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Summary:  The document discusses the importance of selecting appropriate packaging materials for dietary supplements to ensure product safety, efficacy, consumer appeal, and regulatory compliance. ​ It highlights various types of packaging materials such as amber glass bottles, HDPE bottles, PET bottles, aluminum foil pouches, desiccants, child-resistant packaging, and recyclable/biodegradable materials. ​ Additionally, it mentions the significance of caps and closures, detailing basic liners, pressure-sensitive liners, and induction liners, with induction liners being the most secure option for achieving tamper-evident seals. ​ The document emphasizes the role of packaging in protecting supplements from light, moisture, and oxygen, maintaining their quality over… Read More »

Elevating Standards in Dietary Supplement Manufacturing: The Vital Triad of Raw Material Qualification, Risk Assessment, and Testing By: Jennifer Lopez Summary:  Columbia Nutritional is committed to ensuring the quality and safety of their dietary supplements through a rigorous process of raw material qualification, risk assessment, and testing. ​ They adhere to the SIDI guidance document, which provides guidelines for evaluating dietary ingredients. ​ The raw material qualification process involves sourcing materials from trusted suppliers and conducting risk assessments to identify potential hazards. ​ Testing is conducted using state-of-the-art analytical techniques to verify the identity, purity, and potency of the raw… Read More »

The Evolution of Quality: FSMA’s Impact on the Dietary Supplement Industry Summary:  The Food Safety Modernization Act (FSMA), signed into law in 2011, has had a significant impact on the dietary supplement industry. ​ FSMA aimed to shift the focus from reacting to food safety incidents to preventing them altogether. ​ It expanded the regulatory authority of the Food and Drug Administration (FDA) and introduced preventive controls and hazard analysis. ​ FSMA also emphasized supplier verification programs and compliance with current Good Manufacturing Practices (cGMPs). ​ While compliance with FSMA can be challenging for small businesses, it is necessary to… Read More »

Summary: This document describes the process of manufacturing dietary supplements at Columbia Nutritional, emphasizing the importance of collaboration. ​ The steps involved in the process include staging/picking, weighing, blending, encapsulation/tableting, packaging, and warehouse operations. ​ The quality team plays a crucial role in ensuring that the ingredients are correctly selected, the weighing is accurate, the blend is homogeneous, and the finished products meet quality standards. ​ The packaging phase offers customization options to meet customer specifications, and the warehouse operations focus on maintaining inventory integrity and accuracy. ​ ** Several steps take place to physically make a dietary supplement. The… Read More »

Summary:  To mitigate adverse events related to dietary supplements, several measures can be taken. ​ These include strict adherence to Current Good Manufacturing Practices (cGMPs), effective adverse event reporting, rigorous product testing, accurate product labeling, and education and communication initiatives. ​ Adhering to cGMPs ensures high standards in production processes, reducing the risk of contamination or misbranded products. ​ Adverse event reporting is crucial for public health and safety, and reports must be submitted to the FDA within 15 business days. ​ Conducting thorough product testing helps ensure the purity, potency, identity, and safety of dietary supplements. ​ Accurate labeling… Read More »

Manufacturer’s Product Development Group: What to Expect from a Dietary Supplement  In today’s health-conscious society, the demand for dietary supplements to aid in the betterment of health and wellness continues to climb, driven by consumers seeking to enhance their well-being and address specific health concerns. Behind every successful dietary supplement lies a dedicated development team which helped bring these innovative products to market. For brand holders and consumers alike, understanding what to expect from the product development group of a supplement manufacturer is crucial. In this blog post, we’ll explore the key factors to consider and the expectations that should… Read More »

As a dietary supplement manufacturer in a growing industry, it is more important than ever to have a supply chain that can deliver quality ingredients. Having a robust sourcing program is critical not only for the success of the product but ultimately for building confidence with the consumer or private label brand.  Consumers are more knowledgeable now than ever before about what they want and importantly, what they do not want in a supplement. Finding quality special ingredients whether that request is organic, or non-GMO, or verified gluten free is critical to satisfying today’s consumers. The sourcing and qualification process… Read More »

What is Regulatory Compliance?  In simple terms, regulatory compliance means adhering to the laws, rules, and regulations that govern our industry. Failure to comply can have serious consequences, including fines, penalties, and even business closure. Dietary supplements are regulated by the Food and Drug Administration (FDA).  The Dietary Supplement Health and Education Act (DSHEA) was established in 1994 to provide access to a variety of dietary supplements and provide a strong regulatory framework to ensure safe products enter the market.  The implementation of DSHEA provided supplement contract manufacturers and consumer brands with laws to follow.  Often referred to as current… Read More »

Post-COVID, the world has become more aware of the importance of health and wellness.   People are purchasing exercise programs, adopting whole food diets, and leaning on supplements to boost their quality of life.  With supplements growing in popularity among consumers, it becomes increasingly more important to focus on ensuring that quality supplements are on the market.  Dietary supplement brand holders often rely on supplement contract manufacturers to produce quality products.Concern about dietary supplement quality is increasing as manufacturing companies and the ingredients they source may not be up to standard. The Food and Drug Administration (FDA) plays a role in… Read More »