Federal Judges and Agencies

Yesterday we had two very interesting seminars. In the morning, we got the opportunity to watch a Federal Court case and then speak to U.S. District Judge Ricardo Urbina. The case we witness was particularly interesting because it began with reviewing business documents that were exchanged between the plaintiff and the defendant. These were hard to follow and were not very interesting at some points, but then the case turn a dramatic turn. The defendant told the jury how he had to leave work on an extended amount of time because of his psychologist ordered him to for his health. This man became extremely upset at this point and began hysterically crying. Judge Urbina had to call a 10 minute break for this man to gather himself. it was obviously a traumatic experience for this man, and one which none of our class expected based upon the earlier part of the case. It went from uninteresting to chaotic. This just shows how interesting court cases can become.

Our second speaker was Ricardo Carvajal. Mr. Carvajal was previously served as Associate Chief Counsel in FDA's Office of Chief Counsel. He now provides FDA regulatory counseling to manufacturers and marketers of foods, drugs, devices, and cosmetics. This seminar was so interesting to our class because it was relevant to our everyday lives. It showed how federal regulations affect us, and how important this process is. Mr. Carvajal first talked to us about the differences between food, dietary supplements, and drugs. It would seem simple to define these, but as he noted these definitions can become quite complex. He showed us how simple juice labels, that advertise health benefits, can become very difficult to define, and therefore hard to determine which regulations the company must abide by. He also spoke to us about FDA’s involvement in regulating cigarettes. The FDA previously was not involved in this regulation until the mid-nineties. They won a court case based on the idea that cigarettes are a medical device used to delivering nicotine. Because of this definition, the FDA gained jurisdiction. But, interestingly they do not regulate cigars. Overall, I learned much about this complex regulatory agency and how their regulations are so important to our health and safety. I am grateful to have had the opportunity to expand my knowledge in this subject area.