Category: Labels and Claims
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Retailer Audit Readiness: What Major Nutraceutical Retailers Actually Require
When your nutraceutical company is ready to scale into major retail channels, the excitement of potential growth often meets the reality of nutraceutical retailer audit requirements. In our experience working with supplement manufacturers preparing for retail partnerships, understanding these requirements early transforms what could be a stressful scramble into a strategic advantage. Major retailers don’t… Read more
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Structure/Function Claims
Structure/Function Claims: What You Can and Cannot Say on Your Label When marketing dietary supplements, the line between permissible claims and regulatory violations can seem razor-thin. Structure/function claims represent one of the most powerful tools in your marketing arsenal, when used correctly. However, missteps in this area can trigger costly FDA enforcement actions and FTC… Read more
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How FDA Regulations Differ for Pharma vs Medtech vs Nutraceuticals
How FDA Regulations Differ for Pharma vs Medtech vs Nutraceuticals: A Founder’s Guide For founders entering the health and wellness space, understanding FDA regulations is crucial for successful product launches and sustainable growth. The regulatory landscape varies significantly across pharmaceutical drugs, medical devices, and nutraceuticals, each with distinct pathways, requirements, and timelines. In our experience… Read more
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Ingredient Compliance for Emerging Nutraceutical Brands
Ingredient Compliance for Emerging Nutraceutical Brands: Building Success on Solid Foundations The nutraceutical industry presents tremendous opportunities for emerging brands willing to navigate its regulatory landscape thoughtfully. While the path to market may seem complex, understanding ingredient compliance requirements from the outset positions your brand for sustainable growth and market success. Nutraceutical brands approaching compliance… Read more
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QMSR vs ISO 13485: What Medtech Companies Need to Know in 2026
QMSR vs ISO 13485: What Medtech Companies Need to Know in 2026 Quality managers in the medical device industry face increasingly complex decisions about which quality management standards to implement and maintain. Two frameworks consistently emerge at the center of these discussions: the Quality Management System Regulation (QMSR) and ISO 13485. Understanding their differences, overlaps,… Read more
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Claims & Ingredients Compliance for Emerging Brands
Claims & Ingredients: Protect Your Brand from Exposure Expo West is a playground of innovation. You walk down the aisles and see bold promises everywhere: “Gut Healing,” “Brain Boosting,” “Zero Net Carbs,” “Sustainably Sourced.” As a founder, you know that these claims are what sell your product. They are the hook that grabs a consumer’s… Read more