Suppose you are the manager of a Costa Mesa facial cream company and have marketed your products as Covid virus killers because your aunt Bessie told you it does. Things are going great - sales went from $10,000 per month to $200,000 per month with the new marketing plan. The FDA gets complaints from 2 of your customers about the burns on their face from the cream, and 1 other says they used your cream and still got the virus.

a. Can the FDA regulate you? Why or why not?

b. The FDA Administrator sends an emergency notice to you and other face cream people about a rule they will put into effect in 5 days that says you must register with them or pay a $5,000 per day fine. After 10 days, an inspector shows up to inspect your place based on the rule. What is your best defense to the inspector and the law?

c. Presume the rule is somehow valid. The inspector issues you a citation and stop order with a $50,0000 fine for the 10 days you were operating. How do you contest it?

d. Presume the fine is initially held valid by step c, where can you go to contest the fine? e. What will a court likely say if you challenge the rule and the FDA says it was necessary to stop the burns and risk of death?