We are unwilling to blur the distinction between the misdemeanor and felony provisions of Sec. 333(a). The felony provision requires knowledge of the misbranding and proof of specific intent to mislead or defraud connected to the misbranding violation. The government's evidence suggests that local police departments were investigating the distribution of MDMA (as well as unlawful drugs) when the defendants were misbranding MDMA. But merely because the activities of the defendants and the police may have been contemporaneous does not constitute sufficient proof that the defendants knowingly misbranded with the specific intent to mislead or defraud those police departments. For us to so hold would be to adopt a standard which would be inconsistent with the misdemeanor provision of the statute, 21 U.S.C. Sec. 333(a)(1). See Haga, 821 F.2d at 1044-45 n. 17.

In the alternative, nothing in the record indicates that the local police departments, at the times alleged in counts one and four, were accomplishing anything other than routine controlled substance investigations. No evidence even remotely suggests that the local investigation encompassed misbranded drugs. Indeed, sometime after early 1989 (when the misbranding had ceased), a Department of Justice official "provided significant in-depth consultations on the nature and framework of the indictments including a recommendation that the mis-branding provisions of Title 21 be examined for applicability to the facts in the instant case." Affidavit of R. Wintory, supp. vol. XII, doc. 167 at 5, p 12(c). Resort to this theory was necessary, at least in part, because MDMA was not scheduled properly at the federal level until October 1986.

In the end it is not necessarily the novelty of the government's theory, but rather the lack of evidence to support it, which requires reversal of the defendant's convictions on the misbranding counts. We recognize that a defendant may knowingly misbrand with an intent to mislead or defraud a government authority that, for example, sets drug standards, Industrial Laboratories, 456 F.2d at 909, inspects drugs, cf. Cattle King Packing, 793 F.2d at 237, regulates the use of prescription drugs, Bradshaw, 840 F.2d at 872; United States v. Cerrito, 413 F.2d 1270, 1272 (7th Cir.1969), cert. denied, 396 U.S. 1004, 90 S. Ct. 554, 24 L. Ed. 2d 495 (1970), or issues permits to drug wholesalers, Bradshaw, 840 F.2d at 873. What is missing in this case is (1) any conscious involvement by the defendant with a government agency involved in consumer protection which performs any of the above or similar functions, and (2) any link between conscious misbranding activity and a specific intent to mislead or defraud such an agency.

It is not enough to say, as does the government, that the success of the venture to distribute MDMA depended upon misbranding without proving that the defendants misbranded with the intent to mislead or defraud a government agency involved in consumer protection of some sort. Contrary to the government's position, covert criminal activity involving drugs is not synonymous with misbranding with an intent to mislead or defraud. Because the jury was instructed on a theory for which insufficient evidence exists and we cannot "confidently determine that the jury relied on the theory validly supported by the evidence," we must reverse the convictions on counts one and four and also remand for a new trial.17 United States v. Larranaga, 787 F.2d 489, 497-98 (10th Cir.1986). See also United States v. Irwin, 654 F.2d 671, 679-80, 684 (10th Cir.1981), cert. denied, 455 U.S. 1016, 102 S. Ct. 1709, 72 L. Ed. 2d 133 (1982); United States v. Radetsky, 535 F.2d 556, 573 (10th Cir.), cert. denied, 429 U.S. 820, 97 S. Ct. 68, 50 L. Ed. 2d 81 (1976); United States v. Dota, 482 F.2d 1005, 1006 (10th Cir.), cert. denied, 414 U.S. 1071, 94 S. Ct. 583, 38 L. Ed. 2d 477 (1973). But see United States v. Griffin, 913 F.2d 337, 357, 361-65 (7th Cir.1990), cert. granted, --- U.S. ----, 111 S. Ct. 951, 112 L. Ed. 2d 1039 (1991).

REVERSED and REMANDED.