Helping Supplement Brands Navigate FDA and FTC: Why Blue Ocean Regulatory Exists
Why Regulatory Guidance Matters for Supplement Brands
Launching a dietary supplement in today’s market isn’t just about a great formula or compelling marketing. It’s about trust. Consumers demand safety and transparency, regulators demand compliance, and retailers demand documentation (aka “proof”).. Yet for many startups and even established brands, FDA and FTC regulations feel like a maze.
That’s where Blue Ocean Regulatory comes in. With over 20+ years of hands-on experience in supplement compliance, quality systems, and cross-border regulations, we help entrepreneurs and established companies alike avoid costly mistakes and build brands that last.
Our Experience: Two Decades in the Trenches
Brian Yam is the, founder of Blue Ocean Regulatory. He began his career in 2004 inside one of Canada’s largest supplement manufacturers, working directly with FDA and Health Canada requirements. Over the years, he’s served in senior leadership roles for supplement brands and now runs a consultancy dedicated to guiding businesses through the same regulatory challenges.
That depth of experience means we understand not just the regulations, but how they’re interpreted in practice at both a technical level and business level—from 21 CFR 111 and DSHEA in the U.S. to FTC advertising standards and Prop 65 in California, as well as the Natural Health Product Regulations in Canada.
How We Help Brands
Whether you’re preparing to launch your first supplement or expanding a multimillion-dollar product line, Blue Ocean offers support across the entire compliance journey:
• FDA Label Reviews – Ensuring Supplement Facts, ingredient declarations, and marketing claims meet strict 21 CFR requirements.
• Fractional VP of Compliance - We are your remote QA and compliance department, embedded into your operation from R&D to QA Releases to Customer Complaints Handling and more.
• FTC Claim Substantiation – Helping brands back up advertising and avoid misleading claims.
• Quality & GMP Support – Building and auditing systems that meet FDA dietary supplement GMPs (21 CFR 111).
• Amazon & Retail Compliance – Navigating online marketplace requirements and retailer restrictions.
• NPN Submissions - Health Canada requires products to have an NPN prior to market - we can help brands with the application and assessment process.
• Natural Health Product (NHP) Label Review - Ensuring your labels meet Health Canada requirements for NHPs.
• Contract Manufacturer Vetting - We can help ensure your prospective manufacturer meets FDA and Health Canada requirements and support you so that you’re properly onboarded with them.
• FSVP (Foreign Supplier Verification Program) – Guiding importers through U.S. food safety and documentation standards.
Why Brands Trust Blue Ocean
Trust isn’t just earned by quoting regulations—it’s earned through results. Our clients range from emerging startups on Amazon to established supplement brands sold in major retailers. In each case, the goal is the same:
- Protect the brand from regulatory risk
- Build consumer trust through transparency
- Support sustainable growth
By combining deep regulatory expertise with an owner’s perspective, we ensure compliance never becomes a barrier to growth—but rather a competitive advantage.
Building for the Future of Compliance
Regulations evolve, and so must supplement brands. That’s why Blue Ocean is also investing in AI-powered compliance tools, training programs, and done-for-you quality systems. Our goal is to not only guide today’s brands but also shape the future of compliance readiness in the supplement industry.
Ready to Launch or Scale Your Brand?
If you’re ready to launch a supplement brand—or want to ensure your existing products are FDA- and FTC-compliant—Blue Ocean Regulatory is here to help.
Book a consultation today to learn how we can help your brand stand out, stay safe, and thrive.
Website: https://blueoceanregulatory.com
About the Author
Brian Yam is the chief consultant and founder of Blue Ocean Regulatory Inc, helping startup brands navigate FDA and FTC requirements in the dietary supplement/natural health product space. With over 20 years of compliance experience, Brian is committed to helping supplement brands grow– whether through online or brick & mortar – and to find the perfect balance of compliance and business goals; activities include vetting manufacturers, to implementing quality management systems for brands, claims substantiation, to fractional VP of Quality and Regulatory support. Brian is also the founder of the YouTube channel MightyStartup, geared to entrepreneurs looking to start a supplement brand and are new to the world of compliance.