1. Larry Lawless is president of Larry's Luscious Foods (LLF), a manufacturer located in Houston, Texas. Larry is very active in the company's affairs and often makes decisions relating to product formulations, production, and labeling. LLF produces lemon pies in Houston from ingredients that have been shipped from outside Texas. Due to brisk business, Larry contracts with Badactor Products and Houston to make cherry pies under Larry's brand. Larry visited Badactor Products and found them to have high sanitation standards and good manufacturing practices. Larry sends his own QA manager to the Badactor plant every week to check production. No deficiencies are found. Meanwhile, at his plant, Larry notices that the soaring costs of new materials to make lemon pies significantly decrease company profits. He tells his manufacturing and commercial employees, "I do not care how you do it, but you have got to bring down the cost of these raw materials." Three incidents then arise: An FDA inspector in Tennessee finds LLF lemon pies adulterated with rodent excreta. There is substantial evidence of rodent activity in the Tennessee warehouse where the pies are stored. Within one week of Larry's order to reduce the raw material costs, a FDA inspector appears at Larry's plant in Houston and takes samples of four lots of LLF's lemon pies being held in the warehouse awaiting distribution. Analysis of the pies shows that the pies contain citric acid in place of lemon juice, even though the label states "made with real lemons." Before the manufacture of these pies, LLF pies always contained lemon juice. Larry was unaware of the formulation change. An outbreak of salmonellosis in Oklahoma City is traced to Larry's cherry pies produced by Badactor. Subsequent investigation shows that one shipment of milk powder used by Badactor to produce the pies was positive for Salmonella.

A. What specific violations of the Federal Food Drug and Cosmetic Act is Larry guilty of and why?

B. If you were the defense lawyer, how would you argue the case for Larry?

C. Do you think Larry could be liable for criminal prosecution? Explain your answer