Expert in FDA, Food Regulations, Products with Health Claims

Available for your Consulting and Expert Witness Needs

Virginia (VA)
USA

Education

Work History

Consulting Services

Expert Witness

Summary of Expertise:

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Expert began consulting in February 1999, after a 35-year career with the FDA. She has considerable expertise in the regulation of food products, having served as Director of the Division of Programs and Enforcement Policy in the Office of Food Labeling in the Center for Food Safety and Applied Nutrition, and most recently, as Acting Director of the Office of Food Labeling. Expert played a key role in writing the Nutrition Labeling and Education Act (NLEA) regulations in the early 90's, and then had major responsibility for implementing those regulations. This included training industry personnel and regulatory officials in the requirements of the regulations, developing a strategy for enforcing the new labeling requirements, and guiding policy decisions as the agency and the industry struggled to achieve conformance with the greatest change in food labeling in over fifty years. She also helped develop current FDA policies on claims under the Dietary Supplement Health and Education Act and the Food and Drug Administration Modernization Act of 1997. Prior to the changes brought by the NLEA, the consultant was head of a staff responsible for writing regulations and guidance documents dealing with chemical contaminants, filth in food and other issues, in addition to food labeling. Her extensive international harmonization experience includes participation in the NAFTA Technical Working Group on Packaging and Labeling and in several Codex Alimentarius committees. She served as U.S. Delegate to the Codex Committee on Food Labelling. The consultant holds a B.S. in chemistry from Louisiana State University and served nearly ten years as a chemist in FDA's New Orleans and Atlanta Districts prior to transferring to Washington D.C. in 1972.

•	FDA food labeling regulation
•	food additive regulation
•	Food and Drug Administration
•	Food and Drug Administration food regulation
•	Food and Drug Administration regulation
•	food product labeling
•	food regulation
•	Nutrition Labeling and Education Act of 1990

Show Secondary and Basic Areas of Expertise

Localities:
Expert may consult nationally and internationally, and is also local to the following cities: Baltimore, Maryland; Frederick, Maryland; Gaithersburg, Maryland; Bowie, Maryland; Richmond, Virginia; Alexandria, Virginia; Wilmington, Delaware; and Lancaster, Pennsylvania.


Often requested with this expert:

	Food Additives and Ingredients, Food Processing

	FDA Labeling Requirements: Foods and Dietary Supplements

	Food Ingredient, Dietary Supplement, Seafood, FDA

	Food Packaging, Food Safety, Food Quality, Food Additives;...

Education:

Degree		Subject		Institution
B.S.		Chemistry		Louisiana State University

Work History:

Years	Employer	Department	Title	Responsibilities
2006 to	(Undisclosed Consulting Company)		Vice President
1999 to 2006	AAC Consulting Group		Senior Consultant
1997 to 1999	U.S. Food and Drug Administration	Center for Food Safety and Applied Nutrition	Acting Director, Office of Food Labeling	She administered FDA's food labeling program, which included developing regulations, developing enforcement strategies, developing analytical methods, reviewing enforcement actions, answering inquiries and otherwise implementing requirements for nutrition labeling and other food labeling. Duties also included participating as food labeling expert in policy development needed to implement the Dietary Supplement Health and Education Act (e.g., participation in group responsible for developing policy for proposal on structure/ function claims).
1992 to 1997	U.S. Food and Drug Administration	Division of Programs and Enforcement Policy, OFL, CFSAN	Director	She managed the division responsible for regulation writing and enforcement policy for food labeling. Implementation of the NLEA regulations began in 1993. This involved training industry to comply with the regulations, training regulators to enforce the regulations, and providing precedent setting answers to innumerable questions from all parties on interpretation of the regulations. The NLEA regulations constituted the most comprehensive change in food labeling in over 50 years.
1988 to 1992	U.S. Food and Drug Administration	Office of Compliance, CFSAN	Chief, Guidelines and Industry Activities Branch	She supervised development of regulations and other policy documents on various aspects of food regulation, including chemical and microbiological contaminants as well as food labeling. During 1991 and 1992, supervised development of several NLEA regulations, including the comprehensive document on nutrient content claims.
1972 to 1988	U.S. Food and Drug Administration		Guidelines and Compliance Research Branch	She progressively had increasing responsibility for development of regulations and other policy documents on various aspects of food regulation. Supervisory responsibility began in 1976.
1963 to 1972	U.S. Food and Drug Administration	New Orleans District Office and Atlanta District Office	Chemist	Conducted analysis of samples, predominantly food samples, to determine compliance with requirements.

Government Experience:

Years		Agency
1963 to 1999		U. S Food and Drug Administration

Consulting Services:

Recent Client Requests:

Expert in food package labeling for consulting on guidance on compliance with FDA inspection of imported products.
Expert in trade secrets dietary supplement formulas for consulting on labeling requirements for functional drinks and dietary supplements.
Expert in consultimg fda labelling for consulting on Fda labelling.
Seafood USDA FDA expert for consulting on Seafood Processing.
Expert in label review for a new product release.
Expert for consulting on Need on Product Claims.
"Food regulations expert" fda for consulting on Assistance establishing a strategic plan for a non-US FDA.
FDA labeling expert for dietary suplements for consulting on verifying claims with the FDA.
Expert in FDA content claims for consulting on FDA labeling claim for hydrogen enriched water.

Click the green button above to contact Expert for a free initial screening call regarding your expert consulting needs. Expert is available for consulting to corporate, legal and government clients. Remember, your initial screening call to speak with Expert is free.

Expert Witness:

Recent Litigation Client Requests:

FDA expert for consulting on dietary supplement ingredient.
Expert in nutrition labeling for consulting on Saiber.
Dietician expert for consulting on manufacturer's nutritional supplement claims.
Expert in self-heating beverages to consult on their safety and performance.
Fda labeling expert dietary for consulting on FDA dietary supplement.
Label expert for consulting on mislabeling of a dietary supplement.
FDA expert witness for consulting on an atypical antipsychotic..
Expert in field tags for consulting on labeling of product prior to shipping to customers.

Click the green button above to contact Expert for a free initial screening call regarding expert testimony, litigation consulting and support, forensic services, or any related expert witness services. A few litigation needs include product liability, personal injury, economic loss, intellectual property (patent, trademark, trade secret, copyright), and insurance matters. Remember, your initial screening call to speak with Expert is free.

International Experience:

Summary

Codex Alimentarius: She is the U.S. Delegate to Codex Committee on Food Labelling, Alternate Delegate to Codex Committee on Vegetable Proteins, and a member of U.S. delegations to Codex committees on pesticide residues; food additives and contaminants; methods of analysis and sampling; and cereals, pulses and legumes. She is a Member of U. S. Delegation to Codex Alimentarius Commission.


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