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 Expert  726941

Expert in Product Development, Product Safety, Regulatory Compliance, Claims Support, Litigation Support

Available for your Consulting and Expert Witness Needs

Arizona (AZ)
Education Work History Career AccomplishmentsPublicationsConsulting Services Expert Witness Market Research

Summary of Expertise: Listed with other top experts in: 
This expert has training and experience in the following areas: Safety of foods, cosmetics and their ingredients; and medical devices, pharmaceutical actives and excipients. Regulatory affairs related to foods, cosmetics, and medical devices. Product development of foods and cosmetics. Management consulting for R&D environments. Consultant has experience in drafting safety evaluations for consumer products prior to and after commercialization.

For over 20 years, expert provided regulatory compliance expertise to consumer products companies, including food and cosmetic companies, especially in the area of food additive/ingredient and cosmetic ingredient safety, GMP for foods, dietary supplements, and cosmetics. He has also provided support for client in regard to nutrition labeling of foods and dietary supplements.


chemical toxicology


color additive regulation


color additive safety testing


drug safety testing


drug toxicology


FDA food labeling regulation


Federal Food, Drug, and Cosmetic Act


food additive regulation


Food and Drug Administration cosmetic regulation


Food and Drug Administration food regulation


FDA medical device regulation


Food and Drug Administration regulation


food biotechnology


food labeling regulation


food product development


food product labeling


food product research and development management


food regulatory compliance


food safety


food toxicity


food toxicology


medical device premarket approval


Medical Device Reporting regulation


Generally Recognized As Safe


consumer product


consumer safety


cosmetic product


Current Good Manufacturing Practice


food additive safety


nutrition labeling

Show Secondary and Basic Areas of Expertise
Expert may consult nationally and internationally, and is also local to the following cities: Phoenix, Arizona;  Tucson, Arizona;  Mesa, Arizona;  Glendale, Arizona;  Scottsdale, Arizona;  Chandler, Arizona;  Tempe, Arizona;  Gilbert, Arizona;  and Peoria, Arizona.

Often requested
with this expert:

FDA Regulations, Labeling and Compliance; Medical Devices,...
Food Additives and Ingredients, Food Processing
Food Packaging, Food Safety, Food Quality, Food Additives;...
Medical Technology

Year   Degree   Subject   Institution   Honors
1984   Ph.D.   Chemical Toxicology   The American University  
1981   MS   Molecular Biology   The American University  
1978   BS   Biology   The American University  
1990   Diplomate   Board Certified, General Toxicology   American Board of Toxicology, Inc.   DABT

Work History:
Years   Employer   Department   Title   Responsibilities

2005 to







He leads a consulting firm that provides services in the areas of product development, issues management, technology assessment, litigation support, product safety and regulatory affairs to the food and nutritional, medical device, cosmetic, and pharmaceutical industries.

2007 to 2008


Neways, Inc.






Responsible for leading the R&D effort for a $1 billion network marketing firm of over 400 nutritional and personal care products. Coordinates the work of discovery, intellectual property, safety evaluation, product development, scientific and clinical affairs, pilot plant, and quality analytical laboratory. Chief corporate scientist for distributors. Examples of accomplishments are: • Established Neways' first Science Advisory Board. • Commercialized Durian Fusion, the first whole food supplement containing durian fruit. • Commercialized Keratonics line of hair care products and True Touch color cosmetics line.

2003 to 2005


McNeil Nutritionals (Johnson & Johnson)


Safety & Regulatory Affairs




Responsible for leading regulatory compliance and safety assurance for $500 million product portfolio: Splenda® low calorie sweetener, Viactiv® calcium chews, Lactaid® dairy products and supplements, and Benecol® spreads, contributing to 50% annual sales growth YAY. • Spearheaded weight loss claim for Lactaid brand, increasing sales by 14%. • Achieved adoption of position in the EU Health Claims Regulation keeping EU markets open for weight loss nutritionals undergoing clinical development. • External technical representative for defending brands, especially Splenda.

2002 to 2003


Natural Alternatives International, Inc.




Senior Scientist


Responsible for safety and market claims for 8 novel bioactives, bench-top formulating of novel dietary supplements, regulatory compliance of 70 products worldwide, and quality assurance measures. Developed supplement and cosmetic lines for Jennifer O'Neill brand in only 3 months, and conducted clinical studies on three novel bioactive ingredients.

2001 to 2002


Larex, Inc.






Responsible for product and process development, clinical and regulatory affairs, and quality assurance. Led technical effort to support sales to the food, feed, cosmetic and biomedical markets. Obtained FDA acknowledgement of GRAS status for lower-cost Eastern larch arabinogalactan.

1996 to 2001


Abbott Laboratories


Ross Products Division


Director, Regulatory Affairs


Regulatory responsibility for $800 million of Ross products sold in retail or institutional channels, including Ensure® drinks; Vydalin® dietary supplements; HealthSource line of functional foods; Glucerna® medical food; Selsun Blue® and Murine Eye Drops OTC drugs; and Quantum® enteral infusion pumps, PEG tubes, nasogastric tubes, and gastrostomy tubes (registration, 510(k) clearance, and QSR and MDR compliance). • Approved promotional claims and novel ingredients for products yielding incremental annual sales of $80 million. • Catalyzed efforts to market Glucerna in the retail channel, expanding sales more than 20%.

1991 to 1996


Pfizer Inc.


Food Science Group


Associate Director, Safety and Regulatory Affairs


Regulatory responsibility for $300 million of food ingredients. Regulatory compliance for food ingredients such as Litesse® polydextrose bulking agent, Chy-Max® fermentation-derived chymosin, and Veltol® maltol flavor in the United States, Europe, Asia, and Australia. Provided safety and regulatory guidance for new products under development, for license candidates, Drug Master Files, NDC listings, and for existing products. • Spearheaded industry-wide regulatory reform effort that catalyzed the elimination of the backlog of food ingredient approvals at FDA by aligning key industry stakeholders behind FDA-endorsed plan to streamline food ingredient safety review and approval. • Increased Natamax® sales facilitated by self-GRAS determination of natamycin use in cheese. • Prolonged shelf-life of retail ground beef by 3 days with self-GRAS determination of erythorbate. • Secured placement of salatrim, first structured lipid, on JECFA Priority Review List.

1989 to 1991


National Academy of Sciences


Food and Nutrition Board


Director, Food Chemicals Codex


Supervised the Food Chemicals Codex, a compendium of purity standards for food ingredients adopted by FDA, as well as Canada, United Kingdom, and Australia. Completed the Food Additive Survey, which surveyed the use 3,000 additives by 700 U.S. food processors, enabling FDA to track food additive use. • Initiated the Food Forum, a dialogue group consisting of industry, government, academic, and consumer interest members that lead to resolution to food-related issues. • Reduced backlog of Food Chemicals Codex monographs by 50%.

Career Accomplishments:

Society of Toxicology, Institute of Food Technologists


American Board of Toxicology, Inc.

Professional Appointments

Natural Standard

Selected Publications and Publishers  
 - Online  

Government Experience:
Years   Agency   Role   Description
1989 to 1991   National Academy of Sciences   FDA Contractor   Project Director for:

Food Chemicals Codex, Food Additive Survey, and Food Forum

1987 to 1989   EPA   Contractor   Review Toxicologist for pesticide safety

Consulting Services:
Selected Consulting Examples:
  • Expert helped companies with regulatory compliance for their product exports.
  • Expert helped to defend a dietary supplement company in a tort case involving GMP and regulatory compliance issues.
  • Expert drafted safety evaluations and GRAS determinations for food, supplement, and cosmetic ingredients.
  • Expert developed a regulatory compliance system for a medical device manufacturer, and has submitted 510(k)s on their behalf.
  • Expert compiled the scientific and clinical evidence to substantial product claims.
Recent Client Requests:
  • Expert in Food Toxicologist.
  • Expert in OTC Packaging.
  • Expert in Medical Devices Forum
  • Expert in intota for consulting on FDA Food Beverage and liquid Dietary Supplement Regulation.
  • Expert for consulting on Regulatory Affairs for Fragrance / Export from US to Europe / Asia / Middle East.
  • Expert in GRAS Study.
  • Exper expert for consulting on Chemical presence in materials.
  • Consultation on FDA cosmetic regulatory compliance.
  • "Food regulations expert" fda for consulting on Assistance establishing a strategic plan for a non-US FDA.
  • Expert in Consultation regarding labeling claims and requirements.
  • Seafood USDA FDA expert for consulting on Seafood Processing.
  • Expert for consulting on GMP manufacturing of a liquid dietary supplement.
  • Fda dietary supplement review expert for consulting on Dietary Supplement Label review.
  • Expert in FDA Labeling Review.
  • Fda labeling expert to assist with reviewing labels for FDA comliance.
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:
Expert Witness Experience Summary:
I provide litigation support in the areas of numerous issues, including GMP and products claims for dietary supplements, foods, and cosmetics; depositions, expert testimony.
Recent Litigation Client Requests:
  • Expert for consulting on A Request for Your Opinion in defense of a legal matter in cosemetology- eyelash tinting.
  • FDA food labeling expert for consulting on False Labeling of Competitor's Product.
  • Construction lending expert witness for construction loan lender liability litigation case.
  • Expert fda labelling for consulting on Correcting Ingredient Label.
  • FDA regulatory expert for consulting on OTC skin lightening cream product liability case.
  • Biomedical expert for consulting on transvaginal mesh and useof polypropylene.
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:
Years   Country / Region   Summary
2003 to 2005   European Union   He helped to lobby the EU Parliament to insert and maintain innovation-friendly provisions for weight loss claims in the Health Claims Regulation.
2010 to 2010   Canada   He drafted and implemented plan to export food and nutritional products for export into Canada.
2006 to 2006   India   He drafted and submitted a petition for the approval of a novel food ingredient, which was subsequently approved.
2008 to 2008   Australia/NZ   He drafted a response to the Australian government to forge approval of a novel calcium-containing food product.
2009 to 2010   Taiwan   He drafted a petition and obtained approval for a novel food ingredient.

Market Research:
I have served as panelist in IFT, GMA, FDLI, Toxicology Forum, and other industry forums. As a reviewer of product information, I have provided technical claims support for sales efforts.

Click the green button above to contact Expert for a free initial screening call regarding your marketing research, industry research, and company research needs.  For research needs involving multiple experts or secondary research, a Research Director can be assigned to coordinate the work into a custom report for you as a potentially quicker and more cost effective alternative to doing this work yourself or hiring a boutique consultancy.  Remember, your initial screening call to speak with Expert is free.

Additional Skills and Services:
Supplier and Vendor Location and Selection

As VP of R&D at Neways, I have experience in locating and selecting vendors and in streamlining supply chains.

Other Skills and Services

I have provided management consulting in the area of optimizing innovation environments.


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