Expert Details
Product Development, Product Safety, Regulatory Compliance, Claims Support, Litigation Support
ID: 726941
Arizona, USA
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.
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.
Education
| Year | Degree | Subject | Institution |
|---|---|---|---|
| Year: 1984 | Degree: Ph.D. | Subject: Chemical Toxicology | Institution: The American University |
| Year: 1981 | Degree: MS | Subject: Molecular Biology | Institution: The American University |
| Year: 1978 | Degree: BS | Subject: Biology | Institution: The American University |
| Year: 1990 | Degree: Diplomate | Subject: Board Certified, General Toxicology | Institution: American Board of Toxicology, Inc. |
Work History
| Years | Employer | Title | Department |
|---|---|---|---|
| Years: 2005 to Present | Employer: Undisclosed | Title: Principal | Department: sole proprietor |
Responsibilities: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. |
|||
| Years | Employer | Title | Department |
| Years: 2007 to 2004 | Employer: Neways, Inc. | Title: VP | Department: R&D |
Responsibilities: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. |
|||
| Years | Employer | Title | Department |
| Years: 2003 to 2005 | Employer: McNeil Nutritionals (J&J) | Title: Safety & Regulatory Affairs | Department: R&D, Regulatory Compliance |
Responsibilities: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. |
|||
| Years | Employer | Title | Department |
| Years: 2002 to 2003 | Employer: Natural Alternatives International, Inc. | Title: Principal Scientist | Department: R&D |
Responsibilities: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. |
|||
| Years | Employer | Title | Department |
| Years: 2001 to 2002 | Employer: Larex, Inc. | Title: VP | Department: R&D |
Responsibilities: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. |
|||
| Years | Employer | Title | Department |
| Years: 1996 to 2001 | Employer: Abbott Labs | Title: Director, Regulatory Affairs | Department: Ross Products Division |
Responsibilities: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%. |
|||
| Years | Employer | Title | Department |
| Years: 1991 to 1996 | Employer: Pfizer | Title: Safety & Regulatory Affairs | Department: Food Science Group |
Responsibilities: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. |
|||
| Years | Employer | Title | Department |
| Years: 1989 to 1991 | Employer: Food Chemicals Codex | Title: Project Director | Department: Food and Nutrition Board |
Responsibilities: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%. |
|||
Government Experience
| Years | Agency | Role | Description |
|---|---|---|---|
| Years: 1989 to 1991 | Agency: National Academy of Sciences | Role: FDA Contractor | Description: Project Director for:Food Chemicals Codex, Food Additive Survey, and Food Forum |
| Years: 1987 to 1989 | Agency: EPA | Role: Contractor | Description: Review Toxicologist for pesticide safety |
International Experience
| Years | Country / Region | Summary |
|---|---|---|
| Years: 2003 to 2005 | Country / Region: European Union | Summary: He helped to lobby the EU Parliament to insert and maintain innovation-friendly provisions for weight loss claims in the Health Claims Regulation. |
| Years: 2010 to 2010 | Country / Region: Canada | Summary: He drafted and implemented plan to export food and nutritional products for export into Canada. |
| Years: 2006 to 2006 | Country / Region: India | Summary: He drafted and submitted a petition for the approval of a novel food ingredient, which was subsequently approved. |
| Years: 2008 to 2008 | Country / Region: Australia/NZ | Summary: He drafted a response to the Australian government to forge approval of a novel calcium-containing food product. |
| Years: 2009 to 2010 | Country / Region: Taiwan | Summary: He drafted a petition and obtained approval for a novel food ingredient. |
Career Accomplishments
| Associations / Societies |
|---|
| Society of Toxicology, Institute of Food Technologists |
| Licenses / Certifications |
|---|
| American Board of Toxicology, Inc. |
| Professional Appointments |
|---|
| reviewer: Food and Chemical Toxicology, J. Dietary Supplements, Natural Medicines |
Additional Experience
| Expert Witness Experience |
|---|
| I provide litigation support in the areas of numerous issues, including GMP and products claims for dietary supplements, foods, and cosmetics; depositions, expert testimony. |
| Vendor Selection |
|---|
| As VP of R&D at Neways, I have experience in locating and selecting vendors and in streamlining supply chains. |
| Marketing Experience |
|---|
| I have served as a committee member or as a 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. |
| Other Relevant Experience |
|---|
| I have provided management consulting in the area of optimizing innovation environments. |
Fields of Expertise
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, detoxification, functional food, cosmetic raw material specification, Federal Trade Commission, food packaging material, cosmetic product chemistry, cosmetic product development, food shelf life extension, Food and Drug Administration compliance, alginic acid, food processing quality, over-the-counter cosmetic, food pigment, food research and development, food separation, food product shelf-life study, food product coating process, food processing plant safety, 510(k) document, food product nutrient enrichment, food product quality control, environmental regulation, food product quality improvement, Food and Drug Administration food packaging regulation, food-borne illness, food-borne pathogenic bacterium, convenience food development, food industry product development standard, food processing good manufacturing practice, food processing plant sanitizing, food processing technology, food ingredient technology, food industry quality management, food industry total quality control, food industry total quality management, food industry quality control, food industry, device product development, Environmental Protection Agency, Food and Drug Administration, food formulation, food microbiology, food science, food additive, food, Good Manufacturing Practice, Good Laboratory Practice, food regulation, food quality assurance, food product, food processing, food ingredient, food additive environmental effect, drug metabolism, carcinogen