FDA Regulatory Affairs and Labeling Expert for Dietary Supplements, OTC Drugs, and Medical Devices
Technical Consultant #2036
Expertise
- Food and Drug Administration Regulations (FDA), in foods, dietary supplements, cosmetics, OTC drugs, pet foods and medical devices.
- Knowledge of allowable marketing claims for FDA regulated consumer products.
- Research and consumer health product development.
- Nutrition evaluation of food products.
- Product formulation and marketing.
Experience
Undisclosed Company, Owner and Principal, 2001 - Present
- Providing clients with over 20 years' experience in biochemical, pharmacological and nutrition research in academic and industrial settings.
- Assay development, technology evaluation, regulatory affairs and product formulation and marketing.
- FDA regulatory affairs services including labeling and marketing reviews and submissions relevant to foods, dietary supplements, cosmetics, OTC drugs and medical devices.
- Review technologies for patent potential and consumer product applications.
Boston Market Corporation, Golden, CO, Nutrition & Labeling Manager, 2005 - 2007
- Managed food product labeling process to ensure compliance with FDA, USDA and FTC regulations.
- Reviewed global regulatory status and consumer perception of proposed food product ingredients.
- Assist marketing with program development.
NBTY, Inc., Bohemia, NY, Nutrition Researcher, 2002 - 2004
- Reviewed new products for safety and regulatory compliance.
- Reviewed literature for claim and safety data. Serve as FDA, FTC liaison.
NatureSmart, (Whole Foods Market, Inc.), Thornton, CO, Senior Research Scientist, 1997 - 2001
- Responsible for coordination of research efforts for the corporation's largest direct marketing division including new product formulation, literature research and reporting on nutritional supplements for new and existing products.
- Provided technical assistance for review of patents and FDA regulations, design of in-house efficacy studies and coordination of committee to streamline the new product development process.
Honors & Publications
Credentials
- Pharmacologist for the Neuroscience Division of a well-known Pharmaceutical firm.
Academic and Professional Affiliations
- Rocky Mountain Regulatory Affairs Society (Treasurer)
- Institute of Food Technologists; Food Law & Regulation Division; Nutrition Division
Publications and Patents
- Author and Co-Author of many publications (abstracts, symposiums and lectures) presented in peer reviewed journals.
Education
- B.S. Biophysical Sciences, University of Houston, TX