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Export to the USA: FDA-Registered OEM Manufacturing from Malaysia

Q: Is ORIZI Group FDA approved?

No manufacturer is 'FDA approved' for ordinary cosmetics — the FDA does not approve cosmetic products or certify factories. The accurate statement is that Dr Orizi (M) Sdn. Bhd. is an FDA-registered cosmetic facility under MoCRA, and the group's food company holds an FDA food facility registration.

Q: How do US buyers verify ORIZI's credentials?

Each credential is listed with its holding entity on the ORIZI certifications page, with links to official registers where they exist. Sedex-linked customers can view the SMETA audit on the Sedex platform, and audit documents are shared with serious buyers under NDA.

Private label & OEM manufacturer for US brands: MoCRA-ready cosmetics from an FDA-registered facility, FDA-registered food manufacturing, D-U-N-S identification and the ethical-audit evidence US retail procurement asks for.

Direct answer

Yes — a US brand can manufacture cosmetics, personal care and functional food in Malaysia and sell them in the United States. ORIZI Group’s cosmetics company, Dr Orizi (M) Sdn. Bhd., is a US FDA-registered cosmetic facility under MoCRA (the Modernization of Cosmetics Regulation Act of 2022), and the group’s food company holds its own FDA food facility registration, so products from both lines can enter the US compliantly. The brand (as the Responsible Person) handles product listing and labelling; ORIZI prepares the facility information, ingredient documentation and safety substantiation the US side needs.

Who this page is for

A US beauty or wellness brand looking for a “China plus one” manufacturing alternative in Southeast Asia
An Amazon, TikTok Shop or DTC seller that needs an FDA-registered facility behind its listings
A retail or distribution buyer whose procurement team requires ethical-audit and supply-chain documentation

Can a US brand legally sell cosmetics made in Malaysia?

Yes. The United States does not require cosmetics to be made domestically — it requires them to comply with the FD&C Act as amended by MoCRA. Under MoCRA, the facility that manufactures your cosmetic product must be registered with the US FDA, each product must be listed with the FDA by its Responsible Person (normally the brand owner named on the label), and safety substantiation and adverse-event processes must be in place. Registration is renewed every two years.

Dr Orizi (M) Sdn. Bhd., ORIZI Group’s cosmetics manufacturer, is a US FDA-registered cosmetic facility. Two accuracy points that experienced US buyers will appreciate: FDA registration is not an FDA approval or certification — the FDA does not approve ordinary cosmetics and, as it clarified in 2026, does not issue certificates confirming registration — and the product listing is filed by the brand, not the factory. What the factory owes you is a current registration and a complete data pack: ingredient disclosures with INCI names, specifications, stability and safety documentation, and batch records. That is exactly what ORIZI prepares. See the FDA’s official page on cosmetic facility registration and product listing.

What about food and beverage products for the US?

Functional food and beverage follows a different US pathway: the manufacturing facility must hold an FDA food facility registration under the Bioterrorism Act and FSMA (the Food Safety Modernization Act), and the US importer must operate a Foreign Supplier Verification Program (FSVP) covering the foreign manufacturer. ORIZI Group’s food-manufacturing company, D & O Nutraceutical Manufacturing, holds its own US FDA food facility registration and its own D-U-N-S Number, and manufactures under ISO 22000, HACCP and GMP food-safety certifications — the documentation base an FSVP importer needs.

ORIZI’s US-bound food products are manufactured and documented as foods (beverages, functional powders and related formats). Products intended to be marketed as US dietary supplements raise additional labelling and cGMP considerations that should be scoped at the project stage.

Why are US brands moving production to Malaysia?

US buyers describe the same pattern to us from different angles: they want to diversify supply chains beyond a single country, and they want the move to cost them nothing in compliance readiness. Malaysia fits that brief in concrete ways:

What US procurement weighs	How Malaysia (ORIZI Group) answers it
Supply-chain diversification	A “China plus one” base in Southeast Asia with established sea and air freight lanes to the US West and East Coasts
Regulatory readiness	FDA-registered cosmetic and food facilities; ISO 22716 cosmetics GMP; NPRA-listed GMP manufacturer in Malaysia’s own system
Language and documentation	English is the working language of Malaysian industry — specifications, audits and label reviews happen without a translation layer
Ethical sourcing evidence	SA8000 social-accountability certification, Sedex membership with SMETA audit, and a Disney FAMA-authorised facility (see below)
Business verification	D-U-N-S Numbers held by the group’s manufacturing companies for supplier onboarding and credit checks
Ports and shipping lanes	Direct container services from Port Klang — one of the world’s busiest container ports, on the Strait of Malacca — and Penang Port to US West and East Coast gateways
Payment flexibility	Export invoicing and settlement in US dollars or other agreed major currencies

Retail-chain & procurement readiness: the audit evidence US buyers ask for

Selling into US retail chains, licensed-merchandise programmes or large marketplaces is decided as much by procurement and compliance teams as by category buyers. These are the credentials ORIZI Group can put on the table, each named with its holding entity and verifiable on our certifications page:

SA8000 social accountability — Dr Orizi (M) Sdn. Bhd. is certified to SA8000:2014, the international social-accountability standard covering labour practices, health and safety and management systems.
Sedex membership & SMETA audit — Dr Orizi is a Sedex member with a SMETA (Sedex Members Ethical Trade Audit) on the platform, where linked retail customers can review it directly. Sedex is a membership platform and SMETA is an audit methodology — neither is a certification, and we present them accurately.
Disney FAMA-authorised facility — Dr Orizi has passed The Walt Disney Company’s International Labor Standards audit and is authorised to manufacture products bearing licensed character IP under a licensee’s agreement — evidence of the audit depth the facility already sustains. See licensed & character-brand manufacturing.
Packaging sustainability — printed packaging can be sourced through an FSC Chain-of-Custody-certified packaging partner, supporting US retailers’ packaging-sourcing policies. (The FSC certificate belongs to the packaging partner; we state that honestly.)
Halal + quality stack — JAKIM Halal certification and ISO-based quality systems (ISO 22716 for cosmetics; ISO 22000/HACCP for food) round out the compliance file for buyers serving diverse US consumers.

What this means for your brand

For a US brand, the practical sequence is: confirm your product category and claims (cosmetic vs OTC drug vs food — claims decide the pathway), develop or select the formula against US ingredient and labelling rules, manufacture in an FDA-registered facility, then file your MoCRA product listing as the Responsible Person with the data pack we hand over. Brands switching from a China-only supply chain can usually run this as a parallel qualification — sampling and compliance review from Malaysia while current production continues — so the transition carries no gap on shelf. For the documentation list itself, start with our guides to cosmetic export documents and food & beverage export documents, and the complete cosmetic export guide.

Questions about exporting to the USA

Is ORIZI Group FDA approved?

No manufacturer is “FDA approved” for ordinary cosmetics — the FDA does not approve cosmetic products or certify factories. The accurate statement is that Dr Orizi (M) Sdn. Bhd. is an FDA-registered cosmetic facility under MoCRA, and the group’s food company holds an FDA food facility registration. Buyers who see “FDA approved” on a cosmetics factory’s website should treat it as a red flag.

Who is the Responsible Person under MoCRA — the factory or my brand?

Your brand. MoCRA’s Responsible Person is the manufacturer, packer or distributor whose name appears on the product label — for a private label product, that is normally the brand owner. The Responsible Person files the product listing and handles adverse-event reporting; ORIZI supplies the facility registration details, formulas and safety documentation that the filing needs.

Does my US importer need anything for food products?

Yes — under FSMA, the US importer must run a Foreign Supplier Verification Program (FSVP): it verifies that the foreign manufacturer meets US food-safety standards. ORIZI’s food company supports this with its FDA facility registration, ISO 22000/HACCP certifications, specifications and batch documentation.

Can ORIZI support small first runs for a US launch?

For cosmetics, the ready-formula private label programme starts from 50 units per product — practical for validating a DTC or Amazon launch before scaling. Custom OEM development is quoted per project.

How do US buyers verify ORIZI’s credentials?

Each credential is listed with its holding entity on our certifications page, with links to official registers where they exist (for example Malaysia’s NPRA GMP manufacturer list and the official Halal directory). Sedex-linked customers can view the SMETA audit on the Sedex platform, and audit documents are shared with serious buyers under NDA.

Qualifying a Malaysian manufacturer for the US market?

Tell us your category, claims and channel — DTC, Amazon, retail chain or licensed merchandise — and we will map the MoCRA or FSMA pathway and share the compliance file your team needs.

Discuss your US project