Why Supplement Brands Can’t Rely Solely on Contract Manufacturers for Compliance
The Illusion of Safety
Many supplement founders assume that by working with an FDA-registered contract manufacturer or that their product “passes Amazon’s requirements”, that, compliance is fully covered. The manufacturer has GMP certifications, provides Certificates of Analysis, and may even offer label review services.
The reality is that compliance responsibility rests with the brand owner, not the manufacturer. If the FDA or FTC questions your product, they will hold the brand accountable first not the factory where it was made.
Where Manufacturers Stop and Brands Begin
Contract manufacturers are valuable partners, but their focus is often limited to what they can directly control:
• GMP Manufacturing: Producing the product under 21 CFR 111 standards.
• Basic Label Review: Checking that the Supplement Facts panel aligns with the formula.
• Standard Testing: Running microbiological and identity tests, often with limited scope or skip-lot testing. .
Where they often fall short—and where brands must take over—includes:
• Claims Review: A manufacturer might approve 'supports weight loss' because the formula has green tea extract. In reality, the brand needs substantiation studies to make this claim legally defensible and justifies the dose.
• Consumer-Facing Language: A front-panel phrase like 'clinically studied' or "‘clinically proven’ may slip through because it isn’t part of the Supplement Facts. The brand is left exposed to FTC enforcement or lawsuits.
• Retail Compliance: Amazon may require Certificates of Analysis for every batch, but the manufacturer’s COAs often don’t cover heavy metals, allergens, or potency testing in the way Amazon expects. That burden falls on the brand to establish the appropriate specifications.
• International Standards: A Canadian brand working with a U.S. manufacturer may assume the product is ready for sale in Canada. In reality, the NNHPD/Health Canada has different labeling, claim, and pre-market requirements that the manufacturer won’t address.
Real-World Examples of Gaps
• Label Gaps: A manufacturer ensures the ingredients match the formula but does not flag that the brand’s 'immune support' claim triggers substantiation requirements. The brand gets a cease and desist letter from a competitor.
• Testing Shortcuts: The manufacturer tests for yeast and mold but skips heavy metals. When the product enters California, a Prop 65 notice is filed for lead contamination.
• Retailer Pushback: A label passes the manufacturer’s review but fails Amazon’s compliance screen because of a prohibited phrase like 'FDA approved..' The listing is questioned.
• Packaging Dates: Manufacturers may stamp an ‘expiration date’ without the appropriate substantiation and consumer testing reveals a failure at the 2 year mark.
Why Brands Must Own Compliance
As a brand owner, you are legally and strategically responsible for ensuring your product complies with:
- FDA dietary supplement regulations (21 CFR 101, 111, 117)
- FTC advertising requirements
- Prop 65 in California
- Retailer and e-commerce policies
- Health Canada and International market regulations
Relying solely on the manufacturer is like assuming a mechanic can prevent speeding tickets. The manufacturer can build and service the product, but the brand is the one on the road and responsible for how it is driven.
How Blue Ocean Regulatory Fills the Gaps
Blue Ocean Regulatory acts as the compliance safety net for supplement brands. We do not manufacture your product—we protect your business by:
• Viewing compliance at the Brand’s Level: What a manufacturer looks for is different than what a brand needs to be prepared for. We’re extracting 20 years of compliance experience at the brand level and scaling that to your business - catching what manufacturers may miss.
• Conducting Deep Label Reviews: Looking beyond the Supplement Facts panel to evaluate call-outs, marketing language, and litigation risk.
• Validating Claim Substantiation: Confirming that your claims are backed by evidence that can stand up to FTC scrutiny.
• Designing Comprehensive Testing Strategies: Advising on potency, identity, contaminants, heavy metals, allergens, and stability testing that retailers and regulators expect.
• Preparing for Retail Readiness: Ensuring products pass Amazon, Costco, Whole Foods, and international compliance screens.
• Building Long-Term Compliance Culture: Equipping teams with systems and training to manage compliance effectively as the business scales.
The Bottom Line
A contract manufacturer is an essential partner, but not a substitute for a compliance department. The FDA, FTC, and retailers hold the brand accountable. By understanding where manufacturers fall short and stepping in to fill the gaps, you protect your investment, avoid costly enforcement, and earn the trust of consumers.
Ready to launch with confidence? Book a consultation with Blue Ocean Regulatory: 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.