If you could write your own food regulatory act, how would it differ from the current regime?
It would simplify the current one, but it would use many of the same terms. So many of the things that Congress adds to a statute are totally redundant and irrelevant. I keep making the point in class that the food safety law in England of 1263 does not improve one iota upon the food safety law of 2011. So it could be simplified, but it’s something that’s a product of history and it would be incredibly difficult to try to simplify it. People would just go berserk and say no, we have a jurisprudence, let’s stick with it.
You’ve published over 125 articles on food and drug law and health policy and along with your co-authors, you’ve literally written the book on food and drug law. If someone forced you to take sabbatical and research a particular subject in food law, what would it be?
It would probably be historical. I love the history of food law, which if you’ll remember from class, goes back to ancient Sumer. It’s a subject that you could spend an entire lifetime studying and never probe every aspect of it. But if you’re talking about modern food law issues, the impact of the new food safety statute that has just been enacted would certainly be a subject to explore—both the depth of it and the breadth of it. How can the food industry realistically comply with the statute, which is extremely onerous and very demanding? I am concerned about small companies being able to comply with it. I’m equally concerned about exempting small companies. People can be made sick by small companies just as easily as large ones.
There are lots of issues there that I have not yet explored and it’s going to be very interesting. I’m going to give you just one example: records inspection. In the Bioterrorism Act of 2002 there was a slight increase in FDA’s power to get records but FDA had to show serious adverse effects or death. That’s pretty stringent standard. It’s opened up further in the new law, but it doesn’t allow a fishing expedition type of records inspection. So how far does it go, what does it mean, what do the words portend? It’s the type of thing I constantly ask you students in class all the time and you look at me and say, “I don’t know what that means!” and I say, “Nobody knows what it means!”
I was going to ask you which issues you think will be increasingly important in food law, but I think you just answered that question.
Clearly, the new statute. But in the long term there’s a question of whether there will be more and more user fees because of the need for FDA to have additional resources. Second, the burning issue in terms of food safety is pathogens. It has never been the safety of food additives. That’s a trivial issue and FDA has always known that. FDA has always been mystified that the public thinks food additives are a serious issue. The serious issue is pathogens. It’s everything from lettuce, to peanut butter, to fish, to fruit juice. One student a decade ago wrote an article entitled, “Death by Fruit Juice.” These are serious, serious questions because we’re talking life and death. How can you reduce pathogens in the food supply? Is there any legal component to it? What type of regulatory component? How can you control it? There’s salmonella on every farm in the United States and we’re never going to get rid of it. What does that mean? What should we do as a result? These are the types of issues that are of enormous importance.
Did you take any courses that touched on Food Law when you were at Harvard?
None. There were no courses that touched on food and drug law. To my knowledge, there was also no Health Law course. The only relevant course was Administrative Law and it was so highly theoretical as to be not very useful. Now there was one course, a very famous course, called the Legal Process. I took it from Al Sachs who later became Dean and it had a huge impact on me because it touched on, among other things, food and drug law. I learned later on that the reason why was because Al Sachs did food and drug law at Covington. So he included, as one example, the legislative history of the Factory Inspection amendments to the statute. But I certainly didn’t take the course for that reason.
Was your course the first food and drug law course at Harvard?
Yes; that I am certain of. Interestingly, at least five or six professors at Harvard started at Covington doing food and drug law work. But when they came to Harvard, they didn’t teach food and drug law. I used to say to David Shapiro, “Why don’t you teach Food and Drug Law?” but he was off doing Civil Procedure and Federal Courts and things like that. So it wasn’t taught here until I came to do it.
Did you come up with the idea of teaching Food and Drug Law or did someone at the school approach you?
I did not come up with the idea, I assure you. It was a confluence of events. First, I got to know Betsy Bartlett quite well and helped her found the Legal Action Center in New York City and she and I sort of worked together when I was doing pro bono work on the United States Crime Commission. So that was one factor. I got to know Chris Edley, who is now dean at Boalt Hall, but was for many years was an Administrative Law professor here and for many years we used to show up at conferences together. And then the chair of Harvard Law School Alumni Association was a food and drug lawyer and he kept after Bob Clark [then Dean of Harvard Law School] saying that I ought to be invited. So all of a sudden, they got in touch with me and asked me to do this.
There must be former students of yours working with you at Covington now.
Yes, there are students at Covington. Interestingly, as many that are in other fields as there doing food and drug law. And also, there are I am told, 15 graduates of the course now at the Food and Drug Administration.
Do you still keep in contact with any of them?
I do. I keep in contact with an amazing number of students and will frequently have lunch with students who are in Washington. Not just shortly after graduation, but when I come up here there’s a young woman who was in the first class that I taught whom I will occasionally have lunch with. And there’s a fabulous scholar, Ted Rugar, who was in the second class that I taught and on the law review. His paper was published in the law review and he’s now going to become the co-author of the casebook. One of the finest scholars I’ve ever worked with in my class is Glenn Cohen, who of course went to work in Washington after clerking then came back here to be a Petrie-Flom Fellow and is now an assistant professor and a brilliant, brilliant wonderful person I might add.
Is there anything else you would like to share with aspiring food and drug lawyers?
Well, they ought to come to Harvard Law School and take Food and Drug Law, that’s all I can share with them. Seriously, they ought to take a course in food and drug law and they should also do a couple of other things. First, they should go to short courses that are given by the Food and Drug Law Institute and other organizations that will delve down on particular issues, like the future of food standards, which we can only touch on in a general survey course. The second thing they have to do is to start scholarship. I have written at least one published article every year during my career. And you have to make it a priority. It’s easy to say I’m too busy. But as you, for example, in private practice, write memoranda, you’d be amazed by how many of those memoranda, with a little bit of thought, could be turned into an article. I’ve done that many times. That’s why we have the Electronic Book of Student Papers. It’s the first step in scholarship. And I think that’s incredibly important. It’s not just important for the career, it’s important for the development of the lawyer. Finally, I would add a third thing. Start getting accustomed to teaching yourself. In other words, volunteer to teach short courses. Volunteer if there’s a local law school with someone who, usually a private practitioner, who teaches food and drug law. Go meet them and offer to co-teach with them. This is the way you develop.
Has your involvement in food law changed the way you approach food at all?
The only decision I ever made—because I grew up in the diary industry I used to drink whole milk. Now I drink 2% milk. It’s not exactly a big difference. All food is intrinsically safe in a sense and all food can be fit in to a balanced diet. It reminds of Hippocrates, who advised people to eat everything in moderation. And he lived in 300 B.C. There hasn’t been a lot of new nutrition information in the last several centuries.
And finally, what did you have for dinner last night?
I had rainbow trout at Legal Seafood. I had a wonderful time with two students will be coming to Covington for the summer.