Resource Library

Ensuring the safety and quality of dietary supplements is a cornerstone of regulatory compliance. Among the most critical steps in this process is establishing specifications for chemical contaminants. These contaminants, which can arise from raw materials, manufacturing processes, or environmental exposure, must be controlled to meet the standards outlined in the Code of Federal Regulations (CFR). This guide is designed to assist manufacturers in establishing strong chemical contaminant specifications while ensuring regulatory compliance.

Testing complex botanical matrices using HPTLC goes beyond simply running a sample through a machine—it requires a deep understanding of both the plant material’s unique properties and the strengths and limitations of HPTLC. In this article, we’ll explore the intricacies of testing complex botanical samples using HPTLC, highlighting the challenges involved and how this technique can effectively overcome them—even in the most complex matrices.

Pilot-scale and small-batch production play a critical role in food, beverage, and dietary supplement development. These early stage runs allow companies to fine-tune formulations, troubleshoot production challenges, and test market viability before full-scale commercialization. However, without proper planning, pilot production can lead to costly setbacks. This paper outlines key considerations—including food safety, quality control, production troubleshooting, and packaging—to ensure your pilot runs set the stage for a successful market launch.

Advanced analytical methods play a crucial role in identifying emerging contaminants, unexpected adulterants, food contact material migrants, and other unanticipated chemicals that may compromise regulatory compliance and consumer safety for dietary supplements. Read our white paper to learn about suspect screening and non-target analysis workflows.

This webinar explores approaches to method and monograph development while maintaining safety and quality standards specific to the OTC and Dietary Supplement industries. The speakers share industry insights regarding current state and potential changes with a changing administration. Original Air Date: February 24, 2025.

In this on-demand webinar we'll provide you with the tools and knowledge you need to navigate Amazon's Dietary Supplements Policy. Original airdate April 24, 2024.

In this on-demand webinar, you will learn essentials of FDA Form 483 observations, compliance responsibilities, and the dietary supplement regulatory landscape. Original airdate November 16, 2023.

How does Prop 65 relate to dietary supplements? How do I test for heavy metals in dietary supplements to ensure compliance with Prop 65? Is Prop 65 specific to California? Get the answers to these questions and more!

In a recent webinar, experts answered some FAQs about probiotic enumeration, with a focus on the applications of flow cytometry to probiotic products. This blog provides an overview of the questions and answers, including the benefits of flow cytometry, how it compares to plate counts, and considerations for testing.

The current Good Manufacturing Practice (cGMPs) regulations for dietary supplements in the US were implemented in 2007, but there is still a great deal of enforcement activity by FDA. This white paper will provide an overview of the regulations, but more importantly will highlight some of the most commonly cited issues in FDA Form 483 observations.