Category: Kuei-Jung Ni

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

The Petrie-Flom Center Staff Leave a comment

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

kjni Leave a comment

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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FSMA Conference Part 5: International Issues and Trade Implications

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[Ed. Note: On Friday, February 21, the Petrie-Flom Center, the Food Law and Policy Clinic (a division of the Center for Health Law and Policy Innovation), the Food Law Lab, and the Harvard Food Law Society (with support from the Top University Strategic Alliance and the Dean’s Office at Harvard Law School) co-sponsored a conference at HLS called “New Directions for Food Safety: The Food Safety Modernization Act and Beyond.”  This is the final installment in a series of blog posts from the event; video will follow shortly.]

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FSMA Conference Part 4: Benefits, Challenges, and Gaps in FSMA’s Approach

The Petrie-Flom Center Staff Leave a comment

[Ed. Note: On Friday, the Petrie-Flom Center, the Food Law and Policy Clinic (a division of the Center for Health Law and Policy Innovation), the Food Law Lab, and the Harvard Food Law Society (with support from the Top University Strategic Alliance and the Dean’s Office at Harvard Law School) co-sponsored a conference at HLS called “New Directions for Food Safety: The Food Safety Modernization Act and Beyond.”  This week, we will be sharing a series of blog posts from the event, and video will follow shortly.]

By Jeffrey Skopek

Lewis Grossman, Washington College of Law, American University – New Governance, New Challenges

Professor Grossman opened the panel by locating FSMA in the context of the “new governance” movement that has arisen in response to the limits of command and control regulation.   Read More

TOMORROW: “New Directions in Food Safety” conference at Harvard Law School

The Petrie-Flom Center Staff Leave a comment

This one-day conference will bring together experts in food law and regulation to discuss a range of issues including food safety, agriculture, risk regulation strategy, and international issues.

Speakers are:

  • Keynote: Peter Barton Hutt, Harvard Law School/Covington & Burling
  • Alli Condra, Food Law and Policy Clinic, Harvard Law School
  • Marsha Echols, Howard University School of Law
  • Jacob E. Gersen, Food Law Lab, Harvard Law School
  • Lewis Grossman, Washington College of Law, American University
  • Ching-Fu Lin, Petrie-Flom Center, Harvard Law School
  • Sharon Mayl, Senior Advisor for Policy, FDA Office of Foods and Veterinary Medicine
  • Kuei-Jung Ni, Petrie-Flom Center, Harvard Law School/Institute for Technology Law, National Chiao Tung University, Taiwan
  • Margot Pollans, Resnick Food Law and Policy Program, UCLA School of Law
  • Michael Roberts, Resnick Food Law and Policy Program, UCLA School of Law
  • Denis Stearns, Seattle University School of Law
  • Stephanie Tai, University of Wisconsin School of Law

For the full agenda, including paper titles, please visit our website.

This event is free and open to the public, but space is limited and registration is required. To register, please click here.

For questions contact petrie-flom@law.harvard.edu or 617-496-4662.

Sponsored by the Petrie-Flom Center; the Food Law and Policy Clinic (a division of the Center for Health Law and Policy Innovation); the Food Law Lab; and the Harvard Food Law Society; with support from the Top University Strategic Alliance and the Dean’s Office at Harvard Law School.

Subway Stops Using Azodicarbonamide in Bread Production

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By Kuei-Jung Ni

In response to the petition launched by a food blogger, FoodBabe, Subway, a big fast food chain, announced the removal of Azodicarbonamide (ADA) in bread production on February 6. As an ingredient for dough conditioner, the chemical is also used to make yoga mats and shoe rubber. Apart from Subway, other food companies, like McDonald’s, Starbucks, Kraft and Chick-fil-A have been targeted for using the chemicals.

In North America, ADA is a legal additive for food processing as long as the residual does not surpass the safe level. In the United States, it has been listed in the “Generally Recognized as Safe (GRAS)” category that exempts additives from a more restrictive premarket approval by the Food and Drug Administration (FDA).  According to the Codex Alimentarius Commission (Codex) that decides international food safety standards, the safe limit of ADA is up to 45 ppm. The United States and Canada permit the use of the additive at the same levels.

Nevertheless, the World Health Organization has linked the substance to respiratory issues, allergies, and asthma as workers experience environmental exposure where the chemical is manufactured or used. Of course, one would expect that risks would be different for people who consume food containing very small amounts of the chemical; the Center for Science in the Public Interest (CSPI) observes small or negligible risks from consumption, but still urges FDA to ban use or raise the safe level on the grounds that the chemical is an unnecessary additive. Many countries that take a precautionary approach, including UK, the European Union and Australia, outlaw ADA in food production.

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2/21: “New Directions for Food Safety” — conference at Harvard Law School

The Petrie-Flom Center Staff Leave a comment

This one-day conference will bring together experts in food law and regulation to discuss a range of issues including food safety, agriculture, risk regulation strategy, and international issues.

Speakers are:

  • Keynote: Peter Barton Hutt, Harvard Law School/Covington & Burling
  • Alli Condra, Food Law and Policy Clinic, Harvard Law School
  • Marsha Echols, Howard University School of Law
  • Jacob E. Gersen, Food Law Lab, Harvard Law School
  • Lewis Grossman, Washington College of Law, American University
  • Ching-Fu Lin, Petrie-Flom Center, Harvard Law School
  • Sharon Mayl, Senior Advisor for Policy, FDA Office of Foods and Veterinary Medicine
  • Kuei-Jung Ni, Petrie-Flom Center, Harvard Law School/Institute for Technology Law, National Chiao Tung University, Taiwan
  • Margot Pollans, Resnick Food Law and Policy Program, UCLA School of Law
  • Michael Roberts, Resnick Food Law and Policy Program, UCLA School of Law
  • Denis Stearns, Seattle University School of Law
  • Stephanie Tai, University of Wisconsin School of Law

For the full agenda, including paper titles, please visit our website.

This event is free and open to the public, but space is limited and registration is required. To register, please click here.

For questions contact petrie-flom@law.harvard.edu or 617-496-4662.

Sponsored by the Petrie-Flom Center; the Food Law and Policy Clinic (a division of the Center for Health Law and Policy Innovation); the Food Law Lab; and the Harvard Food Law Society; with support from the Top University Strategic Alliance and the Dean’s Office at Harvard Law School.

 

REGISTER NOW: “New Directions for Food Safety” conference at Harvard Law School

The Petrie-Flom Center Staff Leave a comment

This conference will bring together scholars to discuss a range of issues related to the Food Safety and Modernization Act, including FSMA and risk regulation strategy; regulating farm production; benefits, challenges, and gaps in FSMA’s approach; and international issues and trade implications.

Speakers include:

  • KEYNOTE: Peter Barton Hutt, Harvard Law School/Covington & Burling – The Food Safety Modernization Act in Historical Perspective

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New Book: “Science and Technology in International Economic Law”

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I am pleased to post that my new book, “Science and Technology in International Economic Law: Balancing Competing Interests” (co-edited with Professor Bryan Mercurio at the Chinese University of Hong Kong), was recently published by Routledge. In addition to the introduction, the book includes thirteen articles written by scholars from the Asia-Pacific region, Middle East, and Europe. It is the first attempt to explore the status and interaction of and between science, technology and international economic law (namely, trade and investment) with a view to seeking a proper balance between promoting trade/investment liberalization and ensuring that decisions are soundly based and that technological advancement is not hampered.

On the issue of food safety, scientific evidence and trade disputes, I contributed a paper, titled ”Does Science Speak Clearly and Fairly in Trade and Food Safety Disputes? The Search for an Optimal Response of WTO Adjudication to Problematic International Standard-Making,” which appeared previously in the Food & Drug Law Journal, Vol. 68, pp. 97-114 (2013).

The following reveals a brief background and objective of the book:

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