Why Supplement NDA and Intellectual Property Matter for Brands
At SREKE, we understand that a unique formula is the cornerstone of any successful dietary supplement brand. A New Dietary Ingredient (NDA) notification to the U.S. FDA is required when introducing an ingredient not marketed in the U.S. before October 15, 1994. Proper intellectual property (IP) protection safeguards your formulation, packaging, and branding from unauthorized use.
We emphasize that NDAs are regulatory submissions, not patents. While an NDA establishes safety, it does not grant exclusive rights. To protect your innovation, we recommend combining NDA compliance with trademark registration, patent filings, and strict confidentiality agreements throughout the manufacturing process.
Key Manufacturing Considerations at SREKE
Our GMP-certified facility in Guangzhou adheres to ISO 22716, HACCP, and current Good Manufacturing Practice standards. When working with proprietary formulations or novel ingredients, we implement the following safeguards:
- Confidentiality Agreements: All partners sign NDAs before accessing formulation details.
How SREKE Helps You Get to Market Faster
We streamline the path from concept to shelf while maintaining full IP integrity. Our ODM services include:
- Formulation Development: Our R&D team creates custom blends tailored to your target market, using clinically studied ingredients.
Industry Trends and Market Opportunities
Global demand for supplements with novel ingredients—such as adaptogens, nootropics, and plant-based proteins—is rising. According to Grand View Research, the global dietary supplements market was valued at $189.8 billion in 2023 and is projected to grow at 8.9% CAGR through 2030. Brands that secure early NDA approval and protect their IP gain first-mover advantage in competitive categories like gut health and cognitive support.
We also observe increasing regulatory scrutiny in both the U.S. and EU. The EFSA’s Qualified Presumption of Safety (QPS) list and the FDA’s GRAS (Generally Recognized as Safe) framework require rigorous documentation. At SREKE, we ensure all ingredients comply with these standards before production begins.
Frequently Asked Questions
What is an NDA and how does it differ from a patent?
An NDA (New Dietary Ingredient Notification) is submitted to the FDA to prove the safety of a new ingredient. It does not grant ownership rights. A patent protects inventions, formulas, or processes. For comprehensive protection, we advise filing both an NDA (for compliance) and relevant patents (for exclusivity).
Can I keep my formulation confidential during manufacturing?
Yes. At SREKE, we treat all client formulations as strictly confidential. Access is limited to authorized personnel, and all employees sign non-disclosure agreements. We do not share your formula with third parties without written consent.
What are typical MOQs for custom supplement orders?
Our standard MOQ is 5,000 units per SKU for softgels, capsules, tablets, gummies, and powders. For liquid formulations, the MOQ is 3,000 units. These quantities allow cost-effective production while supporting small to mid-sized brands.
Do you assist with FDA or EFSA compliance documentation?
Absolutely. We provide Certificates of Analysis (CoA), GMP certification, and ingredient safety data sheets. For international markets, we can format labels to meet local regulatory requirements, including EU Nutrition Declaration and FDA Supplement Facts panels.
How long does the NDA process take?
The FDA typically reviews an NDA within 75 days. However, this timeline depends on submission completeness. Our team can help prepare a robust dossier, including toxicology data, intended use, and manufacturing specifications, to minimize delays.
Ready to launch your supplement brand? SREKE provides GMP-certified OEM/ODM manufacturing for softgels, capsules, tablets, powders, gummies, and liquids. Contact us for a free quote or email [email protected] — we respond within 24 hours.