China Approves First Imported Health Foods Since 2017

Between August and November 2025, the State Administration for Market Regulation (SAMR) issued registration certificates to six imported health foods. These are the first overseas products approved under the 国食健字 J (“Guoshi Jianzi J”) registration number since regulatory tightening began in 2017.

The approvals mark a notable shift in China’s health food regulatory environment. For international health food manufacturers, importers, and brand owners, they provide clear evidence that the registration pathway for imported health foods has reopened after several years of inactivity.

First Imported Health Food Approvals Since 2017

After several years without approvals, SAMR’s issuance of six ”Guoshi Jianzi J” registration certificates (“J” indicating imported products, as opposed to “G” for domestic certificates) signals a cautious but meaningful regulatory advance.

The six approved products originate from a limited group of jurisdictions and focus on functions already familiar to Chinese regulators, including:

Hong Kong, China: 4 products
Indonesia: 1 product
Singapore: 1 product

Their approved health functions are concentrated in three areas:

Enhancing immunity
Maintaining healthy blood lipid levels
Providing auxiliary protection against chemical liver injury

Taken together, this profile reflects a conservative reopening strategy. By prioritizing familiar jurisdictions and clearly defined health functions, SAMR appears to be limiting technical and scientific uncertainty as it resumes approvals for imported health food products.

Why Imported Health Food Approvals Stalled for Seven Years

The significance of these approvals becomes clearer when viewed against the regulatory developments that led to the prolonged suspension of imported health food registrations.

China's Dual Track System for Health Foods

In 2016, China implemented the “Administrative Measures for Registration and Filing of Health Foods,” formally establishing a dual-track system of registration and filing. Under this framework, imported health foods are, in principle, required to undergo registration rather than filing. This registration process places imported health foods under a higher level of technical review.

From 2017 through 2024, however, several regulatory and market factors effectively prevented approvals, including:

Revisions to functional evaluation and testing methods
Gradually increasing technical review thresholds

As these requirements accumulated, no imported health foods successfully completed the registration process. This resulted in a sustained, seven-year pause in approvals.

SAMR's Five-Year Health Food Sector Review

The registrations issued in 2025 indicate a change in direction. They align with SAMR’s broader five-year review of health food sector rectification and governance. During this review, the authority publicly identified three regulatory priorities:

Expanding the catalog of ingredients eligible for filing
Improving functional evaluation procedures
Optimizing technical review quality

What the Six Approvals Mean for Overseas Companies

With the regulatory channel once again producing approvals, the focus for overseas stakeholders shifts from feasibility to execution and market entry planning.

Registration Enables General Trade Sales

Registered imported health foods may be sold through general trade channels, including pharmacies, supermarkets, and other offline retailers. Compared with cross-border e-commerce models, China health food registration offers several structural advantages:

Pricing and lifecycle stability: Registered products benefit from more predictable pricing, longer commercial lifecycles, and reduced volatility.
Claims and compliance certainty: Regulator-approved claims and clearer labeling requirements reduce the risk of sudden delisting or enforcement action.
Channel execution efficiency: Products are easier for retailers and platforms to list, promote, and manage.

Health Functions Moving First

All six approved products fall within three health functions: immunity enhancement, blood lipid management, and auxiliary protection against chemical liver injury. This concentration suggests that SAMR is prioritizing functions with established evaluation standards and clear regulatory precedent.

For overseas applicants, alignment with these functions may reduce technical uncertainty and improve the likelihood of progress under current review conditions.

Approval Is Only the First Step

While the resumption of approvals represents a genuine opportunity, health food registration in China does not eliminate ongoing regulatory obligations. After approval, overseas brands must continue to manage:

Compliance with Chinese labeling and claim requirements
Review of advertising and promotional materials
Distributor qualification and ongoing compliance oversight
Adverse event monitoring and regulatory reporting

While these regulatory developments offer real market access potential for international stakeholders, only companies prepared to invest in end-to-end regulatory discipline are positioned to realize it.

For companies evaluating whether to pursue registration or filing, or those requiring a China-based authorized agent and a complete submission package, Cisema provides practical regulatory support. With more than 20 years of on-the-ground experience in China, Cisema is well positioned to support overseas health food companies throughout the regulatory lifecycle — contact us today.