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 good manufacturing practices (cGMPs) for dietary supplements, the code of federal regulations 111 (CFR 111) outlines that both dietary supplement contract manufacturers and consumer brand holders must adhere to ensure the safety and quality of their products.
Why is Regulatory Compliance Important? The number 1 reason is that it protects our customers. By following the rules, we help ensure that your products and services are safe and reliable. This gives our customers peace of mind. Proactive compliance can help avoid costly fines and recalls. Here at CN as a dietary supplement manufacturer, we conquer Regulatory Compliance by staying informed on the latest changes in regulations that affect our business. We conduct regular internal and external audits to help us identify any areas at risk, this helps us prevent problems before they occur. Regulatory Compliance may seem like a daunting task, but at the end of the day, it protects our customers, our reputation, and our business.
What does a culture of compliance mean? Compliance isn’t just a box to tick; it’s a mindset. Here at Columbia Nutritional, we are a contract manufacturer that holds a culture of compliance within our organization to be of utmost importance. Embedded ethical practices in our core values emphasize the importance of GMP-certified supplements. We manufacture tablets, powders, and capsules and our facility is NSF, Informed Manufacturer, Organic, and Kosher certified. We strive to be a manufacturing partner with full transparency. By weaving compliance into the fabric of our organization, we have built a fortress against unintentional missteps.
Why companies need to be proactive and not reactive. Here at Columbia Nutritional, we are constantly striving to be the best vitamin manufacturer. As a supplement manufacturer we regularly review our compliance framework, proactively identify and address potential risks, and conduct internal audits to identify and rectify any gaps before they become major issues.
Why is agility important for a vitamin manufacturer? Regulations are living documents, morphing, and evolving with time. Embracing agility is our guiding principle. We stay informed about changes in regulations and are prepared to adapt our policies and procedures and invest in training to keep our team up to speed. In the ever-shifting regulatory landscape, flexibility is our key to success.
Navigating the world of dietary supplements can be overwhelming. Shelving space abounds with colorful bottles promising everything from boosting your energy to strengthening your bones. But with so many choices, how can you be sure you’re feeding your body the good stuff, not harmful contaminants, or hidden ingredients? Enter the shining beacon of trust: NSF certification and Regulatory compliance.
NSF certification, offered by NSF International, a globally recognized leader in public health and safety, signifies a rigorous commitment to quality and safety, far exceeding the minimum regulatory requirements for dietary supplements. Here’s why it should be your top priority when choosing supplements:
Hidden ingredients and unexpected additives? Not at Columbia Nutritional. We are also certified to make USDA Organic, NSF for Sport, Kosher, and Informed Manufacturer certified products. Informed Manufacturer is a global quality assurance program and manufacturing certification for facilities that produce and supply dietary supplements, sports nutrition products, and ingredients. This certification ensures our customers and consumers that there are no banned substances at Columbia Nutritional. Additionally, our facility is registered with Health Canada.
Read More About Informed Manufacturing Here
When navigating vast choices when it comes to vitamin manufacturing, finding the right partner can be overwhelming. You need quality, trust, and expertise to steer your brand to stand out as the best in the dietary supplement industry. That’s where Columbia Nutritional shines, serving as a NSF and Informed Manufacturer certified co-manufacturer.
Quality You Can Trust: Columbia Nutritional’s commitment to excellence is etched in every step of their process. They boast cGMP and NSF certifications, the gold standards for safety and quality control in the industry. Their facility follows strict protocols, ensuring purity, potency, and consistency in every vitamin we produce.
Innovation as Your Sail: Columbia Nutritional isn’t just about meeting current standards; they actively push the boundaries. Our dedicated research and development team constantly explores new technologies and ingredients, allowing you to offer cutting-edge supplements that differentiate your brand from the crowd.
Transparency as Your Map: Openness and honesty are at the heart of Columbia Nutritional’s philosophy. We provide complete transparency throughout the manufacturing process, ensuring you’re always in the loop. From sourcing raw materials to final testing, you’ll have full visibility, leaving no room for uncertainty or doubt.
Flexibility as Your Wind: Adaptability is key in today’s ever-evolving market. Columbia Nutritional understands this, offering a wide range of manufacturing capabilities to fit your specific needs. Whether you require capsules, tablets, or powders, we have the expertise and capacity to meet your expectations.
Partnership as Your Anchor: With Columbia Nutritional, you’re not just a client; you’re a partner. Our team of experienced professionals becomes an extension of your own, collaborating closely to bring your vision to life. We offer customized solutions, expert guidance, and unwavering support throughout every stage of the journey.
Choosing Columbia Nutritional is choosing confidence, innovation, and partnership. It’s choosing a trusted partner in the vitamin manufacturing maze, guiding you towards quality, success, and ultimately, the well-being of your consumers.
Conclusion: A Commitment that Reaches Far Beyond the Label
Regulatory compliance is often viewed as a technical necessity, a box to be ticked on a long list of requirements. But for Columbia Nutritional, it’s much more. It’s a guiding principle, a strategic advantage, and a fundamental pillar of our success.
Read More About The DSHEA Here
About the Author Nalika Brewster:
Nalika Brewster is Columbia Nutritional’s Director of Quality and Regulatory Affairs. In this role, she’s responsible for ensuring that all products meet relevant regulations and standards. Nalika comes to Columbia Nutritional with a wealth of experience having held other quality positions in the food, medical device, biotechnology, and supplement industries.
