Bunk Turkesterone, Lab Testing, Supply Chain & The Supplement Industry - Ft. The Guerrilla Chemist

Derek from placements.com introduces a conversation about the intricacies of the supplement industry's quality control, focusing on third-party testing, supply chain management, and the journey from raw materials to finished products. He highlights the involvement of a senior chemist with expertise in FDA quality systems and a CEO known as the 'Gorilla Chemist' for his innovative supplement formulations. The discussion aims to address recent concerns about under-dosed supplements and the role of lab testing in ensuring product integrity.

The speaker emphasizes the importance of addressing concerns regarding supplement quality control, particularly in light of recent discussions about under-dosed or ineffective supplements. He discusses the role of subject matter experts in dissecting these issues and stresses the need for transparency and due diligence in the industry. The speaker also shares his company's experience with a product called 'tercastrone' and its efforts to ensure its quality and efficacy, despite market hype and challenges.

The speaker defends his company's integrity in the face of criticism and discusses the potential repercussions of compromising on product quality. He outlines the company's commitment to transparency, including sharing lab test results and engaging with subject matter experts to ensure the quality of their supplements. The speaker also addresses the timeline of their product development, emphasizing the company's dedication to creating a high-quality product despite market pressures.

This paragraph delves into the qualification process for new ingredients in the nutraceutical industry, as regulated by 21 CFR Part 111. It covers the importance of establishing specifications for ingredients, evaluating both the material and the vendor, and ensuring safety and efficacy. The discussion includes the use of various analytical techniques such as TLC, HPTLC, HPLC, and GC to verify the identity and potency of ingredients, highlighting the FDA's strict requirements for identity testing to prevent fraud and ensure product safety.

The speaker elaborates on the different analytical techniques used in the nutraceutical industry to ensure the quality of ingredients, such as HPTLC for identity testing and HPLC for potency and safety testing. He also discusses safety tests for heavy metals and microbiological content, emphasizing the importance of these tests in preventing harmful substances from reaching consumers. The paragraph underscores the collaborative effort required to create robust specifications for ingredients, involving experts from laboratories, product development, and quality control units.

The discussion shifts to the Certificate of Analysis (COA), which documents the results of various tests conducted on ingredients to ensure they meet specifications. The speaker explains the significance of the COA in the ongoing quality assurance process, including monitoring tests on initial lots and comparing results to specifications. The paragraph also touches on the concept of vendor qualification, which involves evaluating the reliability and quality of suppliers based on their products' consistency and adherence to standards.

This paragraph provides a detailed look at the qualification process for ingredients and vendors, including the evaluation of multiple lots and the use of test results to approve materials. It discusses the industry practice of accepting a Certificate of Analysis (COA) for ongoing lots after initial lots have met specifications. The speaker also addresses the importance of vendor qualification through audits, questionnaires, and understanding their quality systems, warehouses, and document control processes.

The speaker outlines the process of establishing a new product in the supplement industry, focusing on sourcing and the qualification of ingredients. He discusses the importance of setting specifications for new ingredients, evaluating both the material and the vendor, and ensuring that the material meets quality variables such as identity, assay content, heavy metals, and microbiological safety. The paragraph also covers the use of different analytical techniques for testing ingredients, depending on their properties.

The conversation turns to the role of third-party testing in ensuring the quality of supplements. The speaker discusses the use of liquid chromatography-mass spectrometry (LCMS) for testing finished products, comparing it to the in-house testing done by manufacturers. He emphasizes the value of unbiased, high-sensitivity testing to verify the presence and potency of ingredients, and shares his company's experience with third-party testing for their products.

The speaker explores the complexities of analytical chemistry in the nutraceutical industry, particularly when dealing with botanical extracts and novel compounds. He discusses the challenges of accurately identifying and quantifying ingredients, the importance of using appropriate testing methods, and the potential for variability between laboratories. The paragraph highlights the need for expertise in chromatographic separation and the use of mass spectrometry to ensure accurate analysis.

The speaker underscores the importance of rigorous testing and the expertise required in the nutraceutical industry to ensure the quality and safety of supplements. He discusses the use of high-performance liquid chromatography (HPLC) and liquid chromatography-mass spectrometry (LCMS) for testing, and the need for laboratories to be qualified and accredited. The paragraph also touches on the potential for variability in test results due to differences in laboratory techniques and the importance of using reputable laboratories for testing.

The conversation focuses on the reliability of third-party testing laboratories, particularly in the context of the nutraceutical industry. The speaker discusses his experiences with ABC testing, a laboratory known for its expertise in botanical analysis. He addresses concerns about the laboratory's credibility, given an FDA warning letter related to the medical device industry, and emphasizes the importance of understanding the context of such regulatory actions.

The speaker elaborates on the challenges of testing botanical extracts due to their complex nature, which often contains multiple similar molecules. He discusses the use of UV-Vis spectrophotometry, HPLC, and LCMS to accurately identify and quantify ingredients, and the potential for cross-detection between similar compounds. The paragraph highlights the importance of using appropriate standards and the role of expertise in ensuring accurate test results.

The conversation explores the art of chemistry and the interpretation of test results, particularly in the context of variability between chemists and testing methodologies. The speaker discusses the importance of extraction techniques, chromatographic separation, and detector settings in obtaining accurate results. He emphasizes that while there can be variability in how chemists perform tests, the use of known standards helps to ensure consistency and accuracy in test results.

The speaker outlines the documentation and verification process in the supply chain for the nutraceutical industry. He discusses the importance of Certificates of Analysis (COA), the verification of raw materials, and the role of third-party testing. The paragraph highlights the steps taken by manufacturers to ensure that finished products meet label claims and industry standards, including in-house and third-party testing, and the significance of GMP certification.

The conversation turns to the role of brand owners in ensuring the quality of their products. The speaker discusses the due diligence expected of brand owners, including verifying the claims made by manufacturers and conducting their own testing. He highlights the use of high-sensitivity testing methods such as LCMS by brand owners to independently confirm the presence and potency of ingredients in finished products.

The speaker emphasizes the importance of GMP (Good Manufacturing Practice) certification for manufacturers in the supplement industry. He discusses the standards and guidelines that GMP-certified facilities must follow, including regular audits to ensure compliance. The paragraph also touches on the risks associated with using non-GMP manufacturers and the industry's shift towards stricter quality control measures.

The conversation focuses on the use of Liquid Chromatography-Mass Spectrometry (LCMS) for verifying the presence and quantity of ingredients in supplements. The speaker explains how this high-sensitivity testing method helps in ensuring product integrity and efficacy, providing reliable and accurate results compared to other testing techniques.