Why Supplement NDA and Intellectual Property Protection Matters for Brand Owners
At SREKE, we work with brand owners across 50+ countries who bring innovative formulations to market every year. One of the most critical conversations we have during the product development phase is intellectual property (IP) protection and the use of Non-Disclosure Agreements (NDAs). For supplement brands, protecting your proprietary formulations, unique ingredient blends, and packaging designs is not optional — it is a competitive necessity.
The global dietary supplement market was valued at approximately USD 85 billion in 2024 and continues to grow at a compound annual growth rate (CAGR) of roughly 8-9%, according to industry analyses from Grand View Research and Statista. In a market this dynamic, a single innovative formula can define a brand. That is why safeguarding your IP from concept through manufacturing to final product launch is essential.
When you partner with an OEM/ODM manufacturer, you are sharing sensitive information — your formulation concepts, target demographics, pricing strategy, and go-to-market plans. Without proper NDAs and IP protections in place, that information could be exposed to competitors. At SREKE, we take this responsibility seriously. Our facility operates under strict confidentiality protocols, and we structure every client relationship around clear IP ownership terms from day one.
It is also important to understand the regulatory landscape. The U.S. FDA regulates dietary supplements under the Dietary Supplement Health and Education Act (DSHEA) of 1994, and the European Food Safety Authority (EFSA) oversees supplement ingredients in the EU. Neither agency requires pre-market approval for most supplements, which means the burden of protecting your innovation falls on you — the brand owner. An NDA and robust IP strategy are your primary legal tools.
Key Manufacturing Considerations at SREKE
At SREKE, our Guangzhou manufacturing facility holds GMP certification, ISO 22000, and HACCP compliance. These certifications ensure that our quality management systems include provisions for information security and confidentiality. Here is what brand owners should consider when evaluating a contract manufacturer for IP protection:
1. NDA Execution Before Any Technical Exchange
We require a signed NDA before sharing any formulation details, pricing, or proprietary processes. At SREKE, our legal team reviews every NDA to ensure it covers formulation confidentiality, trade secret protection, and non-solicitation of our staff. We recommend that brand owners also have their legal counsel review our standard NDA terms before signing.
2. Clear Ownership of Formulation IP
Under standard OEM/ODM agreements, the brand owner retains full ownership of their proprietary formulation. At SREKE, our contracts explicitly state that any custom blend, unique dosage form, or proprietary extract combination developed for a client remains the exclusive intellectual property of that client. We do not claim ownership over client-developed formulas.
3. Ingredient Sourcing and Supply Chain Security
Our procurement team sources raw materials from verified suppliers who also operate under confidentiality agreements. For novel ingredients or patented extracts, we maintain secure supply chains to prevent unauthorized duplication. All ingredients we use comply with FDA Food and Drug Administration regulations and EFSA Novel Food regulations where applicable.
4. Facility Access and Information Control
Our manufacturing floors in Guangzhou are restricted-access facilities. Only authorized personnel work on client-specific formulations, and all staff sign individual confidentiality agreements. We maintain separate production scheduling for proprietary formulas to prevent cross-contamination of information between clients.
5. Packaging and Labeling IP
Beyond the formula itself, packaging design, label artwork, and unique delivery formats (such as our signature softgel or gummy structures) can also be protected. At SREKE, we offer in-house packaging design services and ensure that all creative assets remain the property of the brand owner under our standard terms.
6. Compliance with Regulatory Requirements
When filing for regulatory compliance — whether a FDA Dietary Supplement New Drug (DSND) inquiry, a EU Novel Food notification, or a China National Medical Products Administration (NMPA) registration — the protecting party must be clearly identified. At SREKE, we assist our clients in preparing all necessary documentation while ensuring that the brand owner is recognized as the rights holder in all regulatory filings.
How SREKE Helps You Get to Market Faster
Speed to market is a competitive advantage, and IP protection should never slow you down. At SREKE, we have streamlined our NDA and onboarding process so that brand owners can move from initial consultation to production in weeks, not months.
Streamlined Onboarding Process
- Step 1: Sign our standard NDA — completed within 24 hours of your inquiry.
- Step 2: Share your formulation concept or request our ODM portfolio for inspiration.
- Step 3: Our R&D team develops a prototype formula tailored to your specifications.
- Step 4: Review and approve samples, then finalize packaging and labeling.
- Step 5: Begin production with your IP fully protected under contract.
Flexible MOQ and Lead Times
We understand that brand owners at different stages have different needs. At SREKE, our Minimum Order Quantities (MOQs) range from 5,000 to 50,000 units depending on the product format — softgels, capsules, tablets, powders, gummies, and liquids. Our standard lead time is 30 to 45 days from formula approval to shipment, with expedited options available for urgent launches.
ODM Portfolio for Faster Launches
If you do not have a proprietary formulation yet, our ODM (Original Design Manufacturer) program offers a library of pre-developed, GMP-certified formulas that you can customize and brand as your own. These formulas are already compliant with FDA and EFSA regulations, significantly reducing your time to market. All ODM formulas remain the intellectual property of SREKE, but you receive exclusive rights to your customized version under a dedicated agreement.
End-to-End Compliance Support
Our in-house compliance team handles COA (Certificate of Analysis) preparation, third-party lab testing coordination, and regulatory documentation. We ensure that every product leaving our facility meets the labeling and safety standards of your target market — whether that is the United States, the European Union, Southeast Asia, or the Middle East.
Industry Trends and Market Opportunities
The supplement industry is evolving rapidly, and IP protection strategies must evolve with it. At SREKE, we observe several key trends shaping how brand owners approach formulation and intellectual property:
Personalized Nutrition and Proprietary Blends
The personalized supplement market is one of the fastest-growing segments, projected to exceed USD 20 billion by 2027. Brand owners developing personalized or adaptogenic blends are increasingly filing for trade secret protection rather than patents, as the formulation landscape changes faster than patent cycles allow. We advise our clients to consider trade secret protection for proprietary blends and to use NDAs as the first line of defense.
Novel Ingredients and Bioavailability Innovation
Ingredients such as NMN (Nicotinamide Mononucleotide), specialized probiotic strains, and novel cannabinoid extracts are driving innovation. However, regulatory status varies by jurisdiction — NMN, for example, faces evolving FDA guidance, while the EU has strict Novel Food authorization requirements. At SREKE, our regulatory team stays current on these developments and advises clients on compliant formulation paths.
Sustainability and Clean-Label Demands
Consumers increasingly demand clean-label, sustainably sourced supplements. This trend is driving innovation in plant-based softgel capsules, organic ingredient sourcing, and eco-friendly packaging. Brand owners who develop unique clean-label formulations should consider both trademark protection for their brand identity and trade secret protection for their proprietary clean-label processes.
Global Market Expansion
More brand owners are targeting multiple regions simultaneously. At SREKE, we support multi-market compliance, ensuring that your formula meets FDA requirements for the U.S., EFSA standards for the EU, and local regulations for emerging markets in Southeast Asia, the Middle East, and Latin America. Our experience spanning 20+ years in contract manufacturing gives us deep knowledge of regional regulatory nuances.
Partnership Over Transaction
The most successful supplement brands treat their OEM/ODM partner as a strategic ally, not a vendor. At SREKE, we build long-term relationships with our clients, offering ongoing formulation innovation, market intelligence, and regulatory updates. A manufacturer that invests in your success is also invested in protecting your intellectual property — it is in both our interests.
Frequently Asked Questions
What is an NDA in the supplement manufacturing context?
An NDA (Non-Disclosure Agreement) is a legally binding contract between a brand owner and a contract manufacturer that protects confidential information shared during the product development process. At SREKE, our NDA covers formulation details, pricing, supplier information, and business strategy. We sign NDAs with every prospective client before any technical discussion begins.
Can I patent a supplement formula?
Yes, supplement formulas can be patented if they meet the criteria of novelty, non-obviousness, and utility. However, the patent process is costly and time-consuming — typically 2 to 5 years. Many brand owners choose trade secret protection instead, keeping their formulation confidential through NDAs and secure manufacturing agreements. At SREKE, we can guide you on the best IP protection strategy for your specific formula.
Does SREKE claim ownership of my formulation?
No. At SREKE, we explicitly state in our contracts that the brand owner retains full ownership of any proprietary formulation developed for them. We do not resell, share, or use client formulations for other customers. This principle is foundational to our business relationship with every brand we serve.
What is the difference between OEM and ODM?
In OEM (Original Equipment Manufacturer) mode, you provide the formulation and we manufacture it. In ODM (Original Design Manufacturer) mode, we provide pre-developed formulas that you customize and brand. Both models offer full IP protection for your customized version. At SREKE, we offer both pathways depending on your development stage and timeline.
How long does it take to produce a supplement order?
Standard lead times at SREKE range from 30 to 45 days from formula and packaging approval to shipment. This includes raw material procurement, production, quality testing, and packaging. Expedited production is available for urgent launches. Our MOQ starts at 5,000 units for most product formats.
Do you support international regulatory compliance?
Yes. Our compliance team supports FDA registration for the U.S. market, EFSA Novel Food compliance for the EU, and local regulatory requirements for markets in Asia, the Middle East, and Latin America. We provide COAs, ingredient dossiers, and labeling review as part of our service.
What certifications does SREKE hold?
SREKE's manufacturing facility in Guangzhou holds GMP (Good Manufacturing Practice) certification, ISO 22000 food safety management certification, and HACCP (Hazard Analysis and Critical Control Points) certification. We also maintain compliance with FDA cGMP regulations and EU food safety standards.
How do I get started with SREKE?
Getting started is simple. Contact our team via our contact page or email [email protected]. We will send you our standard NDA for signature, and within 24 hours, a dedicated account manager will begin discussing your product vision, target market, and timeline.