China Fines 2 Notifiers for Failing to Upload Cosmetic Efficacy Evaluation Summary

Two general cosmetic enterprises were warned and fined 10,000 yuan respectively for failing to upload the cosmetic efficacy evaluation summary. The supervision and inspection of enterprises\’ implementation status of the new regulation have begun.

Background

In Cosmetic Supervision and Administration Regulation (CSAR), National Medical Products Administration (NMPA) specifies that cosmetic\’s efficacy claims shall be supported by sufficient scientific basis, and requires enterprises to publicize the summary of cosmetic efficacy evaluation. Later on Apr. 9, 2021, NMPA issued the finalized Standards for Cosmetic Efficacy Claim Evaluation, rolling out a detailed plan to standardize and guide the evaluation of cosmetic efficacy claims.

On Jul. 6, 2022, China Tianjin Medical Products Administration (MPA) released two administrative penalties. ^1,2 Two general cosmetic enterprises were warned and fined 10,000 yuan respectively for failing to upload the cosmetic efficacy evaluation summary to the general cosmetic notification information management system. It is worth noting that one of the enterprises has actually done the efficacy evaluation, and can provide the evaluation summary during the on-site inspection, but it was still punished. It can be seen that as long as the evaluation summary is not uploaded in time, the enterprise will face penalties.

This is the first batch of penalty cases for failing to upload an evaluation summary after NMPA required enterprises to evaluate the cosmetic efficacy, which is quite a warning to the industry.

Enterprise	Product	Notification Date	Illegal Activity	Punishment Basis	Punishment
Enterprise A	Essence that claims moisturizing efficacy	Jul. 16, 2021	The efficacy evaluation has been carried out, but the evaluation summary has not been uploaded to the general cosmetic notification information management system before May 1, 2022.	Article 22 of CSAR Efficacy claims of cosmetics shall be supported by sufficient scientific basis. Cosmetics registrants and notifiers shall publicize the summary of the literature document, research data, and/or product efficacy evaluation document which serves as the basis of the efficacy claims on the special website prescribed by the NMPA, and accept public supervision. Article 62 of CSAR If any of the following circumstances occurs, the medical products administration departments shall order enterprises to make corrections and give a warning as well as a fine of more than 10,000 yuan and less than 30,000 yuan. In serious circumstances, the enterprises shall be ordered to suspend the production and/or operation. A fine of more than 30,000 yuan and less than 50,000 yuan shall be imposed. The legal representative or the main responsible person, the person who is directly in charge and other directly responsible persons of the illegal unit shall be fined more than 10,000 yuan and less than 30,000 yuan: (I) Failure to publish the summary of the basis for cosmetic efficacy claims as prescribed; (Omit circumstances II, III, IV, V)	The two enterprises were warned and fined 10,000 yuan.
Enterprise A	Lyophilized tablets that claims moisturizing efficacy	Apr. 22, 2022	The efficacy evaluation has been carried out, but the efficacy evaluation summary has not been uploaded at the time of product notification.
Enterprise B	Essence that claims moisturizing efficacy	Jan. 5, 2022	The efficacy evaluation has not been carried out, and the efficacy evaluation summary has not been uploaded at the time of product notification.
Notes: Due to the regional recurrence of COVID-19 in China in early 2022, Shanghai, Guangdong, Beijing, Jiangsu, Chongqing and Zhejiang MPA issued announcements stating that for cosmetics registered or notified from May 1, 2021 to Dec. 31, 2021, the uploading of efficacy evaluation summary, and supplementary of notification documents can be extended to Dec. 31, 2022. However, Tianjin has not postponed it, and the deadline is still May 1, 2022; Up to now, the efficacy evaluation summaries of these three products have been supplemented. The evaluation methods adopted are literature document investigation and laboratory test.

Under the new cosmetic regulations, as long as enterprises complete the submission of notification documents, their general cosmetic products are considered as “notified” and then can be manufactured and/or imported. However, product “notified” does not equal to product “compliance.\” NMPA and local MPA mainly adopt post-notification supervision as well as post-market supervision and inspection to supervise the notified products. Enterprises may face severe penalties if the notification documents or notified products do not comply with the new regulations.

The two administrative penalties may signal that regulators have begun to inspect the implementation status of the new regulations in the enterprises. ³ It is recommended to pay close attention to the effective time of the new regulations and the expiration time of transitional periods, and prepare notification documents in strict accordance with the new regulations.