Food, Drug and Cosmetic Law Section Home

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    Welcome to the Food, Drug and Cosmetic Law Section
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    Food, Drug and Cosmetic Law Section Annual Meeting Program January 25, 2017
  • Events
    • Food, Drug and Cosmetic Law Section Meeting

      HOT TOPICS IN FOOD DRUG & COSMETIC LAW

      January 26, 2017| New York Hilton Midtown | NYC 

      Under New York’s MCLE rule, this program has been approved for a total of 7.0 credit hours (6.0 Areas of Professional Practice and 1.0 credit in Ethics). This program will NOT qualify for credit for newly-admitted attorneys because it is not a basic practical skills program.  

      Program 
      11:40 a.m. | Nassau West Room 

      SECTION CHAIR: 
      Brian J. Malkin, Esq. Section Chair 
      McGuire Woods, LLP 
      Washington, D.C. 

      PROGRAM-CHAIR
      Brian J. Malkin, Esq.,  
      McGuire Woods, LLP 
      Washington, D.C. 

      11:40 a.m.-11:45 a.m. Welcome
      Brian J. Malkin, Esq., Section Chair 

      11:45 – Ethics of Attorney Advertising 
      Including Blogging, Client Alerts and Social Media and the potential for use of such advertising in other settings. 

      Daniel Lear, J.D. 
      Director of Industry Relations, AVVO 
      Seattle, Washington 

      12:35 p.m. – 1:25 p.m. - Developments in Drug Law 
      Update on reverse payment litigation 3 years after FTC v. Actavis 
      Drug pricing developments, including litigation, investigations and proposed legislation (EpiPen and more) 
      New Drug and New Chemical Entity Definitions 
      Cannabis/Canabidiol (CBD) – Drug or dietary supplement? 
      Old Compounds as New Chemical Entities 

      Speakers: 
      Larissa Bergin, Esq. 
      Jones Day 
      Washington, D.C. 

      Janet Linn, Esq. 
      Bleakley Platt & Schmidt, LLP 
      White Plains, NY 

      Christopher Palermo, Esq. 
      Bleakley Platt & Schmidt, LLP 
      White Plains, NY 

      Jeremy Unruh, Esq. 
      General Counsel and Chief Compliance Officer 
      PharmaCann LLC Chicago, Il. 

       1:25 p.m.- 2:15 p.m. – Medical Device Hot Topics for 2017
      Expected guidance documents 
      Impact of 21st Century Cures Act  
      Update on FDA public hearings on off-label and third-party servicing 
      Vulnerable policies/guidance under the Trump Administration 

      Speakers:  
      Paul Gadiock, J.D.
      Associate Director for Policy
      FDA Center for Devices & Radiological Health (CDRH)
      Washington, D.C.

      Bethany Hills, Esq. 
      Mintz Levin P.C. 
      New York, NY 

      Suzanne O’Shea, J.D. 
      Director (Former Regulatory Counsel at USFDA) 
      Navigant Consulting, Inc. 
      Indianapolis, IN. 

      2:15 p.m.-2:30 p.m. -  Coffee Break

      2:30 p.m. - 3:20 p.m. - Hot Topics in Food/Dietary Supplements
       
      How can a new ingredient intended for use in dietary supplements be brought to market?  
      This panel will compare and contrast FDA’s new final rule for the voluntary notification procedure for substances that are generally 
      recognized as safe (GRAS) vs. FDA’s new draft guidance for New Dietary Ingredient Notifications.  

      Speakers:  
      Dr. Daniel Fabricant, Ph.D.,  EC/CEO 
      Natural Products Association 
      Washington, D.C.  

      Marc Ullman, Esq. 
      Of Counsel 
      Rivkin Radler LLP 
      New York, NY 

      Moderator: 
      Steven Shapiro 
      Rivkin Radler, LLP 
      New York, N.Y. 

      3:20 p.m.- 4:10 p.m. - Animal Health
      Regulation and Application of Animal Biologics 
      Speakers will address the regulation of animal biologics by both the FDA and USDA and how this interrelates to the regulation of human biologics and product development considerations.  

      Speakers:  
      Hans Draayer 
      Chairman of the Board 
      Edge Veterinary Vaccines Consulting Group, LLC 
      Kalamazoo, MI. 

      Dr. Kent McClure 
      General Counsel 
      Animal Health Institute 
      Washington, D.C. 

      Clint Vranian, Esq. 
      Vice President & General Counsel 
      Vitalpet 
      Indianapolis, IN. 

      Moderator: 
      Brian J. Malkin, Esq. 

      4:10 p.m.- 5:00 p.m.-  Recent Enforcement Developments in Organic and Natural Claims for Cosmetics

      Regulatory and self-regulatory officials and plaintiff/defense counsel will address recent enforcement activity concerning organic and natural claims for cosmetics. 
      FTC actions regarding cosmetics, all-natural claims and FTC-USDA study and workshop on organic claims for non-NOP products; 
      NAD decisions regarding challenges over organic and natural claims; 
      FDA requests for comments on use of “natural” in food labeling; and guidance concerning impactful yet compliant organic and natural claims. 

      Speakers: 
      Rebecca L. Griffith, Esq. 
      ASRC National Advertising Division Program 
      Council of Better Business Bureaus 
      New York, NY 

      Deborah A. Marrone 
      Assistant Regional Director 
      Federal Trade Commission 
      Washington, D.C. 

      Sheila A. Millar, Esq. 
      Keller & Heckman LLP 
      Washington, D.C. 

      Moderators: 
      Jennifer L. Orendi, Esq. 
      Managing Attorney 
      Dalimonte Rueb Litigation Group LLP 
      Washington, D.C. 

      Thomas A. Cohn, Esq, 
      Director & Senior Counsel 
      New Avon LLC 
      New York, NY 

      5:00 p.m. – 5:50 p.m.- Updates in Tobacco Product Law
      Legal Status Tobacco Products: Deeming Rule Comes of Age

      Speakers: 
      Dean Cirotta, MBA 
      President and COO 
      EAS Consulting Group 
      Alexandria, VA 

      Mitch Zeller, Director 
      Center for Tobacco Products 
      US Food and Drug Administration 
      Washington, D.C. 

      Moderator: 
      Brian J. Malkin, Esq., Section Chair 

      5:50 p.m. – 6:00 p.m. Concluding Remarks and Annual Business Meeting 
      Brian J. Malkin, Esq. 
      McGuire Woods LLP
      New York, NY
      Biosimilars Substitution Rule-Update 

      6:00 p.m. -7:30 p.m. Offsite Reception (Register Here for the Reception)
      Arent Fox  LLP 
      1675 Broadway 
      New York, NY 

      IMPORTANT INFORMATION 
      Under New York’s MCLE rule, this program has been approved for a total of 7.0 credit hours (6.0 Areas of Professional Practice and 1.0 credit in Ethics). This program will NOT qualify for credit for newly-admitted attorneys because it is not a basic practical skills program, except for the ethics credit. 

      Discounts and Scholarships: New York State Bar Association members and non-members may apply for a discount or scholarship to attend this program, based on financial hardship. This discount applies to the educational portion of the program only. Under this policy, any member of our Association or non-member who has a genuine basis for their hardship, if approved, can receive a discount or scholarship, depending on the circumstances. Request for discounts or scholarships must be received prior to January 13th, 2017. For more details, please contact Lisa Bataille in writing at New York State Bar Association, One Elk Street, Albany, New York 12207 or lbataille@nysba.org. 

      Accommodations for Persons with Disabilities:  NYSBA welcomes participation by individuals with disabilities. NYSBA is committed to complying with all applicable laws that prohibit discrimination against individuals on the basis of disability in the full and equal enjoyment of its goods, services, programs, activities, facilities, privileges, advantages, or accommodations. To request auxiliary aids or services or if you have any questions regarding accessibility, please contact Lisa Bataille at 518-487-5680. 
        For overnight room accommodations, please call the New York Hilton Midtown at 1-800-445-8667 and identify yourself as a member of the New York State Bar Association. Room rates are $260.00 per night plus taxes for single and double occupancy.  Reservations must be made by Friday, December 16, 2016. You also can reserve your overnight room on the web at www.nysba.org/am17accomm. 

      For questions about this specific program, please contact Lisa Bataille at 518-487-5680. For registration questions only, please call the Member Resource Center at 800-582-2452. Fax registration form to 518-463-5993. 


  • Welcome to the Section

    Welcome to the Food, Drug and Cosmetic Law Section 

    More than 70 years ago, the Food, Drug and Cosmetic Law Section became one of the first sections to be formally organized by the New York State Bar Association. During the ensuing years, this group - the first organization in the country to be composed of in-house, law firm, government and trade association attorneys practicing food and drug law - has been a focal point for practitioners in this specialty. We welcome you to our expanded website! 


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  • Join the Section

    Why Join the NYSBA Food, Drug and Cosmetic Law Section?

    Want to improve your professional skills and knowledge? It's easy when you join the Food, Drug and Cosmetic Law Section. Whether it's through meetings, good old-fashioned networking, participating in MCLE programs, professional resources, or legislation, Section activity is the key to keeping you informed on the latest developments in the food, drug and cosmetic law field. The Section also acts as a resource for business, civic and governmental groups.

    View Section's Brochure for Membership Benefits

    Join this Section.

    How much are Section dues? Very affordable with NYSBA membership. View the price list here (scroll down for Section dues).

    The 2014-15 New York State Bar Association Annual Report is now available online. View a brief overview of the Food, Drug & Cosmetic Law Section’s accomplishments, activities and events this past year. 

    Are you interested in volunteering for a Section Committee?  Please email your staff liaison to indicate the committees you wish to join.  Thank you!