Category: Food Safety

What are GM Foods?

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By Joanna Sax
[Ed Note: Cross posted at HealthLawProfBlog.]

I read a lot of press and listen to the politics surrounding genetically modified (GM) foods; but it appears that there is a lack of understanding that almost all of our food supply is integrated with GM crops. I imagine that many readers of this blog already know this, so this may simply be background for some of you.

The focus of the debate appears to be on GM foods that contain some sort of exogenous genetic modification that allows them to be pest or insect resistant, either through DNA or RNAi. That is, a specific DNA or RNAi sequence is inserted into the seed that is known to interfere with a biochemical reaction that allows, for example, the crop to be resistant to a specific type of pest.

But, the reality is that almost all of our crops are genetically modified, if not through the insertion of exogenous DNA or RNAi, then through various husbandry techniques. For example, seeds may be hit with UV radiation, which causes double stranded DNA breaks and subsequent mutations. These seeds are then selected for desired traits, such as pest resistance or other hardy characteristics. So, then through husbandry techniques, the seeds are grown into crops with mutations to the endogenous DNA. For these crops, we know that they demonstrate some sort of feature that is desirable to the farmer (or consumer), but we have little idea about what other mutations they may carry.

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Antibiotics in animal feed and thin statutory interpretation: NRDC v. EPA

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By Guest Contributor Diana R. H. Winters

Legal commentators have spent a lot of time this week sparring over statutory interpretation and the contrasting readings of the ACA by the Halbig and King courts.  The potential consequences of these cases demonstrate just how high the stakes of this enterprise can be.

With less fanfare, the Second Circuit decided a case yesterday that may too have large consequences for the health and welfare of the public.  In NRDC v. EPA, the court reversed a district court’s decision to require FDA to hold hearings on the withdrawal of approval for the use of two antibiotics—penicillin and tetracyclines—in animal feed.  This issue has enormous public health consequences, but the consequences of this case extend beyond antibiotic use, to agency practice in general.  The opinion sanctions egregious agency delay and a tremendous lacuna in decision making.

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Call for Submissions: Journal of Law and the Biosciences

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JLB coverCall for Submissions: Journal of Law and the Biosciences

Deadline: Rolling.

The Journal of Law and the Biosciences (JLB) is actively soliciting original manuscripts, responses, essays, and book reviews devoted to the examination of issues related to the intersection of law and biosciences, including bioethics, neuroethics, genetics, reproductive technologies, stem cells, enhancement, patent law, and food and drug regulation. JLB welcomes submissions of varying length, with a theoretical, empirical, practical, or policy oriented focus.

JLB is the first fully open access peer-reviewed legal journal focused on the advances at the intersection of law and the biosciences. A co-venture between Duke University, Harvard Law School, and Stanford University, and published by Oxford University Press, this open access, online, and interdisciplinary academic journal publishes cutting-edge scholarship in this important new field. JLB is published as one volume with three issues per year with new articles posted online on an ongoing basis.

For more information about JLB, click here. To submit a manuscript, click here.

DUE 6/3: Call for Abstracts: Emerging Issues and New Frontiers for FDA Regulation

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            PFC_Logo_300x300                    FDLI_Logo_380

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the Food and Drug Law Institute are pleased to announce an upcoming collaborative academic symposium:

Emerging Issues and New Frontiers for FDA Regulation

Monday, October 20, 2014 

Washington, DC

We are currently seeking abstracts for academic presentations/papers on the following topics:  Read More

Call for Abstracts: Emerging Issues and New Frontiers for FDA Regulation

The Petrie-Flom Center Staff Leave a comment

PFC_Logo_300x300FDLI_logo_pink

 

 

 

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the Food and Drug Law Institute are pleased to announce an upcoming collaborative academic symposium:

Emerging Issues and New Frontiers for FDA Regulation

Monday, October 20, 2014 

Washington, DC

We are currently seeking abstracts for academic presentations/papers on the following topics:

  • Stem cell therapies
  • Nanotechnologies
  • Genetic (and biomarker) tests
  • Gene therapies
  • Personalized medicine
  • Comparative efficacy research
  • Drug resistant pathogens
  • Globalized markets
  • Tobacco
  • GMO
  • Bioterrorism countermeasures
  • Mobile health technologies
  • Health IT
  • Drug shortages
  • Other related topics

Abstracts should be no longer than 1 page, and should be emailed to Davina Rosen Marano at dsr@fdli.org by Tuesday, June 3, 2014. Questions should also be directed to Davina Rosen Marano.

We will notify selected participants by the end of June.  Selected participants will present at the symposium, and will be expected to submit a completed article by December 15, 2014 (after the event) to be considered for publication in a 2015 issue of FDLI’s Food and Drug Law Journal (FDLJ).  Publication decisions will be made based on usual FDLJ standards.

Review of the FDA Progress on Phasing out Certain Antibiotics: Promise and Problems

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By Kuei-Jung Ni

Faced with increasing concerns about the misuse and overuse of antibiotics for food animals’ growth enhancement, which has caused serious antimicrobial resistance, FDA finally took action in December 2013 by issuing guidelines that ask antibiotics makers to remove the labeling of antibiotics for growth effects on a “voluntary” basis. FDA officials believe that voluntary participation “is the fastest, most efficient way to make these changes.”

As the restriction of antibiotics only applies to growth promotion and disease preventive uses are still permitted, critics argued that the new policy will create a loophole and no guarantee for the decrease of antibiotics’ usage by farmers. Further, without giving FDA any authority to require drug companies to release sales data of antibiotics, some said it remains illusory to monitor and verify the actual usage of the drugs.

According to the FDA’s strategy plan, pharmaceutical companies may respond with their intention of voluntary compliance within three months after the notice. In March 2014, FDA announced that 25 of the 26 drug makers affected have agreed to follow the voluntary withdrawal.  In effect, these food animal producers can only use the companies’ drugs sold in the market for therapy purposes. Indeed, the predominant support by industry signals an encouraging and good starting point for implementing the FDA policy. Nevertheless, it leaves some legal questions unsolved, which may trigger further disputes in the future.

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#BELHP2014 Panel 2, Potential Problems and Limits of Nudges in Health Care

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[Ed. Note: On Friday, May 2 and Saturday, May 3, 2014, the Petrie-Flom Center hosted its 2014 annual conference: “Behavioral Economics, Law, and Health Policy.”  This is an installment in our series of live blog posts from the event; video will be available later in the summer on our website.]

By Matthew L Baum

In this next installment of today’s live-blogging of the conference (and with all of the caveats of live-blogging mentioned by my colleagues and my apologies for any errors or misrepresentations) we have Professors David Hyman (DH), Mark White (MW) and Andrea Freeman (AF) in a panel moderated by Glenn Cohen (GC) on the “Potential Problems and Limits of Nudges in Health Care”.

The panel began with DH, H. Ross & Helen Workman Chair in Law and Director of the Epstein Program in Health Law and Policy, University of Illinois College of Law, and a talk entitled, “what can PPACA teach us about behavioral law and economics” (Patient Protection and Affordable Care Act). DH began with the observation that nudges often work quite well… “unless they don’t”. While many nudges are “sticky”, i.e. they influence behavior in the way they were intended, others are “slippery”, i.e. they fail to influence behavior in the way they were intended. His talk set out to illustrate the phenomenon, and to pose two questions. The first was an empirical question: what makes a nudge sticky vs slippery? The second was philosophical: is it meaningful to talk about a “failed nudge” or when we do, do we really just mean failed marketing? He focused on an analysis of PPACA as a case study.

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Review of the FDA Progress on Phasing out Certain Antibiotics: Promise and Problems

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Faced with increasing concerns about the misuse and overuse of antibiotics for food animals’ growth enhancement, which has caused serious antimicrobial resistance, FDA finally took actions on December, 2013 by issuing guidelines that ask drug makers to remove the labeling of antibiotics for growth effects on a “voluntary” basis. FDA officials believe the voluntary participation “is the fastest, most efficient way to make these change.”

As the restriction of antibiotics only applies to growth promotion and disease preventive uses are still permitted, critics argued that the new policy will create a loophole and no guarantee for the decrease of antibiotics’ usage by farmers. Further, without giving FDA an authority to require drug companies to release sales data of antibiotics, some said it remains illusory to monitor and verify the actual usage of the drugs.

According to the FDA’s strategy plan, pharmaceutical companies may respond their intention of voluntary compliance within three months after the notice. On March, 2014, FDA announced that 25 of the 26 drug makers affected have agreed to follow the voluntary withdrawal. In effect, food animal producers can only use the companies’ drugs sold in the market for therapy purpose. Indeed, the predominant support by industry signals an encouraging and good starting point for implementing the FDA policy. Nevertheless, it leaves some legal questions unsolved, which may trigger further disputes in the future.

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China Issues 2014-2020 Development Blueprint on Food and Nutrition

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By Ching-Fu Lin

China’s highest executive organ, the State Council, put out the Food and Nutrition Development Outline 2014-2020 (the Outline) in February of 2014.  The Outline was jointly drafted by China’s Ministry of Agriculture (MOA) and National Health and Family Planning Commission.  The Ministry of Finance, Ministry of Education, Ministry of Commerce, Ministry of Science and Technology, and National Development and Reform Commission also participated in its development.  Based on a review of China’s growth and problems in food and nutrition, the Outline sets a seven-year plan that highlights basic policy objectives.  The areas of focus are food supply systems, nutrition intake and balance (especially amongst population sub-groups), regulatory and surveillance mechanisms, industry development, research, and education.

The Outline lays out its “guiding strategy” that the government should regard the effective supply of food, balanced nutritional profile, and production-consumption coordination as its chief missions.  To execute these missions, the government identifies certain key products (quality agricultural products, convenient processed foods, and dairy and soy foods), key areas (poor, rural, and newly urbanized areas), and key population groups (the pregnant women and nursing mothers, infants and children, and the elderly) as starting points to promote better food and nutrition development patterns.  Such points are further elaborated in the document.  The guiding strategy ultimately aims to improve public health and a well-off society.

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