Compliance Case Addressing Incorrect HS Code Classification and COA Testing Compliance Issues for β-Nicotinamide Mononucleotide

As a new-type foreign trade service provider driven by both technology transformation and foreign trade business, HiSiaddi has established a "1+2+3+4=1" service system and can supply raw materials of β-nicotinamide mononucleotide from multiple well-known original manufacturers. With over a decade of market experience and deep collaboration with factories on technology transformation, HiSiaddi possesses extensive expertise in product compliance issues. Below is a case demonstrating how HiSiaddi resolved full-chain compliance challenges for β-nicotinamide mononucleotide products. Contact HiSiaddi customer service for more consultation on β-nicotinamide mononucleotide product compliance issues.

Full-Chain Compliance Resolution Case Implemented by HiSiaddi Foreign Trade for a High-End Dietary Group on the US West Coast

I. Client Background (Mid-to-High-End North American Brand, Excluding Low-Grade Bulk Commodity Purchasers)

The purchasing party is PrimeLongevity Biotech Group, based in California, USA. It specializes in high-end clinic anti-aging capsules and medical dietary powders sold in premium private clinics and organic retail chains across the US. Its raw materials comply with USP, FDA dietary raw material specifications, cGMP and California food access standards, with β-NAD⁺ deployed for premium oral compound products and medical nutritional formulations. Previously, the group sourced raw materials exclusively from local API manufacturers in Europe and America. To cut raw material costs, it independently contracted two domestic Chinese NAD manufacturers for an initial 320kg high-purity β-NAD⁺ raw material order. After production completion, five critical compliance obstacles emerged sequentially: incorrect customs tariff code classification, incomplete qualification documents, non-compliant documentation under US import regulations, test reports inadmissible by the FDA and non-compliant production filing. Goods were stranded in domestic warehouses unable to clear customs for export, delaying the scheduled new product launch. The client urgently entrusted HiSiaddi to fully manage full-process compliance rectification.

Mandatory compliance access standards required by the client:

1. Accurate classification and customs tariff codes aligned with US customs tariff schedules, with dual-use labeling distinguishing dietary raw materials and biochemical reagents;

2. COA test reports issued per USP pharmacopoeia testing methods, with heavy metal, endotoxin and solvent residue limits complying with US 21CFR control requirements;

3. Factory possession of domestic export food production enterprise filing records, cGMP system documentation, EINECS EU inventory registration and TSCA US chemical inventory filing materials;

4. MSDS documents compiled in accordance with the GHS global harmonized standard to meet US transportation and port inspection specifications.

II. Four Core Compliance Bottlenecks Encountered During Independent Client Procurement

1. Incorrect HS Code Classification Leading to Confused Customs Declaration Attribute Definition

Domestic manufacturers defaulted to customs tariff codes for biochemical reagents, while the client’s actual end-use application was dietary supplement raw materials. The two code categories carry fully distinct supervision requirements, commodity inspection criteria, export tax rebate policies and US import tariff rates. The reagent code declared by manufacturers triggered US customs risk assessment of misclassification, with high risks of cargo detention and return upon arrival, preventing smooth customs clearance.

2. Non-Compliant COA Test Reports Inadmissible by the US FDA

Factories issued COA reports using domestic standard testing methods, with impurity and endotoxin limit thresholds set per domestic standards rather than USP pharmacopoeia benchmarks. The US importer’s FDA pre-audit deemed the reports invalid, preventing completion of local US import filing. Heavy metal limits for lead, arsenic and cadmium, alongside organic solvent residue indicators, failed to meet California dietary raw material access thresholds.

3. Incomplete Export Supporting Qualifications and Missing Overseas Import Filing Documents

The two supplying factories only held domestic business licenses, lacking China Customs export food production enterprise filing certificates, TSCA US chemical inventory filing receipts and compliant GHS-format MSDS. US customs requires proof of product listing on the TSCA inventory for entry; missing documentation results in full cargo rejection at ports.

4. Non-Compliant Product Packaging Labeling Violating US Food Labeling Regulations

Factory outer packaging labels only displayed Chinese product names and specifications, omitting mandatory English information including CAS number (53-84-9), raw material grade, storage conditions, production batch numbers and manufacturer’s English registration details, violating US mandatory dietary raw material labeling laws and exposing the cargo to fines and label rectification upon arrival.

5. Missing Production Process Documentation Preventing US Importer Qualification Audits

The US brand’s risk control department required full enzymatic production process flowcharts, impurity control explanations and annual stability test data for raw materials. Domestic factories lacked standardized compliance technical dossiers and could only provide basic factory dispatch certificates, failing supplier access audit standards for mid-to-high-end brands.

III. Five-Step Compliance Rectification Solution Implemented by HiSiaddi

Step 1: Re-Accurately Verify Customs Commodity Tariff Codes and Standardize Customs Declaration Attributes

Collaborating with customs brokers and chemical classification specialists, HiSiaddi re-verified the correct HS tariff code based on the product’s actual end-use as a dietary raw material, separating customs declaration documentation for dietary supplement raw materials (not scientific reagents). Commercial invoices and packing lists were uniformly revised to reflect the correct commodity attributes, with export tax rebate declaration elements updated to eliminate Sino-US customs classification disputes. Official customs pre-classification opinions were issued for retention and reference.

Step 2: Re-Execute Full USP Testing and Issue FDA-Admissible COA

Coordinate third-party laboratories with CNAS and USP accreditation to conduct full re-testing of 3 batches of samples in accordance with USP pharmacopoeia testing methods, covering purity, single impurities, total impurities, endotoxins, heavy metals, methanol/ethanol organic solvents and microbial indicators aligned with US limit standards. Batch-specific compliant COA reports with test method traceability statements were issued, supplemented by 6-month accelerated stability test reports to pass the client’s FDA pre-audit.

Step 3: Complete Full Domestic and Overseas Access Qualification Documentation

1. Assist raw material manufacturers in completing China Customs export food production enterprise filing and obtain official filing disclosure certificates published by Chinese government authorities;

2. Collate official certified dossiers of product listing evidence including EINECS EU existing chemical inventory screenshots and TSCA US chemical inventory filing materials;

3. Entrust compliance institutions to recompile bilingual Chinese-English MSDS aligned with GHS 5th revision standards to meet US land and ocean shipping port inspection requirements.

Step 4: Rectify Outer Packaging Labels to Comply with US Labeling Laws

Unified standardized English outer packaging labeling implemented, including CAS registry number, full β-NAD chemical name, USP grade classification, storage temperature and humidity, production batch number, expiry date, manufacturer’s English name and address, and allergen warnings. All labels were reviewed and approved by the client’s US legal department prior to printing.

Step 5: Establish Standardized Supplier Compliance Dossiers

Assist factories in organizing full enzymatic production flowcharts, raw material traceability records, quality control SOPs and annual quality inspection ledgers into standardized exclusive supplier technical archives to meet long-term supplier filing and storage requirements of PrimeLongevity Group, USA.

IV. Compliance Implementation and Smooth Shipment

Following completion of full compliance document rectification, the 320kg β-NAD⁺ raw materials successfully completed domestic customs declaration and commodity inspection, shipped via constant-temperature ocean freight to Los Angeles Port, USA. Full compliant documentation enabled expedited zero-inspection customs clearance by US customs. Raw materials were warehoused and successfully deployed for high-end capsule production lines, allowing the client’s new product launch (delayed by 45 days) to proceed as scheduled across premium US markets.

V. In-Depth Long-Term Cooperation and Industry Summary

1. Extended Long-Term Cooperation

PrimeLongevity Group finalized an annual framework procurement contract of 750kg. All subsequent high-value coenzyme raw material procurement including NADH, NADP and ergothioneine was entrusted to HiSiaddi for China sourcing and full-chain compliance management. Leveraging this compliance case, HiSiaddi supported the client’s expansion of raw material procurement business for regional sub-brands in Canada and Australia. After completing full sets of export compliance documentation, the cooperating domestic factories secured follow-up supply contracts with 2 additional mid-to-high-end wellness brands in Europe and America.

2. Industry Pain Point Summary

Most domestic NAD raw material manufacturers prioritize production and supply with limited awareness of overseas dietary raw material compliance systems, issuing documentation solely aligned with domestic standards without familiarity with USP, FDA, TSCA, GHS and other overseas access regulations. Mid-to-high-end overseas dietary brands operate under stringent compliance risk control protocols, and independent factory sourcing frequently leads to multi-layer compliance traps covering tariff classification, qualification certification, testing, and labeling. Drawing on cross-border raw material compliance expertise, HiSiaddi delivers one-stop full-service compliance solutions covering tariff code verification, qualification agency services, compliance testing, label rectification and dossier archiving, breaking down compliance barriers for high-end domestic raw material exports to North America. Contact HiSiaddi customer service for more consultation on β-nicotinamide mononucleotide product compliance issues.