Supplement Safety Solutions, LLC is a physician-based consulting company focused on enhancing the safety of dietary supplements and natural foods. Our mission is to provide business-savvy medical expertise to help supplement companies maximize product development and minimize liability and risk.
Backed by more than 20 years of collective expertise in dietary supplement research, drug safety and quality assurance, Supplement Safety Solutions was co-founded by Drs. Stephen Schmitz and Hector L. Lopez Jr. to provide expert consulting services to nutritional and dietary supplement companies by focusing on safety, compliance and risk management.
Stephen Schmitz, MD, MPH is a co-founder of Supplement Safety Solutions. For over 15 years, he has worked full-time in drug safety and clinical development for several leading biotech and medical imaging companies in the Boston area, and for a contract research organization (CRO). He is on the editorial board of the International Society of Sports Nutrition (ISSN), and has served as the medical monitor for a variety of drug and medical device studies. He consults with leading dietary supplement companies in safety and risk assessment.
He believes that the dietary supplement industry must significantly enhance their approach to product safety in order to protect itself from misguided calls for regulation of supplements like drugs. He believes that borrowing from selected best practices in drug safety, taken from the pharmaceutical industry, will help supplement manufacturers demonstrate their commitment to product safety.
Hector L. Lopez Jr., MD, CSCS, FAAPMR co-founded Supplement Safety Solutions with Dr. Schmitz in 2012. He was board certified in physical medicine with a uniquely diverse background in clinical research, sports performance enhancement and as director/practitioner at 3 integrative spine and sports medicine facilities. Dr. Lopez was the Chief Medical Officer at the Center for Applied Health Sciences, and had extensive medical monitoring experience with studies involving drugs, biologics and dietary supplements. He was a Fellow of the American Academy of Physical Medicine & Rehabilitation and a key author on numerous articles published by the International Society of Sports Nutrition (ISSN). He has presented internationally on sports nutrition and the seamless integration of medicine with exercise, fitness and nutrition.
Dr. Lopez was a highly regarded leader and innovator in the dietary supplement industry, a loving husband and father, a brilliant physician-scientist and a supportive colleague and friend. He made the world a smarter, safer and healthier place.
Supplement Safety Solutions is a proud member of the Council for Responsible Nutrition (CRN).
Serious Adverse Events Reported with Dietary Supplement Use in the United States: A 2.5 Year Experience Dietary supplement marketers assure the safety of their products by complying with current good manufacturing practices and a host of federal regulations, including those enforced by the Food and Drug Administration (FDA). Post-market surveillance is a key part of…
Effects of Hemp Extract on Markers of Wellness, Stress Resilience, Recovery and Clinical Biomarkers of Safety in Overweight, But Otherwise Healthy Subjects We determined the effects of a commercially available, GRAS (Generally Recognized As Safe) by independent conclusion, CBD-containing hemp oil extract on stress resilience, perceived recovery, mood, affect, body composition, and clinical safety markers…
Post Marketing Safety of Plus CBD™ Products, a Full Spectrum Hemp Extract: A 2-Year Experience The market for products featuring hemp extracts is large and growing larger. However, safety concerns have been raised by medical and regulatory agencies. Post marketing surveillance of full spectrum hemp extract (FSHE) products manufactured and distributed by CV Sciences (CVSI)…
Nutravigilance: principles and practices to enhance adverse event reporting in the dietary supplement and natural products industry Nutravigilance is defined as “the science and activities relating to the detection, assessment, understanding and prevention of adverse effects related to the use of a food, dietary supplement, or medical food”. The nutravigilance approach is derived from well-defined…