Regulatory Discretion, Inc.

MELANIE  M.  FAIRCHILD-DZANIS

 

Education

UCLA SCHOOL OF LAW - J.D., 1985

      Course Emphasis:  Intellectual Property, 
      Unfair Competition

 

UCLA - ANDERSON SCHOOL OF MANAGEMENT - M.B.A., 1985

      Course Emphasis:  Marketing

 

UNIVERSITY of CALIFORNIA at LOS ANGELES - B.A., 1965

      Course Emphasis:  Liberal Arts,
      Elementary Education Credential

 

Employment History

2010–Present REGULATORY DISCRETION, INC. – Santa Clarita, CA

President / Regulatory Consultant - Providing regulatory guidance for product and claims development, with special emphasis on products and communications focusing on nutrition – e.g., infant formula, dietary supplements, weight-loss foods, medical foods, and any products with “functional” claims or ingredients.  Key services include assessing GRAS status of ingredient;, assuring that claim wording is consistent with claim substantiation and that it avoids making unauthorized disease claims; functioning as liaison with FDA at the federal level; participating on crisis-management teams; and contributing strategic guidance on industry efforts toward proactive regulatory change.

 

1986–2010   NESTLÉ USA, INC./NESTLÉ NUTRITION

·  1996–2010   Regulatory Director - Nestlé Nutrition, Glendale, CA

Provided regulatory guidance across all Nestlé Nutrition businesses for claim-support, GRAS establishment, FDA compliance, proactive regulatory change and WIC.

·  1995–1996   Regulatory Director – Nestlé USA, Washington, DC

Provided regulatory guidance across all Nestlé USA Divisionswith special emphasis on Infant Nutrition and PetCare.

·  1986–1995   Senior Counsel – Nestlé USA Legal Dept., Glendale, CA

Specialized in product-law issues and clinical research contracts with special emphasis on Infant Nutrition, HealthCare Nutrition and PetCare.

 

1976–1980   NORMAN EPSTEIN MANAGEMENT – L.A., CA

Associate Personal Manager of Recording Artists - Coordinated album production and budgeting; artists’ liaison with business management, record companies and attorneys.

 

1968–1975   MELANIE DESIGNS – L.A., CA

Fashion Designer and Manufacturer – Owner/operator of wholesale/retail clothing business.

 

1965–1968   LA UNIFIED SCHOOL DISTRICT – L.A., CA

Teacher and Educational Researcher - Designed and administered experimental educational programs and video presentations; taught 3rd and 4th grades; chaired school art department.


Professional Affiliations

State Bar of California – Member since 1985

Food and Drug Law Institute – Member since 1989;

Editorial Advisory Board 2006-2010; Co-editor and author of Vol.2, No.3 FDLI Monograph Series, “Can We Say That? – A Practical Guide to Substantiating Claims for Food and Consumer Health Products” – 2011

Keystone National Policy Dialogue on Food, Nutrition and 
      Health 
- participant 1993–1996

Grocery Manufacturers Association

      – Past chair Functional Foods Working Group

International Food Information Council

      – Past Co-Chair of Functional Foods Committee

International Formula Council

      – Board Member from 1990 to 2010; 
        past Chair of Board of Directors

 

 

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