Regulatory Compliance Becomes the Core Competitiveness in Supplement Formulation: How B&H Leads the Way

As global consumers place increasing emphasis on nutrition and health, competition in the supplement market is no longer limited to who has the best formulation or who sources the newest ingredients — it has evolved into who is more compliant.
In the field of supplement formulation and international OEM production, regulations and compliance have become the critical thresholds determining whether a brand can successfully enter overseas markets.

According to the latest report from NutraIngredients, over 80% of functional food brands worldwide have experienced product launch delays during export due to labeling, formulation, or health claim non-compliance with target-country regulations.
Against this backdrop, B&H, one of China’s leading OEM supplement manufacturers, has deeply studied global regulatory systems. By establishing a comprehensive regulatory database and an integrated compliance audit mechanism, B&H provides clients with a “compliance-by-design” approach — helping brands avoid risks as early as the product design stage.

Why Regulatory Compliance Is the “First Step” in Supplement Formulation Development
In traditional OEM production, many manufacturers focus mainly on production processes and cost control while neglecting regulatory design at the early stage. However, in today’s global supply chain environment, regulatory compliance issues have become the biggest risk factor in brand globalization.

B&H believes that compliance in supplement formulation involves multiple critical dimensions:
·Ingredient Legality Review: Each country sets different requirements for allowable nutrients, botanical extracts, and functional ingredients. For example, under the U.S. FDA’s Dietary Supplement Health and Education Act (DSHEA), the declaration of “New Dietary Ingredients (NDIs)” is highly stringent.

• ·Dosage and Limit Values: The EU and Japan impose strict limits on the Recommended Daily Intake (RDI) of vitamins and minerals; exceeding these thresholds may result in the product being regulated as a drug.
• ·Labeling and Health Claims: Regulatory agencies such as Australia’s TGA and the U.S. FDA prohibit unverified or clinically unproven functional claims.
• ·GMP Production and Traceability: OEM manufacturers must provide fully traceable production records and Certificates of Analysis (COA).

Drawing on years of OEM experience, B&H has developed a “Compliance-First, R&D-Synchronized” model. Its formulation development teams collaborate with regulatory specialists from the outset of each project to ensure that ingredients, dosages, labels, and packaging all meet target-market requirements.

B&H’s Dual-Engine Model: “Regulatory Compliance + R&D”
B&H has built a comprehensive regulatory database covering key markets across Europe, North America, Australia, and Southeast Asia. Working with third-party testing laboratories and international legal consultants, the company has formed a complete formulation compliance framework.

Its core advantages include:

• ·Global Regulatory Alignment: Expertise with major authorities such as the FDA, EFSA, TGA, and HSA.
• ·Multinational Registration Experience: End-to-end support for export filing, registration applications, and label verification.
• ·Built-in Compliance in R&D: Compliance checkpoints are integrated into every stage — from ingredient selection and formulation design to packaging and claims copy.
• ·Integrated OEM Collaboration: Seamless coordination across R&D, regulatory review, manufacturing, testing, and export logistics.

Thanks to this integrated system, B&H has maintained a record of zero product rejections and zero compliance violations among its European and American OEM clients — offering a replicable model for Chinese supplement brands seeking global expansion.

Industry Outlook: Compliance Is No Longer a Constraint, but a Competitive Advantage
Industry observers note that the future supplement market will not be defined by “who offers the lowest price,” but by “who meets the highest standards.” Regulatory compliance is becoming both an industry threshold and a core driver of brand credibility.

According to B&H, “Compliance is not a burden — it’s the moat that protects global brands.”
As global regulations continue to evolve, B&H leverages its strong capabilities in supplement formulation and OEM production to help more Chinese companies enter mainstream international markets with full compliance and confidence.