By Sid Sudberg
Through good science and analytical chemistry, using HPLC/MS, High Performance Thin-Layer Chromatography (HPTLC), and Microscopic analysis of suspected plant adulterants, the FDA identified the source of the adulteration. The FDA published its results and offered a course on use of those methods and tools. They taught HPTLC and Microscopic analysis of crude plant material for the identification of botanical species, so that dietary supplement companies could confidently ensure the herbal ingredients on their labels, were in the bottle.
After completing the FDA courses, Alkemist Labs was created to provide a much needed and essential service for the dietary supplement industry and, more importantly, the consumer. That said, it took almost 13 years for the dietary supplement industry to embrace this concept, especially since it was not yet mandatory. The FDA finally published the cGMP in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, 21 CFR Part 111 in 2007. It required that by 2010, all companies must demonstrate that the material they were using, buying, selling, holding, etc., had documentation to prove that it was tested with a scientifically valid method demonstrating its identity. The FDA was clear that botanical identity was not to be solely based on the seller’s Certificate of Analysis (C of A), but must be independently tested by a qualified lab, accompanied by appropriate documentation. This became known as the ‘100% Identity Rule’.
The FDA rule was instrumental in the success of our business model, since we had amassed over 10 years of data, methods, reference materials and related experience. The actions of another regulatory agency contributed to our next rapid growth spurt.
About five years after we started the Lab, the Therapeutic Goods Administration (TGA) of Australia shut down Australia’s dietary supplement industry, requiring that all dietary supplements in the country be tested for label claim to reopen. Suddenly we went from 35 samples a week to 400 samples requiring testing immediately. I didn’t sleep much that month.
Then and now, our grounding in good science, vast storehouse of reference materials, and knowledge have positioned us to grow and mature along with the industry.
It has always been satisfying to reflect on what we have achieved over the years, and to envision where we are going. While this can be measured in many ways, I feel particularly proud of the fact that Elan, I, and the entire Alkemist Labs Team, play a role in maintaining the health and wellbeing of consumers of natural products. Being among the many fine labs that are the gatekeepers for the quality of natural products, by ensuring that what is on the label is in the bottle, is something we take very seriously.
Over the decades we have observed many changes in the dietary supplement industry. The fact that it is still here and growing suggests to me that it is now even more important to hold everyone involved in this industry accountable, to maintain the highest integrity with excellence as a target. If this is taken seriously by all stakeholders and if we demand and or expect full transparency for confidence to be sustained and improved, this industry will not only survive, but it will also thrive.
Alkemist Labs’ commitment is to excellence. We are again in a growth phase. After many years of leading the industry in botanical quality assurance, both qualitatively and quantitatively, we are about to take the lead in all aspects of quality control for natural products by expanding our services to include, not only identity and strength, but purity, and composition, with the inclusion of pesticide analysis, heavy metals, residual solvents, and microbiology. These services will allow us to further ensure the quality and the safety of these materials.
For me, this business has been and continues to be a labor of love. I am living my dream, realizing a vision that began more than 50 years ago. While keeping my finger on the pulse of all the activities of our lab, from a science perspective, I am actively training new generations of scientists to think creatively. By constantly asking questions we will continue to find solutions that will help companies improve the safety, quality, and efficacy of their dietary supplements.