As a new type of foreign trade service provider driven by both technological transformation and foreign trade services, HiSiaddi has built a "1+2+3+4=1" service system and can supply original goods of glutathione from multiple well-known brands. With over ten years of market experience and technological transformation cooperation with manufacturers, HiSiaddi boasts rich experience in handling product compliance issues. The following is a case of HiSiaddi addressing glutathione compliance issues.
For more inquiries on glutathione product compliance, please contact HiSiaddi customer service.
Purchaser: WellLife Premium Biopharmaceutical Co., Ltd., California, USA. A leading mid-to-high-end brand for functional dietary and medical aesthetic raw materials in North America, its products comply with U.S. FDA DSHEA dietary raw material regulations and cGMP production specifications. It purchases 38 tons of glutathione annually, divided into two major applications: pharmaceutical-grade reduced glutathione (raw materials for soft capsules) and ultra-high-purity refined grade (matching stock solutions for medical aesthetic injections). It previously purchased raw materials from local European and American suppliers. In 2025, it finalized supply from a top domestic glutathione manufacturer in China and paid a deposit for 25 tons of stocked goods, yet four major compliance bottlenecks emerged before shipment, preventing customs clearance and shipment with predicted cargo detention at U.S. ports. Manufacturers could only provide domestic national standard quality inspection certificates, lacking familiarity with U.S. import access rules and unable to rectify compliance documents. The client faced risks of deposit loss, production line shutdown and liquidated damages due to delayed new product launches, so it fully entrusted foreign trade firm HiSiaddi to conduct one-stop rectification of full-chain compliance.
1. Errors in raw material classification and HS code declaration leading to customs classification disputes Domestic manufacturers default to declaring under 2922 tariff item as ordinary food additives, yet the U.S. Customs HTS code system classifies pharmaceutical-grade glutathione as organosulfur compounds under 2930904550. Incorrect classification will trigger higher U.S. import tariffs and port inspection detention. Domestic manufacturers lack experience in declaring pharmaceutical raw materials exported to the U.S. and cannot reorganize declaration documents.
2. Missing FDA dietary raw material filing and factory facility registration U.S. regulations require overseas production factories of imported dietary raw materials to complete FDA food facility registration numbers, supported by English raw material filing dossiers. Suppliers only hold domestic SC and pharmaceutical production licenses without FDA overseas factory registration files, lacking raw material safety supporting documents complying with DSHEA specifications. U.S. importers cannot complete import filing, with a 100% risk of cargo detention upon arrival.
3. COA and MSDS documents fail to meet U.S. pharmaceutical audit standards The manufacturer’s original quality inspection reports adopt Chinese national standard formats, only marking purity and moisture without breakdown data for four heavy metals (lead, arsenic, cadmium, mercury), residual solvents, oxidized GSSG impurities, full microbial items and process impurity traceability. The MSDS follows an outdated domestic national standard version, inconsistent with the Globally Harmonized System of Classification and Labelling of Chemicals under HS codes, which will not be accepted by U.S. FDA audits and cannot be used for customs clearance or NDI filing of the client’s terminal products.
4. Non-compliant product labels and outer packaging with hidden risks of illegal claims Original factory barrels only feature Chinese information, lacking English product name, CAS number (70-18-8), purity, storage conditions, manufacturer information and allergen warnings. Attached raw material instructions contain medical descriptions such as "liver protection therapy, freckle fading and medicinal efficacy". U.S. regulations strictly prohibit labeling therapeutic effects on dietary raw materials, and non-compliant labels may lead to full container return or destruction.
1. HiSiaddi coordinated domestic customs brokers and U.S. customs classification consultants. Based on glutathione’s CAS number, chemical structural formula and actual application (dietary and pharmaceutical raw materials), the domestic export customs code was revised to 2930909099 for organosulfur compounds. Meanwhile, a classification explanation letter corresponding to U.S. Customs official ruling HTS code 2930.90.4550 was issued, attached with supporting documents of molecular structure and product application for domestic customs declaration and pre-declaration of U.S. imports to avoid customs classification audits and additional tariffs.
2. Organize complete declaration elements including component proportion, CAS number, brand model, production process and terminal application, unify Chinese and English declaration documents and complete revised export commodity inspection documents.
1. HiSiaddi assisted manufacturers in sorting out workshop layout drawings, cGMP production quality control documents, full-process process specifications and upstream-downstream raw material traceability documents, and submitted applications to the FDA system on behalf of manufacturers to complete overseas production facility registration and obtain exclusive FDA factory registration numbers, supplementing core qualifications mandatory for U.S. imports.
2. Compile glutathione raw material safety dossiers in accordance with DSHEA dietary supplement raw material specifications, including toxicology summaries, historical safe consumption data and process overviews, complete raw material compliance filing to support the client’s domestic product filing in the U.S. and avoid risks of NDI new dietary raw material declaration.
1. Coordinate manufacturer quality inspection laboratories to complete full-item testing in accordance with U.S. USP standards: break down GSSG oxidized impurities, four heavy metals, microorganisms (Salmonella, E. coli, mold) and residual organic solvents. HiSiaddi uniformly compiled bilingual English COA quality inspection forms, with each indicator benchmarked against U.S. access limits and sealed with Chinese and English factory quality inspection stamps.
2. Entrust compliance laboratories to recompile new version MSDS in accordance with the 6th revised edition of GHS under HS codes, improve hazard classification, storage and transportation specifications, first-aid instructions and import/export compliance clauses, replacing the original domestic version to meet dual inspection requirements of China and U.S. customs and pharmaceutical authorities.
1. Customize unified Chinese-English double-layer aluminum foil vacuum packaging and foreign trade-specific fiber drums, with barrel printing of compliant content: English product name Reduced Glutathione, CAS 70-18-8, purity specifications, manufacturer, batch number, shelf life, storage conditions and allergen reminders.
2. Fully delete all descriptions of medical therapeutic efficacy; raw material instructions only retain compliant labels: antioxidant dietary raw material for dietary supplement formulas, eliminating prohibited claims such as "liver disease treatment, medicinal freckle removal" to comply with FDA label regulatory red lines.
HiSiaddi submitted full compliance documents to U.S. import customs brokers in advance, completing pre-inspection filing with U.S. ports before cargo departure to eliminate customs early warnings and avoid on-site unpacking inspection and detention upon arrival.
1. For the U.S. client: 25 tons of glutathione were shipped from Shanghai Port to Los Angeles in two batches, with zero inspection, zero detention and zero tariff disputes upon arrival. Soft capsules of liposomal glutathione and hospital-line repair essences produced from raw materials successfully completed domestic product filing in the U.S. and entered over 230 high-end health pharmacies and private medical aesthetic chains nationwide in the U.S. Compared with previously sourced European and American raw materials, the comprehensive raw material procurement cost decreased by 27%. The client subsequently added a 42-ton annual long-term order and simultaneously submitted customized procurement demand for acetylated glutathione.
2. For domestic manufacturers: Relying on this full set of FDA compliance dossiers, the factory improved access qualifications for the U.S. market, followed by successive raw material orders for high-end dietary supplements from Mexico and Australia, boosting the factory’s export capacity for high-end glutathione by 30%.
3. For HiSiaddi Foreign Trade: A standardized compliance service system for glutathione covering "customs classification + FDA registration + compliance document revision + label compliance + overseas pre-clearance" was established, enabling subsequent extension of import and export compliance supporting businesses for mid-to-high-end active raw materials such as alpha arbutin, carnosine and lipoic acid.
Most domestic glutathione manufacturers focus on the domestic market and are proficient in national standard production, yet lack awareness of food and drug regulations in European and American countries. When exporting to mid-to-high-end overseas clients, compliance red lines are easily crossed in four dimensions: classification, pharmaceutical registration, documents and labels. Restricted by strict regulations such as FDA and NHP of their home countries, any non-compliant document may lead to huge losses of full container return for overseas mid-to-high-end pharmaceutical enterprises. Leveraging global compliance resources and breaking free from single-manufacturer production thinking, HiSiaddi rectified compliance loopholes across the full chain from export customs declaration to destination country access, helping clients avoid cargo loss and breach risks, and opening a stable compliance channel for domestic high-end glutathione to enter mid-to-high-end supply chains in North America.
For more inquiries on glutathione product compliance, please contact HiSiaddi customer service.
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