Summary
upholding FDCA conviction in case where defendant had labeled drugs as non- consumables in order to avoid federal drug laws because the proof of intended consumption stem[med] from the entire method of doing business, including defendant's above-market prices, his disingenuous disclaimer, the lack of other apparent uses for the products defendant sold, among other facts
Summary of this case from United States v. McConnellOpinion
CAUSE NO. IP02-0009-CR-01-H/F
May 17, 2004
ENTRY ON POST-TRIAL MOTIONS
Defendant Mark Niemoeller runs a business that distributes a variety of substances to buyers. Some of those substances are more commonly distributed through pharmacies pursuant to prescriptions written by physicians. Niemoeller designates most of the substances as "poisonous non-consumables" in an effort to avoid application of federal drug laws. After federal investigators made four purchases of dopamine, 1-dopa (also known as levadopa), and clenbuterol, Niemoeller was charged and later convicted at trial on eight counts of distributing prescription and veterinary prescription drugs without prescriptions, in violation of 21 U.S.C. § 331(a) (k), and 333(a)(2). Trial on several other charges under the Controlled Substance Analogue Act was severed. Those charges remain pending. After trial, Niemoeller filed three motions for judgment of acquittal or a new trial under Rules 29 and 33 of the Federal Rules of Criminal Procedure.
I. Defendant's First Motion
A. Motion for Judgment of Acquittal
Defendant argues that the government failed to meet its burden of proof on two elements of the offenses charged. In considering a motion for judgment of acquittal under Rule 29, the court must view all evidence in the light reasonably most favorable to the prosecution, without weighing credibility of witnesses. United States v. Washington, 184 F.3d 653, 657 (7th Cir. 1999). The issue is whether the evidence, when viewed in the light reasonably most favorable to the prosecution, is sufficient to support a finding of guilt beyond a reasonable doubt. United States v. Beck, 615 F.2d 441, 447-48 (7th Cir. 1980); United States v. Williams, 311 F.2d 721, 723 (7th Cir. 1963); Curley v. United States, 160 F.2d 229, 232 (B.C. Cir. 1947); see also Jackson v. Virginia, 443 U.S. 307, 318-19 n. 11 (1979) ( dicta describing Curley as stating the prevailing standard under Rule 29).
1. Knowledge of Prescription Drug Status
First, defendant Niemoeller argues that the government failed to prove beyond a reasonable doubt that he knew a prescription was required for distribution of the 1-dopa, dopamine, or clenbuterol. The court disagrees as to Counts One through Four, but agrees as to Counts Five through Eight.
a. Counts One through Four — Dopamine and L-Dopa
As to dopamine and 1-dopa, the government's proof of defendant's knowledge was circumstantial but was sufficient to support the jury's verdict. As to those two substances, the government offered evidence that both are treated as prescription drugs under the law, and that such treatment is published in readily available public information. This evidence came from Agent Perino and Dr. Susan Alien, and from Exhibits 101 and 102. There was evidence that the FDA's Orange Book included listings for 1-dopa and dopamine, and Dr. Alien testified that the Orange Book (available on-line) listed all prescription drugs. R. 350-55. The circumstantial proof of Niemoeller's knowledge also includes Niemoeller's whole method of doing business, which required customers to adopt or record a statement disclaiming any intent to consume the products they were purchasing. By this device, Niemoeller and his customers created a transparently fictional record of a lack of intent to consume in the hope of avoiding federal drug laws. The jury could reasonably find that the disclaimer would be used only by someone who was aware of the legal definition of a drug and who sought to avoid a violation by pretending, with a wink and a nod, that no consumption was intended. The evidence allowed the jury to find that Niemoeller was selling to customers who were not, by any stretch of imagination, using the 1-dopa or dopamine for research purposes or for any other purpose not involving human consumption.
b. Counts Five through Eight — Clenbuterol
For clenbuterol, the record is very different. The court has reviewed the record to determine whether the government ever offered evidence that clenbuterol is in fact a veterinary prescription drug. The court concludes that on the trial record, the jury could not find beyond a reasonable doubt that clenbuterol was a veterinary prescription drug. On the first day of trial, Agent Perino testified that the U.S. Pharmacopeia, also known as the National Formulary, was a publication that could be consulted about whether a drug was a prescription drug for humans and animals. Tr. 32. He testified that clenbuterol was in the U.S. Pharmacopeia. Id.; see also Tr. 165. The defense raised a hearsay objection and motion to strike a few questions later, which the court denied because the question had already been answered and the questioning had moved on to the other substances. Tr. 33.
On cross-examination, however, the defense showed that the U.S. Pharmacopeia also included substances that are not prescription drugs, such as sodium chloride, aloe, castor oil, mineral oil, soybean oil, cocoa butter, corn oil, and licorice. Tr. 166-68. Thus, the jury could not reasonably find that the mere listing of a compound or substance in that book establishes that it is a prescription drug. Moreover, in the U.S. Pharmacopeia, admitted in evidence as Defendant's Exhibit 414, clenbuterol is not even listed. Agent Perino testified that he reviewed an FDA statement that said only one company could legally sell clenbuterol, Tr. 168-69, but this testimony was not explained and does not support a finding that the substance is a veterinary prescription drug. Government witness Dr. Susan Alien testified that clenbuterol is not approved for human use in the United States, R. 364, but she never testified that clenbuterol is a veterinary prescription drug.
Agent Perino also admitted on cross-examination that he had not actually consulted the U.S. Pharmacopeia in his clenbuterol investigation. Tr. 168-69.
On this record, the jury could not reasonably find beyond a reasonable doubt that clenbuterol was a veterinary prescription drug, let alone that Niemoeller knew it was a veterinary prescription drug. Accordingly, the government's proof failed as to Counts Five, Six, Seven, and Eight. Defendant Niemoeller is entitled to a judgment of acquittal on those charges.
2. Intended Human Consumption
As his second ground for judgment of acquittal, defendant Niemoeller argues that the government failed to prove that he intended for the 1-dopa and dopamine to be consumed by humans. The government has reiterated its view that such proof is not required. The court stands by its earlier ruling on that issue, but finds that the evidence was sufficient to support the jury's finding of such intent.
Regarding 1-dopa and dopamine, the proof of intended consumption stems from the entire method of doing business, including defendant's above-market prices, his disingenuous disclaimer, the lack of other apparent uses for the products defendant sold, and defendant's choice of advertising channels such as "High Times" magazine. The jury could reasonably find in favor of the government on this issue. The defendant may be tempted to claim it is unfair to find intended consumption based in substantial part on a warning from defendant that says not to consume the substances. In this case, however, reaching that conclusion does not require a trip down a proverbial rabbit-hole (after a bite of an unusual mushroom). The jury could reasonably conclude that the defendant was operating his entire business on the palpable fiction that buyers were promising not to consume the substances for sale, even though the catalog included numerous products that are typically consumed, such as pills. See Tr. 287-90. Also, for example, defendant Niemoeller and the undercover agent discussed ways to administer clenbuterol. Niemoeller suggested using nasal spray bottles, which he also had for sale. With at least a metaphorical wink and nod, he stated: "Of course, I can't advise consumption," while at the same time giving the "warning" that clenbuterol "is highly nasally active." Ex. 47D. Though the government's clenbuterol charges failed on other grounds, this evidence of Niemoeller's business methods on selling other "poisonous non-consumables" helps show that the warnings about not consuming the products were transparent dodges.
B. Motion for New Trial
Niemoeller also argues that even if the court denies judgment of acquittal, the court should order a new trial in the interests of justice. Rule 33 of the Federal Rules of Criminal Procedure provides that the court may grant a new trial "if the interests of justice so require." Under Rule 33, defendant Niemoeller contends he is entitled to a new trial for all the reasons he argued in support of acquittal. The standard for a Rule 33 motion is substantially different from the standard for Niemoeller's Rule 29 motion. The motion for a new trial based on the weight or sufficiency of the evidence could be granted if the court reached the conclusion that the verdict was contrary to the weight of the evidence and that a miscarriage of justice may have resulted. E.g., United States v. Ahen, 761 F. Supp. 1382, 1382-83 (S.D. Ind. 1991); accord, United States v. Alanis, 265 F.3d 576, 591 (7th Cir. 2001); Washington, 184 F.3d at 657-58. Niemoeller also argues that a new trial should be granted because of the government's failure to disclose exculpatory evidence, prosecutorial misconduct, the court's exclusion of dietary supplement evidence, and the court's admission of the "Psychedelic Resource List," a publication with information about Niemoeller's business.
1. Sufficiency of the Evidence
Regarding the sufficiency of the evidence, the court finds the evidence was ample to support the jury's verdict on the dopamine and 1-dopa charges, which are Counts One, Two, Three, and Four. For the reasons discussed above regarding the motion for acquittal, the evidence on those charges amply supported the jury's verdict that Niemoeller knew he was distributing prescription drugs for human consumption, outside the regulated channels for prescription drugs.
2. Brady Material
Niemoeller also argues he is entitled to a new trial on the theory that the government failed to disclose exculpatory evidence in its possession, in violation of the principles of Brady v. Maryland, 373 U.S. 83 (1963). Niemoeller has renewed his pretrial arguments concerning access to "INDs," which are Investigational New Drug reports that drug manufacturers file with the FDA. Niemoeller contends that the INDs probably contain information showing that dopamine, and 1-dopa are not as dangerous as the government argued at trial. Niemoeller also argues that the INDs would have been relevant to impeach Dr. Alien's credibility on the issue of the dangers of the substances in question.
For purposes of deciding this issue, the court assumes that the FDA has some INDs for one or more of these substances that show they are not as dangerous as the government argued at trial. The government did not produce these documents to defendant before trial. The FDA is required to keep INDs confidential, though disclosure to a court is possible when the information is relevant to a judicial proceeding. 21 U.S.C. § 331(j). The prosecution advised in this case that the INDs for the relevant substances would involve "truckloads" of documents.
One element of a Brady claim is prejudice, meaning there is "a reasonable probability that, had the evidence been disclosed to the defense, the result of the proceeding would have been different." Strickler v. Greene, 527 U.S. 263, 280 (1999), quoting United States v. Bagley, 473 U.S. 667, 682 (1985). The question of prejudice is whether "the favorable evidence could reasonably be taken to put the whole case in such a different light as to undermine confidence in the verdict." Strickler, 527 U.S. at 290, quoting Kyles v. Whitley, 514 U.S. 419, 435 (1995).
Niemoeller's theories of prejudice resulting from denial of access to the INDs are not convincing. First, Niemoeller suggests that he wanted to try the issue of whether 1-dopa and dopamine are as dangerous or powerful as the government argued at trial. He suggests, in essence, that he wanted the jury to decide for itself whether the FDA made the right decisions, as a matter of sound public health policy, in determining that these substances should be treated as prescription drugs. That was not an issue for the jury to decide in this case. Information from those interested in persuading the government to change its policy toward these drugs would not have been material to the jury's verdict. Lack of access to that information therefore could not have been prejudicial to Niemoeller.
Nevertheless, Niemoeller argues that the court instructed the jury on the definition of a prescription drug, so as to put these matters at issue. In Court Final Instruction No. 22, the court said:
When used in these instructions, a "prescription drug" is a "drug" that the defendant intended for use by man which (1) because of its toxicity or other potential for harmful effect, or the method of its use, or the collateral measures necessary to its use, is not safe for use except under the supervision of a practitioner licensed by law to administer the drug; or (2) is limited by an approved drug application to use under the professional supervision of a practitioner licensed by law to administer the drug.
This definition did not call upon the jury to conduct a scientific investigation in a three-day trial as to whether the FDA made the right decision in determining that prescriptions should be required for human consumption of dopamine and 1-dopa. The definition, which was drawn from 21 U.S.C. § 353(b)(1)(A), was intended to inform the jury as to why drugs would be treated as prescription drugs, not to invite the jurors to decide for themselves whether the FDA made the right decisions in requiring prescriptions.
As a second theory of relevance, Niemoeller suggests that he would have used information in the INDs to impeach Dr. Alien, a government witness who described the drugs in question and their effects on humans. Her testimony was relevant to the jury by way of background. That evidence was also relevant to show possible effects of consumption and to show an intent to consume. An extended scientific debate with Dr. Alien over just how powerful or just how dangerous these drugs are would not have been material, and the absence of the IND evidence was not prejudicial to Niemoeller within the meaning of the Brady doctrine.
3. Charges of Prosecutorial Misconduct
Niemoeller also argues that the prosecutor acted improperly in three respects at trial, so that fairness requires a new trial.
The first incident arose when the prosecutor was cross-examining Kimberly Naville, who worked for Niemoeller in his business. On direct testimony, the witness had described a "blacklist" that Niemoeller kept, a list of potential customers to whom he would not make sales, because, for example, they had indicated their intent to consume the products they bought. Naville had testified that the undercover name used by the government agent was not on the list, which would presumably support a defense argument that the agent had not said anything that actually put Niemoeller on notice that the agent intended for his purchases to be consumed.
On cross-examination, the government asked Naville whether she was "familiar with the name of Summer Pray." Tr. 278. The witness quickly answered "yes," as defense counsel simultaneously objected and asked to approach the bench. The court had previously granted defendant's sixth motion in limine to exclude matters relating to deaths or injuries from products sold by defendant, unless the government first obtained leave to do so. Docket No. 83. The government's question mentioning Summer Pray's name did not alert the court to the problem, but defense counsel instantly recognized the issue. During the bench conference, the prosecutor explained that Miss Pray had been a college student who received a shipment from defendant's business and who took an overdose of a substance and died.
The prosecutor stated that he did not intend to go into the facts concerning her death. Instead, he wanted to point out only that Miss Pray's father had sent a letter to defendant asking that his daughter be "blacklisted" by the business so that it would not send her any more products. The government wanted to offer evidence that the defendant made another shipment to Miss Pray after he received the letter from her father. The prosecutor wanted to use the evidence to show that the "blacklist" described by witness Neville was not effective or consistent.
During the bench conference, the court made clear that no more questions would be allowed on the subject and that the subject would be closed, based on at least a Rule 403 balance of minimal probative value and great potential for unfair prejudice, confusion and waste of time. Tr. 278-79.
When the court next took a recess, the defendant moved for a mistrial based on the reference to Miss Pray. Tr. 313. The defense argued that the jury could have been improperly influenced by the government's question because Miss Fray's death had received extensive publicity, and had even been the subject of congressional hearings. The court denied the mistrial motion, stating that there was no reason to believe that any jurors would have recognized Miss Pray's name or would attribute any significance to it. Tr. 314. All that the jury had heard was a question asking whether the witness was familiar with the name, and the witness had answered yes. No follow-up questioning occurred.
The court mistakenly recalled the witness' answer as "no," though the "yes" answer and the defense objection were essentially simultaneous. See Tr. 278. The mistake has no effect on this issue.
The prosecutor's question about Summer Pray teetered on the borderline of the court's order in limine. The court is satisfied, however, that the swift remedial action initiated by defense counsel was sufficient. The reference to Miss Pray might have set off alarm bells for those intimately familiar with the public policy debate over the drug laws as applied to some of these unusual drugs. The court had never heard of Miss Pray until the question was asked, and there is no indication that any of the jurors were familiar with her name. In short, the prosecutor took a dangerous risk by asking the question, but the court finds that no harm was done by this mistake. See United States v. Gonzalez, 319 F.3d 291, 297 (7th Cir. 2003) ("Even where the jury has been exposed to evidence that is not properly before it, a defendant is not automatically entitled to a new trial. A new trial is mandated only where there is a reasonable possibility that the evidence had a prejudicial effect.").
Second, the defendant argues that the prosecutor engaged in misconduct by trying to shift the burden of proof to defendant and by trying to undermine defendant's Miranda rights during the rebuttal phase of the closing arguments. The defense had argued that the jury should draw an adverse inference from the fact that one of the agent's tape recordings of his transactions with Niemoeller had malfunctioned. The court declined to give an instruction on the matter because there was no evidence of bad faith. During the rebuttal phase of closing arguments, the prosecutor said: "now, if there is something dirty, something under the table, the defense could have played the tape to you. But there's nothing there." Tr. 506-07. The defense argues this was an improper attempt to shift the burden of production and persuasion to the defense.
The court disagrees. The tape itself was in evidence. Either side could have had it played for the jury. It was fair for the government to defend itself from the charge of misconduct or spoliation by pointing out to the jury that the defense argument was merely an invitation to speculate, and that the defense had the opportunity to bolster its defense by actually playing the tape if it would have supported the theory. The prosecutor made a fair response to a defense argument that could have misled the jury.
Third, also during the rebuttal phase, the prosecutor responded to a defense argument to the effect that Niemoeller did not act clandestinely or with criminal intent. The defense had argued:
If you're engaged in an undercover clandestine dope deal, first thing you ask somebody for the first time, Are you a cop? Are you wearing a body recorder? That didn't happen. There was no reason for it to happen because in [Niemoeller's] mind he was not doing anything wrong.
Tr. 500-01. The government did not object at the time to the suggestion that drug dealers ask their contacts to confess to being government agents. Instead, the prosecutor waited and responded in his rebuttal by saying that he had been prosecuting drug cases for twelve years. He then said: "I would tell you that has just about never happened in any case I've ever prosecuted." Tr. 509. The defense accuses the prosecutor of improper vouching based on his experience in other cases.
There was no objection by the defendant during the prosecutor's closing argument, although an objection would have been sustained. In the absence of an objection, the question is one of plain error. United States v. Anderson, 303 F.3d 847, 854 (7th Cir. 2002); United States v. Scott, 267 F.3d 729, 740 (7th Cir. 2001). The Seventh Circuit instructs courts to apply a two-step inquiry to such claims of prosecutorial misconduct. The first question is whether, in isolation, the remarks were improper. Anderson, 303 F.3d at 854. In the court's view, the remark about the prosecutor's own experience in many other cases was improper. See Anderson, 303 F.3d at 856 (blatantly improper to base argument on implied facts not presented to jury).
The second question is whether the remarks, in light of the record as a whole, denied the defendant a fair trial. Several factors should be considered: (1) the nature and seriousness of the misconduct; (2) the extent to which the comments were invited by the defense; (3) the extent to which any prejudice was ameliorated by the court's instruction to the jury; (4) the defense's opportunity to counter any prejudice; and (5) the weight of the evidence supporting the conviction. Anderson, 303 F.3d at 854, citing Scott, 267 F.3d at 740. The nature and seriousness of the misconduct in this case were not severe. The risk of unfair prejudice was minimal.
A critical issue here was defendant Niemoeller's knowledge and intent. The defense argued that Niemoeller believed he had not done anything wrong, but acknowledged that there were some unusual business practices that needed to be explained, such as the circumstances under which he met the undercover agent who wanted to purchase "poisonous non-consumables." Hence the defense argument that defendant was not "engaged in an undercover clandestine dope deal" because he did not ask whether the agent was wearing a "body recorder" or wire. That argument was based not on evidence but on, at best, a suggestion of "common sense." The argument was marginal, in the court's view, but the court did not intervene. The prosecutor responded with the comment about his experience in other cases, but the same argument could also have been framed easily in terms of "common sense." In fact, the prosecutor completed his thoughts on the subject this way:
In an undercover drug setting, what's going to happen if a drug dealer walks up and asks an undercover police officer, Are you a cop? What's the cop going to do? Mr. Drug Dealer, yes, I am. I'm sorry you figured it out. Or, is he going to say, No? This is ridiculous. It's another red herring.
Tr. 510.
Taken as a whole, this rebuttal to the defense argument did not deny Niemoeller a fair trial. The court cautioned the jury that closing arguments are not evidence, of course, and the jurors presumably were listening to closing arguments with the usual critical skepticism. Also, on the issue of Niemoeller's knowledge and intent, the evidence as a whole strongly supported the prosecution's case as to the dopamine and 1-dopa transactions in this trial. On the whole, the court finds no misconduct by the prosecutor that denied the defendant a fair trial.
See United States v. Young, 470 U.S. 1, 11-13 (1985) (applying "invited response" rule to improper argument and finding no reversible error). The Court in Young stated: "The situation brought before the Court of Appeals was but one example of an all too common occurrence in criminal trials — the defense counsel argues improperly, provoking the prosecutor to respond in kind, and the trial judge takes no corrective action." Id. at 11. Of course, we deal with an adversarial system. When there is no objection to an objectionable point in an argument, the trial judge must decide in a few seconds whether to interrupt a closing argument with his or her own public or private admonition to counsel. In this case, the court made an instant decision for caution and silence, though an admonition would also have been justified.
4. Exclusion of Dietary Supplement Evidence
Defendant Niemoeller also argues that the court erred by excluding evidence that 1-dopa and/or dopamine can qualify as dietary supplements. This subject is addressed separately in the court's discussion concerning defendant's third motion, below.
5. Admission of Redacted Exhibit 64
Defendant also argues that a new trial is needed because the court erred by admitting Exhibit 64, a copy of a publication called the "Psychedelic Resource List." The "Psychedelic Resource List" is a publication that lists a number of sources for a variety of substances, including mushrooms, natural oils, and other plant substances. Page two of Exhibit 64 has a half-page display for Niemoeller's business, JLF Poisonous Non-Consumables. That display appears to be an advertisement, not merely an informational listing provided by the publisher of the list. When Exhibit 64 first came up, the defense objected that the advertisement had not been placed by defendant, so that it offered no evidence of his intent or state of mind. Tr. 203. The government responded that it had obtained the checks that were paid to the publisher. The court ruled that a redacted version of Exhibit 64, with only the cover and the second page with the "advertisement" of defendant, would be admissible if the government laid a sufficient foundation. Tr. 205.
When offering Exhibit 64, the government established that the document had been found in defendant's business premises, but it did not offer then or later any checks or other evidence to show that defendant had actually paid to advertise in the Psychedelic Resource List. The defense stated that it renewed its objection, without elaboration, and the court overruled the objection, without explanation. Tr. 230. On cross-examination of the witness, the defense brought out the absence of records indicating payment or other authorization for the half-page display for JLF Poisonous Non-Consumables. Tr. 233. The defense then renewed its objection, and again the court overruled the objection, again without explanation.
The government argued in closing that the way Niemoeller advertised was evidence of his knowledge and intent, pointing to the advertisement in "High Times" magazine and to Exhibit 64. See Tr. 463.
Upon reflection, the court believes that it probably erred in overruling the defense objection to Exhibit 64, at least on the foundation that was presented. The fact that the document was found in the defendant's business location was not sufficient to lay a foundation for the government's use of the document as evidence of advertising by the defendant. The government never supported its use of Exhibit 64 with the promised evidence that the display was in fact an advertisement that Niemoeller himself had paid for and authorized.
The court does not believe, however, that this apparent error calls for anew trial. The jury heard and saw extensive evidence concerning Niemoeller's business methods. On the specific issue of advertising, there is no doubt that he was advertising in "High Times" magazine, which is difficult to reconcile with the theory that the defendant was selling these chemicals for research purposes and not for consumption. The broader evidence concerning business methods, including the disclaimers and waivers and the fiction of non-consumption, was consistent and strong. The court believes that if admission of Exhibit 64 was an error, it was harmless and did not deny Niemoeller a fair trial. See Brown v. United States, 411 U.S. 223, 231-32 (1973) ("A defendant is entitled to a fair trial but not a perfect one, for there are no perfect trials.").
II. Defendant's Second Motion
The second motion argues that the court erred in denying defendant's motion to dismiss these charges. The original motion to dismiss argued that the indictment was defective and that the bill of particulars could not cure the defect. Defendant's second motion also argues that the court erred by denying the defendant's motion to continue the jury trial. The second motion does not add any new arguments to those presented at the time the court denied the original motions in January 2003. The court believes its original rulings were correct for the reasons stated at that time. See Docket Nos. 73 75. Also, defendant has not shown any prejudice resulting from the denial of the motion to continue. Defendant was fully prepared for trial and had adequate notice of the charges against him in Counts One through Eight.
III. Defendant's Third Motion
The third motion argues that the court erred by excluding defendant's offer to prove that 1-dopa and dopamine can be sold as dietary supplements rather than as prescription drugs. (The motion does not address the clenbuterol sales, upon which the court is granting judgment of acquittal on other grounds.) Niemoeller contends he is entitled to a judgment of acquittal or in the alternative to a new trial. It is difficult to see how the court could rule that excluded evidence would require a judgment of acquittal. The court also finds that the exclusion of this evidence did not deny Niemoeller a fair trial.
Federal law allows the sale and distribution of substances as dietary supplements even if the same substance requires a prescription when distributed as a drug. See 21 U.S.C. § 321(g) (defining "drug" so as to exclude "food" and dietary supplements that comply with 21 U.S.C. § 343(r)); 21 U.S.C. § 321(ff) (defining "dietary supplement").
To sell a substance as a dietary supplement lawfully, the seller must comply with the law's requirements, which are complex enough to rival some of the more obscure portions of the Internal Revenue Code. One of the simplest
For example, the definition provision alone, 21 U.S.C. § 321(ff), provides that the term "dietary supplement"
(1) means a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients:
(A) a vitamin;
(B) a mineral;
(C) an herb or other botanical;
(D) an amino acid;
(E) a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or
(F) a concentrate, metabolite, constituent, extract, or combination of any ingredient described in clause (A), (B), (C), (D), or (E);
(2) means a product that —
(A)(I) is intended for ingestion in a form described in section 350(c)(1)(B)(I) of this title; or
(ii) complies with section 350(c)(1)(B)(ii) of this title;
(B) is not represented for use as a conventional food or as a sole item of a meal or the diet; and
(C) is labeled as a dietary supplement; and
(3) does —
(A) include an article that is approved as a new drug under section 355 of this title or licensed as a biologic under section 262 of Title 42 and was, prior to such approval, certification, or license, marketed as a dietary supplement or as a food unless the Secretary has issued a regulation, after notice and comment, finding that the article, when used as or in a dietary supplement under the conditions of use and dosages set forth in the labeling for such dietary supplement, is unlawful under section 342(f) of this title; and
(B) not include —
(I) an article that is approved as a new drug under section 355 of this title, certified as an antibiotic under section 357 of this title, or licensed as a biologic under section 262 of Title 42, or
(ii) an article authorized for investigation as a new drug, antibiotic, or biological for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public,
which was not before such approval, certification, licensing, or authorization marketed as a dietary supplement or as a food unless the Secretary, in the Secretary's discretion, has issued a regulation, after notice and comment, finding that the article would be lawful under this chapter.
Except for purposes of paragraph (g), a dietary supplement shall be deemed to be a food within the meaning of this chapter.
requirements that would apply in this context is that the substance must be labeled as a "dietary supplement." 21 U.S.C. § 321(ff)(2)(C). Defendant Niemoeller did not label any of the substances in question as dietary supplements. He labeled them as "poisonous non-consumables." His defense at trial was that he did not intend for the 1-dopa and dopamine to be consumed at all.
Niemoeller argues that the dietary supplement evidence would have been relevant on two grounds notwithstanding his theory of defense. His motion points out that government witness Dr. Alien testified that 1-dopa and dopamine could be sold only as prescription drugs. Tr. 362. Niemoeller argues that the dietary supplement evidence would have been used to challenge her credibility and to rebut that testimony. Defendant also argues that he was entitled to offer the evidence simply to show that 1-dopa and dopamine were not as dangerous as the government argued.
Exclusion of the dietary supplement evidence did not deny Niemoeller a fair trial. In the court's view, the exclusion helped keep the trial focused on the relevant issues of Niemoeller's conduct, knowledge, and intent. The fact that a substance might be subject to either of two alternative regulatory schemes is not a defense to a person's refusal to comply with either of the two schemes in distributing the substance for human consumption.
Conclusion
For the foregoing reasons, the court grants defendant Niemoeller's motion for judgment of acquittal as to Counts Five, Six, Seven, and Eight, and denies his motions for judgment of acquittal and for a new trial on Counts One, Two, Three, and Four.
So ordered.