In April 2026, the Drug Administration of Vietnam (DAV) issued four official documents-No. 1461/QLD-MP, No. 1331/QLD-MP, No. 1330/QLD-MP, and No. 1315/QLD-MP-ordering the suspension of distribution, recall, and destruction of a total of 46 batches of non-compliant cosmetics. The recalls were driven by reasons including failure to pass microbiological testing, discrepancies between marketed formulations and registered records, non-compliant label claims, and failure to provide Product Information Files (PIF) within the legally prescribed timeframe.
Categories of Non-Compliance
The 46 recalled batches fall into three categories:
- 1 batch: Microbiological testing failure
The product failed to meet microbiological limits required under applicable regulations, posing potential safety risks.
- 1 batch: Formulation-record discrepancies and non-compliant label claims
The product's marketed formulation did not match its registered records, and the label contained claims inappropriate for cosmetic classification. Specific issues included:
(1) Formulation consistency: The company erroneously used alcohol containing phenoxyethanol to clean bottles prior to packaging. Production records from the supplier confirmed discrepancies in ingredient proportions among the original formula, the batch production formula, and the formula declared on the product label.
(2) Label claims: The product label included inappropriate claims such as "helps warm," "keeps warm," and "prevents colds." Usage instructions described applying the product for skin massage or mixing with bathwater to warm the skin, and applying to skin to soothe swelling from mosquito or insect bites. The product was labeled for use on "infants" and even stated that "when used together with Decicoff lung-clearing syrup during coughs, efficacy is enhanced." Such claims fall outside the definition of cosmetics and contravene Vietnam’s cosmetic labeling regulations.
- 44 batches (37+7): Failure to provide PIF within the legally prescribed timeframe
These products were recalled and ordered for destruction because cosmetic operators failed to present their Product Information Files (PIF) to regulatory authorities within the timeframe required by law upon inspection requests.
Analysis and Recommendations
This recall action by Vietnam’s DAV reflects several notable trends:
(1) PIF compliance is a priority in Vietnam’s cosmetic regulatory enforcement. With 44 out of 46 batches (over 95%) recalled for failure to provide PIFs, it is evident that Vietnamese authorities are intensifying their inspection of PIF availability and completeness. Companies exporting cosmetics to Vietnam should ensure that PIFs are complete and readily accessible, and respond promptly upon receiving inspection notices.
(2) Label claims require careful compliance review. Labels must not contain claims that exceed the definition of cosmetics.
(3) Formulation consistency is a regulatory baseline. The actual formulation of products in circulation must match the registered records. Deviations during manufacturing - including residues from cleaning solvents and discrepancies in ingredient proportions- may be deemed non-compliant.
Vietnam Cosmetic Compliance Requirements
Compliance Requirements
Cosmetics are regulated under Circular No. 06/2011/TT-BYT and Circular No. 29/2020/TT-BYT issued by the Ministry of Health of Vietnam. Before being placed on the market, cosmetics must obtain a cosmetic notification certificate with a product notification number issued by the Drug Administration of Vietnam (DAV) under the Ministry of Health.
Product Information File (PIF/DIP) Requirements
Upon completion of cosmetic registration in Vietnam, the Ministry of Health will issue a cosmetic notification receipt for each product. If a cosmetic product is intended for distribution in Vietnam, a Product Information File (PIF) must be prepared for each product. The PIF must be submitted for presentation when requested by the competent authority during inspections, particularly Part 1, while the remaining parts may be presented within 2 months.
The PIF consists of the following four main parts:
- Administrative documents and product information summary
- Quality and safety data for cosmetic ingredients
- Product quality and safety data
- Product safety and efficacy data
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