Why Scientific and Regulatory Affairs Matter for Supplement Brands
With a U.S. dietary supplement market now topping $60 billion and over 100,000 SKUs, brands face soaring demand—and an FDA that inspects just about 5% of facilities. At Crescent Edge Consulting, we help you build the legal and regulatory team you need to navigate these risks.
In 2024 the FDA issued a warning letter after detecting undeclared pharmaceutical ingredients in weight-loss supplements, triggering a nationwide recall. Let's examine why this matters and what you can do about it.
Why Scientific and Regulatory Affairs for Dietary Supplement Brands Matter
Scientific and regulatory affairs encompass all activities that ensure your products are safe, effective, and compliant with laws like the Dietary Supplement Health and Education Act (DSHEA). This function serves as the bridge between your product development and legal market access.
The consequences of ignoring these responsibilities are severe. Brands face product recalls, substantial fines, and permanent reputation damage.
In 2025, both consumers and the FDA have raised their expectations. The global personalized nutrition and supplement market was valued at $14.02 billion in 2024 and is growing at a CAGR of 14.59%, bringing with it consumers who demand transparency and evidence.
Key Components of Scientific and Regulatory Affairs for Dietary Supplement Brands
Rigorous Scientific Research & Evidence Generation
To withstand FDA and FTC scrutiny, every label claim must be supported by "competent and reliable scientific evidence." In practice, that means conducting robust human clinical trials, publishing in peer-reviewed journals, and ensuring your data align exactly with your product's formula and dosage. Refer to the FDA's Guidance for Industry on substantiation of dietary supplement claims for details on study design and evidence requirements.
Human clinical trials (not just a single study)
Research published in peer-reviewed journals
Evidence that matches your specific product formula and dosage
Animal and test tube studies can support your claims but rarely suffice on their own. The evidence must directly relate to your specific product and claims.
Regulatory Compliance & Submission Management
Compliance with DSHEA remains fundamental. This includes:
New Dietary Ingredient (NDI) notifications for novel ingredients
Adherence to strict labeling requirements
Structure/function claim notifications
The FDA has received approximately 1,300 NDI notifications since 1994. Each submission requires thorough documentation and scientific support. For detailed timelines and requirements see the FDA's NDI guidance.
The FD&C Act requires manufacturers to notify FDA of any new dietary ingredients before marketing.
Quality Assurance & Post-Market Surveillance
Your responsibility doesn't end when products hit the shelves. You must:
Implement robust complaint handling procedures
Report adverse events to regulatory authorities
Maintain Good Manufacturing Practices (GMP) compliance
Obtain NSF/ANSI 455-2 GMP certification to demonstrate third-party compliance
Ensure compliance with adverse event reporting obligations under the Dietary Supplement and Nonprescription Drug Consumer Protection Act.
Since the Final Rule on dietary supplement GMPs was issued in 2007, FDA compliance audits have increased yearly. Continuous monitoring helps prevent regulatory actions.
Building a Robust Scientific and Regulatory Affairs Strategy
Start by assembling a cross-functional team that includes scientists, regulatory specialists, and legal counsel. This team should:
Create clear process flows from research to filing and label approval
Implement regulatory intelligence tools to track changing requirements
Establish documentation systems that maintain data integrity
Adopt a regulatory intelligence platform—such as the one outlined by BioBoston—to automate alerts on global regulation changes.
Consider whether to build in-house expertise or partner with specialists. For many growing brands, a hybrid approach works best.
Need to fill regulatory counsel or QA roles? Crescent Edge Consulting specializes in placing top regulatory affairs and quality professionals.
Benefits of Investing in Scientific and Regulatory Affairs for Dietary Supplement Brands
Proper investment in this area delivers multiple returns:
Strengthened brand credibility and consumer trust
Faster time-to-market with fewer regulatory delays
Protection against legal risks and financial penalties
Competitive differentiation through validated claims
Brands like Thorne Research and Gaia Herbs have built reputations as trustworthy supplement brands partly through their commitment to quality and compliance.
Common Challenges in Scientific and Regulatory Affairs and How to Overcome Them
Even with the best intentions, you'll face hurdles:
Evolving regulations: Establish a regulatory watch team to stay current
Resource constraints: Consider strategic outsourcing for specialized functions
Data integrity issues: Implement robust documentation and regular audits
Many scientific and regulatory challenges are common across countries as the marketplace becomes increasingly global. Addressing these proactively gives you a competitive edge.
Measuring ROI in Scientific and Regulatory Affairs for Dietary Supplement Brands
Track ROI by comparing your compliance investment against avoided fines, recall costs, and revenue retention. Key KPIs include approved claims, launch timelines, audit pass rates and documented cost savings. For tailored ROI modeling, consult with our regulatory recruitment specialists.
Conclusion
Scientific and regulatory affairs are your frontline defense against recalls, fines and reputational damage—while speeding time-to-market and building consumer trust. Audit your current processes with our free Dietary Supplement Compliance Checklist or schedule a strategy session. And when you're ready to staff up, Crescent Edge Consulting can place the precise regulatory affairs and quality assurance talent to close your compliance gaps.
And if you're struggling with regulatory compliance, filling regulatory and quality roles quickly is essential to protect your company.
