VGA helps companies optimize innovation environments, and manage safety and regulatory affairs in the food, dietary supplement and cosmetic industries. Mr. Bigelow is a research and development professional with more than 20 years of experience in leading global technology responsibilities in the food and nutrition industries. He has a proven track record of envisioning, designing and implementing strategies to meet and exceed global research and development, innovation, regulatory and marketing challenges. Mr. Bigelow has been successful in defining mutual objectives, building consensus, and developing strategies to create new product opportunities and is a Board Certified Toxicologist with proven ability to craft product opportunities based on the safety and efficacy of novel proprietary, bioactive ingredients. He has worked for Johnson & Johnson, Abbott Laboratories, Pfizer and Neways International, as well as for several small and early-stage companies including Natural Alternatives International and Larex. He has both extensive industry and government experience in global food and nutritional issues including new product development, claims substantiation, bioactive and product safety and clinical affairs. Mr. Bigelow has been active in International Life Sciences Institute, International Food Information Council, Institute of Food Technologists, Council for Responsible Nutrition, American Herbal Products Association, Society of Toxicology, Roundtable of Toxicology Consultants, and Codex Alimentarius Commission activities for more than 15 years. 
 
 
Health E-Insights: Provide our readers with an overview of Vanguard Global Associates LLC. 
 

Mr. Bigelow: I serve as principal of Vanguard Global Associates LLC (VGA), which is a network of experienced consultants each with their own area of expertise, whose abilities complement one another to provide the appropriate project-based services to our clients. Over the last 20 years VGA has served primarily food, dietary supplement and cosmetic companies, as well as providing expert witness services, as needed. VGA experts have the training and relevant experience in the two primary service areas: safety and regulatory compliance for foods, supplements and cosmetics, and their ingredients. 
 
Health E-Insights: Are there specific categories you focus on?
 
Mr. Bigelow: VGA typically creates safety evaluations including Generally Recognized As Safe (GRAS) determinations and claims dossiers to support product claims, as well as provide GMP compliance for foods, dietary supplements and cosmetics. 
 
Health E-Insights: What are some examples of projects your group has completed on behalf of your clients?
 
Mr. Bigelow: VGA has completed over 40 safety evaluations and GRAS determinations and over 20 claims dossiers on product claims for companies that develop and manufacture food, medical food, dietary supplement and cosmetic products marketed in the U.S. and in other developed countries. 
 
Health E-Insights: What is the current state of affairs for product claims?
 
Mr. Bigelow: The food industry has largely been reluctant to make structure/function claims on many of their food products, whereas structure/function claims are the lifeblood of the supplement industry, which is developing as an industry to substantiate its product claims. As an example, the quantity and quality of the evidence needs to match the nature and specificity of the product claim, yet this is not universally practiced by the supplement industry. In comparison to the food and supplement sectors, the cosmetic industry is relatively accustomed to self-regulatory standards in developing evidence to support cosmetic product claims. 
 
Health E-Insights: If you could wave a magic wand and make an industry change, what would it be?
 
Mr. Bigelow: VGA wishes that all of the members of the supplement industry would take a more systematic approach to substantiate their product claims. In addition, the supplement ingredient companies should take the opportunity to create more GRAS determinations for the use of their ingredient products, all of which will expand their markets to both supplement and food product manufacturers. 
 

Health E-Insights: What are the biggest challenges facing industry leaders today?
 
Mr. Bigelow: The food and supplement industries today need to develop robust supply chain management systems to satisfy quality, safety and label claims attributes expected by their customers. Once the supply chains are adequately managed, the next challenge to the industry will be product claims. The future is bright for the supplement industry because of increasing consumer demand. As the supplement industry becomes more developed, market capitalizations for companies will improve and a consolidation with food and pharmaceutical companies will materialize. 
 
Health E-Insights: What is your idea of perfect happiness?
 
Mr. Bigelow: To help the food and supplement industries develop into fully sustainable businesses without marketing interruptions. Most Americans consume supplements because they believe in their ability to promote health so the supplement industry has every reason to improve in terms of product innovation and consumer acceptance. 
 
Health E-Insights: What is your greatest extravagance?
 
Mr. Bigelow: After my kids were grown, I bought a motorcycle and now spend our free time to tour the western U.S., including the national park system. 

---

Sheldon Baker is a partner in the Baker Dillon Group and has created numerous nutraceutical marketing communications and public relations campaigns for many well-known companies and brands.  For Health E-Insights interview consideration, contact him at Sheldon@BakerDillon.com.