Opinion ID: 2975692
Heading Depth: 5
Heading Rank: 2

Heading: sufficiency of the evidence

Text: 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.