By Sheldon Baker06.02.17
She also spent nearly eight years as an investigator at the U.S. Food and Drug Administration. She has a passion for the dietary supplements and natural products industry and for helping others. Ms. Pavlick has worked in the development of botanical products, utilizing traditional Chinese medicine, ethnomedicinal plants and Ayurveda. Through robust scientific research and collaboration with her mentors, she has assisted in the formulation of products designed to support the negative effects of nutritional deficiencies, stress, aging, and more. With a strong background, education and training in U.S. regulations and quality, she has spent much of her career evaluating the quality and integrity of ingredients and the manufacturing controls used to produce these finished products. Ms. Pavlick graduated from the University of Colorado-Denver, where she received a bachelor’s degree in biology.
Health E-Insights: What did your position entail as a consumer safety officer/investigator for FDA?
Ms. Pavlick: My responsibilities as an investigator included investigations, establishment inspections and conducting other regulatory activities involved in the evaluation of firms within the food commodity, primarily dietary supplement firms. At FDA, I worked in the Denver district office, which oversees Colorado, Utah, New Mexico, and Wyoming, as well as internationally. While I was there, I was honored by my peers and previous supervisors, who recognized me as an expert in dietary supplements. While I was at the FDA, I estimate I completed investigations in more than 200 food and dietary supplement establishments.
Health E-Insights: How involved were you with FSMA?
Ms. Pavlick: When I left FDA, it was training investigators related to the seven elements of FSMA. I left the agency in October 2016. At that time, the agency was not yet conducting FSMA inspections. During my FDA training for FSMA, I attended the required training for a Preventative Controls Qualified Individual and received my certification. . In March 2017, I became a lead instructor to help train our members and the industry.
Health E-Insights: What will be your role at UNPA?
Ms. Pavlick: My role is to support the membership with compliance and quality initiatives by providing education, training and consulting services. Our vision is to keep members informed regarding regulatory changes and trends and to provide potential solutions. I will coach our members by providing regular updates and proactive training. One of my main projects this year is to tackle the top 10 FDA 483 citations for dietary supplement companies with how-to guidance based on my experience and with input from subject-matter experts. (UNPA will host a two-day training course in Provo, UT, June 27-28, addressing key elements of dietary supplement quality.)
Health E-Insights: How do you envision your overall experience assisting industry manufacturers?
Ms. Pavlick: My background and career experience is unique. I worked in the industry for 12 years, but I also worked at FDA for eight years. This combined experience provides me with 20 years of knowledge from inside the trenches. I have boots-on-the-ground experience in over 200 manufacturing facilities. I have seen the industry from an uncommon perspective. Based on this experience, I want to help provide solutions to achieve voluntary compliance.
Health E-Insights: What’s your view of the supplement industry as it is today?
Ms. Pavlick: I visited many companies that were not meeting FDA’s expectations for 21 CFR Part 111—the dietary supplement GMPs. In 2015, about 60% of the facilities I visited were violative. Most often, this non-compliance was not due to deviant behavior but due to a lack of knowledge or resources. I believe that most of the industry wants to be in compliance. This experience led me to realize that training is needed to provide real solutions and tools to reach this goal.
Health E-Insights: With the new federal government administration, do you envision any major obstacles for the supplement industry?
Ms. Pavlick: Traditional thinking is that a Republican administration will be more business friendly, including the perception that this administration will not pursue a regulation-heavy agenda. Yet, we are all looking for style clues to the new administration as cabinet members and their federal departments establish priorities and policies. Even if there is less of an emphasis on regulation in the Trump administration, we are certain that other agencies including, potentially, state attorneys general, will fill any regulatory void.
Health E-Insights: What do you consider your greatest achievement?
Ms. Pavlick: Among all investigators from across the country, I was selected to have Howard Sklamberg, FDA deputy commissioner, global regulatory operations & policy, accompany me during a dietary supplement assignment. Mr. Sklamberg traveled to Denver specifically to observe my inspection. I also received a Certificate of Appreciation for Outstanding Contributions as a Dietary Supplement Investigator in Support of the FDA Mission. I am proud of these. However, I feel the best is yet to come.
Health E-Insights: Is there a historical figure you most identify with?
Ms. Pavlick: One of my pastimes is reading. When not reading, I fill my quiet time with podcasts and audiobooks. I focus my attention on business and history. I find inspiration in many historical figures, including artists, scientists, religious leaders, and politicians. I try to study the positive traits in each of them. I evaluate their strengths and how these have contributed to their successes. I also study their negative attributes and the impact of those. I ultimately try to understand what motivates people and how their behaviors and choices have impacted our society.
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 did your position entail as a consumer safety officer/investigator for FDA?
Ms. Pavlick: My responsibilities as an investigator included investigations, establishment inspections and conducting other regulatory activities involved in the evaluation of firms within the food commodity, primarily dietary supplement firms. At FDA, I worked in the Denver district office, which oversees Colorado, Utah, New Mexico, and Wyoming, as well as internationally. While I was there, I was honored by my peers and previous supervisors, who recognized me as an expert in dietary supplements. While I was at the FDA, I estimate I completed investigations in more than 200 food and dietary supplement establishments.
Health E-Insights: How involved were you with FSMA?
Ms. Pavlick: When I left FDA, it was training investigators related to the seven elements of FSMA. I left the agency in October 2016. At that time, the agency was not yet conducting FSMA inspections. During my FDA training for FSMA, I attended the required training for a Preventative Controls Qualified Individual and received my certification. . In March 2017, I became a lead instructor to help train our members and the industry.
Health E-Insights: What will be your role at UNPA?
Ms. Pavlick: My role is to support the membership with compliance and quality initiatives by providing education, training and consulting services. Our vision is to keep members informed regarding regulatory changes and trends and to provide potential solutions. I will coach our members by providing regular updates and proactive training. One of my main projects this year is to tackle the top 10 FDA 483 citations for dietary supplement companies with how-to guidance based on my experience and with input from subject-matter experts. (UNPA will host a two-day training course in Provo, UT, June 27-28, addressing key elements of dietary supplement quality.)
Health E-Insights: How do you envision your overall experience assisting industry manufacturers?
Ms. Pavlick: My background and career experience is unique. I worked in the industry for 12 years, but I also worked at FDA for eight years. This combined experience provides me with 20 years of knowledge from inside the trenches. I have boots-on-the-ground experience in over 200 manufacturing facilities. I have seen the industry from an uncommon perspective. Based on this experience, I want to help provide solutions to achieve voluntary compliance.
Health E-Insights: What’s your view of the supplement industry as it is today?
Ms. Pavlick: I visited many companies that were not meeting FDA’s expectations for 21 CFR Part 111—the dietary supplement GMPs. In 2015, about 60% of the facilities I visited were violative. Most often, this non-compliance was not due to deviant behavior but due to a lack of knowledge or resources. I believe that most of the industry wants to be in compliance. This experience led me to realize that training is needed to provide real solutions and tools to reach this goal.
Health E-Insights: With the new federal government administration, do you envision any major obstacles for the supplement industry?
Health E-Insights: What do you consider your greatest achievement?
Ms. Pavlick: Among all investigators from across the country, I was selected to have Howard Sklamberg, FDA deputy commissioner, global regulatory operations & policy, accompany me during a dietary supplement assignment. Mr. Sklamberg traveled to Denver specifically to observe my inspection. I also received a Certificate of Appreciation for Outstanding Contributions as a Dietary Supplement Investigator in Support of the FDA Mission. I am proud of these. However, I feel the best is yet to come.
Health E-Insights: Is there a historical figure you most identify with?
Ms. Pavlick: One of my pastimes is reading. When not reading, I fill my quiet time with podcasts and audiobooks. I focus my attention on business and history. I find inspiration in many historical figures, including artists, scientists, religious leaders, and politicians. I try to study the positive traits in each of them. I evaluate their strengths and how these have contributed to their successes. I also study their negative attributes and the impact of those. I ultimately try to understand what motivates people and how their behaviors and choices have impacted our society.
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.
