Sheldon Baker04.03.17
President of the safety and regulatory consulting firm Burdock Group, Orlando, FL, Dr. Burdock is an internationally recognized authority on the safety and U.S. regulation of personal care products, dietary supplements and human and animal food ingredients. He has more than 25 years of experience dealing with regulatory issues related to product safety and risk assessment. He has over 50 publications in scientific journals and over 60 invited presentations. He has published two books, Fenaroli’s Handbook of Flavor Ingredients (four editions) and the Encyclopedia of Food and Color Additives. He is co-author of the chapter Food Toxicology in the 8th edition (current edition) and the previous three editions of Casarett and Doull’s textbook Toxicology, the standard graduate textbook and reference book in the field of toxicology. He has also authored or co-authored additional chapters on safety and regulation of dietary supplements, biotechnology and similar subjects. Dr. Burdock is a diplomat of the American Board of Toxicology, a Fellow of the American College of Nutrition and is a member of several professional societies including, but not limited to the American Chemical Society, the Society for Regulatory Toxicology and Pharmacology, the Society of Toxicology, the American College of Toxicology and the Institute of Food Technologists (Professional Member status).
Health E-Insights: What areas of expertise does your group provide?
Dr. Burdock: We have people on board with degrees in toxicology, nutrition, animal science, chemistry, and biology. We also have two Masters in public health, one person with a certification in project management and, collectively, dozens of years of experience working with FDA and USDA. We use these various areas of expertise and experience to provide our clients with problem solving acumen in safety and regulatory strategies regarding human and animal food ingredients, dietary supplements, cosmetics, personal care products and product contaminations. I emphasize strategies because the definition of what is safe is not always as clear-cut in a regulatory context because you have mitigating factors such as the amount consumed or alternate manufacturing technologies. We also enjoy experience in the various technologies involved with ingredients and supplements including genetically modified organisms, nanotechnology, non-clinical study design and monitoring and, clinical studies as the basis for a claim. We look on the help we provide our clients as more than a yes or no answer on whether something is toxic or not, and take a much larger view which incorporates other factors.
Health E-Insights: Is the pet food and animal feed business expanding?
Dr. Burdock: Yes, as you probably know, the FDA has taken a second look at its historical use of regulatory discretion when it comes to enforcing regulations on pet and animal feed ingredients. In the past, FDA used regulatory discretion for animal feed ingredients listed in the American Association of Feed Control Officials (AAFCO) Official Publication (OP). Now, FDA has decided that 500 ingredients listed in the OP are not compliant with federal law. Many clients are coming to us to get their ingredients compliant with federal law before FDA officially declares the ingredients adulterants or unapproved food additives and demands they be taken off the market.
Health E-Insights: Where will the most significant growth occur in your company in the next few years?
Dr. Burdock: We expect equal growth in human food and animal feed including pet food and in dietary supplements.
Health E-Insights: Do you envision technology changing the supplement industry?
Dr. Burdock: Yes, nanotechnology is a game changer. If for no other reason, nanotechnology can facilitate absorption in the gastrointestinal tract and require less product to achieve the same physiological effect. A secondary benefit of nanotechnology is that, at the nano-size level, substances can exhibit different effects than at larger particle size. This difference in effect may open the door to a vast new catalogue of effects by naturally derived substances. Care must be taken however, to ensure that toxicity is not manifested at the nano-size, when compared to more macro-sized particles.
Health E-Insights: What is the biggest challenge facing supplement manufacturers today?
Dr. Burdock: Maintenance of proprietary information. FDA demands an incredible depth and scope of safety information, all of which must be published, but this furnishes competitors with an unfair advantage to capitalize on the safety information paid for by someone else. Although I believe safety information should be publicly available, I also believe that efficacy data should be kept in a master file, inaccessible to competitors so the founding company can enjoy some return on investment. If we had the same requirements for disclosure for drugs as we do for dietary supplements, would we have any new drugs coming to market?
Health E-Insights: Share a little about your chief inspiration officer?
Dr. Burdock: Our CIO is an eight-year-old Welsh Pembroke Corgi. During the day she goes from office to office, soliciting belly rubs and behind-the-ear scratches in exchange for providing encouragement, occasional tidbits of wisdom and lessons in perseverance. Because she came to us with no tail and with no wagging signal, she was sometimes unsuccessful in conveying her good intention to strangers. She has overcome the challenge of no tail by developing a smile that is immediately recognizable as a sign of good intentions. She also sometimes sleeps near the receptionist’s desk and gives notice to all when the FEDEX or UPS driver is at the door with a package. She is a valuable contributor in many ways, but will always be a friendly and loyal companion to us all.
Health E-Insights: Where do the great ideas come from in your organization?
Dr. Burdock: Because we have such a diverse group in terms of educational background, work histories, diverse scientific journal reading and monitoring regulatory announcements, the best ideas arise when we are all meeting in the conference room over lunch every Monday at the project management meeting. Discussion often begins with a finding on a current project or mention of an article in a journal and various people chime in with their thoughts. These Monday meetings are stimulating and a source of great enjoyment for all.
Health E-Insights: Which talent would you like to most have?
Dr. Burdock: I wish I had much greater math skills, so I could explore the applications of non-zero sum game theory. So much in science and even in regulations is interconnected and those connections can be illustrated by the use of game theory. Remember, one of the first uses of the predecessors of what became game theory, was to determine what people would do in response to various types of taxation schemes. Predicting behavior in response to changes in regulation is not far-fetched. For example, the basis of Reaganomics, the Laffer Curve, can be considered a form of game theory.
Sheldon Baker is CEO of the Baker Dillon Group LLC and has created numerous nutraceutical marketing communications and public relations campaigns for many well-known companies and brands. For Health E-Insights interview consideration and campaign development, contact him at Sheldon@BakerDillon.com.
Health E-Insights: What areas of expertise does your group provide?
Dr. Burdock: We have people on board with degrees in toxicology, nutrition, animal science, chemistry, and biology. We also have two Masters in public health, one person with a certification in project management and, collectively, dozens of years of experience working with FDA and USDA. We use these various areas of expertise and experience to provide our clients with problem solving acumen in safety and regulatory strategies regarding human and animal food ingredients, dietary supplements, cosmetics, personal care products and product contaminations. I emphasize strategies because the definition of what is safe is not always as clear-cut in a regulatory context because you have mitigating factors such as the amount consumed or alternate manufacturing technologies. We also enjoy experience in the various technologies involved with ingredients and supplements including genetically modified organisms, nanotechnology, non-clinical study design and monitoring and, clinical studies as the basis for a claim. We look on the help we provide our clients as more than a yes or no answer on whether something is toxic or not, and take a much larger view which incorporates other factors.
Health E-Insights: Is the pet food and animal feed business expanding?
Dr. Burdock: Yes, as you probably know, the FDA has taken a second look at its historical use of regulatory discretion when it comes to enforcing regulations on pet and animal feed ingredients. In the past, FDA used regulatory discretion for animal feed ingredients listed in the American Association of Feed Control Officials (AAFCO) Official Publication (OP). Now, FDA has decided that 500 ingredients listed in the OP are not compliant with federal law. Many clients are coming to us to get their ingredients compliant with federal law before FDA officially declares the ingredients adulterants or unapproved food additives and demands they be taken off the market.
Health E-Insights: Where will the most significant growth occur in your company in the next few years?
Dr. Burdock: We expect equal growth in human food and animal feed including pet food and in dietary supplements.
Health E-Insights: Do you envision technology changing the supplement industry?
Dr. Burdock: Yes, nanotechnology is a game changer. If for no other reason, nanotechnology can facilitate absorption in the gastrointestinal tract and require less product to achieve the same physiological effect. A secondary benefit of nanotechnology is that, at the nano-size level, substances can exhibit different effects than at larger particle size. This difference in effect may open the door to a vast new catalogue of effects by naturally derived substances. Care must be taken however, to ensure that toxicity is not manifested at the nano-size, when compared to more macro-sized particles.
Health E-Insights: What is the biggest challenge facing supplement manufacturers today?
Dr. Burdock: Maintenance of proprietary information. FDA demands an incredible depth and scope of safety information, all of which must be published, but this furnishes competitors with an unfair advantage to capitalize on the safety information paid for by someone else. Although I believe safety information should be publicly available, I also believe that efficacy data should be kept in a master file, inaccessible to competitors so the founding company can enjoy some return on investment. If we had the same requirements for disclosure for drugs as we do for dietary supplements, would we have any new drugs coming to market?
Health E-Insights: Share a little about your chief inspiration officer?
Health E-Insights: Where do the great ideas come from in your organization?
Dr. Burdock: Because we have such a diverse group in terms of educational background, work histories, diverse scientific journal reading and monitoring regulatory announcements, the best ideas arise when we are all meeting in the conference room over lunch every Monday at the project management meeting. Discussion often begins with a finding on a current project or mention of an article in a journal and various people chime in with their thoughts. These Monday meetings are stimulating and a source of great enjoyment for all.
Health E-Insights: Which talent would you like to most have?
Dr. Burdock: I wish I had much greater math skills, so I could explore the applications of non-zero sum game theory. So much in science and even in regulations is interconnected and those connections can be illustrated by the use of game theory. Remember, one of the first uses of the predecessors of what became game theory, was to determine what people would do in response to various types of taxation schemes. Predicting behavior in response to changes in regulation is not far-fetched. For example, the basis of Reaganomics, the Laffer Curve, can be considered a form of game theory.
Sheldon Baker is CEO of the Baker Dillon Group LLC and has created numerous nutraceutical marketing communications and public relations campaigns for many well-known companies and brands. For Health E-Insights interview consideration and campaign development, contact him at Sheldon@BakerDillon.com.
