Regulatory Discretion, Inc.

She  puts  the  Fun  in Functional   Foods

Melanie Fairchild-Dzanis
JD/MBA, president, Regulatory Discretion, Inc.

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Melanie is a graduate of UCLA law and business schools. She became an independent consultant in January 2010, after working 24 years for Nestlé – including 10 years in the Nestlé Legal Department, and one year in the Nestlé Washington, D.C. Office, prior to returning to California in 1996, to manage the regulatory function for Nestlé’s Nutrition Division.

Melanie has always focused on nutrition-oriented products, spanning the legal/regulatory intensive worlds of infant formula, pet foods, dietary supplements, medical foods, weight-loss shakes, and performance-nutrition products. This interest led to her involvement in multiple activities helping to shape the interpretation of laws and regulations related to products with “functional” claims and ingredients. She was a long-standing member of the Food and Drug Law Institute (FDLI). She participated in the Keystone Dialogue on Food, Nutrition and Health during the mid-1990s, which brought together representatives of industry, academia, consumer groups and regulatory agencies to resolve issues surrounding the implementation of NLEA health and nutrition claims. She also served a term as chair of the GMA Functional Foods Working Group, and several terms as co-chair of the IFIC Committee on Functional Foods and as a member of the US Delegation to the Codex Committee on Nutrition and Foods for Special
Dietary Use.

Melanie specializes in providing guidance for product and claims development. She helps companies insure that their ingredients have FDA authorization for their intended use and that their claim wording is consistent with available substantiation and avoids making unauthorized disease claims. She served as an author and co-editor of the recently published FDLI book, Food and Consumer Health Product Claims Substantiation: A Comprehensive Guide. She also has extensive experience as liaison with FDA at the federal level, as a participant on company crisis-management teams, and in the strategic guidance of industry efforts toward proactive regulatory change.

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