B&H: Integrating Regulatory Compliance into Supplement Formulation Development

In recent years, regulatory authorities around the world have been tightening their scrutiny of supplement formulation and health claims. For example, the U.S. FDA has become more rigorous with its NDI (New Dietary Ingredient) filings, the European EFSA has increased its requirements for the functional validation of botanical extracts, and Australia’s TGA explicitly mandates that any “therapeutic claims” appearing on product labels must be backed by scientific evidence.

In this increasingly regulated environment, Chinese OEM manufacturers aiming to help brands expand globally must not only master “production” but also understand “regulations.”

B&H, a leading OEM supplement manufacturer based in China, is a prime example of this shift. Through years of expertise in supplement OEM manufacturing and regulatory compliance research, B&H has developed an integrated service system that combines formulation development with regulatory review.

Regulatory Compliance: The Core of Supplement Formulation Development
According to B&H, regulatory compliance is not merely the “final checkpoint” before export—it is the primary strategy that should be embedded from the very beginning of formulation design. By incorporating compliance review during the R&D phase, companies can significantly reduce export risks and shorten registration cycles.

B&H’s regulatory team divides the OEM production process into five critical stages:

1.Preliminary Regulatory Research: Identify permitted ingredients and the scope of allowable health claims according to the target country’s regulations.
2.Scientific Validation of Formulation: Collaborate with third-party laboratories to test the stability and bioavailability of key active ingredients.
3.Label Review and Translation Compliance: Verify formulation statements, nutrition facts, and warning labels in multiple languages.
4.GMP Documentation and Record Preparation: Provide COA, MSDS, batch testing reports, and raw material traceability documents.
5.Export Filing and Customs Clearance: Ensure all submissions comply with the importing country’s regulatory requirements and certification formats.

Through this full-chain supervision model, B&H has become one of the few Chinese OEM manufacturers capable of delivering “export-ready compliance” supplement manufacturing services.

The Three Core Values of Regulatory Compliance: Trust, Speed, and Cost Efficiency
Based on numerous international OEM projects, B&H has identified three major benefits of embedding compliance into the formulation and production process:

·Trust Advantage: Compliant products gain quicker approval from overseas distributors and regulators.
·Efficiency Advantage: Properly documented and regulated products shorten customs clearance times by 30–50%.
·Cost Advantage: Reduces the repeated expenses caused by rejected batches, supplementary documentation, or retesting.

Industry observers point out that B&H’s approach reflects a broader transformation among Chinese OEM enterprises—from “manufacturing-oriented” operations to “regulation-driven manufacturing.”

The Future: Compliance as a Core Element of Brand Power
B&H believes the future of supplement formulation design will move into the era of “Regulation as R&D”, where every dosage and every claim is supported by a clear regulatory rationale.

By maintaining continuous international collaboration and an active regulatory update mechanism, B&H helps its global partners achieve:

·Faster market registration and approval
·Safer product distribution pathways
·Stronger global brand credibility

In an era of intensifying global competition in the supplement industry, only those enterprises that combine regulatory compliance with innovative R&D will truly succeed in going global.

Guided by the philosophy of “Regulation First, Compliance in Manufacturing,” B&H is leading Chinese supplement OEM manufacturers toward higher international standards.

Looking ahead, B&H will continue to deepen its presence in supplement formulation, OEM production, and regulatory services, contributing the power of “Intelligent Manufacturing from China” to the global nutrition and health industry.