Opinion ID: 2975692
Heading Depth: 3
Heading Rank: 3

Heading: Appellant Kaminski

Text: Kaminski contends that his prosecution was impermissible due to the FDA’s failure (1) to abide by its own final rule15 providing manufacturers of dietary supplements an eighteen-month grace period within which to comply with new labeling requirements and (2) to provide Kaminski with notice and an opportunity to correct his alleged violation. As the United States points out, however, Kaminski never raised these arguments before the district court, and they are accordingly forfeited unless this court finds plain error. See FED. R. CRIM. P. 52(b) (“A plain error that affects substantial rights may be considered even though it was not brought to the court’s attention.”); United States v. Young, 470 U.S. 1, 15 (1985) (holding that Rule 52(b) “authorizes the Courts of Appeals to correct only particularly egregious errors, those errors that seriously affect the fairness, integrity or public reputation of judicial proceedings” (internal quotation marks and citation omitted)). Moreover, Kaminski’s argument appears to be completely irrelevant to this case, both because (as the jury found) the egg powders are not dietary supplements but drugs and because the charges against him were not based solely on labeling violations. In any event, Kaminski cites no case law to support his assertion that the FDA’s alleged failure to follow its own rule or to provide him with notice and an opportunity to be heard by an agency official precluded the United States from prosecuting him for violations of the FDCA. Moreover, he concedes that (1) the notice provision contains several exceptions, and (2) the FDA did not begin enforcement procedures against him or any other Appellant until after the eighteen-month period had undisputedly expired. See 21 C.F.R. § 7.84(a). Accordingly, Kaminski has failed to show that the district court’s judgment constituted plain error.
Kaminski also contends that the egg products constituted foods, not drugs, under applicable FDA regulations. The United States correctly characterizes this argument as a challenge to the sufficiency of the evidence supporting Kaminski’s convictions, as a finding that the egg products were drugs was a necessary element of each crime with which he was charged. Pursuant to long- 13 Universal arose, in fact, from violations of one of the very FDCA provisions at issue here, which prohibits the introduction into interstate commerce of misbranded foods, drugs, or devices. 21 U.S.C. § 331. 14 Because the resolution of Ovimmune’s challenge to its conviction turns on precisely the same issues implicated by Kaminski’s appeal on the issue, both challenges are resolved in this section, in which, for the sake of brevity, we refer only to Kaminski. 15 Regulations on Statements Made for Dietary Supplements Concerning the Effect of the Product on the Structure or Function of the Body, 65 Fed. Reg. 1000-01 (Jan. 6, 2000) (codified at 21 C.F.R. pt. 101). Nos. 05-3823/3826/4509 United States v. Kaminski et al. Page 15 standing Supreme Court precedent, we determine “whether, after viewing the evidence in the light most favorable to the prosecution, any rational trier of fact could have found the essential elements of the crime beyond a reasonable doubt.” Jackson v. Virginia, 443 U.S. at 319. The relevant provision of the FDCA defines the term “drug” as (A) articles recognized in the official United States Pharmacopoeia, official Homeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any article specified in clause (A), (B), or (C). 21 U.S.C. § 321(g)(1) (emphasis added). Kaminski contends that the egg products are more accurately characterized as dietary supplements. He points to language in § 321(g) providing that a “dietary supplement for which a truthful and not misleading statement is made in accordance with section 343(r)(6) of this title is not a drug under clause (C) solely because the label or the labeling contains such a statement.” Section 343(r)(6), in turn, sets forth the circumstances under which a dietary supplement may bear a label that (1) “claims a benefit related to a classical nutrient deficiency disease”; (2) “describes the role of a nutrient or dietary ingredient intended to affect the structure or function in humans”; or (3) “describes general well-being from consumption of a nutrient or dietary ingredient.” 21 U.S.C. § 343(r)(6)(A). The statute requires that any such label include a disclaimer of any intent “to diagnose, treat, cure, or prevent any disease.” 21 U.S.C. § 343(r)(6)(C). Moreover, § 343(r)(6) requires the supplement’s manufacturer to notify the FDA, within thirty days, of the placement of any such statement on the label of a marketed product. 21 U.S.C. § 343(r)(6). Kaminski’s reliance upon this statutory scheme is unavailing. The egg powders are drugs not because their labels state that they ameliorate nutrient deficiencies, “affect the structure or function in humans,” or promote general health but, rather, because Kaminski and Coleman distributed them to consumers for the express purpose of treating and/or preventing diseases. The pattern of statements made by the defendants, and particularly by Coleman, along with the methods of sale and distribution of the products, conclusively demonstrate this fact. Contrary to Kaminski’s contentions, the FDA’s investigation and the United States’s prosecution were not based solely on “newspaper articles that generally discussed Dr. Coleman’s research and the language of the label,” Kaminski Br. at 26; as explained above, the evidence in this case included not only newspaper articles and labeling materials but also the testimony of consumers who purchased the products for the express purpose of curing illnesses. Accordingly, the evidence was sufficient to lead a reasonable jury to find that the egg products were drugs.
Finally, Kaminski argues that the district court erred in enhancing his base offense level by two levels pursuant to § 3C1.1 of the Guidelines, on the ground that his conduct impeded the investigation and prosecution of Appellants’ crimes. “We review for clear error a district court’s factual findings underlying its decision to impose an obstruction-of-justice enhancement under § 3C1.1. Conclusions as to what facts constitute obstruction of justice are then reviewed de novo.” Davist, 481 F.3d at 427 (internal citation omitted). At the sentencing hearing, the district court found that Kaminski had perjured himself at trial. As noted above, however, the subsequently issued sentencing memorandum does not reflect the perjury finding, and so the district court presumably did not rely upon that finding. In the sentencing Nos. 05-3823/3826/4509 United States v. Kaminski et al. Page 16 memorandum, the district court concluded that Kaminski “attempted to impede the FDA’s investigation” by sending the September 10, 2002 letter to the OIA and by “participat[ing] in petitions to the Acting Commissioner of the FDA, the Secretary of Health and Human Services, and Congresswoman Deborah Pryce.” J.A. at 314 (Sentencing Mem. at 25). As an initial matter, we note that we cannot find support in the record for the district court’s finding that Kaminski participated in any petitions to the government entities listed in the memorandum. The only source cited for that finding is paragraph 39 of Kaminski’s PSR, which mentions only Kaminski’s trial testimony and the September 2002 letter to the FDA. J.A. at 1453 (Kaminski PSR at 9 ¶ 39). Accordingly, we cannot accept the finding that Kaminski impeded the investigation through communications to the Commissioner, Secretary, or Congresswoman, based upon our review of the record. See, e.g., United States v. Stubbs, 11 F.3d 632, 638-39 (6th Cir. 1993). The only evidence properly considered by the district court in imposing the enhancement, then, is Kaminski’s September 10, 2002, letter to the FDA.16 The Application Notes to § 3C1.1 of the Guidelines, pursuant to which the district court imposed the obstruction enhancement, provide examples of the types of conduct ordinarily covered by § 3C1.1. Note 5(b) provides that “making false statements, not under oath,17to law enforcement officers” generally does not constitute obstruction, unless Note 4(g) applies. U.S.S.G. § 3C1.1 cmt. n.5(b). Note 4(g), in turn, states that “providing a materially false statement to a law enforcement officer that significantly obstructed or impeded the official18 investigation or prosecution of the instant offense” will usually be considered obstruction of justice. Id. cmt. n.4(g) (emphases added). Thus, although the language of § 3C1.1 authorizes the imposition of the enhancement for attempts to obstruct justice as well as obstruction itself, the Notes, which describe with greater specificity types of conduct that do and do not fall within the ambit of § 3C1.1, indicate that an attempt that takes the form of a false but unsworn statement to a law-enforcement officer does not suffice to trigger the enhancement—or, phrased in another way, that an unsworn statement to a lawenforcement officer cannot constitute obstruction of justice under § 3C1.1 unless it significantly obstructs or impedes the investigation or prosecution of the offense. See United States v. Jarman, 144 F.3d 912, 914 (6th Cir. 1998) (noting that “the Application Notes to the Sentencing Guidelines are accorded controlling weight”); United States v. Williams, 952 F.2d 1504, 1516 (6th Cir. 1991) (reversing, as clearly erroneous, the district court’s imposition of a § 3C1.1 enhancement, on the ground that the defendant’s unsworn lies to law-enforcement officials did not actually impede the investigation), cited in United States v. Obi, 195 F. App’x 335, 339 (6th Cir. 2006). The question, then, is whether Kaminski’s September 10, 2002, letter to the FDA contained false statements that significantly obstructed the investigation. At the sentencing hearing, Loveland testified unequivocally that the letter had no impact whatsoever on the investigation. J.A. at 1009 (Sentencing Tr. at S159). Indeed, the district court made no finding to the contrary; instead, it 16 As Loveland noted during the sentencing hearing, the indictment had already been returned by the time the September 10, 2002, letter was sent. J.A. at 1008 (Sentencing Tr. at S158). Loveland testified, however, that the investigation continued even after the indictment was handed down. J.A. at 1010 (Sentencing Tr. at S160). 17 In the 2000 edition of the Guidelines Manual, Note 5(b) refers to Note 3(g) instead of 4(g). There is, however, no Note 3(g). In the 2004 Manual Note 5(b) was corrected to refer to Note 4(g), and the corrected version appears in all subsequent editions. 18 “‘Material’ evidence, fact, statement, or information, as used in this section, means evidence, fact, statement, or information that, if believed, would tend to influence or affect the issue under determination.” U.S.S.G. § 3C1.1 cmt. n.6. Nos. 05-3823/3826/4509 United States v. Kaminski et al. Page 17 imposed the enhancement on the basis of Kaminski’s “willful attempt to impede the FDA’s investigation.”19 J.A. at 314 (Sentencing Mem. at 25) (emphasis added). Because the district court’s characterization of the September 10 letter as an attempt at obstruction—and, thus, the district court’s application of the § 3C1.1 enhancement on this basis—was erroneous, resulting in an improperly calculated Guidelines range, we VACATE Kaminski’s sentence and REMAND his case to the district court for resentencing consistent with this opinion. On remand, the district court may consider all relevant record evidence in determining whether an application of the § 3C1.1 enhancement is warranted.