FDA has made it clear through warning letters that dietary supplement companies need to test their raw materials and finished products for 100-percent identity, 100 percent of the time. To better help manufacturers meet these goals, INSIDER has just launched its newest Immersion Center: 100% Identity Testing. Here, you can find slide shows, reports, digital issues and a forum on testing raw materials and products, ensuring cGMP (current good manufacturing practice) compliance.
Our two digital issues in this area cannot be missed by supplement companies that want to stay on the good side of regulators. "Ensuring Ingredient Identity: Focus on Testing Methods" covers replacing economically motivated adulteration with "economically motivated integrity," testing methods that help manufacturers screen for adulteration, and a case study on ingredient identification testing. And "Ensuring Ingredient Identity: Focus on Botanical Materials" offers a primer on botanical testing requirements and methods, the role botanical reference materials (BRMs) play in GMPs, and identity testing of botanical ingredient blends.
INSIDER also reached out to Josef Brinckmann, vice president of sustainability, Traditional Medicinals, a company that prides itself on identity testing of its pharmaceutical-grade botanicals. In this exclusive Q&A, we asked him about the industry's understanding of identity testing requirements, where to find resources and the biggest challenges the industry faces in this area.
INSIDER: Do you think the industry at large has an understanding of the 100-percent identification testing requirements as proscribed under federal law?
Josef Brinckmann: Given the number of warning letters issued by FDA for significant cGMP violations, including not only the failure of companies to conduct at least one appropriate test or examination to verify the identity of ingredients, but failure to even establish written specifications and procedures, it would appear that a segment of the dietary supplement industry is asleep. With that said, competent quality-oriented herbal product companies have always inherently been concerned with making certain that their botanical ingredients are appropriately specified and identified prior to use in a production batch (not just by relying on a suppliers certificate of analysis).
INSIDER: What are the primary misconceptions companies have regarding the requirements of 100-percent identity testing?
JB: Given that five years have passed since FDAs publication of the cGMP regulation, freely available to download from the CFR, it is difficult to understand how a company could have misconceptions about the requirements. But if the text of the regulation is not clear enough, FDA subsequently published a Guidance for Industry compliance guide. Additionally, it can be useful to periodically visit FDAs electronic reading room to read through the dietary supplement cGMP warning letters.
Based on reading the warning letters, it appears some companies do not understand that they still must conduct at least one appropriate test or examination to verify the identity of an ingredient (gross organoleptic, macroscopic, microscopic, chemical analysis or other scientifically valid methods) even if they have qualified the ingredient supplier and have established the reliability of the supplier's certificate of analysis (COA) documents through confirmation of the results. But worse than that, some companies just rely on a suppliers COAs without having qualified the supplier or having established the reliability of their test results.
INSIDER: How would you characterize the level of compliance with 100-percent identity testing?
JB: The level of compliance should be increasing. The requirement to conduct only one appropriate identity test for each ingredient is not too much to askespecially in cases where a qualified ingredient supplier is reliably carrying out and documenting the results of several identity tests for each ingredient; for example, in cases of full monograph testing that may require compliance with macroscopic, microscopic and thin-layer chromatography (TLC) ID tests. If the reliability of the suppliers COA has not been established, however, I would be concerned that only one ID test carried out by the product manufacturer could be insufficient. I have seen cases where a representative botanical sample passes some ID tests (e.g., gross organoleptic, macroscopic and TLC) but fails other ID tests (e.g., gas-chromatographic analysis of the essential oil).
INSIDER: What are some of the main hurdles companies must overcome to get into compliance?
JB: Some natural product company executives may not yet have accepted that they need to invest in, and support, a robust quality management system in order to comply with cGMP regulations (and offer dietary supplement products of consistent composition, identity, quality and strength). Companies who price-buy rather than quality-buy may have difficulties with changing their culture and orientation toward compliance and quality assurance (QA). It does cost more to do it right. And an effective quality management system needs competent qualified persons to run it. In addition to competent herbalists responsible for product development, an herbal dietary supplement companys quality control (QC) unit needs persons trained and qualified in disciplines including botany, natural products chemistry, and pharmacognosy.
INSIDER: What steps is industry taking to help move companies toward compliance?
JB: The herbal trade associations, herbal education organizations, quality standards setting organizations and dietary supplement trade media companies offer useful seminars, webinars, articles and papers, and news analysis concerning cGMP compliance. There are resources available to companies who take compliance seriously.
INSIDER: Are companies implementing methods to do random testing of qualified suppliers, and do you think such random testing fulfils the obligations under the law? What are possible downsides to implementing a procedure such as split lot testing?
JB: Until a supplier is fully qualified, I would suggest that a companys own QC unit verify all written specifications for an ingredient (not just the ID tests) for a reasonable period of time and number of shipments. Once a supplier has proven to reliably report compliance with all specification requirements, a rational skip-lot testing program would reduce testing burden, with the exception of the mandatory minimum one appropriate ID test.
What more? Be sure to visit our 100% Identity Testing Immersion Center.