13 Evidence of a new intended use for Vascepa would establish only one element of an FDCA violation. For example, to establish an FDCA violation under 21 U.S.C. § 331(a), the Government also would have to prove the distribution of Vascepa in interstate commerce. Case 1:15-cv-03588-PAE Document 51 Filed 06/23/15 Page 32 of 63 21   Nat’l Nutritional Foods, 557 F.2d at 334.

2. Defendants Organic Pastures Dairy Company and Mark McAfee are hereby enjoined from violating 21 U.S.C. § 331(a) and (d) as follows: A. Defendants and their directors, officers, agents, representatives, employees, attorneys, successors, assigns, and any and all persons in active concert or participation with them must not introduce or deliver for introduction into interstate commerce any food that is misbranded under 21 U.S.C. § 343(a); B. Defendants and their directors, officers, agents, Case 1:08-cv-01786-OWW-GSA Document 48 Filed 04/20/10 Page 23 of 29 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 24 representatives, employees, attorneys, successors, assigns, and any and all persons in active concert or participation with them must not introduce or deliver for introduction into interstate commerce any “unapproved new drugs” within the meaning of 21 U.S.C. § 321(p); C. Defendants and their directors, officers, agents, representatives, employees, attorneys, successors, assigns, and any and all persons in active concert or participation with them must not int

2. Case 3:16-cv-02364-SCC Document 17-2 Filed 04/28/17 Page 6 of 16 7 The ALJ correctly determined that Cintron was “convicted” of a criminal offense within the meaning of the Act when the District Court accepted Petitioner’s guilty plea, adjudged him guilty, issued a judgment of conviction, and sentenced him for misbranding and adulterating prescription medications with the intent to mislead and defraud in violation of 21 U.S.C. §§ 331(k), 333(a)(2), 351(a)(2)(A) and (B), and 352(a), (b), and (o). See ECF No. 7-1 p. 14; SMUF ¶1, 2, and 3.

In contrast, the proposed injunction would simply prevent Defendants from doing what federal criminal law already forbids—selling misbranded medical devices. 21 U.S.C. §§ 331, 333, 352(f). Defendants can hardly claim any hardship in being enjoined from making illegal sales of a product that confuses consumers and exists in the U.S. market primarily to defraud insurers and Abbott.

Even so, such an interest would be negligible (if not non-existent) because the ANDA would not permit Lannett to distribute any product, as doing so would violate the law. See 21 U.S.C. §§ 331, 351(a)(2)(B) (prohibiting a drug from being commercialized if it was manufactured in violation of cGMP). Next, applying the second Mathews factor, the risk of erroneous deprivation of Lannett’s purported interest was also negligible, if not non-existent, as FDA rescinded an approval mistakenly granted because of a data entry failure, not a problem in judgment.

Penalties include criminal fines, product seizures, injunctions against marketing the product, and civil monetary penalties. 21 U.S.C. §§ 331-334; 21 C.F.R. § 17.2.

1 et seq. 21 U.S.C. § 331(a) prohibits introducing a “misbranded” drug into U.S. v. FedEx Corp. et al. 14 Motion to Dismiss No.

Any failure to fairly and accurately represent the required information about a prescription drug is considered misbranding and is a false and fraudulent statement as a matter of law. See 21 U.S.C. §§331(a) and (b), 352(a), (f), and (n); 21 C.F.R. §201.57.

Failure to distribute a drug with its FDA-approved label is a criminal offense. See 21 U.S.C. §§ 331(c), 333(a), & 352(a), (c). Except in limited circumstances, once a label is approved by the FDA, a manufacturer cannot unilaterally change the label without prior FDA approval.

The same is true in the present case. Under 21 U.S.C. § 333(a)(1), a person who violates 21 U.S.C. § 331, regardless of intent, “shall be imprisoned for not more than one year or fined not more than $1,000, or both.” In contrast, 21 U.S.C. § 333(a)(2) provides that, if any person, “commits such a violation with the intent to defraud or mislead, such person shall be imprisoned for not more than three years or fined not more than $10,000, or both” (emphasis added).