from the archives… Interview with Peter Barton Hutt, “Dean of the Food and Drug Bar” (Part 2 of 2)

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.

 

Originally posted on our old website on 08/21/2011

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from the archives … Interview with Peter Barton Hutt, “Dean of the Food and Drug Bar” (Part 1 of 2)

Dubbed the “dean of the food and drug bar” by the Legal Times, Peter Hutt has been a leading food and drug law practitioner and scholar for almost half a century. Hutt has specialized in food and drug law at the Washington D.C. firm of Covington and Burlington since 1960, pausing only to serve as Chief Counsel of the FDA from 1971 to 1975. A prodigious writer, he is co-author of the widely used casebook Food and Drug Law: Cases and Materials. He has also taught Food and Drug Law at Harvard Law School since 1994. The Food Law Society recently interviewed Hutt about his career, how food law has evolved over the years, and his tenure as Chief Counsel.

How did you get your start in food and drug law?

It began with the fact that my father, and before him his father and grandfather, had a retail diary in Buffalo, New York. Every paper that I wrote through high school, college and law school related to the diary industry. In my third year at Harvard, I read in the Harvard Law Record that there was going to be a lecture by the General Counsel of the FDA. My dad had some issues pending in the New York state legislature relating to food law affecting the diary industry, so I talked to this gentleman, Bill Goodrich, extensively. Finally, after he got tired of answering my questions, he said “Let’s have dinner.” At the end of dinner he offered me a fellowship to study food law at NYU Law School.

I was planning on going back to be a lawyer in Buffalo after law school. My friends there still wonder when I’m coming back. I thought, “well, I’ll put it off a year.” So I went off and got my LLM and then on a lovely day I decided I’d go down and see if there were any jobs in Washington. To make a very long story short, I was offered a job at the Federal Trade Commission, FDA, and Covington and Burling, which at that time had the biggest food and drug law practice and still does today. I thought, “Well, I’ll do this for two years and then go back to Buffalo.” Actually, the interesting part of the story is, when I got the three offers, I asked Bill Goodrich, the Chief Counsel at FDA, “What should I do?” He told me, “Go become a partner at Covington and Burling and then you’ll get a good government job later on. That’s the way it works in Washington.” So I did exactly what he said. I went to Covington, became a partner, and the day he retired he called me at eight in the morning and said, “Do you want to take my place?” and without thinking for an eighth of a second I said “yes” and so off I went to become Chief Counsel of FDA.

How many food and drug lawyers would you say there were when you began your career?

Let me break that down. First, almost every large food or drug company would have an in-house counsel who would, along other responsibilities, deal with food and drug law. In terms of the private bar, there was only a handful that did nothing but food and drug law. Now as an aside, I’ve said forever that if you want to practice food and drug law, it has to be a full time occupation. This isn’t something that you can do part time because every year it gets more complex and difficult. Indeed, most young lawyers today have to specialize within food and drug law. They specialize in medical devices, cosmetics, or prescription drugs or even over the counter drugs. But in those days—let’s face it, I started out in 1960—that’s 51 years ago, I’m afraid I’m dating myself—it was much simpler. For example, drugs were the least significant of the issues. Food was the primary area of food and drug law and there were in Washington D.C. perhaps ten people that I would call food and drug lawyers. Not many more; maybe fifteen. And when I went to be Chief Counsel in 1971, there were fewer than fifteen lawyers on my staff. Now there are ninety.

How many food and drug lawyers would estimate work in D.C. firms today?

First, let me point out that all of what I would call the “top tier” food and drug lawyers are in D.C. with maybe two exceptions, with one or two in Chicago and one or two in New York. The private bar has always been concentrated in D.C. for reasons that none of us are totally clear about because you don’t spend a lot of time going to the agency and you could practice food and drug law from anywhere in the country. Today, if you’re talking about people who really work on food and drug law full-time, there are fewer than fifty. If you count people who are tangentially involved, however, the number’s much larger. I’ll give you a couple of examples, there are lawyers in our firm for example who spend one-hundred percent of their time on transactional work involving the food or drug industry. In order to do that you have to understand food and drug law, but I don’t count them as food and drug lawyers. Same with anti-trust, the same with patents, and all other kinds of fields that tangentially impact food and drug law. That’s why so many people who want to become patent lawyers take my course on food and drug law.

What would you say a typical workday looks like for someone that you would consider a true food and drug lawyer? What type of things do they do?

Well, food and drug law is primarily administrative law. Occasionally, a true food and drug lawyers will get involved in litigation, but it’s very rare. Litigation ties up your time and most food and drug lawyers are accustomed to dealing with clients over the phone—for the most part—maybe by email, but talking to many, many people in any given day. You’re almost always talking to people on the phone, answering questions. You’ll get a call, “can I make this claim on my label” and the conversation may be five minutes. So it’s a counseling type of practice. Occasionally someone will call up and say, “Look we have a new product. We want someone to give us strategic advice that will take half a day, but we want you to come out here to California or wherever because we don’t want to bring ten people to Washington for a meeting.” Sure, that also happens. But it is a counseling-heavy type of practice.

It’s interesting, if you got tied up in litigation, you wouldn’t have time for counseling. Whenever one of my clients gets involved in litigation, I am delighted to hand it off to one of my partners who thinks litigation is fun. I don’t understand why he does, but he does. It’s nowhere near as fun as food and drug law.

How common is to find attorneys whose practices focus solely on food law?

When I started in 1960, that was eighty to ninety percent of food and drug law. Today, it’s ten percent. Because of the overwhelming growth of drugs, medical devices, and biological products. But it’s still possible to focus just on food law. There are a couple of small firms, one in particular in Washington, that focuses primarily on food law, although it does some drug work. It’s Ollson, Frank, and Weeda. Rick Frank and Phil Ollson wanted a niche firm and started focusing on USDA regulation of meat and poultry. That’s a very narrow food law focus, but they became the known experts. It was a brilliant legal niche strategy for them. They became so well known for this that they have pretty much tied up the market. Then they expanded from that into other areas of food and ultimately, perhaps, they touch upon drugs and devices also. But Rick Frank, I think, still to this day specializes in USDA and virtually nothing else.

During your tenure as FDA Chief Counsel, you invented the “regulatory letter,” now called the “warning letter.” Can you explain why you did this and tell us whether there was any pushback on this practice?

In my eleven years in private practice before I went to FDA, I saw how seizures were handled. The FDA would issue a seizure and then the company would put in a claim, run out their inventory for a year, change their label or do whatever they had to do, and then default on the seizure. Now, that seemed to me a travesty of enforcement. The whole idea of a seizure is to stop something and it wasn’t stopping anything for six months or a year as long as the inventory was there. And I figured that if I sent a letter and said “you have fifteen days to reply or we’re going to take serious action, including criminal action,” then that would get people’s attention, and I would get enforcement within a month at most. Now that was the first reason. The second reason was pure economics. In order to conduct a seizure, FDA has to do a massive inspection, then the US Attorney and a court have to sign off on it, and then a US Marshall has to go out and actually sticker the product and “seize it” in the technical sense. That takes a lot of money! Say $5,000 to pick a figure. A letter costs $50. Therefore, I could send 100 letters for the cost of one seizure. So, it just seemed like common sense.

To answer your second question about pushback. Interestingly, there wasn’t any. No one knew how to pushback. After all, all they were receiving was a letter. How could they claim that this was illegal? So, no, there was no pushback on the procedure per se. There was a question—an interesting legal debate—when I started regulatory letters I took the position that they had been cleared by the Office of Chief Counsel and there were only one of two solutions: either the company would agree to change (whatever it was) or FDA would agree that it had been in error. But it would just wouldn’t hang around forever. It wasn’t a friendly letter; it was an enforcement technique.

Originally posted on our old website on 07/06/2011.

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Raw Milk Debate LIVESTREAM

 

Welcome to the LIVESTREAM of the Harvard Food Law Society’s Raw Milk Debate. This link will become active at 6:15 PM on the evening of the event, February 16, 2012. The actual event will begin at 7:15 PM, at which time the stream will go live.
You will need to have the Quicktime Player installed before you can view this stream. The most recent version of the Quicktime player is available for FREE from Apple’s website. We recommend that you use Internet Explorer or Safari to view this stream, as users of other browsers may experience difficulties. More complete information about technical specifications and how to optimize your settings to view this streaming video are explained in this help document (PDF).
For more information about this event, please contact: jabrams@jd12.law.harvard.edu

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Raw Milk Debate

Thursday, February 16, 2012
7:15 – 8:45 PM
Langdell South, HLS
***Open to the Public***

At one time, everyone drank raw milk. But with the invention of pasteurization and its attendant safety benefits, consumption of raw milk in this country almost completely disappeared. In fact, in many states it is illegal to sell raw milk. But a growing segment of the population is clamoring for increased access to raw milk, citing its nutritional benefits. Opponents are skeptical of such nutritional claims and believe the safety risks of unpasteurized milk are simply too high.Join the Food Law Society as we present a debate covering the legal, health, and nutritional merits of raw milk. The participants are:

Fred Pritzker,
Pritzker & Olson Law Firm
Dr. Heidi Kassenborg,
Director, Dairy & Food Inspection Division, Minnesota Dept. of Agriculture
vs.
Sally Fallon Morell,
President, Weston A. Price Foundation
David Gumpert,
Author, The Raw Milk Revolution

ANNOUNCEMENT: This event will be streamed live. The stream will be viewable beginning at 6:15 PM on 2/16/12 on the LIVESTREAM PAGE.
For more information, contact: jabrams@jd12.law.harvard.edu

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Food Soc Social Hour with MIT and Tufts Food/Ag Groups

Thursday, February 2, 2012
6:30 – 8:30 PM
Wasserstein Pub, HLS

Join us for conversation and drinks with like-minded students from MIT and Tufts for our first ever joint social hour.  Hopefully this will be the beginning of a beautiful relationship and of more collaboration to come!  All are welcome!

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Mark Winne, “Fighting Back in an Age of Industrial Agriculture” Discussion & Book Signing

November 15, 2011
12:00 – 1:00 p.m.
Pound 102
Harvard Law School

Mark Winne’s second book, “Food Rebels, Guerrilla Gardeners, and Smart Cookin’ Mamas: Fighting Back in an Age of Industrial Agriculture” takes on the universal struggle between human freedom and authority in its relationship to food. From urban gardening heroes in Cleveland, to feisty farmers in New England, to lower income mothers in Texas, Winne shows how people are reclaiming their connection to their food, health, land, and governments.

Mark is the former Executive Director of the Hartford Food System and a co-founder of a number of food and agriculture policy groups including the City of Hartford Food Policy Commission, the Connecticut Food Policy Council, End Hunger Connecticut!, and the national Community Food Security Coalition. He was an organizer and chairman of the Working Lands Alliance, a statewide coalition working to preserve Connecticut’s farmland, and is a founder of the Connecticut Farmland Trust. Mark was a member of the United States delegation to the 2000 World Conference on Food Security in Rome and is a 2001 recipient of the U.S. Department of Agriculture Secretary’s Plow Honor Award. From 2002 until 2004, Mark was a Food and Society Policy Fellow, a position supported by the W.K. Kellogg Foundation. His essays and opinion pieces have appeared in the Hartford Courant, the Boston Globe, The Nation, In These Times, Sierra Magazine, Orion Magazine, Successful Farming, Yes! Magazine, and numerous organizational and professional journals.

Mark now lives in Santa Fe, New Mexico, where he serves on the Santa Fe Food Policy Council and the Southwest Grass-fed Livestock Alliance.

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Heirloom Thanksgiving

November 14, 2011
5:30 – 8 p.m.
Austin 100
Harvard Law School

5:30 Panel on Sustainable & Responsible Food Production
6:00 Panel on Producing the Special
6:30 Premiere Heirloom Meals’ Thanksgiving
7:30 Dessert & Coffee

Hosted by the Harvard Food Law Society, the Environmental Law Society, and the Environmental Law Review, the PBS special “Heirloom Meals’ Thanksgiving” will make its Boston debut, preceded by two intriguing and insightful panel discussions. Heirloom Meal’s Thanksgiving, airing on PBS stations across the US, celebrates how different cultures in America each give the holidays their own special flavor, with an emphasis on recipes passed down through the generations and shared cooking experiences (for more information, visit www.heirloommeals.com).

The opening panel will focus on sustainable and responsible food production, and will be moderated by Sue McCrory of WBUR’s Public Radio Kitchen.  Featured panelists include Emily Broad of the Harvard Health Law & Policy Clinic, Jesse Laflamme of Pete & Gerry’s Organic Eggs – the first Certified Humane egg farm in the country, and David Waters – CEO of Community Servings in Boston, a social service agency preparing and delivering 1000 free meals a day with an emphasis on locally sourced farm ingredients, and other leaders from companies dedicated to excellence in sustainable food production.

The second panel will feature on the powerful themes in the special, moderated by Heirloom meals creator and producer Carole Murko and Amy Traverso of Yankee Magazine. The panel will also feature Louisa Kasdon and Sara Baer-Sinnott, leaders of on-line media portals, blogs and organizations dedicated to the healthy ways people embrace and enjoy food today, with an emphasis on preserving positive and successful aspects from the past.

After the hour-long screening of Heirloom Meals’ Thanksgiving, the general public will be able to meet all of the panelists and moderators at a reception featuring Jim’s Organic Coffee, Pete & Gerry’s Heirloom Custard (prepared by Community Servings), Stonyfield Oikos Organic Greek Yogurt and Cookiehead Sprouted Grain Brownies.

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Food and Mental Health with Emily Deans, M.D.

October 31, 2011
12 p.m. – 1 p.m.
Pound Hall 100
Harvard Law School

The mental and physical health of the Western world has waxed and waned over the years according to environmental conditions.  In the United States, we have come to an unprecedented time of plentiful food and relative peace on the home front, yet we have increasing mental illness, and live our lives with physical or mental disability longer than ever before. Emily Deans, M.D. will explore how our modern Western diets theoretically contribute to our mental health burden using an evolutionary paradigm as a backdrop.

Emily Deans, M.D. is a board certified adult psychiatrist practicing in Massachusetts.  She graduated from the University of Texas Southwestern Medical School in 2000 and from the Harvard Longwood Psychiatry Residency in 2004, and was a Chief Resident at Brigham and Women’s Hospital in Boston. She is currently a Clinical Instructor in Psychiatry at Harvard Medical school and blogs at evolutionarypsychiatry.blogspot.com.

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“Food Fight” Screening and Discussion with Director Chris Taylor

October 24, 2011
7 p.m. – 9:30 p.m.
Austin North
Harvard Law School

Food Fight (www.foodfightthedoc.com) is a fascinating look at how American agricultural policy and food culture developed in the 20th century, and how the California food movement has created a counter-revolution against big agribusiness. Join us for a screening of this lively documentary followed by a discussion by the film’s creator, Chris Taylor.

Free to Harvard Law School students; Open to the public, $5 admission

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TEDx Harvard Law: Forum on Food Policy

October 21, 2011
8:45 a.m. to 3:45 p.m.
Harvard Law School

TEDxHarvardLaw will focus on food policy and public health, with a specific focus on legal and policy approaches to increasing the supply and demand of healthy foods.

Dr. Robert Lustig will kick off the event with a lecture on “The Sugar Epidemic: Policy vs. Politics,” in which he will argue for a paradigm shift in the public policy approach to obesity.

Among the nine other speakers are Walter Willet, Chair of the Department of Nutrition, Harvard School of Public Health, who will discuss how modern dietary patterns lead to disease; Doug Rauch, former President of Trader Joe’s, who will discuss his innovative idea to bring inexpensive fruits and vegetables to food deserts; and Susan Prolman, Executive Director, National Sustainable Agriculture Coalition, who will discuss the 2012 Farm Bill.

For full information on our TEDx conference, please visit the event page, here.

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